Total Revenues for the Third Quarter Were
$39.7 Million
Avadel Pharmaceuticals plc (NASDAQ:AVDL) today announced its
financial results for the third quarter ended September 30, 2017.
Highlights Include:
- Total revenues for the third quarter 2017 were $39.7 million,
compared to $32.1 million in the third quarter 2016.
- GAAP net income for the third quarter of 2017 was $21.7
million, or $0.52 per diluted share, compared to GAAP net loss of
$20.0 million, or $0.48 per diluted share, in the third quarter of
2016.
- Adjusted net income for the third quarter of 2017 was $3.7
million, or $0.09 per diluted share, compared to an adjusted net
loss of $3.5 million, or $0.08 per diluted share, in the third
quarter of 2016. (1)
- On September 1, 2017, the Company acquired the commercial
license for Noctiva™, the first and only product approved by the
U.S. Food & Drug Administration (FDA) for the treatment of
nocturia due to nocturnal polyuria in adults.
- Cash and marketable securities at September 30, 2017 were
$115.6 million, down from $173.8 million at June 30, 2017, largely
as a result of cash used for the Noctiva license acquisition.
- Cash used for share repurchases totaled $16.7 million for the
nine months ended September 30, 2017.
Mike Anderson, Avadel's Chief Executive Officer,
said, "The third quarter of 2017 was another strong quarter for
Avadel. Operationally, the Company continues to execute. We have
generated $30 million in operating cash flow year-to-date, and we
have maintained our full year revenue guidance of $165-$175
million. Our strong financial performance over the last few years
has allowed us to invest in the development and acquisition of
proprietary specialty products that will provide the Company with
long-term growth opportunities."
Mr. Anderson continued, "In early September, we
took another step forward in the continued pursuit of becoming a
fully integrated specialty pharmaceutical company when we acquired
the license to commercialize Noctiva. Noctiva is the first and only
product approved by the FDA for the treatment of nocturia, and
aligns with our mission to offer patients differentiated specialty
products that are safe and effective. We also believe Noctiva is an
excellent strategic growth opportunity for Avadel, as it is the
only available FDA approved product for this indication and has
excellent patent protection through 2030 with the potential to
deliver meaningful shareholder value."
Third Quarter 2017 Results
Revenues during the third quarter of 2017 were
$39.7 million, compared to $32.1 million during the same period
last year. The increase in revenues was due to Akovaz®, which was
not fully launched in the third quarter of 2016. However, this
increase was partially offset by a decline in Bloxiverz® revenues,
primarily as a result of additional competition to neostigmine in
the form of an alternative molecule, sugammadex, and continued
pricing pressure due to four competing neostigmine products. On a
GAAP basis, net income was $21.7 million during the third quarter
of 2017, or $0.52 per diluted share, compared to a net loss of
$20.0 million, or $0.48 per diluted share, for the same period last
year. This increase in net income on a year-over-year basis was
attributed to $9.9 million of gains related to changes in the fair
value of related party contingent consideration for the third of
quarter 2017, compared to $20.8 million of expense in the same
period last year. Changes in the fair value of related party
contingent consideration are non-cash items, and do not reflect the
cash amount paid to related parties. Cash payments can be found in
the Consolidated Statement of Cash Flows.
Research and development expenses totaled $8.1
million for the third quarter of 2017, flat compared to the same
period last year. Sequentially, research and development
expenses were up from $6.8 million in the second quarter of 2017 as
a result of increased spend on the REST-ON clinical trial. Research
and development expenses are expected to increase in the fourth
quarter of 2017 as the Company continues to open clinical sites in
the United States and looks to add sites in new countries.
Selling, general and administrative expenses
were $11.6 million in the third quarter of 2017, compared to $12.7
million in the same period last year. This decrease was largely due
to a lower in stock based compensation expense period over period,
partially offset by higher payroll and benefit costs as the Company
continues to hire new employees to support future growth of the
business.
Adjusted net income for the third quarter of
2017 was $3.7 million, or $0.09 per diluted share, compared to an
adjusted net loss of $3.5 million, or $0.08 per diluted share, in
the same period last year.(1) The increase in adjusted net
income is largely attributable to an increase in revenues from
Akovaz® and a lower adjusted effective tax rate of 58% compared to
283% in the prior year period. Please see the Supplemental
Information section within this document for a reconciliation of
adjusted net income and adjusted diluted EPS to the respective GAAP
amounts.
2017 Guidance
The Company reiterated its full year revenue guidance of between
$165 and $175 million. During the fourth quarter of 2017, the
Company expects to spend approximately $15 million on launch
preparation costs for Noctiva, and between $8 to $10 million in
research and development costs, principally associated with the
REST-ON clinical trial. For the full year, research and development
costs are now expected to be in the range of $30 to $35 million and
selling, general & administrative costs are expected to be in
the range of $60 to $65 million, inclusive of the Noctiva launch
preparation costs. As a result of the Noctiva costs, the Company
slightly lowered its full year adjusted diluted EPS guidance to
$0.25 to $0.35, down from $0.30 to $0.45.
Conference Call
A conference call to discuss these results has been scheduled
for Wednesday, November 8, 2017 at 10:00 a.m. EST. A question and
answer period will follow management's prepared remarks. To access
the conference call, investors are invited to dial (844) 388-0559
(U.S. and Canada) or (216) 562-0393 (International). The conference
ID number is 6289129. A live audio webcast can be accessed by
visiting the Investors section of the Company’s
website, www.avadel.com. A replay of the webcast will be
archived on Avadel’s website for 90 days following the event.
About Avadel Pharmaceuticals
plc:
Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a
specialty pharmaceutical company that seeks to develop
differentiated pharmaceutical products that are safe, effective and
easy to take through formulation development, by utilizing its
proprietary drug delivery technology and in-licensing / acquiring
new products; ultimately, helping patients adhere to their
prescribed medical treatment and see better results. The Company is
headquartered in Dublin, Ireland with operations in St. Louis,
Missouri, United States and Lyon, France. For more information,
please visit www.avadel.com.
About Noctiva™Noctiva is the
first and only formulation of desmopressin acetate, a vasopressin
analog, approved by the FDA for the treatment of nocturia due to
nocturnal polyuria in adults who awaken at least two times per
night to void. It is a proprietary low-dose formulation of
desmopressin acetate administered through a patent-protected
preservative-free intranasal delivery system. Noctiva is dosed as a
single spray in one nostril 30 minutes before bedtime, and is
approved in two dosage forms of 0.83 mcg and 1.66 mcg. Noctiva is
expected to become available to patients in the second quarter of
2018. (Full Prescribing Information available here).
Important Safety Information and
Indication for Noctiva (desmopressin
acetate)WARNING: HYPONATREMIA
- NOCTIVA can cause hyponatremia. Severe hyponatremia can
be life-threatening, leading to seizures, coma, respiratory arrest,
or death.
- NOCTIVA is contraindicated in patients at increased
risk of severe hyponatremia, such as patients with excessive fluid
intake, illnesses that can cause fluid or electrolyte imbalances,
and in those using loop diuretics or systemic or inhaled
glucocorticoids.
- Ensure serum sodium concentrations are normal before
starting or resuming NOCTIVA. Measure serum sodium within seven
days and approximately one month after initiating therapy or
increasing the dose, and periodically during treatment. More
frequently monitor serum sodium in patients 65 years of age and
older and in patients at increased risk of
hyponatremia.
- If hyponatremia occurs, NOCTIVA may need to be
temporarily or permanently discontinued.
Safe Harbor: This press release
may include forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. The words “will,” “may,”
“believe,” “expect,” “anticipate,” “estimate,” “project” and
similar expressions, and the negatives thereof, identify
forward-looking statements, each of which speaks only as of the
date the statement is made. Although we believe that our
forward-looking statements are based on reasonable assumptions
within the bounds of our knowledge of our business and operations,
our business is subject to significant risks and as a result there
can be no assurance that actual results of our research,
development and commercialization activities and our results of
operations will not differ materially from the results contemplated
in such forward-looking statements. These risks include: (i) risks
relating to our license agreement with Serenity Pharmaceuticals,
LLC including that our internal analyses may overstate the market
opportunity in the United States for the drug desmopressin acetate
(the “Drug”) or we may not effectively exploit such market
opportunity, that significant safety or drug interaction problems
could arise with respect to the Drug, that we may not successfully
increase awareness of nocturia and the potential benefits of the
Drug, and that the need for management to focus attention on the
development and commercialization of the Drug could cause our
ongoing business operations to suffer; and (ii) the other risks,
uncertainties and contingencies described in the Company's filings
with the U.S. Securities and Exchange Commission, including our
annual report on Form 10-K for the year ended December 31, 2016, in
particular under the captions “Forward-Looking Statements” and
“Risk Factors,” including without limitation: our dependence on a
small number of products and customers for the majority of our
revenues; the possibility that our Bloxiverz®,Vazculep® and Akovaz®
products, which are not patent protected, could face substantial
competition resulting in a loss of market share or forcing us to
reduce the prices we charge for those products; the possibility
that we could fail to successfully complete the research and
development for pipeline products we are evaluating for potential
application to the FDA pursuant to our "unapproved-to-approved"
strategy, or that competitors could complete the development of
such products and apply for FDA approval of such products before
us; the possibility that our products may not reach the commercial
market or gain market acceptance; our need to invest substantial
sums in research and development in order to remain competitive;
our dependence on certain single providers for development of
several of our drug delivery platforms and products; our dependence
on a limited number of suppliers to manufacture our products and to
deliver certain raw materials used in our products; the possibility
that our competitors may develop and market technologies or
products that are more effective or safer than ours, or obtain
regulatory approval and market such technologies or products before
we do; the challenges in protecting the intellectual property
underlying our drug delivery platforms and other products; and our
dependence on key personnel to execute our business plan. Except as
may be required by law, we disclaim any obligation to publicly
update any forward-looking statements to reflect events after the
date of this press release.
Non-GAAP Disclosures and
Adjustments
Avadel discloses certain non-GAAP financial
measures, including adjusted net income and loss and adjusted net
income and loss per diluted share, as management believes that a
comparison of its current and historical results would be difficult
if the disclosures were limited to financial measures prepared only
in accordance with generally accepted accounting principles (GAAP)
in the U.S. In addition to reporting its financial results in
accordance with GAAP, Avadel reports certain non-GAAP results that
exclude, if any, fair value remeasurements of its contingent
consideration, impairment of intangible assets, amortization of
intangible assets, restructuring costs, foreign exchange gains and
losses on assets and liabilities denominated in foreign currencies,
but includes the operating cash flows plus any unpaid accrued
amounts associated with the contingent consideration, in
order to supplement investors' and other readers' understanding and
assessment of the Company's financial performance. The
Company's management uses these non-GAAP measures internally for
forecasting, budgeting and measuring its operating
performance. Investors and other readers should review the
related GAAP financial measures and the reconciliation of non-GAAP
measures to their most closely applicable GAAP measure set forth
below and should consider non-GAAP measures only as a supplement
to, not as a substitute for or as a superior measure to, measures
of financial performance prepared in accordance with GAAP. The
table provided within the following “Supplemental Information”
section reconciles GAAP net income and loss and diluted earnings or
loss per share to the corresponding adjusted amounts.
___________________________
1Non-GAAP financial measure: Descriptions of
Avadel’s non-GAAP financial measures are included under the caption
Non-GAAP Disclosures and Adjustments included within this press
release and reconciliations of such non-GAAP financial measures to
their most closely applicable GAAP financial measures are found in
the Supplemental Information section herein.
Contacts: |
Michael F. Kanan |
|
Chief Financial Officer |
|
Phone: (636) 449-1844 |
|
Email: mkanan@avadel.com |
|
|
|
Lauren Stival |
|
Sr. Director, Investor Relations & Corporate
Communications |
|
Phone: (636) 449-5866 |
|
Email: lstival@avadel.com |
AVADEL PHARMACEUTICALS PLC |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF
INCOME (LOSS) |
(In thousands, except per share data) |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
Product
sales and services |
|
$ |
39,147 |
|
|
$ |
31,340 |
|
|
$ |
138,009 |
|
|
$ |
104,858 |
|
License
and research revenue |
|
528 |
|
|
747 |
|
|
484 |
|
|
2,303 |
|
Total |
|
39,675 |
|
|
32,087 |
|
|
138,493 |
|
|
107,161 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of
products and services sold |
|
3,790 |
|
|
2,844 |
|
|
12,253 |
|
|
10,657 |
|
Research
and development expenses |
|
8,095 |
|
|
8,143 |
|
|
22,093 |
|
|
21,135 |
|
Selling,
general and administrative expenses |
|
11,563 |
|
|
12,740 |
|
|
35,804 |
|
|
33,491 |
|
Intangible asset amortization |
|
564 |
|
|
3,702 |
|
|
1,692 |
|
|
10,918 |
|
(Gain)/loss - changes in fair value of related party contingent
consideration |
|
(9,906 |
) |
|
20,848 |
|
|
(30,107 |
) |
|
52,989 |
|
Restructuring (income) costs |
|
(549 |
) |
|
— |
|
|
3,173 |
|
|
— |
|
Total
operating expenses |
|
13,557 |
|
|
48,277 |
|
|
44,908 |
|
|
129,190 |
|
Operating
income (loss) |
|
26,118 |
|
|
(16,190 |
) |
|
93,585 |
|
|
(22,029 |
) |
Investment income, net |
|
1,110 |
|
|
490 |
|
|
2,689 |
|
|
1,080 |
|
Interest
expense, net |
|
(263 |
) |
|
(264 |
) |
|
(789 |
) |
|
(702 |
) |
Other
income (expense) - changes in fair value of related party
payable |
|
768 |
|
|
(1,828 |
) |
|
2,988 |
|
|
(6,135 |
) |
Foreign
exchange gain (loss) |
|
(133 |
) |
|
1,249 |
|
|
(127 |
) |
|
(12 |
) |
Income
(loss) before income taxes |
|
27,600 |
|
|
(16,543 |
) |
|
98,346 |
|
|
(27,798 |
) |
Income
tax provision |
|
5,921 |
|
|
3,451 |
|
|
21,830 |
|
|
18,212 |
|
Net
income (loss) |
|
$ |
21,679 |
|
|
$ |
(19,994 |
) |
|
$ |
76,516 |
|
|
$ |
(46,010 |
) |
|
|
|
|
|
|
|
|
|
Net
income (loss) per share - basic |
|
$ |
0.54 |
|
|
$ |
(0.48 |
) |
|
$ |
1.87 |
|
|
$ |
(1.12 |
) |
Net
income (loss) per share - diluted |
|
0.52 |
|
|
(0.48 |
) |
|
1.81 |
|
|
(1.12 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average number of shares outstanding - basic |
|
40,061 |
|
|
41,241 |
|
|
40,839 |
|
|
41,241 |
|
Weighted
average number of shares outstanding - diluted |
|
41,339 |
|
|
41,241 |
|
|
42,194 |
|
|
41,241 |
|
AVADEL PHARMACEUTICALS PLC |
UNAUDITED CONDENSED CONSOLIDATED BALANCE
SHEETS |
(In thousands, except per share data) |
|
|
September 30, 2017 |
|
December 31, 2016 |
|
|
|
|
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and
cash equivalents |
|
$ |
37,449 |
|
|
$ |
39,215 |
|
Marketable securities |
|
78,161 |
|
|
114,980 |
|
Accounts
receivable |
|
24,080 |
|
|
17,839 |
|
Inventories, net |
|
5,870 |
|
|
3,258 |
|
Prepaid
expenses and other current assets |
|
3,373 |
|
|
5,894 |
|
Total
current assets |
|
148,933 |
|
|
181,186 |
|
Property
and equipment, net |
|
3,180 |
|
|
3,320 |
|
Goodwill |
|
18,491 |
|
|
18,491 |
|
Intangible assets, net |
|
94,256 |
|
|
22,837 |
|
Research
and development tax credit receivable |
|
3,547 |
|
|
1,775 |
|
Income
tax deferred charge |
|
— |
|
|
10,342 |
|
Other |
|
9,020 |
|
|
7,531 |
|
Total
assets |
|
$ |
277,427 |
|
|
$ |
245,482 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
|
Current
liabilities: |
|
|
|
|
Current
portion of long-term debt |
|
$ |
301 |
|
|
$ |
268 |
|
Current
portion of long-term related party payable |
|
30,986 |
|
|
34,177 |
|
Accounts
payable |
|
8,564 |
|
|
7,105 |
|
Deferred
revenue |
|
1,927 |
|
|
2,223 |
|
Accrued
expenses |
|
47,997 |
|
|
17,222 |
|
Income
taxes |
|
7,026 |
|
|
1,200 |
|
Other |
|
507 |
|
|
226 |
|
Total
current liabilities |
|
97,308 |
|
|
62,421 |
|
Long-term
debt, less current portion |
|
614 |
|
|
547 |
|
Long-term
related party payable, less current portion |
|
76,131 |
|
|
135,170 |
|
Other |
|
6,911 |
|
|
5,275 |
|
Total
liabilities |
|
180,964 |
|
|
203,413 |
|
|
|
|
|
|
Shareholders' equity: |
|
|
|
|
Preferred
shares, $0.01 nominal value; 50,000 shares authorized; none issued
or outstanding at September 30, 2017 and December 31, 2016,
respectively |
|
— |
|
|
— |
|
Ordinary
shares, nominal value of $0.01; 500,000 shares authorized; 41,435
and 41,371 issued and outstanding at September 30, 2017 and
December 31, 2016, respectively |
|
414 |
|
|
414 |
|
Treasury
shares, at cost, 1,673 and 0 shares held at September 30, 2017 and
December 31, 2016, respectively |
|
(17,506 |
) |
|
— |
|
Additional paid-in capital |
|
391,416 |
|
|
385,020 |
|
Accumulated deficit |
|
(254,440 |
) |
|
(319,800 |
) |
Accumulated other comprehensive loss |
|
(23,421 |
) |
|
(23,565 |
) |
Total
shareholders' equity |
|
96,463 |
|
|
42,069 |
|
Total
liabilities and shareholders' equity |
|
$ |
277,427 |
|
|
$ |
245,482 |
|
AVADEL PHARMACEUTICALS PLC |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS |
(In thousands) |
|
|
Nine Months Ended September 30, |
|
|
2017 |
|
2016 |
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
Net
income (loss) |
|
76,516 |
|
|
(46,010 |
) |
Adjustments to reconcile net income (loss) to net cash provided by
operating activities: |
|
|
|
|
Depreciation and amortization |
|
2,664 |
|
|
11,555 |
|
Loss on
disposal of property and equipment |
|
— |
|
|
110 |
|
Loss
(gain) on sale of marketable securities |
|
(550 |
) |
|
666 |
|
Foreign
exchange loss |
|
127 |
|
|
12 |
|
Grants
recognized in research and development expenses |
|
— |
|
|
(70 |
) |
Remeasurement of related party acquisition-related contingent
consideration |
|
(30,107 |
) |
|
52,989 |
|
Remeasurement of related party financing-related contingent
consideration |
|
(2,988 |
) |
|
6,135 |
|
Change in
deferred tax and income tax deferred charge |
|
322 |
|
|
(5,680 |
) |
Stock-based compensation expense |
|
6,019 |
|
|
10,541 |
|
Increase
(decrease) in cash from: |
|
|
|
|
Accounts
receivable |
|
(6,240 |
) |
|
(7,594 |
) |
Inventories |
|
(2,612 |
) |
|
2,080 |
|
Prepaid
expenses and other current assets |
|
1,924 |
|
|
671 |
|
Research
and development tax credit receivable |
|
(1,576 |
) |
|
(1,794 |
) |
Accounts
payable & other current liabilities |
|
804 |
|
|
1,291 |
|
Deferred
revenue |
|
(283 |
) |
|
(2,198 |
) |
Accrued
expenses |
|
9,324 |
|
|
2,700 |
|
Accrued
income taxes |
|
5,826 |
|
|
— |
|
Earn-out
payments for related party contingent consideration in excess of
acquisition-date fair value |
|
(24,729 |
) |
|
(14,486 |
) |
Royalty
payments for related party payable in excess of original fair
value |
|
(3,446 |
) |
|
(1,790 |
) |
Other
long-term assets and liabilities |
|
(517 |
) |
|
2,032 |
|
Net cash
provided by operating activities |
|
30,478 |
|
|
11,160 |
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
Purchases
of property and equipment |
|
(533 |
) |
|
(1,000 |
) |
Acquisitions of businesses |
|
— |
|
|
628 |
|
Purchase
of intangible assets |
|
(52,139 |
) |
|
— |
|
Proceeds
from sales of marketable securities |
|
153,398 |
|
|
46,483 |
|
Purchases
of marketable securities |
|
(115,893 |
) |
|
(96,199 |
) |
Net cash
used in investing activities |
|
(15,167 |
) |
|
(50,088 |
) |
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
Earn-out
payments for related party contingent consideration |
|
(961 |
) |
|
(6,834 |
) |
Royalty
payments for related party payable |
|
— |
|
|
(1,117 |
) |
Reimbursement of loans |
|
— |
|
|
(61 |
) |
Cash
proceeds from issuance of ordinary shares and warrants |
|
376 |
|
|
— |
|
Share
repurchases |
|
(16,707 |
) |
|
— |
|
Net cash
used in financing activities |
|
(17,292 |
) |
|
(8,012 |
) |
|
|
|
|
|
Effect of
foreign currency exchange rate changes on cash and cash
equivalents |
|
215 |
|
|
656 |
|
|
|
|
|
|
Net
decrease in cash and cash equivalents |
|
(1,766 |
) |
|
(46,284 |
) |
Cash and
cash equivalents at January 1, |
|
39,215 |
|
|
65,064 |
|
Cash and
cash equivalents at September 30, |
|
$ |
37,449 |
|
|
$ |
18,780 |
|
AVADEL PHARMACEUTICALS PLC |
UNAUDITED SUPPLEMENTAL
INFORMATION |
(In thousands, except per share data) |
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
Revenues by Product: |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
Bloxiverz |
|
$ |
9,920 |
|
|
$ |
15,591 |
|
|
$ |
37,541 |
|
|
$ |
65,958 |
|
Vazculep |
|
9,573 |
|
|
9,340 |
|
|
29,906 |
|
|
29,167 |
|
Akovaz |
|
18,561 |
|
|
5,568 |
|
|
65,110 |
|
|
5,568 |
|
Other |
|
1,093 |
|
|
841 |
|
|
5,452 |
|
|
4,165 |
|
Total
product sales and services |
|
39,147 |
|
|
31,340 |
|
|
138,009 |
|
|
104,858 |
|
License
and research revenue |
|
528 |
|
|
747 |
|
|
484 |
|
|
2,303 |
|
Total
revenues |
|
$ |
39,675 |
|
|
$ |
32,087 |
|
|
$ |
138,493 |
|
|
$ |
107,161 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP to Non-GAAP adjustments for the
three-months ended September 30, 2017 |
|
|
|
|
|
|
|
|
Exclude |
|
Include |
|
|
|
|
|
|
GAAP |
|
Intangible asset amortization |
|
Foreign exchange (gain)/loss |
|
Restructuring impacts |
|
Contingent related party payable fair value
adjustment |
|
Contingent related party payable
paid/accrued |
|
Total adjustments |
|
Adjusted GAAP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales and services |
|
$ |
39,147 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
39,147 |
|
License
and research revenue |
|
528 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
528 |
|
Total |
|
39,675 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
39,675 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
products and services sold |
|
3,790 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
3,790 |
|
Research
and development |
|
8,095 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
8,095 |
|
Selling,
general and administrative |
|
11,563 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
11,563 |
|
Intangible asset amortization |
|
564 |
|
|
(564 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(564 |
) |
|
— |
|
Changes
in fair value of related party contingent consideration |
|
(9,906 |
) |
|
— |
|
|
— |
|
|
— |
|
|
9,906 |
|
|
7,264 |
|
|
17,170 |
|
|
7,264 |
|
Restructuring costs |
|
(549 |
) |
|
— |
|
|
— |
|
|
549 |
|
|
— |
|
|
— |
|
|
549 |
|
|
— |
|
Total |
|
13,557 |
|
|
(564 |
) |
|
— |
|
|
549 |
|
|
9,906 |
|
|
7,264 |
|
|
17,155 |
|
|
30,712 |
|
Operating income
(loss) |
|
26,118 |
|
|
564 |
|
|
— |
|
|
(549 |
) |
|
(9,906 |
) |
|
(7,264 |
) |
|
(17,155 |
) |
|
8,963 |
|
Investment and other income |
|
1,110 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,110 |
|
Interest
expense |
|
(263 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(263 |
) |
Other
expense - changes in fair value of related party payable |
|
768 |
|
|
— |
|
|
— |
|
|
— |
|
|
(768 |
) |
|
(963 |
) |
|
(1,731 |
) |
|
(963 |
) |
Foreign
exchange gain |
|
(133 |
) |
|
— |
|
|
133 |
|
|
— |
|
|
— |
|
|
— |
|
|
133 |
|
|
— |
|
Income (loss) before
income taxes |
|
27,600 |
|
|
564 |
|
|
133 |
|
|
(549 |
) |
|
(10,674 |
) |
|
(8,227 |
) |
|
(18,753 |
) |
|
8,847 |
|
Income
tax provision (benefit) |
|
5,921 |
|
|
201 |
|
|
— |
|
|
— |
|
|
(507 |
) |
|
(515 |
) |
|
(821 |
) |
|
5,100 |
|
Net income (loss) |
|
$ |
21,679 |
|
|
$ |
363 |
|
|
$ |
133 |
|
|
$ |
(549 |
) |
|
$ |
(10,167 |
) |
|
$ |
(7,712 |
) |
|
$ |
(17,932 |
) |
|
$ |
3,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share - diluted(1) |
|
0.52 |
|
|
$ |
0.01 |
|
|
$ |
— |
|
|
$ |
(0.01 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.43 |
) |
|
$ |
0.09 |
|
Weighted average number
of shares outstanding - diluted |
|
41,339 |
|
|
41,339 |
|
|
41,339 |
|
|
41,339 |
|
|
41,339 |
|
|
41,339 |
|
|
41,339 |
|
|
41,339 |
|
(1) Net income (loss) per share - diluted
is calculated by dividing Net income (loss) by the Weighted average
number of shares outstanding - diluted. Note, when recalculated
using this method, the balances in the Total adjustment and
Adjusted GAAP columns may not cross-foot as a result of rounding to
full precision.
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP to Non-GAAP adjustments for the
three-months ended September 30, 2016 |
|
|
|
|
|
|
|
|
Exclude |
|
Include |
|
|
|
|
|
|
GAAP |
|
Intangible asset amortization |
|
Foreign exchange (gain)/loss |
|
Contingent related party payable fair value
adjustment |
|
Contingent related party payable
paid/accrued |
|
Total adjustments |
|
Adjusted GAAP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales and services |
|
$ |
31,340 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
31,340 |
|
License
and research revenue |
|
747 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
747 |
|
Total |
|
32,087 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
32,087 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
products and services sold |
|
2,844 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,844 |
|
Research
and development |
|
8,143 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
8,143 |
|
Selling,
general and administrative |
|
12,740 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
12,740 |
|
Intangible asset amortization |
|
3,702 |
|
|
(3,702 |
) |
|
— |
|
|
— |
|
|
— |
|
|
(3,702 |
) |
|
— |
|
Changes
in fair value of related party contingent consideration |
|
20,848 |
|
|
— |
|
|
— |
|
|
(20,848 |
) |
|
5,884 |
|
|
(14,964 |
) |
|
5,884 |
|
Restructuring costs |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Total |
|
48,277 |
|
|
(3,702 |
) |
|
— |
|
|
(20,848 |
) |
|
5,884 |
|
|
(18,666 |
) |
|
29,611 |
|
Operating income
(loss) |
|
(16,190 |
) |
|
3,702 |
|
|
— |
|
|
20,848 |
|
|
(5,884 |
) |
|
18,666 |
|
|
2,476 |
|
Investment and other income |
|
490 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
490 |
|
Interest
expense |
|
(264 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(264 |
) |
Other
expense - changes in fair value of related party payable |
|
(1,828 |
) |
|
— |
|
|
— |
|
|
1,828 |
|
|
(785 |
) |
|
1,043 |
|
|
(785 |
) |
Foreign
exchange gain |
|
1,249 |
|
|
— |
|
|
(1,249 |
) |
|
— |
|
|
— |
|
|
(1,249 |
) |
|
— |
|
Income (loss) before
income taxes |
|
(16,543 |
) |
|
3,702 |
|
|
(1,249 |
) |
|
22,676 |
|
|
(6,669 |
) |
|
18,460 |
|
|
1,917 |
|
Income
tax provision (benefit) |
|
3,451 |
|
|
1,329 |
|
|
— |
|
|
1,021 |
|
|
(385 |
) |
|
1,965 |
|
|
5,416 |
|
Net income (loss) |
|
$ |
(19,994 |
) |
|
$ |
2,373 |
|
|
$ |
(1,249 |
) |
|
$ |
21,655 |
|
|
$ |
(6,284 |
) |
|
$ |
16,495 |
|
|
$ |
(3,499 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share - diluted(1) |
|
(0.48 |
) |
|
$ |
0.06 |
|
|
$ |
(0.03 |
) |
|
$ |
0.53 |
|
|
$ |
(0.15 |
) |
|
$ |
0.40 |
|
|
$ |
(0.08 |
) |
Weighted average number
of shares outstanding - diluted |
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
(1) Net income (loss) per share - diluted
is calculated by dividing Net income (loss) by the Weighted average
number of shares outstanding - diluted. Note, when recalculated
using this method, the balances in the Total adjustment and
Adjusted GAAP columns may not cross-foot as a result of rounding to
full precision.
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP to Non-GAAP adjustments for the
nine-months ended September 30, 2017 |
|
|
|
|
|
|
|
|
Exclude |
|
Include |
|
|
|
|
|
|
GAAP |
|
Intangible asset
amortization |
|
Foreign exchange
(gain)/loss |
|
Restructuring impacts |
|
Purchase accounting adjustment -
FSC |
|
License revenue |
|
Contingent related party payable
fair value adjustment |
|
Contingent related party payable
paid/accrued |
|
Total adjustments |
|
Adjusted GAAP |
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales and services |
|
$ |
138,009 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
138,009 |
|
License
and research revenue |
|
484 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,100 |
|
|
— |
|
|
— |
|
|
1,100 |
|
|
1,584 |
|
Total |
|
138,493 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,100 |
|
|
— |
|
|
— |
|
|
1,100 |
|
|
139,593 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
Cost of
products and services sold |
|
12,253 |
|
|
— |
|
|
— |
|
|
— |
|
|
(46 |
) |
|
— |
|
|
— |
|
|
— |
|
|
(46 |
) |
|
12,207 |
|
Research
and development |
|
22,093 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
22,093 |
|
Selling,
general and administrative |
|
35,804 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
35,804 |
|
Intangible asset amortization |
|
1,692 |
|
|
(1,692 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,692 |
) |
|
— |
|
Changes
in fair value of related party contingent consideration |
|
(30,107 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
30,107 |
|
|
25,396 |
|
|
55,503 |
|
|
25,396 |
|
Restructuring charges |
|
3,173 |
|
|
— |
|
|
— |
|
|
(3,173 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(3,173 |
) |
|
— |
|
Total |
|
44,908 |
|
|
(1,692 |
) |
|
— |
|
|
(3,173 |
) |
|
(46 |
) |
|
— |
|
|
30,107 |
|
|
25,396 |
|
|
50,592 |
|
|
95,500 |
|
Operating
income (loss) |
|
93,585 |
|
|
1,692 |
|
|
— |
|
|
3,173 |
|
|
46 |
|
|
1,100 |
|
|
(30,107 |
) |
|
(25,396 |
) |
|
(49,492 |
) |
|
44,093 |
|
Investment and other income |
|
2,689 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,689 |
|
Interest
expense |
|
(789 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(789 |
) |
Other
expense - changes in fair value of related party payable |
|
2,988 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(2,988 |
) |
|
(3,428 |
) |
|
(6,416 |
) |
|
(3,428 |
) |
Foreign
exchange gain |
|
(127 |
) |
|
— |
|
|
127 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
127 |
|
|
— |
|
Income
(loss) before income taxes |
|
98,346 |
|
|
1,692 |
|
|
127 |
|
|
3,173 |
|
|
46 |
|
|
1,100 |
|
|
(33,095 |
) |
|
(28,824 |
) |
|
(55,781 |
) |
|
42,565 |
|
Income
tax provision (benefit) |
|
21,830 |
|
|
603 |
|
|
— |
|
|
— |
|
|
17 |
|
|
— |
|
|
(1,776 |
) |
|
(1,822 |
) |
|
(2,978 |
) |
|
18,852 |
|
Net
income (loss) |
|
$ |
76,516 |
|
|
$ |
1,089 |
|
|
$ |
127 |
|
|
$ |
3,173 |
|
|
$ |
29 |
|
|
$ |
1,100 |
|
|
$ |
(31,319 |
) |
|
$ |
(27,002 |
) |
|
$ |
(52,803 |
) |
|
$ |
23,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share - diluted(1) |
|
1.81 |
|
|
$ |
0.03 |
|
|
$ |
— |
|
|
$ |
0.08 |
|
|
$ |
— |
|
|
$ |
0.03 |
|
|
$ |
(0.74 |
) |
|
$ |
(0.64 |
) |
|
$ |
(1.25 |
) |
|
$ |
0.56 |
|
Weighted
average number of shares outstanding - diluted |
|
42,194 |
|
|
42,194 |
|
|
42,194 |
|
|
42,194 |
|
|
42,194 |
|
|
42,194 |
|
|
42,194 |
|
|
42,194 |
|
|
42,194 |
|
|
42,194 |
|
(1) Net income (loss) per share - diluted
is calculated by dividing Net income (loss) by the Weighted average
number of shares outstanding - diluted. Note, when recalculated
using this method, the balances in the Total adjustment and
Adjusted GAAP columns may not cross-foot as a result of rounding to
full precision.
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP to Non-GAAP adjustments for the
nine-months ended September 30, 2016 |
|
|
|
|
|
|
|
|
Exclude |
|
Include |
|
|
|
|
|
|
GAAP |
|
Intangible asset amortization |
|
Foreign exchange (gain)/loss |
|
Purchase accounting adjustments -
FSC |
|
Contingent related party payable fair value
adjustment |
|
Contingent related party payable
paid/accrued |
|
Total adjustments |
|
Adjusted GAAP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales and services |
|
$ |
104,858 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
104,858 |
|
License
and research revenue |
|
2,303 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,303 |
|
Total |
|
107,161 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
107,161 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
products and services sold |
|
10,657 |
|
|
— |
|
|
— |
|
|
(1,525 |
) |
|
— |
|
|
— |
|
|
(1,525 |
) |
|
9,132 |
|
Research
and development |
|
21,135 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
21,135 |
|
Selling,
general and administrative |
|
33,491 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
33,491 |
|
Intangible asset amortization |
|
10,918 |
|
|
(10,918 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(10,918 |
) |
|
— |
|
Changes
in fair value of related party contingent consideration |
|
52,989 |
|
|
— |
|
|
— |
|
|
— |
|
|
(52,989 |
) |
|
19,321 |
|
|
(33,668 |
) |
|
19,321 |
|
Total |
|
129,190 |
|
|
(10,918 |
) |
|
— |
|
|
(1,525 |
) |
|
(52,989 |
) |
|
19,321 |
|
|
(46,111 |
) |
|
83,079 |
|
Operating
income (loss) |
|
(22,029 |
) |
|
10,918 |
|
|
— |
|
|
1,525 |
|
|
52,989 |
|
|
(19,321 |
) |
|
46,111 |
|
|
24,082 |
|
Investment and other income |
|
1,080 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,080 |
|
Interest
expense |
|
(702 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(702 |
) |
Other
expense - changes in fair value of related party payable |
|
(6,135 |
) |
|
— |
|
|
— |
|
|
— |
|
|
6,135 |
|
|
(2,618 |
) |
|
3,517 |
|
|
(2,618 |
) |
Foreign
exchange gain |
|
(12 |
) |
|
— |
|
|
12 |
|
|
— |
|
|
— |
|
|
— |
|
|
12 |
|
|
— |
|
Income
(loss) before income taxes |
|
(27,798 |
) |
|
10,918 |
|
|
12 |
|
|
1,525 |
|
|
59,124 |
|
|
(21,939 |
) |
|
49,640 |
|
|
21,842 |
|
Income
tax provision (benefit) |
|
18,212 |
|
|
3,920 |
|
|
— |
|
|
533 |
|
|
2,986 |
|
|
(1,165 |
) |
|
6,274 |
|
|
24,486 |
|
Net
income (loss) |
|
$ |
(46,010 |
) |
|
$ |
6,998 |
|
|
$ |
12 |
|
|
$ |
992 |
|
|
$ |
56,138 |
|
|
$ |
(20,774 |
) |
|
$ |
43,366 |
|
|
$ |
(2,644 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share - diluted(1) |
|
(1.12 |
) |
|
$ |
0.17 |
|
|
$ |
— |
|
|
$ |
0.02 |
|
|
$ |
1.36 |
|
|
$ |
(0.50 |
) |
|
$ |
1.05 |
|
|
$ |
(0.07 |
) |
Weighted
average number of shares outstanding - diluted |
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
|
41,241 |
|
(1) Net income (loss) per share - diluted is calculated by
dividing Net income (loss) by the Weighted average number of shares
outstanding - diluted. Note, when recalculated using this method,
the balances in the Total adjustment and Adjusted GAAP columns may
not cross-foot as a result of rounding to full precision.
Avadel Pharmaceuticals (NASDAQ:AVDL)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024