- Company Reports Preliminary Total Net Product
Sales Expected to be Between $150 million and $152 million,
Exceeding High End of Prior Guidance
Novelion Therapeutics Inc. (NASDAQ:NVLN) (TSX:NVLN), a
biopharmaceutical company dedicated to developing new standards of
care for individuals living with rare diseases (the “Company”),
today reported preliminary pro forma unaudited 2016 net product
sales for its subsidiary and other business updates. Mary Szela,
chief executive officer, plans to discuss these and other topics
during a live presentation at the 35th Annual J.P. Morgan
Healthcare Conference in San Francisco scheduled for Wednesday,
January 11, 2017, at 4 p.m. PST (7 p.m. EST). The presentation will
be webcast live and accessible through the “Investors” section of
Novelion’s website, www.novelion.com.
“We enter 2017 with a highly-differentiated
portfolio of marketed and development-stage rare disease products
with near- and mid-term opportunities to grow the commercial
pillars of our business,” said Mary Szela, chief executive officer
of Novelion.
“In 2017, we will focus on expanding access to
metreleptin globally, and on development of the therapy’s
pleiotropic effects to explore new opportunities to treat patients
suffering from a range of low leptin-mediated metabolic rare
diseases. In addition, we will work closely with Japanese health
care providers with the goal of providing JUXTAPID to the more than
160 registered HoFH patients in that market, over time, and with
U.S. physicians to retain those adult HoFH patients for whom
JUXTAPID represents an important and differentiated therapy,” Szela
continued.
2016 Preliminary Results & Business
Update
- MYALEPT® (metreleptin): Novelion, through its
subsidiary, expects preliminary, pro forma unaudited net product
sales of MYALEPT for the full year 2016 to be between $50 million
and $51 million. As of December 31, 2016, there were approximately
125 active commercial patients on MYALEPT therapy globally,
approximately 98 of whom are U.S. patients. Active patient numbers
used in this press release are based upon internal estimates and
criteria.
- JUXTAPID® (lomitapide):
Novelion, through its subsidiary, expects preliminary, pro forma
unaudited net product sales of JUXTAPID for full year 2016 to be
between $100 million and $101 million. As of December 31, 2016,
there were approximately 340 active commercial patients on JUXTAPID
therapy globally, approximately 232 of whom are U.S. patients.
- Novelion ended 2016 with approximately $108 million (unaudited)
in unrestricted cash.
- In November 2016, Novelion’s subsidiary repaid all of its
outstanding obligations and amounts under the $25 million credit
facility with Silicon Valley Bank.
- On December 22, 2016, Novelion’s subsidiary submitted a
marketing authorization application (MAA) to the European Medicines
Agency (EMA) seeking approval for metreleptin as replacement
therapy to treat complications of leptin deficiency in patients
with congenital or acquired generalized lipodystrophy (GL) and in a
subset of patients with partial lipodystrophy (PL). As with GL
patients, in the pivotal NIH study, the subset of PL patients saw
significant improvement in key efficacy measures, including
reductions in HbA1c and triglycerides. The Company, through its
subsidiary, will seek to market metreleptin in the EU under the
tradename MYALEPTA®. If approved, metreleptin would be the first
medication available in the EU to treat GL and PL.
- On December 16, 2016, Novelion’s subsidiary launched JUXTAPID
in Japan. Japan represents a unique market opportunity for
JUXTAPID, with an identified population of more than 160 patients
with homozygous familial hypercholesterolemia (HoFH) and favorable
pricing and reimbursement. The Company anticipates annual peak
sales of approximately $30 million.
- Also in December 2016, Novelion’s subsidiary entered into a
licensing agreement with Amryt Pharma (“Amryt”) for the exclusive
rights to LOJUXTA® (lomitapide) hard capsules in certain European
and Middle Eastern territories. Amryt will pay Novelion
sales-related payments and royalties on product sales in the
licensed territories, and will also be responsible for ongoing
regulatory and post-marketing obligations and commitments in
support of the brand.
2017 Outlook
- Novelion’s subsidiary is planning to submit a supplemental
biologics licensing application (sBLA) for MYALEPT to treat a
subset of PL patients in the U.S. in the first half of 2017. If
approved, this label expansion could double the addressable market
in the U.S. for MYALEPT.
- Novelion’s subsidiary plans to file applications for regulatory
approval of MYALEPT to treat GL and a subset of PL in Brazil,
Colombia, Argentina, Turkey and Canada.
- Novelion plans to meet with FDA and EMA in the first half of
2017 to gather feedback on its proposed development plans for
zuretinol. Zuretinol, if approved, has the potential to receive a
pediatric priority review voucher.
2017 Financial Guidance
The company provides the following revenue
guidance for full year 2017:
- Total net products sales of between $155 million and $165
million;
- MYALEPT net product sales of between $75 million and $80
million; and
- JUXTAPID net product sales of between $80 million and $85
million.
About Novelion Therapeutics
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 potential treatment of inherited retinal disease caused by
underlying mutations in RPE65 or LRAT genes.
Forward-Looking Statements
Certain statements in this press release
constitute “forward-looking statements” of Novelion within the
meaning of the Private Securities Litigation Reform Act of 1995 and
constitute “forward-looking information” within the meaning of
applicable Canadian securities laws, including statements regarding
expectations such as sales of our products, cash usage, operating
expense, planned regulatory filings and activities, drug
development, marketing authorizations and label expansions, as well
as long-term growth prospects. Forward-looking statements are
based on estimates and assumptions made by Novelion in light of
current conditions and expected future developments, as well as
other factors that Novelion believes are appropriate in the
circumstances, including but not limited to, our financial position
and execution of our business strategy, post-merger synergies,
resolution of litigation and investigations, receipt of regulatory
approvals, and product competition, market acceptance, sales,
pricing, reimbursement and side effects. 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. Many such risks, uncertainties
and other factors are taken into account as part of our assumptions
underlying these forward-looking statements and include, among
others, the following: : the possibility that the anticipated
benefits and synergies from the merger transaction between Novelion
and Aegerion Pharmaceuticals, Inc. 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 Aegerion’s products, 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 and Japan, 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 net revenues for MYALEPT in the U.S. may be
negatively impacted if there are more Medicaid patients prescribed
MYALEPT than we expect; the risk that named patient sales for
Aegerion’s products 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 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; the risk associated with our ability to be granted a Rare
Pediatric Disease Designation and any subsequent qualification for
a Rare Pediatric Disease Priority Review Voucher, including the
risk that zuretinol will not qualify under the current or any
future applicable criteria for designation as a Rare Pediatric
Disease or that an NDA for zuretinol will not qualify for a
Priority Review Voucher, and the risk that future changes to the
zuretinol program and/or the Voucher Program, including related to
the transferability of the Priority Review Voucher, limit the
future benefits of the Rare Pediatric Disease Designation and/or
Priority Review Voucher. The terms of Aegerion’s
agreement in principle related to its class action litigation
include risks related to the final approval by the court of the
final settlement terms, including that the payment amount and
availability of insurance could be amended and 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
agreement in principle, and the possibility that the
court may materially alter or fail to approve the settlement
terms. 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, including the
agreement in principle to settle such litigation, commercial
operations and contracts.
This press release also contains
“forward-looking information” that constitutes “financial outlooks”
within the meaning of applicable Canadian securities laws. This
information is provided to give investors general guidance on
management’s current expectations of certain factors affecting our
business, including our financial results. Given the uncertainties,
assumptions and risk factors associated with this type of
information, including those described above, investors are
cautioned that the information may not be appropriate for other
purposes.
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, Novelion'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 www.sec.gov. Except as required by law, 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.
Investors and others should note that we
communicate with our investors and the public using our company
website www.novelion.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.
U.S. INDICATIONS AND IMPORTANT SAFETY
INFORMATION
MYALEPT® (metreleptin) for injection is a leptin analog
indicated as an adjunct to diet as replacement therapy to treat the
complications of leptin deficiency in patients with congenital or
acquired generalized lipodystrophy. LIMITATIONS OF USE: The
safety and effectiveness of MYALEPT for the treatment of
complications of partial lipodystrophy or for the treatment of
liver disease, including nonalcoholic steatohepatitis (NASH), have
not been established.
Anti-metreleptin antibodies with neutralizing activity have been
identified in patients treated with MYALEPT. T-cell lymphoma has
been reported in patients with acquired generalized lipodystrophy,
both treated and not treated with MYALEPT. For more detailed
information, please see additional Important Safety
Information and the Prescribing Information for
MYALEPT.
JUXTAPID® (lomitapide) capsules is a microsomal
triglyceride transfer protein inhibitor indicated as an adjunct to
a low-fat diet and other lipid-lowering treatments, including LDL
apheresis where available, to reduce low-density lipoprotein
cholesterol, total cholesterol, apolipoprotein B, and
non-high-density lipoprotein cholesterol in patients with
homozygous familial hypercholesterolemia (HoFH). Limitations of
Use The safety and effectiveness of JUXTAPID have not been
established in patients with hypercholesterolemia who do not have
HoFH, including those with heterozygous familial
hypercholesterolemia (HeFH). The effect of JUXTAPID on
cardiovascular morbidity and mortality has not been determined.
JUXTAPID can cause elevations in transaminases, as well
as increases in hepatic fat, with or without concomitant increases
in transaminases. Because of the risk of hepatotoxicity, JUXTAPID
is available only through a restricted distribution program called
the JUXTAPID REMS PROGRAM. For more detailed information, please
see additional Important Safety
Information and the Prescribing
Information for JUXTAPID.
CONTACT:
Amanda Murphy, Director, Investor Relations & Corporate Communications
Novelion Therapeutics
857-242-5024
amanda.murphy@novelion.com
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