UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE TO
TENDER OFFER
STATEMENT UNDER SECTION 14(d)(1) OR 13(e)(1)
OF THE SECURITIES EXCHANGE ACT OF 1934
VECTIVBIO HOLDING AG
(Name of Subject Company (Issuer))
Ironwood
Pharmaceuticals, Inc.
(Name of Filing Person—Offeror)
Ordinary Shares, CHF 0.05 nominal value per
share
(Title of Class of Securities)
H9060V 101
(CUSIP Number of Class of Securities)
100 Summer Street, Suite 2300
Boston, Massachusetts 02110
(617) 621-7722
(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)
Copy to:
Charles K. Ruck, Esq.
Daniel E. Rees, Esq.
Andrew Clark, Esq.
Ian Nussbaum, Esq.
Latham & Watkins LLP
1271 Avenue of the Americas
New York, NY 10020
(212) 906-1200
x Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.
Check the appropriate boxes below to designate any transactions to which the statement relates:
x Third-party offer subject to Rule 14d-1.
¨ Issuer tender offer subject to Rule 13e-4.
¨ Going-private transaction subject to Rule 13e-3.
¨ Amendment to Schedule 13D under Rule 13d-2.
Check the following box if the filing is a final amendment reporting the results of the tender offer: ¨
If applicable, check the appropriate box(es) below to designate the appropriate rule provision(s) relied upon:
¨ Rule 13e-4(i) (Cross-Border Issuer Tender Offer)
¨ Rule 14d-1(d) (Cross-Border Third Party Tender Offer)
This filing relates solely to preliminary communications made before the commencement of a planned tender offer by Ironwood Pharmaceuticals, Inc., a Delaware corporation (“Ironwood”), for all of the outstanding registered ordinary shares, nominal value of CHF 0.05 per share (the “Shares”), of VectivBio Holding AG, a corporation limited by shares organized under the laws of Switzerland (“VectivBio”), for $17.00 per Share, net to the shareholders of VectivBio in cash, without interest and subject to any applicable withholding taxes, pursuant to the Transaction Agreement, dated as of May 21, 2023 by and between Ironwood and VectivBio (“Transaction Agreement”).
Important Information About the Tender Offer
The description contained herein is for informational purposes only and is not a recommendation, an offer to buy or the solicitation of an offer to sell any of VectivBio’s shares. The tender offer described in this document has not yet 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 Securities and Exchange Commission (the “SEC”), and VectivBio will file a solicitation/recommendation statement on Schedule 14D-9 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, when they become available, 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 shareholders 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.
Forward-Looking Statement of Ironwood
Certain statements in this document may constitute “forward-looking statements,” including those regarding the expected nature, timing and benefits of the transaction. 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 Ironwood’s or VectivBio’s 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 Transaction 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 Ironwood and VectivBio to consummate the transaction; (4) risks that the proposed transaction disrupts the current plans and operations of Ironwood or VectivBio; (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). Ironwood and VectivBio can give no assurance that the conditions to the transaction will be satisfied. Neither Ironwood nor VectivBio 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.
Exhibit Index
Exhibit 99.1
FOR IMMEDIATE RELEASE
Ironwood Enters into Definitive Agreement to Acquire VectivBio, a Clinical-Stage Biotech Company Pioneering Novel Treatments for Severe Rare Gastrointestinal Diseases
- 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 -
BOSTON and BASEL, Switzerland – May 22, 2023 – 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.
1 Rights to apraglutide in Japan have been exclusively licensed to Ashai Kasei Pharma Corporation (AKP)
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.
###
Contacts:
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
Exhibit 99.2
Creating Value for GI Patients and Shareholders Acquisition of VectivBio
Safe Harbor Statement 2 Certain statements in this communication may constitute “forward - looking statements”. Forward - looking statements may be typical ly 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 result s or developments anticipated by such forward looking statements will be realized or, even if substantially realized, that they wi ll 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 i nclude, but are not limited to, the following factors: the risk that the conditions to the closing of the transaction are not satisfied, inc luding 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; litigation relating to the trans act ion; uncertainties as to the timing of the consummation of the transaction and the ability of each of VectivBio and Ironwood to consummate the transaction; risks that the proposed transaction disrupts the current plans and operations of VectivBio or Ironwood; the ability of Ironwood and/or VectivBio to retain and hire key personnel; competitive responses to the proposed transaction; unexpected costs, charges or expenses resultin g from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of t he transaction; the prospects, including clinical development, regulatory approvals, and commercial potential of apraglutide ; 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; risks regarding preclinical and clinical development, manufacturing and formulation development of linaclotide, IW - 3300, CNP - 104, apraglutide and other product candidates; the risk that clinical programs and studies, inducing for the linaclotide pediatric program, CNP - 104, IW - 3300 or apraglutide , may not progress or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment, manufacturing, economic or other reasons; the risk that findings from completed nonclinical and clinical studies may not be replicated in later studies; the efficacy, safety and tol era bility of linaclotide and other product candidates; the risk that the therapeutic opportunities for LINZESS, apraglutide or other product candidates are not as expected; decisions by regulatory and judicial authorities; outcomes in legal proceedings to protect or enforce the patents rela ting to either Ironwood or VectivBio , respective products and product candidates, as applicable, including abbreviated new drug application litigation; the risk that financial and operating results may differ from our projections; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that planned investments do not have the anticipated effect on Iron wood revenues; and 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 here in 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 ). Ironwood and VectivBio can give no assurance that the conditions to the transaction will be satisfied. Neither Ironwood nor VectivBio 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. LINZESS® is a registered trademark of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this presentation ar e t he property of their respective owners. All rights reserved.
Ironwood Participants • Tom McCourt Chief Executive Officer Mike Shetzline, M.D., Ph.D Chief Medical Officer • Sravan Emany Chief Financial Officer Andrew Davis Chief Business Officer 3
Apraglutide is a Potential Best - in - Class 1 GLP - 2 for SBS - IF • Designed for enhanced potency, selectivity and unique convenience of weekly dosing • High conviction in clinical program based on compelling data generated to date and proven GLP - 2 class Leverages Ironwood’s GI Capabilities and Success • GI expertise in regulatory, medical affairs and commercial execution building on blockbuster success of LINZESS • Gastroenterologist focus supports potential commercial launch with limited incremental investment $1B 2 Apraglutide Peak Net Sales Potential; Enhances Compelling Financial Profile • Provides catalyst with potential to extend Ironwood’s growth horizon through the 2030s • Ironwood expects to continue to deliver sustained profits and generate cash flow Advancing the treatment of GI diseases and redefining the standard of care for GI patients Acquisition of VectivBio advances Ironwood’s GI leadership and creates value for patients and shareholders 4 1 Agraglutide has not been proven effective or safe for its intended use and there is no guarantee that it will receive regulatory approval t o commercialize. 2 Ironwood management estimate, not risk - adjusted.
5 Discovery Preclinical Phase 1 Phase 2 Phase 3 Marketed Anticipated Milestones / Catalysts IBS - C & CIC 1 Pediatric FC & IBS - C PDUFA Date: June 14, 2023 (FC in 6 - 17 year - olds) Adult Short Bowel Syndrome with Intestinal Failure (Intend to Initiate Pediatric SBS - IF Phase 3 After Topline Results in Adults) Top - Line Results: End of 2023 Acute Graft Versus Host Disease (GvHD) Interim Results: 1H 2023 Primary Biliary Cholangitis (PBC) Early Data Assessing T - cell Response: 2H 2023 Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS) Various Metabolic Programs 3 Early - Stage LINZESS Apraglutide 2 CNP - 104 IW - 3300 Pivotal Proof of Concept Proof of Concept sNDA Filed; PDUFA Date for FC : June 14, 2023 Proof of Concept Programs from VectivBio 1 Chronic Idiopathic C onstipation. 2 Rights to apraglutide in Japan have been exclusively licensed to Ashai Kasei Pharma Corporation (AKP). 3 Includes VB - 1197 (Malonic and Propionic Acidemia), VB - 1200 (Urea Cycle Disorders), VB - 1300 (Fatty Acid Oxidation Disorders), VB0 1400 (Amino Acidopathies ). Strengthens GI pipeline with several near - term development milestones to drive shareholder value
Apraglutide : Potential Best - in - Class GLP - 2 for SBS - IF
Short Bowel Syndrome with Intestinal Failure (SBS - IF) is a condition with high unmet need bariatric surgery, etc. 1 A severe condition that may require life - long p arenteral s upport (PS) 1 Bowel Surgery Intestinal resection(s) due to IBD, trauma, mesenteric infarction, Intestinal failure (IF) requires permanent PS PS is the I.V. administration of fluids and nutrients • Increased mortality 2,4 • Significant morbidity 2,3 • Reduced QoL 2,5,6 • Burden to the healthcare system 7 CIC Stoma Significant Number of Adult Patients 8 ~17k U.S. & Europe ~1k Japan Short Bowel Syndrome with Intestinal Failure ( SBS - IF) 7 anatomical subtypes 1 1 Pironi L et al. Clin Nutr . 2016. 2 Parrish CR et al. Gastroenterol Hepatol (N. Y.) 2017. 3 Billiauws L et al. J Visc Surg. 2018. 4 Schalamon J et al. Best Pract Res Clin Gastroenterol. 2003. 5 Howard L. Gastroenterology. 2006. 6 Ballinger R et al. ISPOR 2019. 7 Plamjariyakul U et al. Nurs Econ. 2010. 8 Based on market research commissioned by VectivBio and published literature. 9 Colon - in - continuity. 9
Apraglutide Target Product Profile * Enabled by pharmacologic and developmental strategy Potential to reduce parenteral support for SBS - IF patients and improve quality of life Designed for enhanced potency, selectivity and to be longer - acting vs. other GLP - 2s Designed to evaluate efficacy in both stoma and colon - in - continuity SBS - IF patient populations Weekly dosing 1,2 to improve patient experience Differentiated Pharmacology Novel Phase 3 Design Differentiated Dosing Apraglutide : poised to establish a new standard of care for Short Bowel Syndrome with Intestinal Failure (SBS - IF) 8 * Management expectations based on clinical trials to date. 1 Eliasson J et al. JPEN J Parenter Enteral Nutr . 2021. 2 Eliasson J et al. DDW® 14 2021.
Leverages Ironwood’s GI Capabilities and Success
Apraglutide has potential to achieve $1B in peak net sales Current GLP - 2 Sales Net Sales Apraglutide Peak Sales Potential Gattex in 2022 ~$750M Expand use outside the U.S. $1B + 2 Apraglutide target product profile can enable market leadership position in SBS - IF (Stoma and CIC 1 ) Potential Apraglutide Growth Drivers ~14k SBS - IF patients remain untreated by GLP - 2s out of ~17k in U.S. and Europe 3 Improve persistency Increase utilization 10 1 Colon - in - continuity. 2 Ironwood management estimate, not risk - adjusted. 3 Komodo Health claims data analysis (US), 2022; IQVIA MIDAS data analysis (EU), 2022.
Apraglutide CNP - 104 Indication / Disease Area Adults with IBS - C and Chronic Idiopathic Constipation SBS - IF (Stoma & Colon - In - Continuity) Primary Biliary Cholangitis (PBC) Addressable market 40M adults (US) 1 ~9K (US) 2 ~130K patients (US) 3 Call point Gastroenterologist and primary care Gastroenterologist Gastroenterologist and Hepatologist Existing prescription market ط ط ط Significant unmet need ط ط ط Development phase Marketed Phase 3 Phase 2 Ironwood has a commercial track record of successfully launching into large, validated markets with high unmet need Apraglutide enhances Ironwood’s GI portfolio 11 ط ط ط ط ط ط 1 Lieberman GI Patient Landscape survey, 2010; U.S. Census data. 2 Based on market research commissioned by VectivBio and published literature. 3 Increasing Prevalence of Primary Biliary Cholangitis and Reduced Mortality With Treatment,” Clinical Gastroenterology and Hepatology 2018;16:1342 - 1350.
Enhances compelling financial profile
$0.4B 1 YE 2022 YE 2028 Late 2030s LINZESS (2029 LOE) Apraglutide CNP-104 $1.5B+ 2 peak sales potential ~$1.0B 2 Apraglutide and CNP - 104 have the potential to extend Ironwood’s growth horizon through the 2030s 13 Pro Forma Ironwood Long Term (Assuming Approval) Ironwood Today 13 1 2022 Ironwood revenue. . 2 Ironwood management estimate, not risk - adjusted.
• Holders of VECT will be entitled to receive $17.00/share • Total transaction aggregate consideration of ~$1B, net of VectivBio cash and debt • 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 • Terms of the definitive transaction agreement and related transactions have been approved by both Ironwood and VectivBio Boards of Directors • Anticipated closing in the second half of 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 • Ironwood expects to provide an update on its 2023 adjusted EBITDA financial guidance upon close of the transaction Acquisition of VectivBio positions Ironwood for long - term growth to drive shareholder value Transaction Overview 14
• If approved, potential apraglutide SBS - IF commercial launch in 2025 • Ironwood expects to generate greater than $175 million in operating cash flows per year on a pro forma basis ahead of potential apraglutide commercial launch • Expect transaction to be accretive to earnings per share beginning in 2026 • Complimentary GI focus of lead clinical asset expected to yield operating leverage through utilizing Ironwood S&M infrastructure, and moderate near - term G&A synergies • Ironwood anticipates roughly 3x total net leverage 1 at close, and to de - lever below 2x ahead of potential apraglutide launch • Apraglutide has the potential to significantly enhance Ironwood’s long - term revenue and profit growth horizon through the 2030s with $1B + 2 potential peak sales in SBS - IF • Diversifies commercial portfolio which compliments CNP - 104 in a GI rare disease indication Near - Term Financial Impact Long - Term Financial Impact Acquisition of VectivBio enhances and extends Ironwood’s compelling financial profile 15 1 Reflects total debt, less Ironwood cash divided by adjusted EBITDA per credit agreement, which includes certain permitted adj us tments and add - backs. 2 Ironwood management estimate, not risk - adjusted.
Apraglutide is a Potential Best - in - Class 1 GLP - 2 for SBS - IF Leverages Ironwood’s GI Capabilities and Success $1B 2 Apraglutide Peak Net Sales Potential; Enhances Compelling Financial Profile Acquisition of VectivBio advances Ironwood’s GI leadership and creates value for patients and shareholders 16 1 Agraglutide has not been proven effective or safe for its intended use and there is no guarantee that it will receive regulatory approval t o commercialize. 2 Ironwood management estimate, not risk - adjusted. Advancing the treatment of GI diseases and redefining the standard of care for GI patients
Additional Information and Where to Find It The description contained herein is for informational purposes only and is not a recommendation, an offer to buy or the solic ita tion of an offer to sell any shares of VectivBio’s ordinary shares. The tender offer for VectivBio’s outstanding ordinary shares described in this presentation has not commenced. At the time the tender offer is commenced, Ironwood will file or cause to be filed a Tender O ffe r Statement on Schedule TO with 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 car efully 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 cha rge on the SEC’s website at www.sec.gov . 17
CORPORATE PARTICIPANTS Andrew Davis Ironwood Pharmaceuticals, Inc. - Senior VP & Chief Business Officer Michael Shetzline Ironwood Pharmaceuticals, Inc. - Chief Medical Officer, Senior VP and Head of Research & Drug Development Sravan Kumar Emany Ironwood Pharmaceuticals, Inc. - Senior VP, Principal Financial Officer & CFO Thomas A. McCourt Ironwood Pharmaceuticals, Inc. - CEO & Director CONFERENCE CALL PARTICIPANTS Boris Peaker TD Cowen, Research Division - MD & Senior Research Analyst David A. Amsellem Piper Sandler & Co., Research Division - MD & Senior Research Analyst Timothy Chiang Capital One Securities, Inc., Research Division - Research Analyst PRESENTATION Operator Ladies and gentlemen, good morning. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood announces acquisition of VectivBio Conference Call. Today's conference is being recorded. (Operator Instructions) Thank you. And I will now turn the conference over to Tom McCourt, Chief Executive Officer. You may begin. Thomas A. McCourt - Ironwood Pharmaceuticals, Inc. - CEO & Director Thanks, Abby, and good morning or good afternoon, everyone. I'm Tom McCourt, Chief Executive Officer of Ironwood Pharmaceuticals, and I'm delighted that you've joined us today as we take you through this exciting announcement in our agreement to acquire VectivBio. Before I continue, please take a moment to review our safe harbor statement on Slide 2. Joining me today are Sravan Emany, Ironwood's Chief Financial Officer; Mike Shetzline, our Chief Medical Officer; Andrew Davis, our Chief Business Officer; and following our remarks, we will open the call with a question-and-answer session. As was highlighted in our press release issued earlier this morning, Ironwood is entering into a definitive agreement to acquire VectivBio, which on close of the transaction, will expand our GI portfolio and further strengthen our position to become the leading GI health care company. VectivBio is a Switzerland-based clinical stage biopharmaceutical company. We've been long admiring VectivBio because of their focus on developing treatments for severe rare conditions with high unmet medical need, including short bowel syndrome with intestinal failure. This acquisition fits squarely within our previously defined strategic framework, and we believe it represents a critical step for Ironwood to achieve our vision and deliver value to our patients and shareholders. There are several reasons we believe that this is the right transaction for Ironwood today. The addition of VectivBio establishes Ironwood as a fully integrated biopharma with a leading commercial product in LINZESS and a strong pipeline for future growth with several key development milestones over the next 12 months. VectivBio's lead asset, Apraglutide, is a potential best-in-class GLP-2 analog that we believe is highly differentiated and have successfully developed and approved, poised to become the standard of care in the treatment of short bowel syndrome with intestinal failure. A disease which there is considerable unmet medical need. We have high conviction for apraglutide's clinical program based on the mechanism of action, the enhanced potency, the extended half-life the unique convenience of weekly dosing and the compelling data to date. We believe Ironwood is best positioned to maximize the potential value MAY 22, 2023 / 12:30PM, IRWD.OQ - Ironwood Pharmaceuticals, Inc., VectivBio Holding AG - M&A Call |
of Apraglutide for patients and shareholders by leveraging our expertise in clinical development, regulatory, medical affairs and commercial execution. As evidenced, by the blockbuster success we've had with LINZESS. Short bowel syndrome with intestinal failure is primarily treated by gastroenterologists where we have a strong network that we've built over the past decade. We believe that there will be a significant opportunity to drive significant operating leverage through Ironwood's existing commercial capabilities to support the potential commercial launch if approved. Finally, we believe the acquisition creates an attractive financial profile in the long term with Apraglutide providing a significant catalyst to extend Ironwood's growth horizon and the potential to deliver sustained profits and cash through the 2030s. On Slide 5, you can see the expanded development portfolio created through this acquisition. We have several exciting clinical data and regulatory milestones expected this year. First, we have an upcoming June PDUFA date for the potential LINZESS functional constipation indication in children and adolescents, ages 6 to 17 years old. Second, we expect early data from CNP-104 for the potential treatment of primary biliary cholangitis in the second half of the year. And finally, with Apraglutide, we expect the top line Phase III readout by the end of the year for the potential treatment of short bowel syndrome with intestinal failures. We're particularly excited about our pipeline that now includes multiple highly innovative clinical stage assets, including Apraglutide and CNP-104. We believe both have the potential to address a significant unmet medical need and is successfully developed and approved, can redefine standard of care for patients suffering from short bowel syndrome with intestinal failure as well as PBC, respectively. Now I'll turn it over to Mike. Michael Shetzline - Ironwood Pharmaceuticals, Inc. - Chief Medical Officer, Senior VP and Head of Research & Drug Development Thanks, Tom. I'm excited to talk to you about a potential new standard of care for patients suffering from shortfall syndrome with intestinal failure. SBS-IF is a severe organ failure condition where the small bowel is not able to keep up with the fluid and nutritional requirements of the body, which may require a lifelong parenteral support. SBS-IF associated with increased mortality, significant morbidity, high economic burden and reduced quality of life. Patients with the most severe SBS-IF may require parenteral support infusions for up to 10 to 15 hours per day, often 7 days a week. This condition impacts approximately 18,000 adult patients across the United States, Europe and Japan. There's a considerable need in this patient population for therapeutic options that ideally aim to help provide enteral autonomy. Enteral autonomy is getting the patient back to the state where the small bowel is able to keep up with their metabolic needs and the patient no longer requires parenteral support. Moving to Slide 8. There are 3 key reasons why we believe that Apraglutide has the potential to be best-in-class and the new standard of care in SBS-IF. First, Apraglutide with GLP-2 analog designed for enhanced potency, selectivity and to be longer-acting versus other GLP-2s. Second, the ongoing Phase III study has been designed to evaluate efficacy in both SBS-IF patient populations, stoma and colon and continuity. Third, Apraglutide has the potential for differentiated convenience of weekly dosing versus other GLP-2 therapies. In summary, we have a high level of conviction in apraglutide's clinical program based on its mechanism of action, it's designed for enhanced potency, selectivity and extended half-life as well as well as compelling data to date. We're looking forward to the top line results of the STARS III Phase III (sic) [STARS Phase III] expected by the end of this year. With that, I'll now turn the presentation back to Tom. MAY 22, 2023 / 12:30PM, IRWD.OQ - Ironwood Pharmaceuticals, Inc., VectivBio Holding AG - M&A Call |
Thomas A. McCourt - Ironwood Pharmaceuticals, Inc. - CEO & Director Thanks, Mike. I'd like to spend a few minutes framing the Apraglutide commercial opportunity in short bowel syndrome with intestinal failure. As I mentioned earlier, we believe Apraglutide has the potential to achieve $1 billion in peak net sales and significantly expand the treated patients in SBS with intestinal failure, based on this unique product profile Mike just outlined. For reference, Gattex, the first-generation GLP-2 is the SBS with intestinal failure -- is indicated for a intestinal failure reported roughly $750 million in net sales in 2022. We believe the potential to address the Stomas and colon in continuity population combined with the convenient once-weekly dosing presents the opportunity to potentially decrease the days on parenteral support and achieve greater sales success versus other GLP-2s. And there is the potential to expand use outside the United States as Ironwood retains the optionality for ex-U.S. commercial strategy moving forward. Slide 11 shows many similarities between Apraglutide and Ironwood GI portfolio today. We believe Ironwood is the right company to continue to lead Apraglutide through to development and potential approval. Ironwood as a leading commercial, regulatory and clinical development capabilities, given our significant focus and expertise in GI and our deep relationships across the GI community. This acquisition has the potential to enhance our GI portfolio, which now includes a blockbuster marketed product in LINZESS, which continues to deliver impressive demand growth, a Phase II asset in CNP-104 and upon close of the transaction, a Phase III clinical asset in Apraglutide. We believe all 3 of these assets represent opportunities that have the potential to advance standard of care for GI patients and position us well for future growth. I now would like to turn the call over to Sravan, who's going to review the transaction details in financials. Sravan Kumar Emany - Ironwood Pharmaceuticals, Inc. - Senior VP, Principal Financial Officer & CFO Thanks, Tom. The addition of VectivBio and the commercial launch potential for Apraglutide provides additional near-term revenue potential with the line of sight for Ironwood to replace revenues attributable to LINZESS by its 2029 patent expiration and it provides long-term revenue and profit growth potential through the 2030s. We believe that Apraglutide, if approved, has the potential to reach $1 billion in net sales in short bowel syndrome with intestinal failure and represents a highly synergistic opportunity with our existing commercial capabilities in GI. Apraglutide and CNP-104 provide Ironwood with 2 exciting assets for the treatment of rare GI diseases with potential for combined peak net sales of greater than $1.5 billion. Now on Slide 14, I'll review the key transaction terms. Pursuant to the terms of the transaction agreement, Ironwood will commence a tender offer to acquire all outstanding shares of VectivBio for $17 per share in cash, which represents aggregate consideration approximately $1 billion. In conjunction with this transaction, Ironwood will have access to a new $500 million 4-year revolving credit facility. We expect to fund this transaction through a combination of cash on hand and drawn funds on the new facility. We anticipate this transaction will close in the second half of 2023, subject to satisfaction of all closing conditions, including HSR approval and the valid tender of at least 80% of all VectivBio shares. We expect to provide updated full year 2023 adjusted EBITDA guidance upon closing of the transaction. Moving forward, we continue to maintain our focus on generating sustained profits and meaningful cash flows while potentially extending our growth horizon through the 2030s. Ironwood expects to generate greater than $175 million in operating cash flows each year on a pro forma basis ahead of a potential Apraglutide commercial launch. We expect the transaction to be accretive to earnings per share beginning in 2026, and we expect adjusted EBITDA to return to greater than $250 million by the end of 2025. Additionally, we anticipate being able to realize significant operating leverage with the addition of Apraglutide and the overlap of Ironwood's existing commercial and development capabilities in GI. Ironwood anticipates total net debt to EBITDA of roughly 3x at closing. And we expect cash flows from LINZESS will support a rapid delevering to below 2x total net debt to EBITDA, ahead of a potential Apraglutide commercial launch in 2025. MAY 22, 2023 / 12:30PM, IRWD.OQ - Ironwood Pharmaceuticals, Inc., VectivBio Holding AG - M&A Call |
Moving forward, we will continue to prioritize investments to maximize the value of LINZESS, progress Apraglutide and CNP-104 towards commercialization and manage our capital structure through debt paydown, while maintaining the flexibility to evaluate additional opportunities for capital deployment. To wrap up, today's announcement is an exciting step forward as we continue to strengthen our position to become the leading GI health care company. It represents an opportunity to accelerate Ironwood's growth well beyond LINZESS LOE while providing innovative treatments for GI patients. We believe that Ironwood is best positioned to maximize the full potential of Apraglutide because of our GI expertise and capabilities. Both CNP-104 and Apraglutide represent exciting opportunities with the potential to deliver significant value to patients, physicians and shareholders. We look forward to collaborating with the talented and hard-working VectivBio team. Together, we can advance important research and clinical development in serious rare GI diseases and develop Apraglutide met to address unmet needs in short bowel syndrome with intestinal failure. Our shared expertise, passion and promising pipelines will greatly expand the reach of our public health contributions and the impact we can make on patient lives and create value for all our stakeholders. Operator, you may now open up the line for questions. QUESTIONS AND ANSWERS Operator (Operator Instructions) We will take our first question from David Amsellem with Piper Sandler. David A. Amsellem - Piper Sandler & Co., Research Division - MD & Senior Research Analyst Quite transformative. So a couple of questions. First, as you were vetting Apraglutide, how are you thinking about the competitive landscape particularly wanted to pick your brain on glepaglutide and also the GLP-1 [Lanreotide] ? And how are you thinking about those agents vis-a-vis APRA. So that's number one. And then number two, understood that GATTEX certainly has its limitations, but in the not-too-distant future, it is going to lose exclusivity. So I guess with that in mind, how are you thinking about pricing and help us understand your assumptions here? Maybe it's too soon to ask, but for her to give it a shot. Sravan Kumar Emany - Ironwood Pharmaceuticals, Inc. - Senior VP, Principal Financial Officer & CFO Thanks, David. And I'll let Tom answer the first part of the question, and then Andrew Davis will answer the second part. Thomas A. McCourt - Ironwood Pharmaceuticals, Inc. - CEO & Director Thanks, Sravan. Obviously, this is a tremendous opportunity for us. I think you're very familiar with short bowel syndrome with intestinal failure. This is a very debilitating disease, while Gattex was certainly a step forward, as you mentioned, there's a lot of limitations with regard to daily dosing, it's potency, its effect across the spectrum of patients. And when we looked at Apraglutide, we clearly see this as a potential best-in-class agent has clearly enhanced potency, the once-weekly dosing versus daily dosing is a tremendous advancement. And of course, the clinical data we've seen to date with regard to its efficacy is really quite stunning. So I think when I look at that profile versus the other GLP-2s, it clearly stands out on its own. And I think we're very excited to move forward with it. As far as some of our thoughts as far as go-to-market strategy and pricing, I'm going to have Andrew maybe address that, Andrew? MAY 22, 2023 / 12:30PM, IRWD.OQ - Ironwood Pharmaceuticals, Inc., VectivBio Holding AG - M&A Call |
Andrew Davis - Ironwood Pharmaceuticals, Inc. - Senior VP & Chief Business Officer Yes, thanks. So I think it is a little early for us to comment or guide on pricing at this point. We closed or signed this late last night, but I think we'll provide an update on that as we roll forward with our commercial activities going forward. David A. Amsellem - Piper Sandler & Co., Research Division - MD & Senior Research Analyst Okay. That's helpful. If I may just sneak in a quick follow-up. Just for my own edification regarding the market. Are you thinking over the commercial life of the product, that this is going to be just a product that will be used just on patients on parenteral support or are there patients with short vol who are not on parenteral support, where this could also be an audience over time? Michael Shetzline - Ironwood Pharmaceuticals, Inc. - Chief Medical Officer, Senior VP and Head of Research & Drug Development Yes. Thanks, David. It's a good question. The main mechanism of action, as you know, for the GLP-2 class rests in restoring sort of the gut lining or the epithelium that provides the enhanced absorptive capacity, which gives the main clinical benefit, which is enhanced fluid absorption and nutrient absorption. So from that capacity, it really does fit best with patients requiring parenteral support because parental support is when you have to take nutrients and fluid that you can't get orally by another route, the parenteral route or IV. So I think it lends itself best for that. There certainly are a subgroup of patients with short bowel syndrome who don't necessarily need parenteral support but I think the more relevant cohort is the patient population who don't require greater than 3 days per week of parenteral sport. There is a group of short bowel syndrome intestinal failure patients who only need 1 or 2 days a week. They're not currently in the Phase II program, to be clear, but they are a relevant population in terms of requiring parenteral support, who would be, I think, a group that we should think very strongly about the utility of a once-weekly therapy for that patient population. Operator We will take our next question from Tim Chiang with Capital One Securities. Timothy Chiang - Capital One Securities, Inc., Research Division - Research Analyst Could you talk a little bit about the differences with Apraglutide, especially in the CIC treatment population, it seems like the company had shown some positive data in just that subpopulation. And could you talk a little bit about the significance of that? Sravan Kumar Emany - Ironwood Pharmaceuticals, Inc. - Senior VP, Principal Financial Officer & CFO Yes. Mike, why don't you respond out to. Michael Shetzline - Ironwood Pharmaceuticals, Inc. - Chief Medical Officer, Senior VP and Head of Research & Drug Development Sure, sure. It is a really important question because, as you know, historically, the relevance is that the GLP-2s as they've moved through commercial use and obviously, we're talking about GATTEX in the setting. The clinical development program really didn't show a benefit in the colon and continuity population. The primary benefit was derived from the stoma population. And the reason for that is, is that primary output was really parenteral support volume and based on urinary output. And the Vectiv development team really did a great job, I think, in terms of the development program design to really tease that out and work with that to look at how to better address the colon and continuity population because it is different physiologically, it's different. MAY 22, 2023 / 12:30PM, IRWD.OQ - Ironwood Pharmaceuticals, Inc., VectivBio Holding AG - M&A Call |
We know factually that the colon sits there primarily to absorb fluid. It certainly does other activities, don't give you on, but the colon does, in some ways, function as a big nephron and absorb fluid. So they clearly have a different way of managing fluid in a good way for patients who need parenteral support but have a colon. And their deficit is primarily around nutrients, not necessarily volume. So what the development team of Vectiv did was they instituted a unique with the coloning algorithm that allows those patients to be managed differently through the clinical trial. Still urinary output is a key factor in determining the parenteral support volumes but the other aspects of their physiology are also taken into consideration including their nutrient status [clerk] intake, A stool form and frequency in those entities. So in the STARS Phase III, they actually instituted that design to better tease out the clinical benefit in colon and continuity patients. So we think that's a huge advantage and likely potentially differentiating and leading us potentially to this best-in-class standard of care for short bowel syndrome with intestinal failure. The study you're alluding to the nutrition study has already demonstrated a very robust clinical benefit in colon and continuity patients. And it really is the first approach in that regard for a weekly therapy to demonstrate this level of clinical benefit in colon and continuity patients? Timothy Chiang - Capital One Securities, Inc., Research Division - Research Analyst And Mike, maybe just one follow-up on APRA. Obviously, there's slightly different PK profile with APRA versus the existing products on the market. Can you talk a little bit about the significance of that and also the half-life? Michael Shetzline - Ironwood Pharmaceuticals, Inc. - Chief Medical Officer, Senior VP and Head of Research & Drug Development What profile? Sorry, I missed the PK/PD, sorry. Thanks for the clarification. Yes, I think the key real physiology or pharmacology behind APRA , Apraglutide is the fact that it is a more potent and more selective GLP-2. This really allows for this extended half-life it provides its extended half-life and then gives us the opportunity or provide Vectiv, obviously, on the front end, the opportunity for weekly dosing. So it is, and it's been looked at in preclinical studies quite extensively comparing to the other GLP-2 agents, and it really does have very robust superiority in terms of at the preclinical level on selectivity and potency. Thomas A. McCourt - Ironwood Pharmaceuticals, Inc. - CEO & Director Mike, maybe you can comment on the contrast of the half-life of Apraglutide versus inorganic . Michael Shetzline - Ironwood Pharmaceuticals, Inc. - Chief Medical Officer, Senior VP and Head of Research & Drug Development Yes, sure. So the native peptide right, the thing in the body is really half-life is on the order of minutes. Gattex obviously made strides in that regard by having a half-life of a couple of hours. That's why it had to have a daily dosing. But Apraglutide really gets into the spectrum of a 70-hour half-life, which provides for the weekly opportunity from a convenience perspective. Timothy Chiang - Capital One Securities, Inc., Research Division - Research Analyst Okay. No, that's very helpful. Do you think that there would be any difference in side effects at all versus telopeptide with APRA? Michael Shetzline - Ironwood Pharmaceuticals, Inc. - Chief Medical Officer, Senior VP and Head of Research & Drug Development Yes. So today, obviously, we're following safety quite closely. We know the safety, obviously, from a class. There's been a lot of data out from the other GLP 2s including GATTEX. We certainly don't see any reason to be concerned from a safety perspective. I think the potency part is what gives us the opportunity to have a lot of exposure throughout the week on the receptors from an agonist perspective to provide the epithelial reconstitution MAY 22, 2023 / 12:30PM, IRWD.OQ - Ironwood Pharmaceuticals, Inc., VectivBio Holding AG - M&A Call |
of the regrowth necessary to improve the absorptive capability of small valve. So we think that's actually leading more on the enhanced efficacy provision throughout the week. Operator (Operator Instructions) And we will take our next question from Boris Peaker with Cowen. Boris Peaker - TD Cowen, Research Division - MD & Senior Research Analyst My first question is on the pivotal study readout later this year for Apraglutide, what do you need to see in that data to support your $1 billion in peak sales thesis? Sravan Kumar Emany - Ironwood Pharmaceuticals, Inc. - Senior VP, Principal Financial Officer & CFO Yes. Mike, why don't you. Michael Shetzline - Ironwood Pharmaceuticals, Inc. - Chief Medical Officer, Senior VP and Head of Research & Drug Development Yes. So I think the key feature, obviously, is the benefit in weekly parenteral support. I think that's the linchpin. Obviously, it's been the regulatory-approved endpoint. It's certainly the endpoint that VectivBio worked with the agencies to agree upon. I think that's the main outcome. I think the nuances which provide an upside here and a unique feature for best-in-class reside around some of the other key endpoints that the Vectiv team has built into the clinical program. And they really include the ability to look at stoma and CIC patients uniquely. And again, you know the 24-week is the primary end point that's obviously built in individually from the stoma patients. But critically, they're looking deeply at the colon and continuity benefit. And as I mentioned earlier, using that weaning algorithm, there certainly is a reason to believe that can demonstrate improved outcomes in colon and continuity. But also very importantly, there's an aspect to the design, including the statistical analysis that we'll try to tease out the benefit from the -- for the colon and continuity patients around enteral autonomy and that's actually taking those patients and weaning them completely off parenteral support. That has happened, and we know that GLP-2s can achieve that. I think with the extended half-life and enhanced potency as well as the clinical trial design, that's a unique opportunity for Apraglutide and the Vectiv team really has championed that approach. Thomas A. McCourt - Ironwood Pharmaceuticals, Inc. - CEO & Director Yes. First, just a couple of initial thoughts as we've done, obviously, a big deal of market research on this as well as through our due diligence. A couple of things. What we do see with Gattex is there's a rapid -- very low adherence rate over a year or 2-year period of time, roughly 50% discontinue within 12 months, almost 70% a year or 2. And as what's driving that is really the lack of clinical benefit, one, with this broader population. So obviously, having more effective agent on a broader population, obviously, is going to drive growth. I think the other thing that we fully expect is greater adherence. Now there's certainly challenges with daily injections versus a once-week injection. But I think what's going to really drive it is the overall efficacy of the drug. And I think that's what we're hoping to see and fully expect to see out of the clinical trial and the unique design. Michael Shetzline - Ironwood Pharmaceuticals, Inc. - Chief Medical Officer, Senior VP and Head of Research & Drug Development Yes. And just to add to what Tom just said, that's the key feature of this enhanced opportunity around the CIC efficacy because that will play into the primary endpoint for the total population. MAY 22, 2023 / 12:30PM, IRWD.OQ - Ironwood Pharmaceuticals, Inc., VectivBio Holding AG - M&A Call |
Boris Peaker - TD Cowen, Research Division - MD & Senior Research Analyst Your -- so just a quick follow-up. Your $1 billion sales potential does that assume that some of these patients are weaned off parenteral support in study? Or is that just upside that's not critical to your assumption? Thomas A. McCourt - Ironwood Pharmaceuticals, Inc. - CEO & Director I mean, as far as we're looking at it,what is it going to take to penetrate the market. Based on all the adoption work we've done with prescribers they really like the broad application. And it's certainly the weaning algorithm is obviously very attractive to say we can actually get people off parenteral nutrition, but also just the raw convenience of managing these patients, which is really, really difficult to manage these patients. And it has obviously a high morbidity and mortality. So as I go back to our real premise on why we love this agent, it's really about this whole clinical profile, starting with potency and certainly convenience. But also, as was mentioned earlier, the strength of the clinical data to date, which obviously is going to be somewhat -- it's going to be predictive of what we hope to see in the Phase III trial later this year. Operator And ladies and gentlemen, this concludes today's conference call, and we thank you for your participation. You may now disconnect. DISCLAIMER Refinitiv reserves the right to make changes to documents, content, or other information on this web site without obligation to notify any person of such changes. In the conference calls upon which Event Transcripts are based, companies may make projections or other forward-looking statements regarding a variety of items. Such forward-looking statements are based upon current expectations and involve risks and uncertainties. Actual results may differ materially from those stated in any forward-looking statement based on a number of important factors and risks, which are more specifically identified in the companies' most recent SEC filings. Although the companies may indicate and believe that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate or incorrect and, therefore, there can be no assurance that the results contemplated in the forward-looking statements will be realized. THE INFORMATION CONTAINED IN EVENT TRANSCRIPTS IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE CONFERENCE CALLS. IN NO WAY DOES REFINITIV OR THE APPLICABLE COMPANY ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY EVENT TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S CONFERENCE CALL ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS. ©2023, Refinitiv. All Rights Reserved. 15608137-2023-05-22T14:11:15.363 MAY 22, 2023 / 12:30PM, IRWD.OQ - Ironwood Pharmaceuticals, Inc., VectivBio Holding AG - M&A Call |
The Additional Information and Where to Find It
The description contained herein is for informational purposes only and is not a recommendation, an offer to buy or the solicitation of an offer to sell any of VectivBio’s ordinary shares. The tender offer for VectivBio’s outstanding ordinary shares described in this communication 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 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 communication may constitute “forward-looking statements,” including those regarding the expected nature, timing and benefits of the transaction. 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 Ironwood’s or VectivBio’s 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 Transaction 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 Ironwood and VectivBio to consummate the transaction; (4) risks that the proposed transaction disrupts the current plans and operations of Ironwood or VectivBio; (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). Ironwood and VectivBio can give no assurance that the conditions to the transaction will be satisfied. Neither Ironwood nor VectivBio 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.
Exhibit 99.4
For Breaking News, Pharma and Trade Media:
Subject: Ironwood to Acquire VectivBio
Hi XXXX,
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, just announced that it has agreed to acquire VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare gastrointestinal conditions in an all-cash deal valued at $1 billion, net of VectivBio cash and debt.
The full press release announcing the acquisition is below, key highlights include:
· | Ironwood agreed to acquire VectivBio through commencement of a $17.00 all-cash tender offer for all outstanding shares of VectivBio |
· | With an estimated aggregate consideration of $1 billion, net of VectivBio cash and debt, the transaction has been approved by the Boards of Directors of both Ironwood and VectivBio and is expected to close in the second half of 2023 |
· | Transaction advances Ironwood’s vision of becoming the leading GI healthcare company |
· | Upon close, transaction adds to Ironwood’s pipeline apraglutide, a next generation, long-acting GLP-2 analog in a Phase 3 study for short bowel syndrome with Intestinal Failure (SBS-IF) |
· | Apraglutide has received orphan drug designation for the treatment of adult patients with SBS-IF. There are approximately 18,000 adult patients suffering from SBS-IF in the U.S., Europe and Japan |
· | Ironwood believes apraglutide has the potential to reach $1 billion in peak net sales if successfully developed and approved |
If you have any questions, please do not hesitate to call or email me.
Best,
Beth Calitri, Head of Communications
FOR IMMEDIATE RELEASE
Ironwood Enters into Definitive Agreement to Acquire VectivBio, a Clinical-Stage Biotech Company Pioneering Novel Treatments for Severe Rare Gastrointestinal Diseases
- 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 -
BOSTON and BASEL, Switzerland – May 22, 2023 – 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.
1 Rights to apraglutide in Japan have been exclusively licensed to Ashai Kasei Pharma Corporation (AKP)
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.
###
Contacts:
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
Exhibit 99.5
Subject: Boston-based Ironwood to Acquire Swiss-based VectivBio
Hi XXXX,
Boston-based Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, just announced that it has agreed to acquire Switzerland-based and VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare gastrointestinal conditions in a deal valued at $1 billion, net of VectivBio cash and debt.
The full press release announcing the acquisition is below, key highlights include:
· | Ironwood agreed to acquire VectivBio through commencement of a $17.00 all-cash tender offer for all outstanding shares of VectivBio |
· | With an estimated aggregate consideration of $1 billion, net of VectivBio cash and debt, the transaction has been approved by the Boards of Directors of both Ironwood and VectivBio and is expected to close in the second half of 2023 |
· | Transaction advances Ironwood’s vision of becoming the leading GI healthcare company |
· | Upon close, transaction adds to Ironwood’s pipeline apraglutide, a next generation, long-acting GLP-2 analog in a Phase 3 study for short bowel syndrome with Intestinal Failure (SBS-IF) |
· | Apraglutide has received orphan drug designation for the treatment of adult patients with SBS-IF. There are approximately 18,000 adult patients suffering from SBS-IF in the U.S., Europe and Japan |
· | Ironwood believes apraglutide has the potential to reach $1 billion in peak net sales if successfully developed and approved |
If you have any questions, please do not hesitate to call or email me.
Best,
Beth Calitri, Head of Communications
FOR IMMEDIATE RELEASE
Ironwood Enters into Definitive Agreement to Acquire VectivBio, a Clinical-Stage Biotech Company Pioneering Novel Treatments for Severe Rare Gastrointestinal Diseases
- 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 -
BOSTON and BASEL, Switzerland – May 22, 2023 – 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.
1 Rights to apraglutide in Japan have been exclusively licensed to Ashai Kasei Pharma Corporation (AKP)
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.
###
Contacts:
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
Exhibit 99.6
[Dear Valued Partners & Vendors / INSERT CUSTOMARY GREETING],
I am writing to share some exciting news about Ironwood. Earlier today, we announced that Ironwood has entered into a definitive agreement to acquire VectivBio, a Switzerland-based clinical-stage biopharmaceutical company focused on developing treatments for severe, rare GI conditions with high unmet medical need. With the potential addition of VectivBio, Ironwood is taking the next step in becoming the leading GI healthcare company. You can read the joint press release here [INSERT HYPERLINK TO RELEASE].
Like Ironwood, VectivBio is fiercely committed to advancing the treatment of GI diseases through deep scientific expertise and a relentless passion to transform patient lives. VectivBio’s lead investigational asset, apraglutide, is a next-generation, synthetic GLP-2 analog that is currently in Phase 3 of development for the treatment of Short Bowel Syndrome with Intestinal Failure (SBS-IF), which affects an estimated 18,000 adults in the U.S., EU and Japan. SBS-IF is largely managed by gastroenterologists. Many of these patients remain untreated due to the limited options on the market today, and there is strong momentum underway to advance this asset through the clinic with topline results of its Phase 3 trial expected by the end of the year.
This is an exciting transaction that we believe positions us to provide you with even greater support for patients suffering from GI diseases. Today, Ironwood has a blockbuster asset in LINZESS, strong GI development and commercial functions, and a promising pipeline of development assets like CNP-104 and IW-3300. We believe that this transaction will further strengthen our innovative portfolio and pipeline and has the potential to meaningfully accelerate our growth horizon. Furthermore, given Ironwood’s proven expertise, infrastructure and track record of GI drug development, we believe we are well-positioned to maximize the value of apraglutide, if successfully developed and approved.
There are a number of approvals required and conditions that must be satisfied before the transaction is completed, which we expect to occur in the second half of 2023. In the meantime, Ironwood and VectivBio will continue to operate as two independent businesses, and it remains business as usual.
Please note that this transaction announcement does not change any of our current plans or support for LINZESS or our other clinical programs.
Your usual contact remains the same and we will continue to work with you as we always have.
As always, thank you for your continued support of Ironwood. We look forward to building upon our partnership as we enter our next phase of growth.
If you have any additional questions, please feel free to reach out.
Sincerely,
XXX
Additional Information and Where to Find It
The description contained herein is for informational purposes only and is not a recommendation, an offer to buy or the solicitation of an offer to sell any of VectivBio’s ordinary shares. The tender offer for VectivBio’s outstanding ordinary shares described in this communication 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 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 communication may constitute “forward-looking statements,” including those regarding the expected nature, timing and benefits of the transaction. 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 Ironwood’s or VectivBio’s 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 Transaction 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 Ironwood and VectivBio to consummate the transaction; (4) risks that the proposed transaction disrupts the current plans and operations of Ironwood or VectivBio; (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 maybe obtained for free at the SEC’s website at http://www.sec.gov). Ironwood and VectivBio can give no assurance that the conditions to the transaction will be satisfied. Neither Ironwood nor VectivBio 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.
Exhibit 99.7
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Additional Information and Where to Find It
The description contained herein is for informational purposes only and is not a recommendation, an offer to buy or the solicitation of an offer to sell any of VectivBio’s ordinary shares. The tender offer for VectivBio’s outstanding ordinary shares described in this communication 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 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 communication may constitute “forward-looking statements,” including those regarding the expected nature, timing and benefits of the transaction. 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 Ironwood’s or VectivBio’s 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 Transaction 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 Ironwood and VectivBio to consummate the transaction; (4) risks that the proposed transaction disrupts the current plans and operations of Ironwood or VectivBio; (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). Ironwood and VectivBio can give no assurance that the conditions to the transaction will be satisfied. Neither Ironwood nor VectivBio 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.