~ Achieved Net Product Sales of $2.5
Million for KEVEYIS® (dichlorphenamide), a
67% Revenue Growth Increase over the Previous Quarter ~
Strongbridge Biopharma plc, (Nasdaq:SBBP), a global
commercial-stage biopharmaceutical company focused on the
development and commercialization of therapies for rare diseases
with significant unmet needs, today provided a corporate update and
reported third quarter 2017 financial results.
“Strongbridge continues to evolve into a leading
global rare disease biopharmaceutical company with KEVEYIS®
(dichlorphenamide), RECORLEV™ (levoketoconazole) and veldoreotide,
a strong balance sheet and top talent with significant rare disease
experience,” said Matthew Pauls, president and chief executive
officer of Strongbridge Biopharma. “We are pleased with our third
quarter performance, and believe that 2018 will be an exceptional
year for Strongbridge with the acceleration of KEVEYIS sales due to
our increased commercial investment and results from our two Phase
3 studies for RECORLEV.”
Recent Corporate Highlights
Early KEVEYIS Launch Results Demonstrate
Significant Market Demand; Previously Announced Commercial
Expansion Proceeding as Planned
- Achieved net product sales of $2.5 million during the third
quarter of 2017, a 67% increase, compared to $1.5 million in the
second quarter of 2017.
- Within the first two quarters of the KEVEYIS launch,
Strongbridge cumulatively generated more than 80 new patient start
forms (i.e., prescriptions for KEVEYIS).
- Implementing the previously announced increased investment in
KEVEYIS commercial efforts to:
- Expand the Company’s experienced rare disease field-based team,
including increasing from 12 to 21 sales representatives, along
with the addition of three regional business directors and three
patient access managers.
- Build upon Primary Periodic Paralysis (PPP) disease-state
education programs and KEVEYIS branded promotional
initiatives.
- Support the recent national launch of the Uncovering Periodic
Paralysis genetic testing program.
RECORLEV Phase 3 Clinical Development
Program Continues to Progress
- In October 2017, the Data and Safety Monitoring Board (DSMB),
which meets semi-annually, recommended that the Phase 3 SONICS
study evaluating RECORLEV continue as planned.
- Strongbridge now anticipates enrollment of the first patient in
the Phase 3 LOGICS study in the fourth quarter of 2017.
- The Company anticipates reporting top-line results from SONICS
in the second quarter of 2018 and LOGICS in the fourth quarter of
2018.
Initiating a Series of Pre-Clinical
Studies to Explore the Differentiating Features of
Veldoreotide
- Veldoreotide is a novel, investigational somatostatin analog
(SSA) that possesses unique somatostatin receptor (SSTR)
interaction characteristics compared with currently marketed
SSAs. Strongbridge has filed a patent application for its PLGA
microspheres-based proprietary long-acting formulation for
veldoreotide.
- Strongbridge is initiating a series of pre-clinical studies
that seek to determine additional differentiating features of
veldoreotide in endocrine and non-endocrine conditions. These
studies will allow the Company to optimally focus any future
investments in veldoreotide, and may provide additional
intellectual property protection.
- With the initiation of these product differentiation studies,
Strongbridge determined that it was appropriate to update its
accounting valuation of the veldoreotide asset as of September 30,
2017. Pursuant to the updated valuation, Strongbridge recorded a
non-cash intangible asset impairment charge during the third
quarter of 2017.
Completed Recent Public Equity Offering Raising Net
Proceeds of $23.4 Million; Existing Resources Sufficient to Achieve
Positive Cash Flows From Operating Activities
- Strongbridge completed an underwritten public offering of
4,000,000 ordinary shares in October 2017.
- The total net proceeds of the offering were approximately $23.4
million, after deducting the underwriting discounts and commissions
and estimated offering expenses payable by the Company.
- The Company believes that the combination of existing cash
resources at September 30, 2017, together with the net proceeds
from the recent public offering, provides sufficient cash under its
current operating plan, which includes increased commercial
investment in KEVEYIS and the potential U.S. regulatory approval
and launch of RECORLEV, to achieve consistent positive cash flows
from operating activities.
Third Quarter 2017 Financial
ResultsFor the three months ended September 30, 2017,
basic and diluted net loss attributable to ordinary shareholders on
a GAAP basis was $35.1 million, or $0.98 per share, compared to a
basic and diluted net loss attributable to ordinary shareholders of
$7.6 million, or $0.36 per share, for the same period in 2016. The
net loss for the three months ended September 30, 2017 included
$24.2 million in charges consisting of a non-cash impairment charge
of $20.7 million related to in-process research and development
recorded for the veldoreotide program and a loss of $3.5 million on
the early extinguishment of debt that was repaid in July 2017 in
connection with establishing a new credit facility. Net loss for
the three months ended September 30, 2017 was also higher than the
same period in 2016 due to increased operating expenses associated
with the commercialization of KEVEYIS, which was launched in April
2017, offset in part by net revenues recorded from KEVEYIS product
sales.
For the three months ended September 30, 2017,
non-GAAP basic and diluted net loss attributable to ordinary
shareholders was $13.1 million, or $0.35 per share, compared to a
non-GAAP basic and diluted net loss attributable to ordinary
shareholders of $6.5 million, or $0.31 per share, for the same
period in 2016. The increase in non-GAAP net loss was primarily due
to increased operating expenses associated with the
commercialization of KEVEYIS, which was launched in April 2017,
offset in part by net revenues recorded from KEVEYIS product
sales.
Non-GAAP net loss for the three months ended
September 30, 2017 excludes $1.3 million of non-cash intangible
asset amortization, a $20.7 million non-cash intangible asset
impairment charge, $1.3 million of non-cash stock-based
compensation expense, $1.5 million of non-cash interest and debt
extinguishment expense, $2.0 million of non-cash unrealized gains
on fair value of warrants, and a $0.9 million non-cash income tax
benefit. Non-GAAP net loss for the three months ended September 30,
2016 excludes $1.1 million of non-cash stock-based compensation
expense.
As a result of the April 2017 KEVEYIS launch,
the Company recorded net revenues of $2.5 million and cost of goods
sold of $0.6 million for the three months ended September 30, 2017.
No revenue or cost of goods sold was recognized for the same period
of 2016.
Research and development expenses were $4.5
million for each of the three months ended September 30, 2017 and
the three months ended September 30, 2016.
Selling, general and administrative expenses
were $8.5 million for the three months ended September 30, 2017,
compared to $3.1 million for the same period in the prior year. The
increase during the 2017 period was primarily due to costs incurred
to establish the commercial and corporate infrastructure necessary
to support the launch and ongoing commercialization of KEVEYIS.
Year-to-Date September 2017 Financial
ResultsFor the nine months ended September 30, 2017, basic
and diluted net loss attributable to ordinary shareholders on a
GAAP basis was $94.7 million, or $2.67 per share, compared to a
basic and diluted net loss attributable to ordinary shareholders
$32.6 million, or $1.54 per share, for the same period in 2016. The
net loss for the nine months ended September 30, 2017 included
$52.4 million in charges consisting of a non-cash unrealized loss
of $28.2 million on the fair value of the Company’s warrant
liability, a non-cash impairment charge of $20.7 million related to
in-process research and development recorded for the veldoreotide
program, and a loss of $3.5 million on the early extinguishment of
debt that was repaid in July 2017 in connection with establishing a
new credit facility. The net loss for the nine months ended
September 30, 2016 included a non-cash intangible asset impairment
charge of $5.2 million. Net loss for the nine months ended
September 30, 2017 was also higher than the same period in 2016 due
to increased operating expenses associated with the
commercialization of KEVEYIS, which was launched in April 2017,
offset in part by net revenues recorded from KEVEYIS product
sales.
For the nine months ended September 30, 2017,
non-GAAP basic and diluted net loss attributable to ordinary
shareholders was $35.3 million, or $0.99 per share, compared to a
non-GAAP basic and diluted net loss attributable to ordinary
shareholders of $24.8 million, or $1.16 per share, for the same
period in 2016. The increase in non-GAAP net loss was primarily due
to increased operating expenses associated with the
commercialization of KEVEYIS, which was launched in April 2017,
offset in part by net revenues recorded from KEVEYIS product sales
and lower research and development expenses.
Non-GAAP net loss for the nine months ended
September 30, 2017 excludes $3.8 million of non-cash intangible
asset amortization, a $20.7 million non-cash intangible asset
impairment charge, $3.9 million of non-cash stock-based
compensation expense, $28.2 million of non-cash unrealized losses
on fair value of warrants, $2.2 million of non-cash interest and
debt extinguishment expense, and $0.7 million of non-cash income
tax expense. Non-GAAP net loss for the nine months ended September
30, 2016 excludes $3.5 million of non-cash stock-based compensation
expense, a $5.2 million non-cash intangible asset impairment
charge, and a $0.9 million non-cash income tax benefit.
As a result of the April 2017 KEVEYIS launch,
the Company recorded net revenues of $4.1 million and cost of goods
sold of $1.0 million for the nine months ended September 30, 2017.
No revenue or cost of goods sold was recognized for the same period
of 2016.
Research and development expenses were $12.1
million for the nine months ended September 30, 2017, compared to
$15.9 million for the same period in the prior year. The decrease
during the 2017 period was primarily due to a planned decrease in
development activity for veldoreotide, decreased development spend
related to programs discontinued during 2016, and a timing-related
decrease in expenses relating to the ongoing clinical trials for
RECORLEV.
Selling, general and administrative expenses
were $26.1 million for the nine months ended September 30, 2017,
compared to $11.3 million for the same period in the prior year.
The increase during the 2017 period was primarily due to costs
incurred to establish the necessary commercial and corporate
infrastructure to support the launch and ongoing commercialization
of KEVEYIS.
Strongbridge had $44.4 million of cash and cash
equivalents and $40.0 million in outstanding debt as of September
30, 2017, compared to $66.8 million of cash and cash equivalents
and $20.0 million in outstanding debt as of December 31, 2016.
After adjusting for the net proceeds of the public offering
completed in October 2017, Strongbridge had pro forma cash and cash
equivalents of $67.8 million as of September 30, 2017. The Company
believes the combination of existing cash resources at September
30, 2017 and the net proceeds from its October 2017 public offering
provides sufficient cash under its current operating plan, which
includes increased commercial investment in KEVEYIS and the
potential U.S. regulatory approval and launch of RECORLEV, to
achieve consistent positive cash flows from operating
activities.
Use of Non-GAAP Financial Measures In addition
to the results prepared in accordance with U. S. generally accepted
accounting principles, or GAAP, this press release also includes
certain financial measures, which have been adjusted and are not in
accordance with generally accepted accounting principles (“Non-GAAP
financial measures”). These Non-GAAP financial measures include
adjusted income from operations, adjusted net income, and adjusted
net income per diluted share. In accordance with Regulation G of
the Securities and Exchange Commission, the Company has provided a
reconciliation of these Non-GAAP financial measures with the most
directly comparable financial measure calculated in accordance with
GAAP.
These Non-GAAP financial measures are not
intended to replace GAAP financial measures. They are presented as
supplemental measures of our performance in an effort to provide
our stakeholders better visibility into the Company’s ongoing
operating results and to allow for comparability to prior periods
as well as to other companies’ results. Management uses these
Non-GAAP financial measures to assess the financial health of the
Company’s ongoing operating performance. Management encourages our
stakeholders to consider all of our financial measures and to not
rely on any single financial measure to evaluate our
performance.
Conference Call Information
Strongbridge will host a conference call
on Tuesday, November 14 at 8:30 a.m. ET. To access
the live call, dial 844-285-7153 (domestic) or 478-219-0180
(international) with conference ID 6499657. The conference call
will also be audio webcast from the Company’s website
at www.strongbridgebio.com under the “Investor/Webcasts
and Presentations” section. A replay of the call will be made
available for one week following the conference call. To hear a
replay of the call, dial 855-859-2056 (domestic) or 404-537-3406
(international) with conference ID 6499657.
About Strongbridge Biopharma
Strongbridge Biopharma is a
commercial-stage global biopharmaceutical company focused on the
development and commercialization of therapies for rare diseases
with significant unmet needs. Strongbridge's first commercial
product is KEVEYIS® (dichlorphenamide), the first and only
FDA-approved treatment for hyperkalemic, hypokalemic, and related
variants of Primary Periodic Paralysis. KEVEYIS has orphan drug
exclusivity status in the U.S. through August 7, 2022. In addition
to establishing this neuromuscular disease franchise, the Company
has a clinical-stage pipeline of therapies for rare endocrine
diseases. Strongbridge's lead compounds include
RECORLEV™ (levoketoconazole), a cortisol synthesis
inhibitor currently being studied for the treatment of endogenous
Cushing's syndrome, and veldoreotide, a next-generation
somatostatin analog being investigated for the treatment of
acromegaly, with potential additional applications in Cushing's
syndrome and neuroendocrine tumors. Both RECORLEV and veldoreotide
have received orphan designation from the U.S. Food and Drug
Administration and the European Medicines Agency. For more
information, visit www.strongbridgebio.com.
About KEVEYIS
KEVEYIS® (dichlorphenamide) is indicated for the treatment of
primary hyperkalemic periodic paralysis, primary hypokalemic
periodic paralysis, and related variants. In clinical studies, the
most common side effects of KEVEYIS were a numbness or tingling,
difficulty thinking and paying attention, changes in taste, and
confusion. These are not all of the possible side effects that you
may experience with KEVEYIS. Talk to your doctor if you have any
symptoms that bother you or do not go away. You are encouraged to
report side effects to Strongbridge Biopharma at 1-855-324-8912, or
to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch/.
For additional KEVEYIS important safety information and the
full prescribing information visit www.keveyis.com.
Forward-Looking StatementsThis
press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release,
are forward-looking statements. These statements relate to future
events and involve known and unknown risks, including, without
limitation, uncertainties regarding Strongbridge's strategy, plans,
future financial position, anticipated investments, costs and
results, outcomes of product development efforts, status and
results of clinical trials, and objectives of management for future
operations. The words "anticipate," "estimate," "expect," "intend,"
"may," "plan," "potential," "project," "target," "will," "would,"
or the negative of these terms or other similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. These
forward-looking statements are based on current expectations,
estimates, forecasts and projections and are not guarantees of
future performance or development and involve known and unknown
risks, uncertainties and other factors. The forward-looking
statements contained in this press release are made as of the date
of this press release, and Strongbridge Biopharma does
not assume any obligation to update any forward-looking statements
except as required by applicable law.
Contacts:
Corporate and Media Relations Elixir Health
Public Relations Lindsay Rocco +1 862-596-1304
lrocco@elixirhealthpr.com
Investor RelationsU.S.:The Trout Group Marcy
Nanus +1 646-378-2927 mnanus@troutgroup.com
Europe:First HouseMitra Hagen Negård+47 21 04
62 19strongbridgebio@firsthouse.no
USA 900 Northbrook Drive Suite 200 Trevose,
PA 19053 Tel. +1 610-254-9200 Fax. +1 215-355-7389
STRONGBRIDGE BIOPHARMA plc |
|
Select Consolidated Balance Sheet
Information |
|
(Unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
2017 |
|
|
2016 |
|
|
( in thousands) |
|
Consolidated
Balance Sheet Data: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
44,366 |
|
|
$ |
66,837 |
|
Total
assets |
|
|
92,105 |
|
|
|
137,531 |
|
Total
liabilities |
|
|
111,757 |
|
|
|
70,559 |
|
Total
stockholders’ (deficit) equity |
|
|
(19,652 |
) |
|
|
66,972 |
|
|
|
|
|
|
|
|
|
STRONGBRIDGE BIOPHARMA plc |
|
Consolidated Statement of Operations and
Comprehensive Loss |
|
(Unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Net product
sales |
$ |
2,533 |
|
|
$ |
- |
|
|
$ |
4,062 |
|
|
$ |
- |
|
|
Total revenues |
|
2,533 |
|
|
|
- |
|
|
|
4,062 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (excluding amortization of intangible asset) |
$ |
591 |
|
|
$ |
— |
|
|
$ |
968 |
|
|
$ |
— |
|
|
Selling, general and administrative |
|
8,484 |
|
|
|
3,117 |
|
|
|
26,068 |
|
|
|
11,260 |
|
|
Research and development |
|
4,504 |
|
|
|
4,516 |
|
|
|
12,113 |
|
|
|
15,882 |
|
|
Amortization of intangible asset |
|
1,256 |
|
|
|
— |
|
|
|
3,767 |
|
|
|
— |
|
|
Impairment of intangible asset |
|
20,723 |
|
|
|
— |
|
|
|
20,723 |
|
|
|
5,228 |
|
|
Total cost and expenses |
|
35,558 |
|
|
|
7,633 |
|
|
|
63,639 |
|
|
|
32,370 |
|
|
Operating loss |
|
(33,025 |
) |
|
|
(7,633 |
) |
|
|
(59,577 |
) |
|
|
(32,370 |
) |
|
Other income (expense),
net: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on fair value of warrants |
|
1,953 |
|
|
|
— |
|
|
|
(28,194 |
) |
|
|
— |
|
|
Interest expense |
|
(1,364 |
) |
|
|
— |
|
|
|
(2,838 |
) |
|
|
— |
|
|
Foreign exchange loss |
|
(11 |
) |
|
|
(20 |
) |
|
|
(36 |
) |
|
|
(64 |
) |
|
Loss on early extinguishment of debt |
|
(3,545 |
) |
|
|
— |
|
|
|
(3,545 |
) |
|
|
— |
|
|
Other income (expense), net |
|
82 |
|
|
|
35 |
|
|
|
107 |
|
|
|
(1,211 |
) |
|
Total
other income (expense), net |
|
(2,885 |
) |
|
|
15 |
|
|
|
(34,506 |
) |
|
|
(1,275 |
) |
|
Loss before income
taxes |
|
(35,910 |
) |
|
|
(7,618 |
) |
|
|
(94,083 |
) |
|
|
(33,645 |
) |
|
Income tax (expense)
benefit |
|
850 |
|
|
|
— |
|
|
|
(652 |
) |
|
|
926 |
|
|
Net loss |
|
(35,060 |
) |
|
|
(7,618 |
) |
|
|
(94,735 |
) |
|
|
(32,719 |
) |
|
Net loss attributable
to non‑controlling interest |
|
— |
|
|
|
17 |
|
|
|
— |
|
|
|
122 |
|
|
Net loss attributable
to Strongbridge Biopharma |
$ |
(35,060 |
) |
|
$ |
(7,601 |
) |
|
$ |
(94,735 |
) |
|
$ |
(32,597 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to ordinary shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(35,060 |
) |
|
$ |
(7,601 |
) |
|
$ |
(94,735 |
) |
|
$ |
(32,597 |
) |
|
Net loss per share
attributable to ordinary shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.98 |
) |
|
$ |
(0.36 |
) |
|
$ |
(2.67 |
) |
|
$ |
(1.54 |
) |
|
Weighted-average shares
used in computing net loss per share attributable to ordinary
shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
35,716,247 |
|
|
|
21,205,382 |
|
|
|
35,463,496 |
|
|
|
21,205,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STRONGBRIDGE BIOPHARMA plc |
|
Reconciliation of Non-GAAP Financial
Measures |
|
(Unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
2017 |
|
|
|
Operating loss |
|
Loss before income taxes |
|
Net loss attributable to ordinary shareholders |
|
Net loss per share attributable to ordinary
shareholders |
|
|
|
|
GAAP |
|
|
|
|
($33,025 |
) |
|
($35,910 |
) |
|
($35,060 |
) |
|
($0.98 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible asset (a) |
|
$1,256 |
|
|
$1,256 |
|
|
$1,256 |
|
|
$0.04 |
|
|
|
Impairment
of intangible asset (a) |
|
|
$20,723 |
|
|
$20,723 |
|
|
$20,723 |
|
|
$0.58 |
|
|
|
Stock-based
compensation - Research & Development (b) |
$324 |
|
|
$324 |
|
|
$324 |
|
|
$0.01 |
|
|
|
Stock-based
compensation - Selling, General & Admin. (b) |
$1,007 |
|
|
$1,007 |
|
|
$1,007 |
|
|
$0.03 |
|
|
|
Unrealized
gain on fair value of warrants (c) |
|
|
— |
|
|
($1,953 |
) |
|
($1,953 |
) |
|
($0.05 |
) |
|
|
Non-cash
interest and debt extinguishment expenses (d) |
|
— |
|
|
$1,501 |
|
|
$1,501 |
|
|
$0.04 |
|
|
|
Non-cash
income tax (benefit) expense (e) |
|
|
|
($850 |
) |
|
($850 |
) |
|
($0.02 |
) |
|
|
|
|
|
|
|
|
Adjusted |
|
|
|
|
($9,715 |
) |
|
($13,902 |
) |
|
($13,052 |
) |
|
($0.35 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
2016 |
|
|
|
|
|
|
|
Operating loss |
|
Loss before income taxes |
|
Net loss attributable to ordinary shareholders |
|
Net loss per share attributable to ordinary
shareholders |
|
|
|
|
|
|
|
|
GAAP |
|
|
|
|
($7,633 |
) |
|
($7,618 |
) |
|
($7,601 |
) |
|
($0.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation - Research & Development (b) |
$205 |
|
|
$205 |
|
|
$205 |
|
|
$0.01 |
|
|
|
Stock-based
compensation - Selling, General & Admin. (b) |
$898 |
|
|
$898 |
|
|
$898 |
|
|
$0.04 |
|
|
|
|
|
|
|
|
|
Adjusted |
|
|
|
|
($6,530 |
) |
|
($6,515 |
) |
|
($6,498 |
) |
|
($0.31 |
) |
|
|
|
|
|
|
|
|
STRONGBRIDGE BIOPHARMA plc |
|
Reconciliation of Non-GAAP Financial
Measures |
|
(Unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
2017 |
|
|
|
Operating loss |
|
Loss before income taxes |
|
Net loss attributable to ordinary shareholders |
|
Net loss per share attributable to ordinary
shareholders |
|
|
|
|
GAAP |
|
|
|
|
($59,577 |
) |
|
($94,083 |
) |
|
($94,735 |
) |
|
($2.67 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible asset (a) |
|
$3,767 |
|
|
$3,767 |
|
|
$3,767 |
|
|
$0.11 |
|
|
|
Impairment
of intangible asset (a) |
|
|
$20,723 |
|
|
$20,723 |
|
|
$20,723 |
|
|
$0.58 |
|
|
|
Stock-based
compensation - Research & Development (b) |
$822 |
|
|
$822 |
|
|
$822 |
|
|
$0.02 |
|
|
|
Stock-based
compensation - Selling, General & Admin. (b) |
$3,042 |
|
|
$3,042 |
|
|
$3,042 |
|
|
$0.09 |
|
|
|
Unrealized
loss on fair value of warrants (c) |
|
|
— |
|
|
$28,194 |
|
|
$28,194 |
|
|
$0.80 |
|
|
|
Non-cash
interest expense and loss on early extinguishment of debt (d) |
|
— |
|
|
$2,213 |
|
|
$2,213 |
|
|
$0.06 |
|
|
|
Non-cash
income tax (benefit) expense (e) |
|
|
— |
|
|
|
— |
|
|
$652 |
|
|
$0.02 |
|
|
|
|
|
|
|
|
|
Adjusted |
|
|
|
|
($31,223 |
) |
|
($35,322 |
) |
|
($35,322 |
) |
|
($0.99 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
2016 |
|
|
|
|
|
|
|
Operating loss |
|
Loss before income taxes |
|
Net loss attributable to ordinary shareholders |
|
Net loss per share attributable to ordinary
shareholders |
|
|
|
|
|
|
|
|
GAAP |
|
|
|
|
($32,370 |
) |
|
($33,645 |
) |
|
($32,597 |
) |
|
($1.54 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation - Research & Development (b) |
$401 |
|
|
$401 |
|
|
$401 |
|
|
$0.02 |
|
|
|
Stock-based
compensation - Selling, General & Admin. (b) |
$3,120 |
|
|
$3,120 |
|
|
$3,120 |
|
|
$0.15 |
|
|
|
Impairment
of intangible asset (a) |
|
|
$5,228 |
|
|
$5,228 |
|
|
$5,228 |
|
|
$0.25 |
|
|
|
Non-cash
income tax (benefit) expense (e) |
|
|
— |
|
|
|
— |
|
|
($926 |
) |
|
($0.04 |
) |
|
|
|
|
|
|
|
|
Adjusted |
|
|
|
|
($23,621 |
) |
|
($24,896 |
) |
|
($24,774 |
) |
|
($1.16 |
) |
|
|
|
|
|
|
|
|
(a) The effects of amortization of the intangible assets
and charges related to the impairment of the intangible assets are
excluded because these charges are non-cash, and we believe such
exclusion facilitates investors’ ability to more accurately compare
our operating results to those of our peer companies.
(b) The effects of non-cash employee stock-based compensation
are excluded because of varying available valuation methodologies
and subjective assumptions. We believe this is a useful
measure for investors because such exclusion facilitates comparison
to peer companies who also provide similar non-GAAP disclosures and
is reflective of how management internally manages the
business.
(c) The unrealized gain or loss on fair value of warrants are
excluded due to the nature of this charge, which is non-cash and
related primarily to the effect of changes in the company’s stock
price at a point in time. We believe such exclusion facilitates
investors’ ability to more accurately compare our operating results
to those of our peer companies.
(d) The effects of non-cash interest and debt extinguishment
charges are excluded. We believe such exclusion facilitates an
understanding of the effects of the debt service obligations on the
Company’s liquidity and comparisons to peer group companies, and is
reflective of how management internally manages the business.
(e) The effect of non-cash tax expense or benefit related to
valuation allowance adjustments of the deferred income tax asset is
excluded because of its non-recurring nature. We believe such
exclusion facilitates investor’s ability to more accurately compare
our operating results to those of our peer companies.
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