Novelion Therapeutics Inc. (NASDAQ:NVLN), a biopharmaceutical
company dedicated to developing and commercializing innovative new
therapies for individuals living with rare and unmet need diseases
(“Novelion” or the “Company”), today reported financial results for
the second quarter ended June 30, 2017 and provided an
overview of recent business highlights, including an update on its
clinical development programs for metreleptin.
Chief Executive Officer Mary Szela commented,
“We continue to transform Novelion into a leading rare and orphan
disease company and have prioritized our clinical development
strategy for metreleptin, our core focus and anticipated future
growth driver. We believe metreleptin presents a ‘pipeline in a
drug’ potential opportunity, given the breadth of its potential
effects across a wide range of potential indications under a
hypoleptinemic dysmetabolic disorder (HDD) umbrella.”
Hypoleptinemic dysmetabolic disorder is a
spectrum of metabolic sequelae secondary to underlying leptin
deficiency. HDD patients differ from epidemic “lifestyle”
diseases such as common obesity, type 2 diabetes mellitus/insulin
resistance and dyslipidemia, in that low leptin is the driver of
the metabolic dysfunction.
Ms. Szela continued, “The next phase in our
transformation will be focused on continuing to maximize the
pipeline potential of metreleptin, while working to grow global
sales of JUXTAPID® and MYALEPT®."
Second Quarter 2017 Highlights &
Business Update
• MYALEPT: Novelion
reported net revenues of MYALEPT of $20.2 million in the second
quarter of 2017, which includes a one-time adjustment of $2.3
million, representing previously deferred U.S. sales, resulting
from a change in estimate in revenue recognition practices which
allows the Company to recognize U.S. revenues upon sale to our
distributor rather than upon delivery by the distributor to the
patient. $14.9 million, or 74%, of these revenues were from
prescriptions written in the U.S. Excluding the $2.3 million
one-time adjustment, MYALEPT revenues grew 28% from the first
quarter of 2017.
• JUXTAPID: Novelion
reported net revenues of JUXTAPID of $20.7 million in the second
quarter of 2017, $11.1 million, or 54%, of which were from
prescriptions written in the U.S. This represents sequential global
growth of 29% from the first quarter of 2017.
• Novelion reported total net revenues of $40.9
million in the second quarter of 2017. Total net sales increased
29%, excluding one-time adjustments, from the first quarter of
2017.
• Novelion ended the second quarter of 2017 with
$83.3 million in unrestricted cash, compared with $84.8 million at
the end of the first quarter of 2017.
• Novelion completed a comprehensive program
evaluation and prioritization exercise of metreleptin that
considered factors such as strategic fit, likelihood of clinical
success and commercial opportunity. As a result, the Company has
identified three indications as metreleptin development priorities:
HDD obesity, HDD liver disease, and infertility associated with
hypothalamic amenorrhea. The Company believes these therapeutic
opportunities for metreleptin may, assuming successful clinical
development, regulatory approvals and commercial execution in all
three indications, present a combined addressable commercial
opportunity of potentially over $1 billion. The Company plans to
provide further detail on these indications and clinical
development plans later this year.
• Novelion’s marketing authorization application
for metreleptin was accepted by the European Medicines Agency in
January of 2017. Regulatory authorities have requested and the
Company is conducting a user testing study, in order to confirm
dosing accuracy, to be submitted in conjunction with the Company’s
Day 120 responses. Due to this request, the timeline for review and
potential approval will be delayed by approximately three months,
in order to complete the request. The Company now expects a CHMP
opinion in the first quarter of 2018 and remains encouraged by its
ongoing interactions with the European regulatory
authorities.
• On July 1, 2017, Novelion appointed John
Orloff, M.D., to its board of directors. Dr. Orloff is providing
strategic guidance as the Company executes its metreleptin
life-cycle management and R&D plans. In addition, on August 1,
2017, Novelion announced the appointment of Mark DiPaolo to its
board of directors. Mr. DiPaolo brings to the board a focus on
capital allocation and maximizing shareholder value.
2017 Financial Guidance
The Company is revising its previously stated
net revenues financial guidance for full year 2017 and now
expects:
- Total net revenues between $135 million and $145 million,
compared to the prior range of between $155 million and $165
million;
- MYALEPT net revenues between $65 million and $70 million,
compared to the prior range of between $75 million and $80 million;
and
- JUXTAPID net revenues between $70 million and $75 million,
compared to the prior range of between $80 million and $85
million.
Second 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 second quarter
of 2017 were $40.9 million compared to the prior year’s second
quarter net revenues of $0. GAAP net revenues for MYALEPT in the
second quarter of 2017 were $20.2 million compared to $0 for the
same period in 2016. GAAP net revenues for JUXTAPID in the second
quarter of 2017 were $20.7 million compared to $0 in the prior
year.
For the three-month period ended June 30, 2017,
the Company recognized a one-time increase in net revenue of $2.3
million, resulting from a change in estimate in revenue recognition
practices for MYALEPT sales in the U.S. and representing previously
deferred product sales. In the second quarter of 2017, to improve
distribution efficiency, the Company signed a letter of intent for
the distribution of JUXTAPID with the same specialty pharmacy that
distributes MYALEPT. Prior to the second quarter of 2017, the
Company accounted for MYALEPT shipments using a deferred revenue
recognition model (sell-through). Beginning in the second quarter
of 2017, to align its revenue streams of JUXTAPID and MYALEPT under
the same distributor, the Company is recognizing sales for MYALEPT
when the product is shipped to its distributor (sell-in).
GAAP total operating expenses for the second
quarter of 2017 were $38.4 million compared to total operating
expenses of $7.4 million for the same period in 2016. GAAP SG&A
expenses were $26.5 million in the second quarter of 2017 compared
to $4.5 million for the same period in 2016. GAAP R&D expenses
were $10.8 million in the second quarter of 2017 compared to $2.9
million for the same period in 2016.
During the second quarter of 2017, SG&A
expenses on a pro forma basis were $25.1 million compared to $41.3
million for the same period in 2016. The decrease in pro forma
SG&A expenses in the second quarter of 2017 compared with the
same period in 2016 was primarily related to a reduction in
headcount and legal and consulting fees.
During the second quarter of 2017, R&D
expenses on a pro forma basis were $10.7 million compared to $12.6
million for the same period in 2016. The decrease in R&D
expenses in the second quarter of 2017 compared with the same
period in 2016 was primarily related to a reduction in
headcount.
GAAP net loss in the second quarter of 2017 was
$21.4 million compared to GAAP net loss of $5.1 million during the
same period in 2016.
Net loss on a pro forma basis in the second
quarter of 2017 was $1.4 million, compared to $26.4 million for the
same period in 2016.
First Six Months of 2017 Financial Results
GAAP total net revenues for the first six months
of 2017 were $70.9 million compared to $0 for the same period of
2016. GAAP net revenues for MYALEPT for the first six months of
2017 were $34.1 million compared to $0 for the same period in 2016.
GAAP net revenues for JUXTAPID for the first six months of 2017
were $36.8 million compared to $0 in same period in 2016.
GAAP total operating expenses for the first six
months of 2017 were $73.6 million compared to total operating
expenses of $16.3 million for the same period in 2016. GAAP
SG&A expenses were $51.0 million in the first six months of
2017 compared to $10.4 million for the same period in 2016. GAAP
R&D expenses were $20.1 million for the first six months of
2017 compared to $5.9 million for the same period in 2016.
For the first six months of 2017, SG&A
expenses on a pro forma basis were $48.0 million compared to $83.3
million for the same period in 2016. For the first six months of
2017, R&D expenses on a pro forma basis were $19.7 million
compared to $25.2 million for the same period in 2016.
GAAP net loss for the first six months of 2017
was $52.4 million compared to GAAP net loss of $27.0 million during
the same period in 2016.
Net loss on a pro forma basis for the first six
months of 2017 was $10.1 million, compared to $97.4 million for the
same period in 2016.
As of June 30, 2017, the Company’s consolidated
unrestricted cash balance was $83.3 million, compared to $84.8
million at March 31, 2017 and $108.9 million at December 31, 2016.
As of June 30, 2017, there were 18.6 million shares outstanding. At
June 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.
Conference Call Details
Novelion will hold a conference call to discuss
its financial results, business highlights and outlook today,
August 8, 2017 at 8:30 a.m. ET. In addition, the Company will
answer questions about its business and current financial
guidance.
To listen to the conference call, dial
(866) 516-3002; international callers dial
(760) 298-5082. In addition, the presentation will be webcast
live, and may be accessed for up to 90 days following the call, by
visiting the “Investors” section of Novelion’s website,
www.novelion.com. An accompanying slide presentation also can be
accessed via the “Investors” section of the website.
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, planned
regulatory filings, approvals and activities, maximizing the value
of metreleptin and potential additional indications, 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, 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 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 in the event we elect to do so. 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 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, 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
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.
|
Novelion Therapeutics Inc. |
Condensed Consolidated Statements of
Operations |
(unaudited) |
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
(In 000s) |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Net revenues |
|
$ |
40,877 |
|
|
$ |
— |
|
|
$ |
70,861 |
|
|
$ |
— |
|
Cost of product
sales |
|
14,277 |
|
|
— |
|
|
30,722 |
|
|
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Selling,
general and administrative |
|
26,514 |
|
|
4,474 |
|
|
50,965 |
|
|
10,410 |
|
Research
and development |
|
10,824 |
|
|
2,929 |
|
|
20,124 |
|
|
5,919 |
|
Restructuring charges |
|
1,034 |
|
|
— |
|
|
2,485 |
|
|
— |
|
Total operating
expenses |
|
38,372 |
|
|
7,403 |
|
|
73,574 |
|
|
16,329 |
|
Loss from
operations |
|
(11,772 |
) |
|
(7,403 |
) |
|
(33,435 |
) |
|
(16,329 |
) |
Interest (expense)
income, net |
|
(9,613 |
) |
|
54 |
|
|
(18,825 |
) |
|
129 |
|
Fair value loss on
investment |
|
— |
|
|
2,256 |
|
|
— |
|
|
(10,704 |
) |
Other income (expense),
net |
|
75 |
|
|
(22 |
) |
|
127 |
|
|
(99 |
) |
Loss before provision
for income taxes |
|
(21,310 |
) |
|
(5,115 |
) |
|
(52,133 |
) |
|
(27,003 |
) |
Provision for income
taxes |
|
(126 |
) |
|
(5 |
) |
|
(265 |
) |
|
(11 |
) |
Net loss |
|
$ |
(21,436 |
) |
|
$ |
(5,120 |
) |
|
$ |
(52,398 |
) |
|
$ |
(27,014 |
) |
Net loss per common
share—basic and diluted |
|
$ |
(1.15 |
) |
|
$ |
(0.48 |
) |
|
$ |
(2.82 |
) |
|
$ |
(2.56 |
) |
Weighted-average shares
outstanding—basic and diluted |
|
18,609 |
|
|
10,565 |
|
|
18,575 |
|
|
10,565 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novelion Therapeutics Inc. |
Condensed Consolidated Balance
Sheets |
(unaudited) |
|
|
|
|
|
(In 000s) |
|
June 30, 2017 |
|
December 31, 2016 |
Cash and cash
equivalents |
|
$ |
83,254 |
|
|
$ |
108,927 |
|
Restricted cash |
|
253 |
|
|
390 |
|
Accounts receivable,
net |
|
13,445 |
|
|
9,339 |
|
Inventories |
|
68,260 |
|
|
74,721 |
|
Insurance proceeds
receivable |
|
22,000 |
|
|
22,000 |
|
Prepaid expenses and
other current assets |
|
9,002 |
|
|
9,762 |
|
Property and equipment,
net |
|
3,744 |
|
|
4,159 |
|
Intangible assets,
net |
|
237,820 |
|
|
250,324 |
|
Other assets |
|
2,498 |
|
|
1,160 |
|
Total
assets |
|
$ |
440,276 |
|
|
$ |
480,782 |
|
|
|
|
|
|
Accounts payable and
accrued liabilities |
|
$ |
48,077 |
|
|
$ |
54,789 |
|
Provision for legal
settlement |
|
63,137 |
|
|
64,010 |
|
Convertible Notes,
net |
|
241,389 |
|
|
225,584 |
|
Other noncurrent
liabilities |
|
587 |
|
|
612 |
|
Total
liabilities |
|
353,190 |
|
|
344,995 |
|
Total stockholders’
equity |
|
87,086 |
|
|
135,787 |
|
Total
liabilities and stockholders’ equity |
|
$ |
440,276 |
|
|
$ |
480,782 |
|
|
|
|
|
|
|
|
|
|
|
Novelion Therapeutics Inc. |
Reconciliation of GAAP to Non-GAAP Financial
Information |
(unaudited) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
(In 000s) |
2017 |
|
2016 |
|
2017 |
|
2016 |
Net loss
reconciliation: |
|
|
|
|
|
|
|
GAAP net loss |
$ |
(21,436 |
) |
|
$ |
(5,120 |
) |
|
$ |
(52,398 |
) |
|
$ |
(27,014 |
) |
Stock
based compensation |
1,094 |
|
|
36 |
|
|
2,493 |
|
|
36 |
|
Amortization of acquired intangible assets |
6,273 |
|
|
— |
|
|
12,504 |
|
|
— |
|
Amortization of debt discount |
8,063 |
|
|
— |
|
|
15,805 |
|
|
— |
|
Inventory
fair value step-up |
3,576 |
|
|
— |
|
|
9,028 |
|
|
— |
|
2016
Aegerion non-GAAP net loss (Note 1) |
— |
|
|
(21,324 |
) |
|
— |
|
|
(70,425 |
) |
Restructuring charge related to acquisition |
1,034 |
|
|
— |
|
|
2,485 |
|
|
— |
|
Non-GAAP net loss |
$ |
(1,396 |
) |
|
$ |
(26,408 |
) |
|
$ |
(10,083 |
) |
|
$ |
(97,403 |
) |
|
|
|
|
|
|
|
|
GAAP net loss per
common share - basic and diluted |
$ |
(1.15 |
) |
|
$ |
(0.48 |
) |
|
$ |
(2.82 |
) |
|
$ |
(2.56 |
) |
|
|
|
|
|
|
|
|
Non-GAAP net loss per
common share - basic |
$ |
(0.08 |
) |
|
$ |
(2.50 |
) |
|
$ |
(0.54 |
) |
|
$ |
(9.22 |
) |
|
|
|
|
|
|
|
|
GAAP and Non-GAAP
weighted-average common shares outstanding — basic |
18,609 |
|
|
10,565 |
|
|
18,575 |
|
|
10,565 |
|
|
|
|
|
|
|
|
|
Net revenues
reconciliation: |
|
|
|
|
|
|
|
GAAP net revenues |
$ |
40,877 |
|
|
$ |
— |
|
|
$ |
70,861 |
|
|
$ |
— |
|
2016
Aegerion revenues (Note 1) |
— |
|
|
44,530 |
|
|
— |
|
|
80,246 |
|
Non-GAAP net
revenues |
$ |
40,877 |
|
|
$ |
44,530 |
|
|
$ |
70,861 |
|
|
$ |
80,246 |
|
|
|
|
|
|
|
|
|
Cost of product
sales reconciliation: |
|
|
|
|
|
|
|
GAAP cost of product
sales |
$ |
14,277 |
|
|
$ |
— |
|
|
$ |
30,722 |
|
|
$ |
— |
|
Amortization of acquired intangible assets |
(6,273 |
) |
|
— |
|
|
(12,504 |
) |
|
— |
|
Inventory
fair value step-up |
(3,097 |
) |
|
— |
|
|
(8,206 |
) |
|
— |
|
Aegerion
non-GAAP cost of product sales (Note 1) |
— |
|
|
17,342 |
|
|
— |
|
|
26,815 |
|
Non-GAAP cost of
product sales |
$ |
4,907 |
|
|
$ |
17,342 |
|
|
$ |
10,012 |
|
|
$ |
26,815 |
|
|
|
|
|
|
|
|
|
Selling,
general and administrative reconciliation: |
|
|
|
|
|
|
|
GAAP selling, general
and administrative |
$ |
26,514 |
|
|
$ |
4,474 |
|
|
$ |
50,965 |
|
|
$ |
10,410 |
|
Stock
based compensation |
(980 |
) |
|
(14 |
) |
|
(2,104 |
) |
|
(14 |
) |
Inventory
fair value step-up |
(479 |
) |
|
— |
|
|
(822 |
) |
|
— |
|
Aegerion
non-GAAP SG&A (Note 1) |
— |
|
|
36,828 |
|
|
— |
|
|
72,940 |
|
Non-GAAP selling,
general and administrative |
$ |
25,055 |
|
|
$ |
41,288 |
|
|
$ |
48,039 |
|
|
$ |
83,336 |
|
|
|
|
|
|
|
|
|
Research and
development reconciliation: |
|
|
|
|
|
|
|
GAAP research and
development |
$ |
10,824 |
|
|
$ |
2,929 |
|
|
$ |
20,124 |
|
|
$ |
5,919 |
|
Stock
based compensation |
(114 |
) |
|
(22 |
) |
|
(389 |
) |
|
(22 |
) |
Aegerion
non-GAAP R&D (Note 1) |
— |
|
|
9,730 |
|
|
— |
|
|
19,263 |
|
Non-GAAP research and
development |
$ |
10,710 |
|
|
$ |
12,637 |
|
|
$ |
19,735 |
|
|
$ |
25,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1 - Includes financial information from
pre-merger Aegerion for the three and six months ended June 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 Communications
Novelion Therapeutics
857-242-5024
amanda.murphy@novelion.com
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