VIVUS Executes on its Strategic Vision with the Closing of its Acquisition of PANCREAZE® and Previously Announced Financing ...
June 11 2018 - 7:30AM
VIVUS, Inc. (Nasdaq:VVUS) (the “Company”), a biopharmaceutical
company, today announced that it has met the closing conditions,
including Hart-Scott-Rodino review, related to the Company’s
previously announced acquisition of U.S. and Canadian rights to
PANCREAZE® (pancrelipase) Delayed-Release Capsules for the
treatment of exocrine pancreatic insufficiency (EPI) from Janssen
Pharmaceuticals, Inc. (Janssen) for $135 million. Concurrently,
VIVUS completed its previously announced financing agreement with
Athyrium Capital Management, L.P. (Athyrium).
“The restructuring of a portion of our debt
coupled with the acquisition of a cash flow generating asset,
PANCREAZE, will move VIVUS towards our goal of becoming an
operating profit generating specialty pharmaceutical company.
The PANCREAZE transaction fits a well-defined strategy of acquiring
assets utilizing VIVUS’ improving operational and financial
discipline as a base platform,” said John Amos, Chief Executive
Officer at VIVUS. “We expect the addition of PANCREAZE will
contribute to revenue beginning in the third quarter of 2018 while
leveraging our operating expense base. PANCREAZE exemplifies
the types of synergistic assets we seek to acquire. We are
excited to close this acquisition and move forward with a company
that is designed to serve as a platform to acquire additional
assets that we believe will generate significant clinical and
commercial value.”
Mark Oki, Chief Financial Officer at VIVUS
added, “Completing the debt restructuring transaction with Athyrium
is an important step toward achieving the goal of a properly
levered balance sheet. This restructuring creates the
financial flexibility we need to continue acquiring additional
cash-flow positive assets that we believe will enhance our product
portfolio and revenue potential.”
Approved in 2010, PANCREAZE is a pancreatic
enzyme preparation consisting of pancrelipase, an extract derived
from porcine pancreatic glands, as well as other enzyme classes,
including porcine-derived lipases, proteases and amylases.
The pancreatic enzymes in PANCREAZE act like digestive
enzymes physiologically secreted by the pancreas. PANCREAZE
is specifically indicated for the treatment of exocrine pancreatic
insufficiency due to cystic fibrosis or other conditions.
The Senior Secured Note Purchase Agreement with
investment funds managed by Athyrium provides for $110 million of
Senior Secured Notes, with an additional $10 million of Senior
Secured Notes available for issuance upon meeting certain financial
thresholds or repurchasing the Company’s Convertible Notes at
certain prices. The Senior Secured Notes due 2024 bear
interest at 10.375% and will be interest-only for the first three
years. Concurrently with the Senior Secured Notes issuance,
VIVUS repurchased the $60 million of Convertible Notes held by
funds managed by Athyrium, at a discount to par.
About PANCREAZEPANCREAZE is a
prescription medicine used to treat people who cannot digest food
normally because their pancreas does not make enough enzymes due to
cystic fibrosis or other conditions. PANCREAZE may help your
body use fats, proteins, and sugars from food. PANCREAZE
contains a mixture of digestive enzymes including lipases,
proteases, and amylases from pig pancreas. PANCREAZE is safe
and effective in children when taken as prescribed by your
doctor.
IMPORTANT SAFETY INFORMATIONWhat is the
most important information I should know about
PANCREAZE?
- PANCREAZE may increase your chance of having a serious, rare
bowel disorder called fibrosing colonopathy that may require
surgery.
- The risk of having this condition may be reduced by following
the dosing instructions that your healthcare provider gave
you.
Call your doctor right away if you have
any unusual or severe stomach area (abdominal)
pain, bloating, trouble passing stool (having bowel movements),
nausea, vomiting, or diarrhea.
Take PANCREAZE exactly as prescribed by your
doctor. Do not take more or less PANCREAZE than directed by
your doctor.
What are the possible side effects of
PANCREAZE?PANCREAZE may cause serious side
effects, including:
- A rare bowel disorder called fibrosing
colonopathy.
- Irritation of the inside of your mouth.
This can happen if PANCREAZE is not swallowed
completely.
- Increase in blood uric acid levels. This
may cause worsening of swollen, painful joints (gout) caused by an
increase in your blood uric acid levels.
- Allergic reactions including trouble with
breathing, skin rashes, or swollen lips.
Call your doctor right away if you have
any of these symptoms.The most common side effects include
pain in your stomach (abdominal pain) and gas. Other possible
side effects: PANCREAZE and other pancreatic enzyme products are
made from the pancreas of pigs, the same pigs people eat as pork.
These pigs may carry viruses. Although it has never been
reported, it may be possible for a person to get a viral infection
from taking pancreatic enzyme products that come from pigs.
These are not all the side effects of PANCREAZE.
Talk to your doctor about any side effect that bothers you or
does not go away.
You may report side effects to FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
What should I tell my doctor before taking
PANCREAZE?Tell your doctor if you:
- are allergic to pork (pig) products.
- have a history of blockage of your intestines, or scarring or
thickening of your bowel wall (fibrosing colonopathy).
- have gout, kidney disease, or high blood uric acid
(hyperuricemia).
- have trouble swallowing capsules.
- have any other medical condition.
- are pregnant or plan to become pregnant.
- are breast-feeding or plan to breast-feed.
Tell your doctor about all the medicines
you take, including prescription and nonprescription
medicines, vitamins, and herbal supplements.
The Product Information and Medication Guide for
PANCREAZE is available at www.pancreaze.net.
About VIVUSVIVUS is a
biopharmaceutical company committed to the development and
commercialization of innovative therapies that focus on advancing
treatments for patients with serious unmet medical needs. For
more information about the Company, please visit www.vivus.com.
Forward-Looking
StatementsCertain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995 and are subject to risks,
uncertainties and other factors, including risks and uncertainties
related to potential change in our business strategy to enhance
long-term stockholder value, including the acquisition of revenue
generating products and the strengthening of our balance sheet;
risks and uncertainties related to our agreement with Janssen
Pharmaceuticals, Inc. for the acquisition of all product rights for
PANCREAZE in the U.S. and Canada; risks and uncertainties related
to our ability to successfully commercialize PANCREAZE, including
the timing, strategy and tactics of the commercialization and our
reliance on Janssen Pharmaceuticals, Inc. to transition PANCREAZE
to us in a timely and effective manner; risks and uncertainties
related to our commercialization of PANCREAZE as a new product and
our recently changed management team initiating the
commercialization of PANCREAZE; risks and uncertainties related to
our ability to address or further reduce our outstanding
balance of the Convertible Notes due in 2020; risks and
uncertainties related to our expected future revenues, operations
and expenditures; risks and uncertainties related to our ability to
identify and acquire development and cash flow generating assets;
and risks and uncertainties related to the impact, if any, of
changes to our Board of Directors and senior management team.
These risks and uncertainties could cause actual results to differ
materially from those referred to in these forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. Investors should read the risk factors
set forth in VIVUS’ Form 10-K for the year ended December 31, 2017
as filed on March 14, 2018, and as amended by the Form 10-K/A filed
on April 26, 2018, and periodic reports filed with the Securities
and Exchange Commission. VIVUS does not undertake an
obligation to update or revise any forward-looking statements.
VIVUS, Inc.Mark OkiChief Financial
Officer oki@vivus.com650-934-5200
Investor Relations: Lazar PartnersDavid
CareyManaging Directordcarey@lazarpartners.com212-867-1768
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