-- Transaction creates strong, diversified
rare-disease focused portfolio-- Novelion Therapeutics completes
concurrent financing of approximately $22 million -- Company to
host conference call today at 4:30 p.m. ET
Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) (“Aegerion”) and QLT
Inc. (NASDAQ:QLTI) (TSX:QLT) (“QLT”) today announced the completion
of their merger transaction, as a result of which Aegerion is now
an indirect wholly-owned subsidiary of QLT. In conjunction with the
closing of the merger, QLT changed its name to Novelion
Therapeutics Inc. (“Novelion”). Novelion’s common shares will begin
trading on The NASDAQ Global Select Market under the symbol NVLN as
of market open on November 30, 2016 and on the Toronto Stock
Exchange under the symbol NVLN as of market open on or about
December 1, 2016. In the interim, Novelion’s shares will
continue to trade on the NASDAQ Global Select Market under the
symbol QLTI and Toronto Stock Exchange under the symbol QLT.
“We are pleased to announce the closing of this transaction,”
said Mary Szela, Chief Executive Officer of Novelion. “We expect
that our multi-asset portfolio of approved treatments, coupled with
our pipeline, global commercial capabilities, strong intellectual
property for our therapies, and improved financial position, will
allow Novelion to create significant value for shareholders, while
also enabling us to invest for growth. We look forward to executing
on our mission of meaningfully impacting the lives of patients
suffering from rare diseases.”
In conjunction with the closing of the merger, a broad-based
investor syndicate, including Deerfield, Armistice Capital,
Broadfin Capital, Healthcare Value Capital, JW Asset Management, K2
& Associates Investment Management, Sarissa Capital, Jason
Aryeh, and Tiger Legatus Capital Management, invested approximately
$22 million in QLT. Novelion has an unrestricted cash balance of
over $100 million to support future operations and potential
targeted business development initiatives.
The holders of shares of Aegerion common stock outstanding
immediately prior to the merger will receive, as merger
consideration, 1.0256 Novelion common shares in exchange for each
share of Aegerion common stock held.
Novelion will operate mainly under the leadership of Aegerion’s
management team prior to the merger, including Mary Szela as Chief
Executive Officer, Gregory Perry as Chief Financial and
Administrative Officer, and John Orloff as Executive Vice
President, Head of Research and Development. The newly constituted
Board of Directors is comprised of ten members - four Aegerion
designees, four QLT designees, one designee from Broadfin Capital
and one designee from Sarissa Capital Management. Novelion’s
principal headquarters are located in Vancouver, British Columbia,
with business operations in Cambridge, Massachusetts.
Financial Guidance
- Expect full year 2016 global net product sales for JUXTAPID®
and MYALEPT® to be between $145 and $150 million.
- Expect to provide Novelion’s full year 2017 financial guidance
in early January.
Upcoming Milestones
- Expect to submit a marketing authorization application for
metreleptin as a potential treatment for GL and a subset of partial
lipodystrophy patients in the EU in the fourth quarter of
2016.
- Following regulatory and pricing approval for JUXTAPID in Japan
for the treatment of homozygous familial hypercholesterolemia
(HoFH), we expect to launch in January 2017.
Conference Call & Webcast:Novelion will
host a conference call and webcast at 4:30 p.m. ET today. The live
call may be accessed by phone by calling (866) 516-3002 (U.S.) or
(760) 298-5082 (international). The webcast may be accessed on the
Investor Relations section of Novelion’s website, www.novelion.com,
to be launched following the close of market today.
About Novelion Therapeutics Inc.Novelion
Therapeutics is a biopharmaceutical company dedicated to developing
new standards of care for individuals living with rare diseases.
The company seeks to advance its portfolio of rare disease
therapies by investing in science and clinical development.
Novelion has a diversified commercial portfolio through its
indirect subsidiary, Aegerion Pharmaceuticals, Inc., which includes
MYALEPT® and JUXTAPID®, and is also developing zuretinol acetate
for the treatment of inherited retinal disease caused by underlying
mutations in RPE65 or LRAT genes.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding: financial projections for 2016; the
anticipated approval of MYALEPT in the EU and other regulatory
activities related to MYALEPT; the planned launch of JUXTAPID in
JAPAN; and the anticipated growth of the Novelion business and the
creation of significant value for our stockholders. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties, many of which are beyond our control, which could
cause actual results to differ materially from those contemplated
in these forward-looking statements. In particular, the risks and
uncertainties include: the possibility that the anticipated
benefits and synergies from the proposed merger cannot be fully
realized or may take longer to realize than expected; the
possibility that costs or difficulties related to the integration
of Aegerion and QLT operations will be greater than expected; the
risk that market acceptance of JUXTAPID and MYALEPT in the U.S. may
not continue at the levels we expect, and may be lower outside the
U.S., including in Brazil, than we expect; the risk that the
conversion of prescriptions for JUXTAPID or MYALEPT into patients
on therapy may be lower than we expect or the drop-out rate may be
higher than we expect; the risk that the prevalence of the diseases
Aegerion’s products treat, or that we are pursuing treatment for,
may be lower than we estimate, and that it may be more difficult to
identify patients than we expect; the risk that the side effect
profile or other results for Aegerion’s products in commercial use
and in further clinical studies are inconsistent, in scope and
severity, with the side effect profile and other results observed
in the pivotal study of each drug; the risk that the negative
impact of the launch of PCSK9 inhibitors on JUXTAPID sales will be
greater than we currently expect, particularly in the U.S., where
the negative impact has been greater than we expected to date, or
that other competitive products will negatively impact our results;
the risk that private or government payers may refuse to reimburse
Aegerion’s or our products, or may impose onerous restrictions that
hinder reimbursement or significantly limit or cap the price
Aegerion or we charge or the number of reimbursed patients who
receive products; the risk that revisions to the JUXTAPID Risk
Evaluation and Mitigation Strategies (REMS) Program may negatively
impact U.S. sales; the risk that our business may be negatively
impacted if there are more Medicaid patients prescribed MYALEPT
than we expect; the risk that named patient sales in Brazil and
other key countries outside the U.S. may not be at the levels we
expect; the risk that regulatory authorities in regions or
countries where either of Aegerion’s products is not yet approved
may refuse to approve such products or additional indications for
such products, such approvals are not made on a timely basis or
such approvals impose significant restrictions or require
additional development; the risk that exchange rates will
negatively impact the amount of net product sales recognized; the
risk that the initiation of future clinical trials may be delayed;
the risk that we will not be successful in our lifecycle management
or business development efforts; the risk that Aegerion’s and our
patent portfolios and marketing and data exclusivity may not be as
strong as we anticipate; the risk of unexpected manufacturing
issues affecting future supply; the risk that Aegerion incurs more
costs than we expect in responding to investigations, defending
litigation and resolving litigation; the risk that any of the
foregoing may cause product sales revenue to be lower than we
expect, or that we may incur unanticipated expenses in connection
with our activities; the risk that Aegerion may not be able to
enter into agreements with third parties respect to lomitapide as
part of our strategic reevaluation on acceptable terms, or at all,
and the risk that our reputation may be harmed and we may be
affected by negative publicity if Aegerion is unable to enter into
agreements with third parties with respect to supplying lomitapide
in the markets from which Aegerion intends to withdraw; the risk
that we may not be able to successfully execute strategic plans,
including our cost-reduction program; and the other risks inherent
in the commercialization, drug development and regulatory approval
process. In addition, Aegerion's agreement in principle with the
U.S. Department of justice (“DOJ”) and the U.S. Securities and
Exchange Commission (“SEC”) relating to the investigations by these
agencies and the terms of potential final settlements with these
agencies include risks associated with the required approvals of
final settlement terms by relevant government agencies, such as the
proposed settlement with the DOJ being subject to approval of
supervisory personnel within the DOJ and relevant federal and state
agencies and approval by a U.S. District Court judge of the
criminal plea and sentence and the civil settlement agreement, and
the proposed settlement with the SEC being subject to review by
other groups in the SEC and approval by the Commissioners of the
SEC. The terms of the preliminary agreements in principle may
change following further negotiations. The amount and terms
of any final settlement may be substantially higher and less
favorable than we anticipate based on the terms of the preliminary
agreements in principle. Final settlement terms could include
the imposition of additional penalties, further limiting Aegerion’s
ability to conduct its business as currently conducted and as
planned to be conducted. Additionally, the DOJ and the SEC each
likely will outline their views of the factual background in
connection with any final settlement. The government's
recitation of their assessment of the background could lead to
additional legal claims or investigations by state government
entities or private parties and may have adverse effects on
Aegerion’s existing class action litigation, commercial operations
and contracts. For additional disclosure regarding these and
other risks we face, see the disclosure contained in the "Risk
Factors" section of Aegerion's Quarterly Report on Form 10-Q filed
on November 4, 2016, QLT’s Annual Report on Form 10-K filed on
February 25, 2016 (and amended on April 29, 2016) and Quarterly
Report on Form 10-Q filed on November 1, 2016 and each company’s
other public filings with the SEC, available on the SEC's website
at http://www.sec.gov. We undertake no obligation to update or
revise the information contained in this press release, whether as
a result of new information, future events or circumstances or
otherwise, except as required by law.
Investors and others should note that we communicate with our
investors and the public using our company websites,
www.aegerion.com and www.qltinc.com, including, but not limited to,
company disclosures, investor presentations and FAQs, SEC filings,
press releases, public conference calls transcripts and webcast
transcripts. The information that we post on these websites could
be deemed to be material information. As a result, we encourage
investors, the media and others interested to review the
information that we post there on a regular basis. The contents of
our website shall not be deemed incorporated by reference in any
filing under the Securities Act of 1933, as amended.
CONTACT:
Amanda Murphy, Associate Director, Investor & Public Relations
857-242-5024
Amanda.Murphy@aegerion.com
Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR)
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