Innocoll Holdings plc (Nasdaq:INNL), a global, specialty
pharmaceutical company with late stage development programs
targeting areas of significant unmet medical needs, today announced
financial and operating results for the three months ended
September 30, 2016. Using our proprietary collagen-based technology
platform, we manufacture and supply a range of biodegradable and
fully bioresorbable pharmaceutical products and medical devices
that are precision-engineered for targeted use.
“As we recently announced, Innocoll achieved an
exciting, new milestone with the submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA),
for XARACOLL for the treatment of post-surgical pain,” said Tony
Zook, Chief Executive Officer of Innocoll. “We anticipate an FDA
acceptance of the NDA, for review, by the end of this year, and
with a target Prescription Drug User Fee Act (PDUFA) action date in
late August 2017, this achievement will take us another step closer
to the approval and launch of XARACOLL in potentially less than one
year. In preparation, our Saal Germany based manufacturing facility
has completed its construction phase, and we are on schedule to
undergo pre-approval inspections soon. In addition to progressing
XARACOLL, we were also pleased to announce the advancement of
COLLAGUARD upon successful demonstration of medical safety in its
pre-clinical studies, which cleared the way for our submission of
an Investigational Device Exemption (IDE) this month for the
prevention of post-surgical adhesions. The COLLAGUARD program is an
ideal complement to XARACOLL, which we believe will position
Innocoll competitively in the hospital segment. We reported earlier
this month that while COGENZIA showed trends of clinical
improvement as adjunct treatment of Diabetic Foot Infections
(DFIs), the top-line results did not reach statistical significance
for the primary endpoint. We will continue to assess all strategic
options to bring these much needed new products to the market and
the medical community. We plan to manage our cash runway until
after the anticipated XARACOLL NDA approval, expected in the third
quarter of 2017, and we feel confident about our ability to finance
the commercialization of XARACOLL as well as our pipeline”.
Third Quarter 2016 and Recent
Highlights
- Submitted an NDA for XARACOLL to the FDA for the treatment of
postsurgical pain
- FDA acceptance anticipated by the end of 2016, with a target
PDUFA action date in late August 2017.
- Presented supportive pharmacokinetic data at American Society
of Anesthesiologists (ASA) Annual Meeting in Chicago, in
October.
- Medical publication and presentation of full Phase 3 data are
targeted for 2Q 2017. Also under preparation to be published next
year are the results of our Health Economics (HECON) study,
demonstrating the health economic benefits of using XARACOLL.
- Assessment of strategic options around product development
continues, as well the planning and preparation for
commercialization has ramped up.
- Advanced COLLAGUARD (INL-003), a collagen film being developed
as a medical device implanted at the time of surgery for the
prevention of postsurgical adhesions
- Completed pre-clinical studies that demonstrated safety as a
surgical adhesion barrier in preclinical studies.
- The positive data support filing of an IDE this quarter, 4Q
2016. Thereafter, a Pilot (Feasibility) Study, for the prevention
of post-surgical adhesions in patients undergoing open myomectomy,
could be initiated next year, assuming the availability of
resources to fund the study.
- Announced that Phase 3 clinical trials for COGENZIA showed
trends toward clinical response, but top-line data did not achieve
statistical significance in improving clinical cure in DFIs
- The two COACT Phase 3 clinical trials in patients with
moderate to severe DFIs studied COGENZIA administered in
conjunction with the standard of care (SOC): systemic antibiotics
and wound therapy. Based on top-line data, the COGENZIA plus SOC
arm did not meet its primary endpoint of clinical cure of infection
after 28 days versus placebo plus SOC or versus SOC alone.
- While Innocoll continues to analyze the results, and there were
trends toward clinical response in the COGENZIA and placebo
collagen-matrix arms, the top-line data suggests that neither
COACT-1 nor COACT-2 achieved statistical significance.
- COGENZIA and the placebo collagen-matrix were well tolerated,
and the incidence of overall adverse events was similar across all
three treatment arms.
- Continued expansion of Saal manufacturing facilities on
schedule with successful completion of key stages
- New Quality Control Laboratories approved and operational.
- On-time completion of the CMC Sections and submission of the
XARACOLL NDA to the FDA.
- Construction phase of the commercial manufacturing area
completed. Site qualification/validation activities on target
for completion prior to year-end.
- Successful completion of a EU “Notified Body” medical device
inspection.
- Continuing efforts in preparation for Pre-approval Inspection
by FDA. Initial 3rd Party, ex-FDA compliance audit
completed.
Third Quarter 2016 Financial
Results
Net Loss Attributable to Ordinary Shareholders:
Innocoll Holdings plc reported a net loss attributable to its
ordinary shares of $17.2 million, or $0.58 per share, for the third
quarter of 2016, compared to a loss of $9.1 million, or $0.39 per
share, for the third quarter of 2015.
Non-GAAP basic and diluted net loss excluding
non-cash expense with respect to share-based compensation and fair
value gains and losses on warrants was $15.2 million or $0.51 per
share, for the third quarter of 2016, compared to a loss of $12.5
million or $0.53 per share, for the third quarter of 2015.
The weighted average number of ordinary shares
outstanding increased from 23.4 million in the third quarter of
2015 to 29.7 million in the third quarter of 2016, primarily as a
result of Innocoll's follow-on public offering in the second
quarter of 2016. The total number of shares outstanding as at
September 30, 2016 was 29.7 million.
Revenues: Revenues were $0.9 million for the
third quarter of 2016 compared to $0.7 million in the third quarter
of 2015. This increase was primarily due to an increase in sales to
EUSA Pharma of CollatampG, our gentamicin implant for the treatment
and prevention of post-surgical infection, following the
stabilization of the EUSA Pharma business following the transfer
from Jazz Pharmaceuticals.
Research and Development (R&D) Expenses:
R&D expenses were $8.4 million for the third quarter of 2016
compared to $7.7 million for the third quarter of 2015. R&D
expenses in the third quarter of 2016 included $7.5 million in
external clinical research expenses, which was primarily driven by
our Phase 3 COGENZIA efficacy trials. R&D expenses are expected
to decrease significantly in the future as the company concludes
the COGENZIA clinical studies and files its NDA for
XARACOLL.
General and Administrative (G&A) Expenses:
G&A expenses were $7.1 million for the third quarter of 2016
compared to $6.0 million for the third quarter of 2015. Excluding
share-based compensation charges, G&A expenses for the third
quarter of 2016 were $4.9 million, as compared to $4.2 million for
the third quarter of 2015. The increase in G&A, excluding
stock-based compensation, was primarily due to our continued
infrastructure to support clinical programs and some
pre-commercialization investment.
Other Operating (Expense)/Income: Other expense
was $0.6 million for the third quarter of 2016 compared to other
income of $5.2 million for the third quarter of 2015. Other expense
in the third quarter of 2016 consisted primarily of accrued
interest on the company’s existing loan with the European
Investment Bank (EIB) and foreign exchange losses, partially offset
by the fair value income of warrants outstanding. Other income in
the third quarter of 2015 consisted primarily of $5.2 million fair
value income of investor options outstanding.
Nine Month 2016 Financial
Results
Net Loss Attributable to Ordinary Shareholders:
Innocoll Holdings plc reported a net loss attributable to its
ordinary shareholders of $53.1 million, or $2.05 per share, for the
nine months ended September 30, 2016, compared to a loss of $43.1
million, or $1.96 per share, for the nine months ended September
30, 2015.
Non-GAAP basic and diluted loss excluding
non-cash expense with respect to share-based compensation and fair
value gains and losses on warrants was $51.5 million or $1.99 per
share, for the nine months ended September 30, 2016, compared to a
loss of $25.6 million, or $1.17 per share, for the nine months
September 30, 2015.
The weighted average number of Innocoll ordinary
shares outstanding increased from 21.9 million during the nine
months ended September 30, 2015, to 25.9 million during the nine
months ended September 30, 2016, primarily as a result of
Innocoll’s follow-on public offering in the second quarter of 2016.
The total number of shares outstanding at September 30, 2016 was
29.7 million.
Revenues: Revenues were $3.8 million for the
nine months ended September 30, 2016 compared to $2.0 million for
nine months ended September 30, 2015. This increase was primarily
due to an increase in sales to EUSA Pharma of CollatampG, our
gentamicin implant for the treatment and prevention of
post-surgical infection, following the stabilization of the EUSA
Pharma business following the transfer from Jazz
Pharmaceuticals.
Research and Development (R&D)
Expenses: R&D expenses were $34.0 million for the nine
months ended September 30, 2016 compared to $18.0 million for the
nine months ended September 30, 2015. R&D expenses in the nine
months ended September 30, 2016 included $31.1 million in external
clinical research expenses, which was primarily due to ramp-up and
completion of our Phase 3 XARACOLL efficacy trials and the ramp-up
of our Phase 3 COGENZIA efficacy trials. R&D expenses are
expected to decrease significantly in the future as the company
concludes the COGENZIA clinical studies and files its NDA for
XARACOLL.
General and Administrative (G&A)
Expenses: G&A expenses were $20.6 million for the nine
months ended September 30, 2016 compared to $13.6 million for the
nine months ended September 30, 2015. Excluding share-based
compensation charges, G&A expenses for the nine months ended
September 30 2016 were $14.3 million compared to $10.0 million for
the nine months ended September 30, 2015. The increase in G&A,
excluding stock-based compensation, was primarily due to $2.2
million of one-off expenses related to the re-domiciliation of the
company to Ireland, our continued infrastructure to support
clinical programs, and some pre-commercialization investment.
Other Operating Income/(Expense): Other income
was $2.9 million for the nine months ended September 30, 2016
compared to an expense of $9.3 million for the nine months ended
September 30, 2015. Other income in the nine months ended September
30, 2016 consisted primarily of non-cash items due to the fair
value income of warrants outstanding, partially offset by accrued
interest on the company’s existing loan with the EIB and foreign
exchange losses. Other expense in the nine months ended September
30, 2015 consisted primarily of $13.9 million fair value expense of
warrants outstanding, partially offset by foreign exchange gains of
$4.6 million.
Cash Position
As of September 30, 2016, cash and cash
equivalents totaled $30.4 million compared to $53.8 million as of
June 30, 2016.
We expect that our rate of expenses will
decrease significantly as our clinical study for COGENZIA concluded
and as we finalise completion of the expansion of our Saal, Germany
manufacturing facility. We plan to manage our resources to extend
the cash runway until after the anticipated XARACOLL NDA approval,
expected in the third quarter of 2017.
For further financial information for the
quarter ended September 30, 2016, please refer to the financial
statements appearing at the end of this release.
Conference Call
Innocoll management will host a conference call
today at 8:30 a.m. ET to discuss third quarter financial results
and provide a business update.
To participate in the conference call, please
dial 877-407-9039 (domestic) or 201-689-8470 (international) and
ask for the "Innocoll third quarter financial results conference
call." A live webcast of the call can be accessed under "Events and
Presentations" in the Investors section of the Company's website at
www.innocoll.com.
An archived webcast recording and telephone
replay will be available on the Innocoll website beginning
approximately two hours after the call. To access the telephone
replay, please dial 877-870-5176 for domestic callers or
858-384-5517 for international callers and entering the conference
code: 48285346. The telephone replay will be available until 11:59
p.m. ET on November 29, 2016.
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. Our
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. The
company's 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.
Our 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 our native
collagen products — from extraction/purification of type-1 collagen
through final delivery form — are manufactured at our 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™, DermaSil™,
Durieva™, and Zorpreva™ 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 COGENZIA and our other product candidates;
our interpretation of the data and results from our COACT-1 and
COACT-2 clinical trials, or from our XARACOLL trials; our plans to
develop and commercialize XARACOLL and its market potential; the
potential therapeutic and other benefits of XARACOLL and our other
product candidates; the success of our registration program for
COLLAGUARD; our ability to compete in the hospital segment;
Innocoll's 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 trials and results of such trials, the risk that
the FDA may not accept our NDA for XARACOLL or may not accept
pooled data, plans and objectives for regulatory approval 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 the data from
our clinical trials of 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; the size and growth of the potential markets for XARACOLL
and our ability to serve those markets; our manufacturing and
marketing capabilities; our ability to expand our Saal
manufacturing facilities on time or otherwise; our ability to file
an IDE for COLLAGUARD prior to the end of the year or thereafter;
our ability to initiate a COLLAGUARD Pilot (Feasibility) Study; our
continuing ability to fund studies or commercialization efforts for
any of our potential products; or other actions and factors
discussed in the "Risk Factors" section of our Annual Report on
Form 20-F for the year ended December 31, 2015, which is on file
with the Securities and Exchange Commission. 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.
| |
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| INNOCOLL HOLDINGS PLC |
|
|
|
| CONDENSED CONSOLIDATED STATEMENT OF
COMPREHENSIVE LOSS (UNAUDITED) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
Three |
|
Three |
|
Nine |
|
Nine |
| |
|
|
|
|
|
|
months |
|
months |
|
months |
|
months |
| |
|
|
|
|
|
|
ended |
|
ended |
|
ended |
|
ended |
| |
|
|
|
|
|
|
09/30/16 |
|
09/30/15 |
|
09/30/16 |
|
09/30/15 |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Thousands of US$ (except share and share
data) |
|
|
($'000) |
|
($'000) |
|
($'000) |
|
($'000) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Revenue |
|
$ |
|
918 |
|
$ |
|
660 |
|
$ |
|
3,783 |
|
$ |
|
1,983 |
|
| Cost of
sales |
|
|
|
(1,834 |
) |
|
|
(1,247 |
) |
|
|
(5,423 |
) |
|
|
(4,076 |
) |
| Gross
loss |
|
|
|
(916 |
) |
|
|
(587 |
) |
|
|
(1,640 |
) |
|
|
(2,093 |
) |
| Research
and development expenses |
|
|
|
(8,444 |
) |
|
|
(7,722 |
) |
|
|
(34,020 |
) |
|
|
(17,999 |
) |
| General and
administrative expenses |
|
|
|
(7,125 |
) |
|
|
(6,028 |
) |
|
|
(20,552 |
) |
|
|
(13,617 |
) |
| Loss from
operating activities - continuing operations |
|
|
(16,485 |
) |
|
|
(14,337 |
) |
|
|
(56,212 |
) |
|
|
(33,709 |
) |
| Other
(expense)/income |
|
|
|
(613 |
) |
|
|
5,228 |
|
|
|
2,926 |
|
|
|
(9,289 |
) |
|
Loss before income tax |
|
|
|
(17,098 |
) |
|
|
(9,109 |
) |
|
|
(53,286 |
) |
|
|
(42,998 |
) |
| Income tax
(expense)/benefit |
|
|
|
(106 |
) |
|
|
(34 |
) |
|
|
181 |
|
|
|
(96 |
) |
|
Loss for the period - all attributable to equity
holders |
|
|
|
|
|
|
|
|
| of
the company |
|
|
|
(17,204 |
) |
|
|
(9,143 |
) |
|
|
(53,105 |
) |
|
|
(43,094 |
) |
|
Other comprehensive income/(loss): |
|
|
|
|
|
|
|
|
|
| Currency
translation adjustment |
|
|
|
28 |
|
|
|
3 |
|
|
|
80 |
|
|
|
(448 |
) |
|
Total comprehensive loss for the period |
|
$ |
|
(17,176 |
) |
$ |
|
(9,140 |
) |
$ |
|
(53,025 |
) |
$ |
|
(43,542 |
) |
| Basic and
diluted loss per share |
|
$ |
|
(0.58 |
) |
$ |
|
(0.39 |
) |
$ |
|
(2.05 |
) |
$ |
|
(1.96 |
) |
|
|
| INNOCOLL HOLDINGS PLC |
|
|
|
| NON-GAAP NET EARNINGS
(UNAUDITED) |
|
|
|
| |
Three |
|
Three |
|
Nine |
|
Nine |
| |
|
months |
|
months |
|
months |
|
months |
| |
|
ended |
|
ended |
|
ended |
|
ended |
| |
|
09/30/16 |
|
09/30/15 |
|
09/30/16 |
|
09/30/15 |
|
Numerator for non-GAAP loss per share -Thousands
of |
|
| US$ (except share and share data) |
|
|
|
($'000) |
|
($'000) |
|
($'000) |
|
($'000) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net loss -
basic |
|
$ |
|
(17,204 |
) |
$ |
|
(9,143 |
) |
$ |
|
(53,105 |
) |
$ |
|
(43,094 |
) |
| Share based
payments |
|
|
2,218 |
|
|
|
1,865 |
|
|
|
6,232 |
|
|
|
3,570 |
|
| Fair value
(gain)/expense on warrants |
|
|
(175 |
) |
|
|
(5,186 |
) |
|
|
(4,592 |
) |
|
|
13,948 |
|
| Non-GAAP
net loss - basic and diluted |
|
|
(15,161 |
) |
|
|
(12,464 |
) |
|
|
(51,465 |
) |
|
|
(25,576 |
) |
|
Denominator - number of shares: |
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding - basic and diluted |
|
|
29,674,827 |
|
|
|
23,374,789 |
|
|
|
25,910,533 |
|
|
|
21,949,930 |
|
|
Loss per share: |
|
|
|
|
|
|
|
|
| Basic and
diluted |
|
$ |
|
(0.51 |
) |
$ |
|
(0.53 |
) |
$ |
|
(1.99 |
) |
$ |
|
(1.17 |
) |
| |
|
|
|
|
|
|
|
| INNOCOLL HOLDINGS PLC |
|
| CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED) |
|
| at September 30, 2016 and December 31,2015 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
| Thousands of
US$ |
|
|
|
|
|
09/30/16 |
|
12/31/15 |
|
|
| |
|
|
|
|
|
|
|
|
| |
($'000) |
|
($'000) |
|
|
Assets |
|
$ |
|
$ |
|
|
|
Current assets |
|
|
|
|
|
| Cash and
cash equivalents |
|
|
30,402 |
|
|
|
42,186 |
|
|
| Trade and
other receivables |
|
|
5,342 |
|
|
|
4,567 |
|
|
|
|
Inventories |
|
|
2,180 |
|
|
|
1,808 |
|
|
|
| Deferred
tax asset |
|
|
372 |
|
|
|
- |
|
|
| Total
current assets |
|
|
38,296 |
|
|
|
48,561 |
|
|
| Property,
plant and equipment |
|
|
14,030 |
|
|
|
4,199 |
|
|
| Other
assets |
|
|
187 |
|
|
|
- |
|
|
| Total
non-current assets |
|
|
14,217 |
|
|
|
4,199 |
|
|
|
Total assets |
|
$ |
|
52,513 |
|
$ |
|
52,760 |
|
|
|
Liabilities |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
| Trade and
other payables |
|
$ |
|
15,122 |
|
$ |
|
14,411 |
|
|
|
| Deferred
income |
|
|
1,817 |
|
|
|
2,219 |
|
|
|
| Current
taxes payable |
|
|
95 |
|
|
|
20 |
|
|
| Deferred
tax liability |
|
|
- |
|
|
|
263 |
|
|
|
Total current liabilities |
|
|
17,034 |
|
|
|
16,913 |
|
|
| Interest
bearing loans and borrowings |
|
|
30,001 |
|
|
|
16,400 |
|
|
| Warrant
liability |
|
|
6,905 |
|
|
|
11,498 |
|
|
| Defined
benefit pension liability |
|
|
50 |
|
|
|
49 |
|
|
|
Total non-current liabilities |
|
|
36,956 |
|
|
|
27,947 |
|
|
|
Total liabilities |
|
|
53,990 |
|
|
|
44,860 |
|
|
|
Equity |
|
|
|
|
|
| Share
capital |
|
|
324 |
|
|
|
1,943 |
|
|
| Additional
paid -in capital |
|
|
218,647 |
|
|
|
173,353 |
|
|
| Currency
translation reserve |
|
|
(1,164 |
) |
|
|
(1,244 |
) |
|
| Treasury
shares |
|
|
(27 |
) |
|
|
- |
|
|
| Accumulated
deficit |
|
|
(219,257 |
) |
|
|
(166,152 |
) |
|
| Total
equity attributable to equity holders of the company |
|
|
(1,477 |
) |
|
|
7,900 |
|
|
|
Total liabilities and equity |
|
$ |
|
52,513 |
|
$ |
|
52,760 |
|
|
| |
|
|
|
|
| INNOCOLL HOLDINGS PLC |
|
| CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
(UNAUDITED) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
Three |
|
Three |
|
Nine |
|
Nine |
|
| |
|
|
|
|
|
|
months |
|
months |
|
months |
|
months |
|
| |
|
|
|
|
|
|
ended |
|
ended |
|
ended |
|
ended |
|
| Thousands of
US$ |
|
|
|
|
|
09/30/16 |
|
09/30/15 |
|
09/30/16 |
|
09/30/15 |
|
| |
|
($'000) |
|
($'000) |
|
($'000) |
|
($'000) |
|
|
Operating activities loss for the period |
|
$ |
|
(17,204 |
) |
$ |
|
(9,143 |
) |
$ |
|
(53,105 |
) |
$ |
|
(43,094 |
) |
|
| Adjustments
for: |
|
|
|
|
|
|
|
|
|
| Other
(income)/expense |
|
|
613 |
|
|
|
(5,228 |
) |
|
|
(2,926 |
) |
|
|
9,289 |
|
|
| Income tax
(benefit)/expense |
|
|
106 |
|
|
|
34 |
|
|
|
(181 |
) |
|
|
96 |
|
|
| Loss on the
sale of fixed assets |
|
|
(1 |
) |
|
|
(2 |
) |
|
|
(1 |
) |
|
|
(1 |
) |
|
| Non-cash
items |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property, plant & equipment |
|
|
101 |
|
|
|
97 |
|
|
|
309 |
|
|
|
267 |
|
|
| Share based
payment |
|
|
2,218 |
|
|
|
1,865 |
|
|
|
6,232 |
|
|
|
3,570 |
|
|
| Foreign
exchange gains/(losses) |
|
|
(16 |
) |
|
|
(49 |
) |
|
|
(86 |
) |
|
|
(307 |
) |
|
|
Operating cash outflows before movements in working
capital |
|
|
(14,183 |
) |
|
|
(12,426 |
) |
|
|
(49,758 |
) |
|
|
(30,180 |
) |
|
| Increase in
inventories |
|
|
(86 |
) |
|
|
(113 |
) |
|
|
(372 |
) |
|
|
(231 |
) |
|
|
Decrease/(increase) in trade and other receivables |
|
|
(406 |
) |
|
|
(27 |
) |
|
|
(775 |
) |
|
|
(3,078 |
) |
|
| Increase in
trade and other payables |
|
|
(4,167 |
) |
|
|
475 |
|
|
|
711 |
|
|
|
2,376 |
|
|
|
(Decrease)/increase in deferred income and defined benefit pension
liability |
|
|
(32 |
) |
|
|
(178 |
) |
|
|
(401 |
) |
|
|
170 |
|
|
| Income
taxes paid |
|
|
(257 |
) |
|
|
(34 |
) |
|
|
(380 |
) |
|
|
(99 |
) |
|
| Net
cash used in operating activities |
|
|
(19,131 |
) |
|
|
(12,303 |
) |
|
|
(50,975 |
) |
|
|
(31,042 |
) |
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
| Purchases
of property, plant and equipment |
|
|
(4,203 |
) |
|
|
(1,087 |
) |
|
|
(9,700 |
) |
|
|
(1,928 |
) |
|
| Proceeds
from disposals of property, plant and equipment |
|
|
1 |
|
|
|
2 |
|
|
|
1 |
|
|
|
2 |
|
|
| Interest
received |
|
|
5 |
|
|
|
70 |
|
|
|
13 |
|
|
|
68 |
|
|
| Restricted
cash |
|
|
(187 |
) |
|
|
- |
|
|
|
(187 |
) |
|
|
- |
|
|
| Net
cash used in investing activities: |
|
|
(4,384 |
) |
|
|
(1,015 |
) |
|
|
(9,873 |
) |
|
|
(1,858 |
) |
|
|
Cash inflows from financing activities: |
|
|
|
|
|
|
|
|
|
| Proceeds
from issue of shares |
|
|
10 |
|
|
|
40 |
|
|
|
37,416 |
|
|
|
16,032 |
|
|
| Proceeds
from interest bearing loans & borrowings |
|
|
- |
|
|
|
- |
|
|
|
11,240 |
|
|
|
|
| Net
cash inflows from financing activities |
|
|
10 |
|
|
|
40 |
|
|
|
48,656 |
|
|
|
16,032 |
|
|
| Net
decrease in cash and cash equivalents |
|
|
(23,505 |
) |
|
|
(13,278 |
) |
|
|
(12,192 |
) |
|
|
(16,868 |
) |
|
| Cash and
cash equivalents at the beginning of the period |
|
|
53,795 |
|
|
|
53,795 |
|
|
|
42,186 |
|
|
|
55,382 |
|
|
| Effect of
foreign exchange rate changes |
|
|
112 |
|
|
|
(1,560 |
) |
|
|
408 |
|
|
|
443 |
|
|
|
Cash and cash equivalents at the end of the
period |
|
$ |
|
30,402 |
|
$ |
|
38,957 |
|
$ |
|
30,402 |
|
$ |
|
38,957 |
|
|
| |
|
|
|
|
|
|
|
|
| INNOCOLL HOLDINGS PLC |
|
| RECONCILIATION OF NON-GAAP NET LOSS TO NEAREST
COMPARABLE GAAP MEASURE (UNAUDITED) |
|
|
|
| |
Three |
|
Three |
|
Nine |
|
Nine |
|
| |
|
months |
|
months |
|
months |
|
months |
|
| |
|
ended |
|
ended |
|
ended |
|
ended |
|
| |
|
09/30/16 |
|
09/30/15 |
|
09/30/16 |
|
09/30/15 |
|
| |
|
| Thousands of
US$ |
|
|
|
|
|
($'000) |
|
($'000) |
|
($'000) |
|
($'000) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net loss
attributable to equity holders of the company |
$ |
|
(17,204 |
) |
$ |
|
(9,143 |
) |
$ |
|
(53,105 |
) |
$ |
|
(43,094 |
) |
|
|
| Share based
payments |
|
|
2,218 |
|
|
|
1,865 |
|
|
|
6,232 |
|
|
|
3,570 |
|
|
|
| Fair value
(gain)/expense on warrants |
|
|
(175 |
) |
|
|
(5,186 |
) |
|
|
(4,592 |
) |
|
|
13,948 |
|
|
|
| Non-GAAP
net loss |
|
|
(15,161 |
) |
|
|
(12,464 |
) |
|
|
(51,465 |
) |
|
|
(25,576 |
) |
|
|
| |
|
|
|
|
|
|
|
|
|
|
Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com
Jeannie Sorenson, M.D.
Vice President, Investor Relations
(314) 458-7355
jsorenson@innocoll.com
Innocoll AG (NASDAQ:INNL)
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From Aug 2024 to Sep 2024
Innocoll AG (NASDAQ:INNL)
Historical Stock Chart
From Sep 2023 to Sep 2024
