~ Launched KEVEYIS® (dichlorphenamide) to U.S.
Primary Periodic Paralysis Community, Established Strongbridge
CareConnection Patient Services and Support Program, and Mobilized
12-Person Highly-Experienced Rare Disease Sales Team in April 2017
~
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 updates on its
KEVEYIS® (dichlorphenamide) launch progress and recent business
highlights, and reported second quarter 2017 financial results.
“With the launch of KEVEYIS, the second quarter
was transformational for Strongbridge. We are delighted by the
early uptake trends we saw during the quarter, including converting
more than 85 percent of the 80 pre-existing patients on KEVEYIS to
our commercial supply and patient assistance program, generating
more than 30 new patient start forms and receiving favorable payer
coverage. We also completed a robust quantitative market analysis,
which indicates that the number of diagnosed PPP patients is
approximately double our prior estimates. Based upon early trends
and the expanded market size, we are currently evaluating
increasing our commercial investment in KEVEYIS,” said Matthew
Pauls, president and chief executive officer of Strongbridge
Biopharma.
KEVEYIS Launch Highlights:
- Successfully transitioned more than 85 percent of 80
pre-existing KEVEYIS patients to Strongbridge’s commercial supply
and patient assistance program during the second quarter.
- Significant KEVEYIS market demand demonstrated by more than 30
new patient start forms generated by 12-person sales team in their
first 10 weeks in the field.
- KEVEYIS currently has broad and favorable payer coverage.
- Achieved net product sales of $1.5 million during the second
quarter.
- In an effort to better understand the U.S. prevalence of PPP,
partnered with a leading provider of pharmaceutical data to analyze
their longitudinal claims database, which covers more than 250
million lives. Based upon use of diagnosis codes and
prescription history, this analysis indicates that there are 4,000
to 5,000 active patients in the United States diagnosed with PPP,
or twice earlier estimates that were based upon scientific
literature and physician research.
- Early uptake and upward adjustment of estimated diagnosed
patients provide basis for the evaluation of near-term increased
commercial investment via expansion of the sales team, a
genetic-testing program, and disease-state education and KEVEYIS
promotional initiatives.
“We also achieved a significant milestone for
our rare endocrine disease franchise during the second quarter with
the completion of enrollment in the Phase 3 SONICS study evaluating
RECORLEV in endogenous Cushing’s syndrome,” Pauls added. “Lastly,
the new funds from our recent financing have strengthened our
financial position to extend our cash runway beyond the potential
launch of RECORLEV, and to positive operating cash flows.”
Additional Recent Business Highlights:
- RECORLEV™ (levoketoconazole) Phase 3 Clinical
Development Program and Timelines Remain Consistent with Prior
Guidance, as Demonstrated by Recent SONICS Study Enrollment
Completion and Anticipated LOGICS Study Initiation in Q3
2017 The Phase 3 SONICS study evaluating RECORLEV, a
next-generation cortisol synthesis inhibitor for the treatment of
endogenous Cushing’s syndrome, completed enrollment with 94 total
patients in July 2017, after the Company permitted several
qualified patients to enroll in the study subsequent to achieving
the target enrollment of 90 patients. As previously announced,
Strongbridge anticipates reporting top-line SONICS results in the
second quarter of 2018. Also, as previously announced, the Company
has strengthened its RECORLEV Phase 3 development plan to include
LOGICS, which includes a nine-week, placebo-controlled treatment
phase, that will supplement the long-term efficacy and safety
data from SONICS. Strongbridge anticipates that the first LOGICS
patient will be enrolled during the third quarter of 2017, with
top-line data anticipated in the third quarter of 2018.
- Financial Position Strengthened; Sufficient Existing
Resources Under Current Plan to Achieve Consistent Positive Cash
Flows from Operating Activities Strongbridge
recently announced that it entered into a $50 million senior credit
facility with CRG LP (“CRG”), a healthcare-focused investment firm,
to retire its pre-existing credit facility and provide additional
capital for the Company. Strongbridge initially borrowed $40
million under the term loan agreement and has the option to borrow
an additional $10 million based upon the achievement of a certain
revenue milestone on or prior to June 30, 2018. Concurrent with the
initial borrowing, CRG purchased $3 million of the Company’s
ordinary shares at a price of $6.98 per share. The Company believes
that the combination of existing cash resources at June 30, 2017
together with the net proceeds from the CRG debt and equity
financing provides sufficient cash under its current operating
plan, which includes the potential U.S. regulatory approval and
launch of RECORLEV, to achieve consistent positive cash flows from
operating activities.
Second Quarter 2017 Results
For the three months ended June 30, 2017, basic
and diluted net loss attributable to ordinary shareholders on a
GAAP basis was $30.2 million, or $0.86 per share, compared to a
basic and diluted net loss attributable to ordinary shareholders of
$12.8 million, or $0.61 per share, for the same period in 2016. The
increase in GAAP net loss was primarily due to a non-cash
unrealized loss of $15.2 million on the fair value of the Company’s
warrant liability.
For the three months ended June 30, 2017,
non-GAAP basic and diluted net loss attributable to ordinary
shareholders was $12.2 million, or $0.34 per share, compared to a
non-GAAP basic and diluted net loss attributable to ordinary
shareholders of $7.4 million, or $0.34 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 launch of
KEVEYIS in April 2017.
Non-GAAP net loss for the three months ended
June 30, 2017 excludes $1.3 million of non-cash intangible asset
amortization, $1.4 million of non-cash stock-based compensation
expense, $15.2 million of non-cash unrealized losses on fair value
of warrants, $0.3 million of non-cash interest expense, and a $0.1
million non-cash income tax benefit. Non-GAAP net loss for the
three months ended June 30, 2016 excludes $1.1 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 $1.5 million and cost of goods
sold of $0.4 million for the three months ended June 30, 2017. No
revenue or cost of goods sold was recognized for the same period of
2016.
Research and development expenses were $4.1
million for the three months ended June 30, 2017, compared to $4.6
million for the same period in the prior year. The decrease during
the 2017 period was primarily due to decreased development spend
related to programs discontinued during 2016, a planned decrease in
development activity for veldoreotide, and a timing-related
decrease in expenses relating to the ongoing clinical trials for
RECORLEV.
Selling, general and administrative expenses
were $10.1 million for the three months ended June 30, 2017,
compared to $4.0 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 June 2017
Results
For the six months ended June 30, 2017, basic
and diluted net loss attributable to ordinary shareholders on a
GAAP basis was $59.7 million, or $1.69 per share, compared to a
basic and diluted net loss attributable to ordinary shareholders
$25.0 million, or $1.18 per share, for the same period in 2016. The
increase in GAAP net loss was primarily due to a non-cash
unrealized loss of $30.1 million on the fair value of the Company’s
warrant liability.
For the six months ended June 30, 2017, non-GAAP
basic and diluted net loss attributable to ordinary shareholders
was $22.3 million, or $0.64 per share, compared to a non-GAAP basic
and diluted net loss attributable to ordinary shareholders of $18.3
million, or $0.86 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 launch of KEVEYIS in April
2017.
Non-GAAP net loss for the six months ended June
30, 2017 excludes $2.5 million of non-cash intangible asset
amortization, $2.5 million of non-cash stock-based compensation
expense, $30.1 million of non-cash unrealized losses on fair value
of warrants, $0.7 million of non-cash interest expense, and $1.5
million of non-cash income tax expense. Non-GAAP net loss for the
six months ended June 30, 2016 excludes $2.4 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 $1.5 million and cost of goods
sold of $0.4 million for the six months ended June 30, 2017. No
revenue or cost of goods sold was recognized for the same period of
2016.
Research and development expenses were $7.6
million for the six months ended June 30, 2017, compared to $11.4
million for the same period in the prior year. The decrease during
the 2017 period was primarily due to decreased development spend
related to programs discontinued during 2016, a planned decrease in
development activity for veldoreotide, and a timing-related
decrease in expenses relating to the ongoing clinical trials for
RECORLEV.
Selling, general and administrative expenses
were $17.6 million for the six months ended June 30, 2017, compared
to $8.1 million for the same period in the prior year. The increase
during the 2017 period was primarily due to costs incurred to
establish the necessary commercial and corporate infrastructure to
support the launch and ongoing commercialization of KEVEYIS.
Strongbridge had $33.9 million of cash and cash
equivalents and $20.0 million in outstanding debt as of June 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 debt and equity financing
completed in July 2017 and the repayment of its pre-existing credit
facility, Strongbridge had pro forma cash and cash equivalents of
$53.3 million and pro forma outstanding debt of $40 million as of
June 30, 2017. The Company believes the combination of existing
cash resources at June 30, 2017 and the net proceeds from the debt
and equity financing completed in July 2017 provides sufficient
cash under its current operating plan, which includes 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 Monday, August 7 at 9:00 a.m. ET. To access the live call, dial
844-285-7153 (domestic) or 478-219-0180 (international). 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 61074112.
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, size of patient population, 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.
STRONGBRIDGE BIOPHARMA plc |
|
Select Consolidated Balance Sheet
Information |
|
(Unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
2017 |
|
|
2016 |
|
|
( in thousands) |
|
Consolidated
Balance Sheet Data: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
33,864 |
|
$ |
66,837 |
|
Total
assets |
|
|
103,712 |
|
|
137,531 |
|
Total
liabilities |
|
|
93,882 |
|
|
70,559 |
|
Total
shareholders’ equity |
|
|
9,830 |
|
|
66,972 |
|
STRONGBRIDGE BIOPHARMA plc |
|
Consolidated Statement of Operations and
Comprehensive Loss |
|
(Unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Net
product sales |
$ |
1,529 |
|
|
$ |
- |
|
|
$ |
1,529 |
|
|
$ |
- |
|
|
Total revenues |
|
1,529 |
|
|
|
- |
|
|
|
1,529 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales (excluding amortization of intangible asset) |
$ |
377 |
|
|
$ |
— |
|
|
$ |
377 |
|
|
$ |
— |
|
|
Research
and development |
|
4,128 |
|
|
|
4,572 |
|
|
|
7,609 |
|
|
|
11,366 |
|
|
Selling,
general and administrative |
|
10,142 |
|
|
|
4,014 |
|
|
|
17,584 |
|
|
|
8,143 |
|
|
Amortization of intangible asset |
|
1,255 |
|
|
|
— |
|
|
|
2,511 |
|
|
|
— |
|
|
Impairment of intangible asset |
|
— |
|
|
|
5,228 |
|
|
|
— |
|
|
|
5,228 |
|
|
Total
cost and expenses |
|
15,902 |
|
|
|
13,814 |
|
|
|
28,081 |
|
|
|
24,737 |
|
|
Operating loss |
|
(14,373 |
) |
|
|
(13,814 |
) |
|
|
(26,552 |
) |
|
|
(24,737 |
) |
|
Other income (expense),
net: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on fair value of warrants |
|
(15,219 |
) |
|
|
— |
|
|
|
(30,147 |
) |
|
|
— |
|
|
Interest
expense |
|
(737 |
) |
|
|
— |
|
|
|
(1,474 |
) |
|
|
— |
|
|
Foreign
exchange (loss) gain |
|
(14 |
) |
|
|
3 |
|
|
|
(25 |
) |
|
|
(44 |
) |
|
Other
income (expense), net |
|
60 |
|
|
|
44 |
|
|
|
25 |
|
|
|
(1,246 |
) |
|
Total
other income (expense), net |
|
(15,910 |
) |
|
|
47 |
|
|
|
(31,621 |
) |
|
|
(1,290 |
) |
|
Loss before income
taxes |
|
(30,283 |
) |
|
|
(13,767 |
) |
|
|
(58,173 |
) |
|
|
(26,027 |
) |
|
Income tax (expense)
benefit |
|
92 |
|
|
|
871 |
|
|
|
(1,502 |
) |
|
|
926 |
|
|
Net loss |
|
(30,191 |
) |
|
|
(12,896 |
) |
|
|
(59,675 |
) |
|
|
(25,101 |
) |
|
Net loss attributable
to non‑controlling interest |
|
— |
|
|
|
55 |
|
|
|
— |
|
|
|
105 |
|
|
Net loss attributable
to Strongbridge Biopharma |
$ |
(30,191 |
) |
|
$ |
(12,841 |
) |
|
$ |
(59,675 |
) |
|
$ |
(24,996 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to ordinary shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(30,191 |
) |
|
$ |
(12,841 |
) |
|
$ |
(59,675 |
) |
|
$ |
(24,996 |
) |
|
Net loss per share
attributable to ordinary shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.86 |
) |
|
$ |
(0.61 |
) |
|
$ |
(1.69 |
) |
|
$ |
(1.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
used in computing net loss per share attributable to ordinary
shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
35,335,026 |
|
|
|
21,205,382 |
|
|
|
35,335,026 |
|
|
|
21,205,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STRONGBRIDGE BIOPHARMA plc |
|
Reconciliation of Non-GAAP Financial
Measures |
|
(Unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2017 |
|
|
|
Operating loss |
|
Loss before income taxes |
|
Net loss attributable to Strongbridge Biopharma |
|
Net loss per share attributable to ordinary
shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP |
|
|
|
|
($14,373 |
) |
|
($30,283 |
) |
|
($30,191 |
) |
|
($0.86 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible asset (a) |
|
$1,255 |
|
|
$1,255 |
|
|
$1,255 |
|
|
$0.04 |
|
|
|
Stock-based
compensation - Research & Development (b) |
$281 |
|
|
$281 |
|
|
$281 |
|
|
$0.01 |
|
|
|
Stock-based
compensation - Selling, General & Admin. (b) |
$1,082 |
|
|
$1,082 |
|
|
$1,082 |
|
|
$0.03 |
|
|
|
Unrealized
loss on fair value of warrants (c) |
|
|
— |
|
|
$15,219 |
|
|
$15,219 |
|
|
$0.43 |
|
|
|
Non-cash
interest expense (d) |
|
|
|
— |
|
|
$270 |
|
|
$270 |
|
|
$0.01 |
|
|
|
Non-cash
income tax (benefit) expense (e) |
|
|
— |
|
|
|
— |
|
|
($92 |
) |
|
$0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted |
|
|
|
|
($11,755 |
) |
|
($12,176 |
) |
|
($12,176 |
) |
|
($0.34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
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|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2016 |
|
|
|
|
|
|
|
Operating loss |
|
Loss before income taxes |
|
Net loss attributable to Strongbridge Biopharma |
|
Net loss per share attributable to ordinary
shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP |
|
|
|
|
($13,814 |
) |
|
($13,767 |
) |
|
($12,841 |
) |
|
($0.61 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation - Research & Development (b) |
($87 |
) |
|
($87 |
) |
|
($87 |
) |
|
$0.00 |
|
|
|
Stock-based
compensation - Selling, General & Admin. (b) |
$1,177 |
|
|
$1,177 |
|
|
$1,177 |
|
|
$0.06 |
|
|
|
Impairment
of intangible asset (a) |
|
|
$5,228 |
|
|
$5,228 |
|
|
$5,228 |
|
|
$0.25 |
|
|
|
Non-cash
income tax (benefit) expense (e) |
|
|
— |
|
|
|
— |
|
|
($871 |
) |
|
($0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted |
|
|
|
|
($7,496 |
) |
|
($7,449 |
) |
|
($7,394 |
) |
|
($0.34 |
) |
|
|
|
|
|
|
|
|
STRONGBRIDGE BIOPHARMA plc |
|
Reconciliation of Non-GAAP Financial
Measures |
|
(Unaudited, in thousands, except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2017 |
|
|
|
Operating loss |
|
Loss before income taxes |
|
Net loss attributable to Strongbridge Biopharma |
|
Net loss per share attributable to ordinary
shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP |
|
|
|
|
($26,552 |
) |
|
($58,173 |
) |
|
($59,675 |
) |
|
($1.69 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible asset (a) |
|
$2,511 |
|
|
$2,511 |
|
|
$2,511 |
|
|
$0.07 |
|
|
|
Stock-based
compensation - Research & Development (b) |
$498 |
|
|
$498 |
|
|
$498 |
|
|
$0.01 |
|
|
|
Stock-based
compensation - Selling, General & Admin. (b) |
$2,035 |
|
|
$2,035 |
|
|
$2,035 |
|
|
$0.06 |
|
|
|
Unrealized
loss on fair value of warrants (c) |
|
|
— |
|
|
$30,147 |
|
|
$30,147 |
|
|
$0.85 |
|
|
|
Non-cash
interest expense (d) |
|
|
|
— |
|
|
$712 |
|
|
$712 |
|
|
$0.02 |
|
|
|
Non-cash
income tax (benefit) expense (e) |
|
|
— |
|
|
|
— |
|
|
$1,502 |
|
|
$0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted |
|
|
|
|
($21,508 |
) |
|
($22,270 |
) |
|
($22,270 |
) |
|
($0.64 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2016 |
|
|
|
|
|
|
|
Operating loss |
|
Loss before income taxes |
|
Net loss attributable to Strongbridge Biopharma |
|
Net loss per share attributable to ordinary
shareholders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP |
|
|
|
|
($24,737 |
) |
|
($26,027 |
) |
|
($24,996 |
) |
|
($1.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation - Research & Development (b) |
$196 |
|
|
$196 |
|
|
$196 |
|
|
$0.01 |
|
|
|
Stock-based
compensation - Selling, General & Admin. (b) |
$2,222 |
|
|
$2,222 |
|
|
$2,222 |
|
|
$0.10 |
|
|
|
Impairment
of intangible asset (a) |
|
|
$5,228 |
|
|
$5,228 |
|
|
$5,228 |
|
|
$0.25 |
|
|
|
Non-cash
income tax (benefit) expense (e) |
|
|
— |
|
|
|
— |
|
|
($926 |
) |
|
($0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted |
|
|
|
|
($17,091 |
) |
|
($18,381 |
) |
|
($18,276 |
) |
|
($0.86 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) The effects of amortization of the
intangible asset acquired in the KEVEYIS acquisition, and charges
related to impairment of the intangible asset acquired in the
BioPancreate acquisition 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 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 charges
related to the term loan 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 resulting from the acquisition of BioPancreate 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.
Contacts:
Corporate and Media Relations
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
lrocco@elixirhealthpr.com
Investor Relations
U.S.:
The Trout Group
Marcy Nanus
+1 646-378-2927
mnanus@troutgroup.com
Europe:
First House
Mitra Hagen Negård
+47 21 04 62 19
strongbridgebio@firsthouse.no
USA
900 Northbrook Drive
Suite 200
Trevose, PA 19053
Tel. +1 610-254-9200
Fax. +1 215-355-7389
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