Novelion Therapeutics Inc. (NASDAQ:NVLN), a biopharmaceutical
company dedicated to developing and commercializing innovative new
therapies for individuals living with rare diseases (“Novelion” or
the “Company”), today reported financial results for the third
quarter ended September 30, 2017, announced that it has
commenced a search for a new chief executive officer (“CEO”) to
lead the Company in the next stage of growth, and provided an
overview of recent business highlights. Chief Executive Officer
Mary Szela has resigned for personal reasons, effective
immediately.
To lead the company until a permanent CEO is
appointed, the Board announced the creation of an interim Office of
the Chief Executive Officer, comprised of Jeffrey Hackman,
Novelion’s Chief Operating Officer, Jason Aryeh, Chairman of
the Board of Directors and Mark Corrigan, Director. The Board has
also formed a search committee, which has commenced efforts to
identify candidates who will bring strong strategic and operational
direction to the enterprise.
Jason Aryeh said, “Novelion’s strategy and
mission will continue to focus on supporting access to our marketed
therapies for patients globally and pursuing the development of our
product portfolio in order to support long-term and sustainable
growth. The board is confident in its ability to identify a
successor who will effectively drive improved growth and
shareholder value by reinvigorating the Company’s plans in support
of our key objectives.”
Mr. Aryeh continued, “We recognize the energy that Mary Szela
brought to her role as CEO. Much has been accomplished in her
tenure, including the merger to create Novelion, and we thank her
for her dedication.”
Third Quarter 2017 Highlights &
Business Update
- JUXTAPID: Novelion reported net revenues of
JUXTAPID of $15.2 million in the third quarter of 2017, $10.3
million, or 68%, of which were from prescriptions written in the
U.S.
- MYALEPT: Novelion reported net revenues of
MYALEPT of $13.5 million in the third quarter of 2017. $11.3
million, or 84%, of these revenues were from prescriptions written
in the U.S.
- Novelion reported total net revenues of $28.7 million in the
third quarter of 2017.
- The Company is continuing its efforts to stabilize JUXTAPID in
the U.S., and continues to make progress with the launch in
Japan.
- Novelion ended the third quarter of 2017 with $70.5 million in
unrestricted cash, compared with $83.3 million at the end of the
second quarter of 2017.
- Novelion’s marketing authorization application for metreleptin
was accepted by the European Medicines Agency in January of 2017.
In October 2017, the company submitted its responses to the Day 120
Questions, and based on current timelines, continues to anticipate
EMA approval in the first half of 2018.
- Novelion appointed Jeffrey Hackman as Executive Vice President
and Chief Operating Officer, effective November 1, 2017. Mr.
Hackman will lead the company’s commercial efforts, business
development, manufacturing and supply chain initiatives. Mr.
Hackman was most recently senior vice president, head of the US
Internal Medicine and Oncology franchises for Shire. In this role,
Mr. Hackman was a member of the US commercial leadership team and
was responsible for sales, marketing, business insights and
analytics for eight licensed products within Shire's US rare
disease portfolio.
- Novelion appointed Murray Stewart, M.D. as Executive Vice
President, Head of R&D, effective November 27, 2017. Dr.
Stewart will lead the company’s clinical development activities,
provide strategic regulatory guidance for the pipeline and
commercial product initiatives, and maintain oversight of global
medical affairs, publications and registry activities. Dr. Stewart
will join Novelion from GlaxoSmithKline (GSK) where he is currently
chief medical officer with global responsibility for patient
well-being across the vaccines, pharmaceutical and consumer
business units.
- Novelion appointed Suzanne Bruhn, Ph.D. to its board of
directors, effective October 1, 2017. Dr. Bruhn is president and
chief executive officer of Proclara Biosciences, Inc. Prior to
joining Proclara, Dr. Bruhn served as president and chief executive
officer of Promedior, Inc. She also served as a member of the board
of directors of Raptor Pharmaceuticals from 2011 until it was
acquired by Horizon Pharma in 2016. Previously, Dr. Bruhn served as
senior vice president, strategic planning and program management at
Shire from 1998 until 2012.
2017 Financial Guidance
The Company reiterated its previously stated net revenues
financial guidance for full year 2017 and expects:
- Total net revenues between $135 million and $145 million;
- JUXTAPID net revenues between $70 million and $75 million;
and
- MYALEPT net revenues between $65 million and $70 million.
Third Quarter 2017 Financial Results
On November 29, 2016, the Company completed its
acquisition of Aegerion Pharmaceuticals, Inc. (“Aegerion”). The
acquisition has been accounted for as a business combination in
which Novelion was considered the acquirer of Aegerion. As such,
under U.S. Generally Accepted Accounting Principles (“GAAP”), the
financial statements of Novelion are treated as the historical
financial statements of the consolidated companies, with the
results of Aegerion being included from November 29, 2016. This
release also includes pro forma adjusted non-GAAP financial
information showing pro forma results of operations of Novelion as
if the acquisition had occurred on January 1, 2016. Reconciliation
of the financial results on a GAAP versus non-GAAP basis are
provided below the financial information that follows.
GAAP total net revenues for the third quarter of
2017 were $28.7 million compared to the prior year’s third quarter
net revenues of $0. GAAP net revenues for JUXTAPID in the third
quarter of 2017 were $15.2 million compared to $0 in the prior
year. GAAP net revenues for MYALEPT in the third quarter of 2017
were $13.5 million compared to $0 for the same period in
2016.
GAAP total operating expenses for the third
quarter of 2017 were $38.6 million compared to total operating
expenses of $6.0 million for the same period in 2016. GAAP SG&A
expenses were $21.4 million in the third quarter of 2017 compared
to $3.2 million for the same period in 2016. GAAP R&D expenses
were $17.1 million in the third quarter of 2017 compared to $2.9
million for the same period in 2016.
On a pro forma basis, during the third quarter
of 2017, SG&A expenses were $20.2 million compared to $28.2
million for the same period in 2016. The decrease in pro forma
SG&A expenses in the third quarter of 2017 compared with the
same period in 2016 was primarily related to a reduction in
headcount and legal and consulting fees.
On a pro forma basis, during the third quarter
of 2017, R&D expenses were $16.9 million compared to $12.7
million for the same period in 2016. The decrease in R&D
expenses in the third quarter of 2017 compared with the same period
in 2016 was primarily related to a reduction in headcount.
GAAP net loss in the third quarter of 2017 was
$49.7 million compared to GAAP net loss of $5.9 million during the
same period in 2016.
On a pro forma basis, net loss in the third
quarter of 2017 was $16.6 million, compared to $14.3 million for
the same period in 2016.
As part of the Merger between QLT and Aegerion, the Company
acquired inventory, a portion of which is classified as non-current
based on its forecasted consumption exceeding one year. An excess
and obsolescence analysis is run to determine the need to adjust
inventory carrying values. In the third quarter, that analysis led
to a write down of inventory of approximately $17.3 million.
First Nine Months of 2017 Financial Results
GAAP total net revenues for the first nine
months of 2017 were $99.5 million compared to $0 for the same
period of 2016. GAAP net revenues for JUXTAPID for the first nine
months of 2017 were $51.9 million compared to $0 in same period in
2016. GAAP net revenues for MYALEPT for the first nine months of
2017 were $47.6 million compared to $0 for the same period in
2016.
GAAP total operating expenses for the first nine
months of 2017 were $112.1 million compared to total operating
expenses of $22.3 million for the same period in 2016. GAAP
SG&A expenses were $72.4 million in the first nine months of
2017 compared to $13.6 million for the same period in 2016. GAAP
R&D expenses were $37.2 million in the first nine months of
2017 compared to $8.8 million for the same period in 2016.
On a pro forma basis, for the first nine months
of 2017, SG&A expenses were $68.2 million compared to $111.5
million for the same period in 2016. For the first nine months of
2017, R&D expenses on a pro forma basis were $36.6 million
compared to $37.9 million for the same period in 2016.
GAAP net loss for the first nine months of 2017
was $102.1 million compared to GAAP net loss of $33.0 million
during the same period in 2016.
On a pro forma basis, net loss for the first
nine months of 2017 was $26.7 million, compared to $111.7 million
for the same period in 2016.
As of September 30, 2017, the Company’s
consolidated unrestricted cash balance was $70.5 million, compared
to $83.3 million at June 30, 2017 and $108.9 million at December
31, 2016. As of September 30, 2017, there were 18.6 million shares
outstanding. At September 30, 2017, total debt was $325 million,
reflecting the principal amount of convertible debt issued by
Aegerion and consolidated as a result of the acquisition.
About Novelion Therapeutics
Novelion Therapeutics is a biopharmaceutical
company dedicated to developing new standards of care for
individuals living with rare diseases. Novelion has a diversified
commercial portfolio through its indirect subsidiary, Aegerion
Pharmaceuticals, Inc., and is also developing zuretinol acetate for
the potential treatment of a rare inherited retinal disease caused
by underlying mutations in RPE65 or LRAT genes. The Company seeks
to advance its portfolio of rare disease therapies by investing in
science and clinical development.
Non-GAAP Results
The non-GAAP results in this press release,
including, without limitation, non-GAAP net revenues,
non-GAAP operating expenses, non-GAAP R&D expenses and non-GAAP
SG&A expenses and non-GAAP net loss, are provided as a
complement to results provided in accordance with GAAP because
management believes, when considered together with the GAAP
information, these non-GAAP financial measures help indicate
underlying trends in the Company's business, are important in
comparing current results with prior period results and provide
additional information regarding the Company’s financial
performance. In particular, management believes that the pro-forma
financial information facilitates the evaluation of the impact of
Novelion’s acquisition of Aegerion on the business and performance
of the Company. Management also uses these non-GAAP financial
measures to establish budgets and operational goals that are
communicated internally and externally, and to manage the Company's
business and evaluate its performance. The non-GAAP financial
measures have no standardized meaning under GAAP and therefore may
not be comparable to similar measures presented by other companies.
The non-GAAP financial measures are not intended to be considered
in isolation or as a substitute for, or superior to, the financial
measures prepared and presented in accordance with GAAP and should
be reviewed in conjunction with the relevant GAAP financial
measures. A reconciliation of the GAAP financial results to
non-GAAP financial results is included in the attached financial
information.
Forward-Looking Statements
Certain statements in this press release
constitute “forward-looking statements” of Novelion within the
meaning of applicable laws and regulations and constitute
“forward-looking information” within the meaning of applicable
Canadian securities laws, including statements regarding
expectations, such as expectations about 2017 revenues, improving
growth and shareholder value, stabilizing the Company’s base
commercial business, adjusting expenses to build long-term value,
planned regulatory filings, approvals and activities, maximizing
the value of metreleptin and potential additional indications, drug
development, marketing authorizations and label expansions,
improving product utilization, 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, 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 risk that we may not be able to raise
sufficient capital to pursue the development of metreleptin in
additional indications; the risk that we may not be able to
re-structure the Aegerion outstanding convertible debt on terms
that are acceptable to us; 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 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 JUXTAPID and
MYALEPT 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 JUXTAPID and MYALEPT 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
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
lomitapide or metreleptin, or may impose onerous restrictions that
hinder reimbursement or significantly limit or cap the price of
such products or the number of reimbursed patients who receive
products; the risk that revisions to the JUXTAPID Risk Evaluation
and Mitigation Strategies (REMS) Program, and the implementation of
the revised 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 net revenues for JUXTAPID in the U.S.
may be negatively impacted by Medicare patients not being able to
afford JUXTAPID; the risk that named patient sales for JUXTAPID and
MYALEPT 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 JUXTAPID or MYALEPT is not yet approved
may refuse to approve such products or that regulatory authorities
may refuse to approve 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
revenues recognized; the risk that the initiation of future
clinical trials may be delayed or that larger or a greater number
of clinical trials necessary to obtain approvals of indications for
our products may be required; 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 commercial or clinical 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 net 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; and the risk that we
may not be able to outlicense zuretinol. 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") relating to the
investigation by this agency and the terms of the proposed final
settlement include risks associated with the required approval of
final settlement terms by a U.S. District Court judge of the
criminal plea and sentence and the civil settlement
agreement. The plea agreement has not been approved by the
U.S. District Court judge. If the District Court were not to
approve the plea agreement, Aegerion may be required to negotiate a
less favorable resolution of the DOJ investigation that could
include the imposition of additional penalties or compliance terms,
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 outlined their views of the factual
background in connection with the 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 an appropriate subject of reliance for other
purposes.
For additional disclosure regarding these and
other risks we face, see the disclosure contained in the "Risk
Factors" section of Novelion's Annual Report on Form 10-K filed on
March 30, 2017, as updated in the “Risk Factors” section of
Novelion’s Quarterly Report on Form 10-Q filed on November 9, 2017
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
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
low-density lipoprotein (LDL) apheresis where available, to reduce
LDL 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.
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.
Novelion Therapeutics Inc.Condensed
Consolidated Statements of Operations(unaudited) |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
(In 000s) |
2017 |
|
2016 |
|
2017 |
|
2016 |
Net revenues |
$ |
28,669 |
|
|
$ |
— |
|
|
$ |
99,530 |
|
|
$ |
— |
|
Cost of product
sales |
29,505 |
|
|
— |
|
|
60,227 |
|
|
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
Selling,
general and administrative |
21,395 |
|
|
3,162 |
|
|
72,360 |
|
|
13,572 |
|
Research
and development |
17,112 |
|
|
2,855 |
|
|
37,236 |
|
|
8,774 |
|
Restructuring charges |
56 |
|
|
— |
|
|
2,541 |
|
|
— |
|
Total operating
expenses |
38,563 |
|
|
6,017 |
|
|
112,137 |
|
|
22,346 |
|
Loss from
operations |
(39,399 |
) |
|
(6,017 |
) |
|
(72,834 |
) |
|
(22,346 |
) |
Interest (expense)
income, net |
(9,897 |
) |
|
110 |
|
|
(28,722 |
) |
|
240 |
|
Fair value loss on
investment |
— |
|
|
— |
|
|
— |
|
|
(10,704 |
) |
Other income (expense),
net |
49 |
|
|
(144 |
) |
|
176 |
|
|
(244 |
) |
Loss before provision
for income taxes |
(49,247 |
) |
|
(6,051 |
) |
|
(101,380 |
) |
|
(33,054 |
) |
(Provision for)
recovery of income taxes |
(497 |
) |
|
115 |
|
|
(762 |
) |
|
104 |
|
Net loss |
$ |
(49,744 |
) |
|
$ |
(5,936 |
) |
|
$ |
(102,142 |
) |
|
$ |
(32,950 |
) |
Net loss per common
share—basic and diluted |
$ |
(2.67 |
) |
|
$ |
(0.56 |
) |
|
$ |
(5.49 |
) |
|
$ |
(3.12 |
) |
Weighted-average shares
outstanding—basic and diluted |
18,648 |
|
|
10,565 |
|
|
18,599 |
|
|
10,565 |
|
Novelion Therapeutics
Inc.Condensed Consolidated Balance
Sheets(unaudited) |
|
(In 000s) |
September 30, 2017 |
|
December 31, 2016 |
Cash and cash
equivalents |
$ |
70,501 |
|
|
$ |
108,927 |
|
Restricted cash |
503 |
|
|
390 |
|
Accounts receivable,
net |
14,516 |
|
|
9,339 |
|
Inventories |
55,861 |
|
|
74,721 |
|
Insurance proceeds
receivable |
22,000 |
|
|
22,000 |
|
Prepaid expenses and
other current assets |
7,641 |
|
|
9,762 |
|
Property and equipment,
net |
3,450 |
|
|
4,159 |
|
Intangible assets,
net |
231,546 |
|
|
250,324 |
|
Other assets |
2,303 |
|
|
1,160 |
|
Total
assets |
$ |
408,321 |
|
|
$ |
480,782 |
|
|
|
|
|
Accounts payable and
accrued liabilities |
$ |
56,676 |
|
|
$ |
54,789 |
|
Provision for legal
settlement |
63,050 |
|
|
64,010 |
|
Convertible Notes,
net |
249,789 |
|
|
225,584 |
|
Other liabilities |
539 |
|
|
612 |
|
Total
liabilities |
370,054 |
|
|
344,995 |
|
Total stockholders’
equity |
38,267 |
|
|
135,787 |
|
Total
liabilities and stockholders’ equity |
$ |
408,321 |
|
|
$ |
480,782 |
|
Novelion Therapeutics
Inc.Reconciliation of GAAP to Non-GAAP Financial
Information(unaudited) |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
(In 000s) |
2017 |
|
2016 |
|
2017 |
|
2016 |
Net loss
reconciliation: |
|
|
|
|
|
|
|
GAAP net loss |
$ |
(49,744 |
) |
|
$ |
(5,936 |
) |
|
$ |
(102,142 |
) |
|
$ |
(32,950 |
) |
Stock-based compensation |
926 |
|
|
217 |
|
|
3,419 |
|
|
253 |
|
Amortization of acquired intangible assets |
6,274 |
|
|
— |
|
|
18,778 |
|
|
— |
|
Amortization of debt discount |
8,399 |
|
|
— |
|
|
24,205 |
|
|
— |
|
Inventory
fair value step-up |
17,472 |
|
|
— |
|
|
26,500 |
|
|
— |
|
2016
Aegerion non-GAAP net loss (Note 1) |
— |
|
|
(8,597 |
) |
|
— |
|
|
(79,022 |
) |
Restructuring charge related to acquisition |
56 |
|
|
— |
|
|
2,541 |
|
|
— |
|
Non-GAAP net loss |
$ |
(16,617 |
) |
|
$ |
(14,316 |
) |
|
$ |
(26,699 |
) |
|
$ |
(111,719 |
) |
|
|
|
|
|
|
|
|
GAAP net loss per
common share - basic and diluted |
$ |
(2.67 |
) |
|
$ |
(0.56 |
) |
|
$ |
(5.49 |
) |
|
$ |
(3.12 |
) |
|
|
|
|
|
|
|
|
Non-GAAP net loss per
common share - basic |
$ |
(0.89 |
) |
|
$ |
(1.36 |
) |
|
$ |
(1.44 |
) |
|
$ |
(10.57 |
) |
|
|
|
|
|
|
|
|
GAAP and Non-GAAP
weighted-average common shares outstanding — basic |
18,648 |
|
|
10,565 |
|
|
18,599 |
|
|
10,565 |
|
|
|
|
|
|
|
|
|
Net revenues
reconciliation: |
|
|
|
|
|
|
|
GAAP net revenues |
$ |
28,669 |
|
|
$ |
— |
|
|
$ |
99,530 |
|
|
$ |
— |
|
2016
Aegerion revenues (Note 1) |
— |
|
|
35,387 |
|
|
— |
|
|
115,633 |
|
Non-GAAP net
revenues |
$ |
28,669 |
|
|
$ |
35,387 |
|
|
$ |
99,530 |
|
|
$ |
115,633 |
|
|
|
|
|
|
|
|
|
Cost of product
sales reconciliation: |
|
|
|
|
|
|
|
GAAP cost of product
sales |
$ |
29,505 |
|
|
$ |
— |
|
|
$ |
60,227 |
|
|
$ |
— |
|
Amortization of acquired intangible assets |
(6,274 |
) |
|
— |
|
|
(18,778 |
) |
|
— |
|
Inventory
fair value step-up |
(16,989 |
) |
|
— |
|
|
(25,195 |
) |
|
— |
|
Aegerion
non-GAAP cost of product sales (Note 1) |
— |
|
|
6,718 |
|
|
— |
|
|
33,533 |
|
Non-GAAP cost of
product sales |
$ |
6,242 |
|
|
$ |
6,718 |
|
|
$ |
16,254 |
|
|
$ |
33,533 |
|
|
|
|
|
|
|
|
|
Selling,
general and administrative reconciliation: |
|
|
|
|
|
|
|
GAAP selling, general
and administrative |
$ |
21,395 |
|
|
$ |
3,162 |
|
|
$ |
72,360 |
|
|
$ |
13,572 |
|
Stock-based compensation |
(710 |
) |
|
(137 |
) |
|
(2,814 |
) |
|
(159 |
) |
Inventory
fair value step-up |
(483 |
) |
|
— |
|
|
(1,305 |
) |
|
— |
|
Aegerion
non-GAAP SG&A (Note 1) |
— |
|
|
25,177 |
|
|
— |
|
|
98,117 |
|
Non-GAAP selling,
general and administrative |
$ |
20,202 |
|
|
$ |
28,202 |
|
|
$ |
68,241 |
|
|
$ |
111,530 |
|
|
|
|
|
|
|
|
|
Research and
development reconciliation: |
|
|
|
|
|
|
|
GAAP research and
development |
$ |
17,112 |
|
|
$ |
2,855 |
|
|
$ |
37,236 |
|
|
$ |
8,774 |
|
Stock-based compensation |
(216 |
) |
|
(80 |
) |
|
(605 |
) |
|
(94 |
) |
Aegerion
non-GAAP R&D (Note 1) |
— |
|
|
9,910 |
|
|
— |
|
|
29,173 |
|
Non-GAAP research and
development |
$ |
16,896 |
|
|
$ |
12,685 |
|
|
$ |
36,631 |
|
|
$ |
37,853 |
|
|
Note 1 - Includes financial information from
pre-merger Aegerion for the three and nine months ended September
30, 2016, excluding stock based compensation, amortization of
acquired intangible assets, amortization of debt discount and
deferred financing fees, inventory fair value step-up,
restructuring expense and goodwill impairment. |
CONTACT:
Amanda Murphy, Director, Investor Relations
& Corporate CommunicationsNovelion
Therapeutics857-242-5024amanda.murphy@novelion.com
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