Innocoll Holdings plc Announces Fourth Quarter and Full-Year 2016 Financial and Operating Results and Provides Corporate Update
(Thomson Reuters ONE) -
ATHLONE, Ireland, March 16, 2017 (GLOBE NEWSWIRE) -- Innocoll Holdings plc
(Nasdaq:INNL), a global, commercial stage, specialty pharmaceutical company with
late stage development programs targeting areas of significant unmet medical
need announced financial and operating results for the three months and full
year ended December 31, 2016. Innocoll manufactures and supplies a range of
pharmaceutical products and medical devices using its proprietary collagen-based
biodegradable and fully bioresorbable technology platform.
"In 2016, Innocoll successfully achieved milestones, but also faced challenges.
On the one hand, XARACOLL achieved positive pivotal results in Phase 3 trials
and we were able to substantially finalize the expansion of our manufacturing
facility in Saal, Germany. On the other hand, COGENZIA did not achieve
statistical significance in improving clinical cure in diabetic foot infections
(DFI) and XARACOLL received the Refusal-to-File letter from the U.S. Food and
Drug Administration (FDA)," said Tony Zook, Chief Executive Officer of Innocoll.
"In February 2017, we attended a Type-A meeting with representatives of the FDA
to review pathways forward following our receipt of the Refusal-To-File letter.
During the meeting, we proposed a plan to conduct an additional short-term
Pharmacokinetic study and several short-term non-clinical studies, which we
believe will allow us to submit a revised NDA to the FDA by the end of 2017. If
the formal minutes from the Type-A meeting, which we expect to receive at the
end of this month, confirm that the FDA agrees with our plan, we would submit a
revised NDA to the FDA soon after the completion of the additional studies,
assuming adequate financing to commence the proposed studies, and further
assuming positive results."
Innocoll plans to update investors with additional information about the outcome
of its Type A meeting shortly after receiving formal written FDA minutes. In the
interim, Innocoll intends to continue to explore strategic options to maximize
value to its shareholders.
Fourth Quarter 2016 and Recent Updates
* Substantially finalized expansion of its Saal, Germany manufacturing
facility.
* Following receipt of the XARACOLL Refusal to File Letter in December, 2016,
in January 2017, Innocoll requested a Type A meeting with the FDA, which was
held in late February 2017. At the meeting, management presented a plan for
a path forward, including an additional short-term Pharmacokinetic study and
several short-term non-clinical studies, which assuming FDA concurrence,
adequate financing and further positive trial results, could enable Innocoll
to submit a revised NDA for XARACOLL in the latter part of 2017.
Fourth Quarter 2016 Financial Results
Net Loss Attributable to Ordinary Shareholders: Innocoll reported a net loss
attributable to ordinary shares of $3.8 million, or $0.13 per share, for the
fourth quarter of 2016, compared to a loss of $7.7 million, or $0.33 per share
for the fourth quarter of 2015.
Non-GAAP diluted loss excluding nonrecurring items was $7.6 million or $0.26 per
share, for the fourth quarter of 2016, compared to a loss of $16.9 million or
$0.72 per share, for the fourth quarter of 2015.
The weighted average number of ordinary shares outstanding increased from 23.5
million in the fourth quarter of 2015 to 29.7 million in the fourth quarter of
2016, primarily as a result of the follow-on public offering in the second
quarter of 2016.
Revenues: Revenues were $0.6 million for the fourth quarter of 2016 as compared
to $0.9 million for the fourth quarter of 2015. This decrease was primarily due
to lower sales to EUSA Pharma of CollatampG®.
Research and Development (R&D) Expenses: R&D expenses were $4.7 million for the
fourth quarter of 2016 as compared to $11.7 million for the fourth quarter of
2015. R&D expenses in the fourth quarter of 2016 included $3.7 million in
external clinical research expenses, which was primarily driven by the
finalization of our Phase 3 Cogenzia efficacy trials.
General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for
the fourth quarter of 2016 as compared to $6.1 million for the fourth quarter of
2015. Excluding stock-based compensation charges, G&A expenses for the fourth
quarter of 2016 were $2.6 million as compared to $5.7 million for the fourth
quarter of 2015. The decrease in G&A excluding stock-based compensation was
primarily due to reduction in discretionary expenses and prior year expenses
relating to the company's re-domiciliation to Ireland.
Other Operating Income: Other operating income was $7.1 million for the fourth
quarter of 2016 as compared to $10.9 million for the fourth quarter of 2015.
Other income in the fourth quarter of 2016 consisted primarily of fair value
income of warrants outstanding and foreign exchange gains, partially offset by
accrued interest on the company's existing loan with the European Investment
Bank (EIB). Other income in the fourth quarter of 2015 consisted primarily of
$9.7 million fair value income of warrants outstanding.
Full Year 2016 Financial Results
Net Loss Attributable to Ordinary Shareholders: Innocoll reported a net loss
attributable to ordinary shareholders of $57.0 million, or $2.12 per share, for
the year ended December 31, 2016, compared to a loss of $50.9 million, or $2.28
per share for the year ended December 31, 2015.
Non-GAAP diluted loss excluding nonrecurring items was $59.1 million or $2.20
per share, for the year ended December 31, 2016, compared to a loss of $42.8
million, or $1.92 per share, for the year ended December 31, 2015.
The weighted average number of ordinary shares outstanding increased from 22.3
million during the year ended December 31, 2015, to 26.9 million during the year
ended December 31, 2016, primarily as a result of the follow-on public offering
in the second quarter of 2016.
Revenues: Revenues were $4.4 million for the year ended December 31, 2016 as
compared to $2.9 million for year ended December 31, 2015. This increase was
primarily due to an increase in sales to EUSA Pharma of Collatamp G, our
gentamicin implant for the treatment and prevention of post-surgical infection.
Research and Development (R&D) Expenses: R&D expenses were $38.7 million for
the year ended December, 31 2016 as compared to $29.8 million for the year ended
December 31, 2015. R&D expenses in the year ended December 31, 2016 included
$34.8 million in external clinical research expenses, which was primarily due to
the completion of our pivotal Phase 3 studies of XARACOLL and Cogenzia. R&D
expenses are expected to significantly decrease going forward.
General and Administrative (G&A) Expenses: G&A expenses were $25.4 million for
the year ended December 31, 2016 as compared to $19.7 million for the year ended
December 31, 2015. Excluding stock-based compensation charges, G&A expenses
for the year ended December 31 2016 were $16.9 million as compared to $15.7
million for the year ended December 31, 2015. The increase in G&A, excluding
stock-based compensation, was primarily due to our continued infrastructure
build out to support clinical programs and expenses related to the company's re-
domiciliation to Ireland.
Other Operating Income: Other operating income was $10.0 million for the year
ended December 31, 2016 as compared to $1.6 million for the year ended December
31, 2015. Other income for the year ended December 31, 2016 consisted primarily
of non-cash items due to the fair value income of warrants outstanding and
foreign exchange gains, partially offset by accrued interest on the company's
existing loan with the EIB. Other expense for the year ended December 31, 2015
consisted primarily of foreign exchange gains of $5.6 million, partially offset
by fair value expense of warrants outstanding of $4.0 million.
Cash Position
As of December 31, 2016, cash and cash equivalents totalled $15.8 million
compared to $30.4 million as of September 30, 2016. For further financial
information for the period ending December 31, 2016, please refer to the
financial statements appearing at the end of this release.
In management's opinion, Innocoll's anticipated expenditures during the next 12
months to advance its current operations, including plans to conduct further
studies to enable it to submit a revised NDA for XARACOLL and to develop
CollaGUARD will be greater than the amount of its current cash and cash
equivalents. The Company may not be able to generate revenues from the sale of
XARACOLL until the end of 2018, if at all.
Innocoll's need for additional capital will vary depending on a variety of
circumstances, including, for example, if it is required to conduct additional
tests not currently contemplated, the level and timing of regulatory approval,
as well as the extent to which it chooses to establish collaboration, co-
promotion, distribution or other similar agreements for its products and product
candidates. Moreover, changing circumstances may cause it to spend cash
significantly faster than it currently anticipates, and it may need to spend
more cash than currently expected because of circumstances beyond its control.
To the extent that Innocoll's capital resources are insufficient to meet its
future operating and capital requirements, it will need to finance its cash
needs through public or private equity offerings, debt financings, corporate
collaboration and licensing arrangements, or strategic alternatives.
About Innocoll Holdings plc
Innocoll is a global, specialty pharmaceutical company with late stage
development programs that is dedicated to engineering better medicines to help
patients get better. Its proprietary, biocompatible, and biodegradable collagen
products are precision-engineered for targeted use. Applied locally to surgery
sites, they are designed to provide a range of benefits. Its late stage product
pipeline is focused on addressing a number of large unmet medical needs,
including: XARACOLL for the treatment of postoperative pain and CollaGUARD (INL-
003), a barrier for the prevention of post-surgical adhesions.
Innocoll's currently approved products include: CollaGUARD® (ex-US), COLLATAMP®
G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which
are sold globally through strategic partnerships, including those with Takeda,
EUSA Pharma, Biomet 3i and Biomet. All of its native collagen products - from
extraction/purification of type-1 collagen through final delivery form - are
manufactured at its certified, integrated plant in Saal, Germany.
For more information, please visit www.innocoll.com.
CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, COGENZIA®
LidoColl®, LiquiColl®, and XARACOLL® are registered trademarks, and
CollaPress(TM), DermaSil(TM), Durieva(TM), and Zorpreva(TM) are trademarks of
the company.
Use of Non-GAAP Financial Measures
This press release includes certain numerical measures that are or may be
considered "non-GAAP financial measures" under the SEC's Regulation G. "GAAP"
refers to generally accepted accounting principles in the United States. The
reconciliations of such measures to the most comparable GAAP figures, in
accordance with Regulation G, are included herein.
To supplement our unaudited consolidated financial statements prepared in
accordance with U.S. GAAP, we disclose certain non-GAAP, financial measures. We
define adjusted non-GAAP earnings per share as basic and diluted earnings per
share excluding share-based payments and fair value expense or income on
warrants outstanding. We believe adjusted non-GAAP earnings per share is
meaningful to our investors to enhance their understanding of our financial
condition and results. The items excluded from non-GAAP earnings per share
represent significant non-cash expense or income that may be settled through
issuance of shares included in our authorized or contingent capital. We believe
that non-GAAP earnings per share excluding these non-cash items may provide
securities analysts, investors and other interested parties with a useful
measure of our operating performance and cash requirements. Disclosure in this
press release of non-GAAP earnings per share is intended as a supplemental
measure of our performance. Non-GAAP earnings per share should not be considered
as an alternative to earnings per share, profit (loss) or any other performance
measure derived in accordance with U.S. GAAP. Our presentation of adjusted
earnings per share should not be construed to imply that our future results will
be unaffected by unusual non-cash or non-recurring items.
Forward-looking Statements
Any statements in this press release about our ongoing development of XARACOLL;
the results of our Type-A meeting with the FDA regarding a proposed path forward
for XARACOLL; our ability to successfully implement a path forward for XARACOLL
and submit a revised NDA in connection therewith; our ability to finance any
additional studies required by the FDA prior to our ability to submit a revised
NDA for XARACOLL; our ability to successfully complete and receive positive
results from any studies required by the FDA in connection with a proposed
revised NDA for XARACOLL; our plans to develop and commercialize XARACOLL and
its market potential; the potential therapeutic and other benefits of XARACOLL
and our other product candidates; our cash position and ability to continue as a
going concern; our anticipated expenditures during the next 12 months to advance
our current operations, including plans to conduct further studies towards the
submission of a revised NDA for XARACOLL and to develop CollaGUARD; our ability
to maximize value to our shareholders through strategic options; our current
expectations regarding future events, including statements regarding the
therapeutic benefit, safety profile and commercial value of XARACOLL, plans and
objectives for present and future clinical and non-clinical trials and studies
and results of such trials and studies, the risk that the FDA may not accept our
proposal to conduct additional studies towards the submission of a revised NDA
for XARACOLL and other statements containing the words "anticipate," "believe,"
"estimate," "expect," "intend," "goal," "may", "might," "plan," "predict,"
"project," "target," "potential," "will," "would," "could," "should,"
"continue," and similar expressions, constitute forward-looking statements
within the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such forward-
looking statements as a result of various important factors. Such forward-
looking statements involve substantial risks and uncertainties including, but
not limited to, the risk that the FDA and foreign regulatory authorities may not
agree with our interpretation of needed additional clinical and non-clinical
studies towards our submission of a revised NDA for XARACOLL and may require us
to conduct additional clinical trials; XARACOLL may not receive regulatory
approval or be successfully commercialized, including as a result of the FDA's
or other regulatory authorities' decisions regarding labeling and other matters
that could affect its availability or commercial potential; our plans to develop
and manufacture XARACOLL; our manufacturing and marketing capabilities; or other
actions and factors discussed in the "Risk Factors" section of our Annual Report
on Form 10-K for the year ended December 31, 2016, which we expect to file with
the Securities and Exchange Commission on March 16, 2017. We may not actually
achieve the plans, intentions or expectations disclosed in our forward-looking
statements, and you should not place undue reliance on our forward-looking
statements. In addition, the forward-looking statements included in this press
release represent our views as of the date of this release. We anticipate that
subsequent events and developments will cause our views to change. We do not
assume any obligation to update any forward- looking statements, whether as a
result of new information, future events or otherwise, except as required by
law.
The scientific information discussed in this news release related to Innocoll's
product candidates is preliminary and investigative. Such product candidates are
not approved by the U.S. Food and Drug Administration, and no conclusions can or
should be drawn regarding the safety or effectiveness of the product candidates.
INNOCOLL HOLDINGS PLC
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (UNAUDITED)
Three Three Twelve Twelve
months months months months
ended ended ended ended
12/31/16 12/31/15 12/31/16 12/31/15
Thousands of US$ (except
share and share data) ($'000) ($'000) ($'000) ($'000)
-------------------------------- ----------- ----------- ----------- ----------
Revenue $ 590 $ 885 $ 4,372 $ 2,870
Cost of
sales (1,563 ) (1,255 ) (6,986 ) (5,328 )
----------- ----------- ----------- ----------
Gross loss (973 ) (370 ) (2,614 ) (2,458 )
----------- ----------- ----------- ----------
Research and
development expenses (4,695 ) (11,743 ) (38,715 ) (29,821 )
General and
administrative
expenses (4,894 ) (6,093 ) (25,446 ) (19,743 )
Loss on disposals of
property, plant &
equipment (9 ) - (8 ) -
----------- ----------- ----------- ----------
Loss from operating activities
- continuing operations (10,571 ) (18,206 ) (66,783 ) (52,022 )
Other income 7,075 10,850 10,000 1,573
----------- ----------- ----------- ----------
Loss before income
tax (3,496 ) (7,356 ) (56,783 ) (50,449 )
Income tax expense (351 ) (307 ) (171 ) (407 )
----------- ----------- ----------- ----------
Loss for the period - all
attributable to equity holders
of the
company (3,847 ) (7,663 ) (56,954 ) (50,856 )
----------- ----------- ----------- ----------
Other
comprehensive
loss:
Currency translation
adjustment (189 ) (137 ) (108 ) (4,460 )
----------- ----------- ----------- ----------
Total comprehensive
loss for the period $ (4,036 ) $ (7,800 ) $ (57,062 ) $ (55,316 )
----------- ----------- ----------- ----------
Basic and diluted loss
per share $ (0.13 ) $ (0.33 ) $ (2.12 ) $ (2.28 )
----------- ----------- ----------- ----------
INNOCOLL HOLDINGS PLC
NON-GAAP NET EARNINGS (UNAUDITED)
Three Three Twelve Twelve
months months months months
ended ended ended ended
12/31/16 12/31/15 12/31/16 12/31/15
Numerator for non-
GAAP loss per
share -Thousands
of
US$ (except
share and
share data) ($'000) ($'000) ($'000) ($'000)
-------------------- -------------- -------------- -------------- -------------
Net
loss -
basic $ (3,847 ) $ (7,663 ) $ (56,954 ) $ (50,856 )
Share
based
payments 2,315 417 8,547 3,982
Fair value
(gain)/expense
on warrants (6,051 ) (9,703 ) (10,644 ) 4,067
-------------- -------------- -------------- -------------
Non-GAAP net
loss - basic
and diluted (7,583 ) (16,949 ) (59,051 ) (42,807 )
-------------- -------------- -------------- -------------
Denominator -
number of
shares:
Weighted-average
shares outstanding
- basic and
diluted 29,716,973 23,453,482 26,867,343 22,328,908
-------------- -------------- -------------- -------------
Loss
per
share:
Basic
and
diluted $ (0.26 ) $ (0.72 ) $ (2.20 ) $ (1.92 )
INNOCOLL HOLDINGS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
at December 31, 2016 and December 31,2015
Thousands of US$ 12/31/16 12/31/15
-------------------------------------------------- ------------ ------------
($'000) ($'000)
Assets $ $
Current assets
Cash and cash equivalents 15,765 42,186
Trade and other
receivables 6,836 4,567
Inventories 2,403 1,808
------------ ------------
Total current
assets 25,004 48,561
------------ ------------
Property, plant and equipment 16,698 4,199
Deferred tax asset 125 -
Other assets 175 -
------------ ------------
Total non-current assets 16,998 4,199
------------ ------------
Total assets $ 42,002 $ 52,760
------------ ------------
Liabilities
Current
liabilities
Trade and other payables $ 13,505 $ 14,411
Deferred income 1,827 2,219
Current taxes payable 36 20
------------ ------------
Total current liabilities 15,368 16,650
------------ ------------
Interest bearing loans and
borrowings 28,948 16,400
Warrant liability 854 11,498
Deferred tax liability - 263
Defined benefit pension
liability 28 49
------------ ------------
Total non-current
liabilities 29,830 28,210
------------ ------------
Total liabilities 45,198 44,860
------------ ------------
Equity
Share capital 324 1,943
Additional paid -in
capital 220,965 173,353
Currency translation
reserve (1,352 ) (1,244 )
Treasury shares (27 ) -
Accumulated deficit (223,106 ) (166,152 )
------------ ------------
Total equity attributable to equity holders of
the company (3,196 ) 7,900
------------ ------------
Total liabilities and
equity $ 42,002 $ 52,760
------------ ------------
INNOCOLL HOLDINGS PLC
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (UNAUDITED)
Three Three Twelve Twelve
months months months months
ended ended ended ended
Thousands of
US$ 12/31/16 12/31/15 12/31/16 12/31/15
---------------------------- ----------- ------------ ------------ -----------
($'000) ($'000) ($'000) ($'000)
Operating
activities loss
for the period $ (3,847 ) $ (7,663 ) $ (56,954 ) $ (50,856 )
Adjustments
for:
Other income (7,075 ) (10,850 ) (10,000 ) (1,573 )
Income tax
expense 351 307 171 407
Loss on disposals of
property, plant &
equipment 9 - 8 -
Non-cash
items
Depreciation of
property, plant &
equipment 105 86 414 348
Share based
payment 2,315 417 8,547 3,982
Foreign exchange
gains/(losses) 121 48 37 53
----------- ------------ ------------ -----------
Operating cash outflows
before movements in
working capital (8,021 ) (17,655 ) (57,777 ) (47,639 )
----------- ------------ ------------ -----------
Increase in
inventories (223 ) (451 ) (595 ) (602 )
Increase in trade
and other
receivables (1,492 ) (3,644 ) (2,269 ) (3,807 )
(Decrease)/increase in
trade and other
payables (1,617 ) 8,274 (906 ) 9,078
(Decrease)/increase in
deferred income and
defined benefit pension
liability (12 ) (35 ) (413 ) 207
Income taxes
paid (163 ) (31 ) (543 ) (129 )
----------- ------------ ------------ -----------
Net cash used in
operating
activities (11,528 ) (13,542 ) (62,503 ) (42,892 )
----------- ------------ ------------ -----------
Cash flows from
investing
activities:
Purchases of property,
plant and equipment (2,745 ) (1,322 ) (12,445 ) (3,262 )
Proceeds from disposals of
property, plant and
equipment 13 - 14 2
Interest
received 19 14 32 81
Restricted
cash - - (187 ) -
----------- ------------ ------------ -----------
Net cash used in
investing
activities: (2,713 ) (1,308 ) (12,586 ) (3,179 )
----------- ------------ ------------ -----------
Cash inflows from
financing
activities:
Proceeds from
issue of shares 3 814 37,419 16,728
Proceeds from interest
bearing loans &
borrowings - 16,331 11,240 16,331
----------- ------------ ------------ -----------
Net cash inflows from
financing activities 3 17,145 48,659 33,059
----------- ------------ ------------ -----------
Net decrease in cash
and cash equivalents (14,238 ) 2,295 (26,430 ) (13,012 )
Cash and cash equivalents
at the beginning of the
period 30,402 42,213 42,186 55,382
Effect of foreign
exchange rate
changes (399 ) (2,322 ) 9 (184 )
----------- ------------ ------------ -----------
Cash and cash
equivalents at the end
of the period $ 15,765 $ 42,186 $ 15,765 $ 42,186
----------- ------------ ------------ -----------
INNOCOLL HOLDINGS PLC
RECONCILIATION OF NON-GAAP NET LOSS TO NEAREST COMPARABLE GAAP MEASURE
(UNAUDITED)
Three Three Twelve Twelve
months months months months
ended ended ended ended
12/31/16 12/31/15 12/31/16 12/31/15
Thousands of
US$ ($'000) ($'000) ($'000) ($'000)
------------------------------- ---------- ----------- ----------- -----------
Net loss attributable to
equity holders of the company $ (3,847 ) $ (7,663 ) $ (56,954 ) $ (50,856 )
Share based
payments 2,315 417 8,547 3,982
Fair value
(gain)/expense on
warrants (6,051 ) (9,703 ) (10,644 ) 4,067
---------- ----------- ----------- -----------
Non-GAAP net
loss (7,583 ) (16,949 ) (59,051 ) (42,807 )
---------- ----------- ----------- -----------
Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona(at)innocoll.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Innocoll Holdings plc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 16.03.2017 - 21:25 Uhr
Sprache: Deutsch
News-ID 530827
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contact information:
Town:
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