Synergy Pharmaceuticals Provides Business Update
25 Ottobre 2018 - 11:00PM
Business Wire
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) (the “Company” or
“Synergy”), a biopharmaceutical company focused on the development
and commercialization of novel gastrointestinal (GI) therapies,
today provided a business update.
Strategic Review UpdateIn April 2015, prior to the FDA
approval and launch of TRULANCE® (plecanatide) in 2017, Synergy
hired a top tier advisory firm to engage external parties and
evaluate all strategic options available to the Company, including
US and ex-US partnerships and a possible sale of the Company.
Ultimately, there were no offers to acquire the Company and no
partnership opportunities emerged in this evaluation that it
believed aligned with the Company strategically or financially. As
a result, Synergy determined the best course of action for the
business and Synergy shareholders at that time was to commercialize
on its own. However, the Company has always remained open to, and
committed to exploring all strategic and business development
opportunities to enhance shareholder value. These efforts resulted
in several recently announced partnerships and collaborations in
2018, including two ex-US licensing deals for TRULANCE and a
collaboration with the National Cancer Institute for Synergy’s
second asset, dolcanatide.
In May 2018, Synergy announced that it was running a strategic
review process. As part of this extensive review, the Company,
assisted by outside strategic and financial advisors, has been
exploring multiple options and alternatives to create and enhance
shareholder value. The Company held in-depth discussions with
numerous potential counterparties regarding various strategic
alternatives during this process. To date, the offers received to
acquire Synergy have been significantly below the Company’s current
market value, and it has been unable to consummate any partnership
opportunities. At this time, Synergy does not believe that it will
obtain any offers that are significantly higher in value than those
received to date. Nevertheless, Synergy remains committed to the
continued evaluation of all opportunities to enhance shareholder
value, and there is no set timetable for completing this
process.
Liquidity UpdateIn parallel with the strategic review
process, Synergy has been seeking to renegotiate the terms of its
term loan agreement with CRG Servicing LLC (“CRG”). The Company has
been unable to further amend the agreement with respect to the
financial and revenue covenants, and the Company has decided to
forego drawing down on any additional amounts pursuant to its term
loan agreement. Moreover, the Company’s term loan agreement
contains a minimum liquidity covenant that absent relief from CRG
may not be satisfied. Synergy is continuing discussions with CRG
for covenant relief and in parallel the Company is currently
pursuing financing alternatives that better align with its
business, but there is no assurance that the Company can secure
CRG’s consent or otherwise obtain any such financing on
commercially reasonable terms, in which case the Company could
default under the term loan agreement and may have to pursue or
otherwise accelerate strategic alternatives, including the
possibility of seeking bankruptcy protection to protect stakeholder
value in the event other options are not reasonably executable.
Further updates on financing alternatives will be provided when
available.
Financial UpdateTRULANCE uptake in 2018 has been slower
than anticipated due to a highly competitive market access
environment and slower than anticipated overall market growth. As a
result, based on the Company’s current updated forecasts, Synergy
is projecting TRULANCE total net sales for 2018 to be between $42.0
million to $47.0 million, which would be below the minimum revenue
covenant of $61.0 million set forth in its term loan agreement with
CRG. Under the terms of the agreement, Synergy will be required to
repay principal and pay prepayment penalties in an amount equal to
$38.0 million to $51.0 million if total net sales fall within the
expected range noted above. Such principal repayment and prepayment
penalties will be due no later than March 31, 2019. As previously
announced, the Company has continued to evaluate opportunities to
reduce cash expenditures to better align with anticipated revenues
and available capital.
Third Quarter Financial ResultsThe Company plans to
release its third quarter financial results aftermarket on
Thursday, November 8, 2018.
About Synergy PharmaceuticalsSynergy is a
biopharmaceutical company focused on the development and
commercialization of novel gastrointestinal (GI) therapies. The
company has pioneered discovery, research and development efforts
around analogs of uroguanylin, a naturally occurring human GI
peptide, for the treatment of GI diseases and disorders. Synergy’s
proprietary GI platform includes one commercial product TRULANCE®
(plecanatide) and a second product candidate - dolcanatide. For
more information, please visit www.synergypharma.com.
Forward-Looking StatementsCertain statements in this
press release are forward-looking within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by the use of forward- looking words such as
"anticipate," "planned," "believe," "forecast," "estimated,"
"expected," and "intend," among others. These forward-looking
statements are based on Synergy's current expectations and actual
results could differ materially. There are a number of factors that
could cause actual events to differ materially from those indicated
by such forward-looking statements. These factors include, but are
not limited to, substantial competition; our ability to continue as
a going concern; our need for additional financing; whether we can
obtain financing on commercially reasonable terms; our ability to
meet our obligations under the term loan agreement; uncertainties
of patent protection and litigation; uncertainties of government or
third party payer reimbursement; limited sales and marketing
efforts and dependence upon third parties; and risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations. As with any pharmaceutical under development,
there are significant risks in the development, regulatory approval
and commercialization of new products. There are no guarantees that
future clinical trials discussed in this press release will be
completed or successful or that any product will receive regulatory
approval for any indication or prove to be commercially successful.
Investors should read the risk factors set forth in Synergy's
Annual Report on Form 10-K for the year ended December 31, 2017 and
other periodic reports filed with the Securities and Exchange
Commission. While the list of factors presented here is considered
representative, no such list should be considered to be a complete
statement of all potential risks and uncertainties. Unlisted
factors may present significant additional obstacles to the
realization of forward-looking statements. Forward-looking
statements included herein are made as of the date hereof, and
Synergy does not undertake any obligation to update publicly such
statements to reflect subsequent events or circumstances.
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version on businesswire.com: https://www.businesswire.com/news/home/20181025006041/en/
Edelman for SynergyTed McHugh and Nicole Briguet,
212-704-8164SynergyIR@edelman.com
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