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 and six months
ended June 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.
“I am pleased that in the second quarter, we
continued to make solid progress in advancing our clinical
programs, delivering on important key milestones,” said Tony Zook,
Chief Executive Officer of Innocoll. “XARACOLL achieved positive
pivotal results in Phase 3 trials, and we are now preparing to
submit an NDA to the FDA for the treatment of post-operative pain.
Our second Phase 3 drug candidate COGENZIA, for the treatment of
diabetic foot infections, completed enrollment of its two clinical
trials in late June, with top-line data expected in the early
fourth quarter of this year. We also advanced COLLAGUARD, for the
prevention of surgical adhesions, into pre-IDE studies as planned.
The expansion of our manufacturing facility in Saal, Germany,
continues to make headway. The Government of Upper Bavaria has
approved our new laboratories for use, and we expect to complete
the construction phase of the Saal facility’s commercial
manufacturing area this quarter. We have started to ramp up our
commercial infrastructure as well by hiring additional talent with
deep experience in launching successful pharmaceutical products.
Our vision is to provide physicians and patients with innovative
new therapeutic options developed from our technology platform,
thus serving unmet medical needs while simultaneously increasing
shareholder value, and we will continue to work hard on those
commitments.”
Second Quarter 2016 and Recent
Highlights
- Announced positive pivotal data in two Phase 3 clinical trials
for XARACOLL, which demonstrated highly statistically significant
results as a long-acting anesthetic in the reduction of surgical
pain following hernia repair. Full analysis of the data will be
submitted for medical publication and to the U.S. Food and Drug
Administration (FDA) through an NDA for the treatment of
post-operative pain, by early 4Q 2016.
- Completed enrollment in two Phase 3 clinical studies studying
COGENZIA in diabetic foot infections. Top line data from these
studies are anticipated in the early fourth quarter of this year,
followed closely by an NDA submission if the data is positive.
COGENZIA’s QIDP designation provides potential eligibility for Fast
Track priority review.
- Started non-clinical studies for COLLAGUARD, with data expected
later this quarter. Assuming positive results and availability of
resources, filing of an IDE package is expected to follow.
- Received approval from Government of Upper Bavaria of new
quality-controlled laboratories at Saal facility. On track to
complete the construction phase of the commercial manufacturing
area in the third quarter of 2016, with qualification / validation
activities targeted for the fourth quarter of this year.
Activities initiated to prepare for pre-approval inspection by the
FDA after submission of the XARACOLL NDA.
- Continued to ramp up on commercial capabilities, including
exceptional hires in Suzanne Delaney (formerly of GlaxoSmithKline)
as Vice President of Sales and Ken Graham (formerly of Bayer) as
Vice President of Managed Markets. Each brings nearly 25 years of
pharmaceuticals sales and marketing experience from previous
leadership roles, with successful launches of multiple widely
recognized pharmaceutical brand drugs.
- Strengthened our financial position through the additions of
cash totaling approximately $49 million to the balance sheet in
June. The drawdown of the second tranche from the European
Investment Bank (EIB) added $11.2 million, following positive Phase
3 data for XARACOLL. In addition, Innocoll’s completion of a public
offering of ordinary shares raised gross proceeds of approximately
$40 million. At June 30, 2016, cash and equivalents totaled $53.8
million, compared to $22.7 million as of March 31, 2016. The
company plans to manage its resources to extend the cash runway for
at least a year and until after the anticipated XARACOLL NDA
approval, the company’s priority, expected in the third quarter of
2017.
Second Quarter 2016 Financial
Results
Net Loss Attributable to Ordinary Shareholders:
Innocoll Holdings plc reported a net loss attributable to its
ordinary shares of $12.8 million, or $0.53 per share of Innocoll
Holdings plc, for the second quarter of 2016, compared to a loss of
$27.6 million, or $1.24 per share of Innocoll Holdings plc, for the
second quarter of 2015.
Non-GAAP diluted net loss excluding non-cash
expense with respect to share-based compensation and fair value
gains and losses on investor options was $15.1 million or $0.62 per
share of Innocoll Holdings plc, for the second quarter of 2016,
compared to a loss of $10.8 million or $0.49 per share of Innocoll
Holdings plc, for the second quarter of 2015.
The weighted average number of ordinary shares
outstanding increased from 22.3 million in the second quarter of
2015 to 24.4 million in the second quarter of 2016, primarily as a
result of Innocoll Holdings plc’s follow-on public offering in the
second quarter of 2016. The total number of shares outstanding as
at June 30, 2016 was 29.7 million.
Revenues: Revenues were $1.3 million for the
second quarter of 2016 as compared to $0.6 million in the second
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 $10.6 million for the second quarter of 2016
as compared to $4.9 million for the second quarter of 2015. R&D
expenses in the second quarter of 2016 included $9.6 million in
external clinical research expenses, which was primarily driven by
our Phase 3 COGENZIA efficacy trials and the conclusion of our
Phase 3 XARACOLL efficacy trials. R&D expenses are expected to
decrease significantly in the future as the company concludes the
COGENZIA clinical studies and files the XARACOLL
NDA.
General and Administrative (G&A) Expenses:
G&A expenses were $6.0 million for the second quarter of 2016
as compared to $4.2 million for the second quarter of 2015.
Excluding stock-based compensation charges, G&A expenses for
the second quarter of 2016 were $3.9 million as compared to $3.4
million for the second quarter of 2015. The increase in G&A,
excluding stock-based compensation, was primarily due to our
continued infrastructure build out to support clinical programs and
the initiation of our pre-commercialization investment.
Other Operating Income/(Expense): Other income
was $4.3 million for the second quarter of 2016 as compared to
other expense of $17.8 million for the second quarter of 2015.
Other income in the second quarter consisted primarily of non-cash
items due to the fair value income of investor options outstanding
and foreign exchange gains, partially offset by interest on the
company’s existing loan with the European Investment Bank (EIB).
Other expense in the second quarter of 2015 consisted primarily of
$15.9 million fair value expense of investor options outstanding
and foreign exchange losses of $1.9 million.
Six Month 2016 Financial
Results
Net Loss Attributable to Ordinary Shareholders:
Innocoll Holdings plc reported a net loss attributable to its
ordinary shareholders of $35.9 million, or $1.50 per share of
Innocoll Holdings plc, for the six months ended June 30, 2016,
compared to a loss of $34.0 million, or $1.60 per share of Innocoll
Holdings plc for the six months ended June 30, 2015.
Non-GAAP diluted loss excluding non-cash expense
with respect to share-based compensation and fair value gains and
losses on investor options was $36.3 million or $1.51 per share of
Innocoll Holdings plc, for the six months ended June 30, 2016,
compared to a loss of $13.1 million, or $0.62 per share of Innocoll
Holdings plc, for the six months June 30, 2015.
The weighted average number of Innocoll Holdings
plc ordinary shares outstanding increased from 21.2 million during
the six months ended June 30, 2015, to 24.0 million during the six
months ended June 30, 2016, primarily as a result of Innocoll
Holdings plc’s follow-on public offering in the second quarter of
2016. The total number of shares outstanding as at June 30, 2016
was 29.7 million.
Revenues: Revenues were $2.9 million for the six
months ended June 30, 2016 as compared to $1.3 million for six
months ended June 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 $25.6 million for the six
months ended June 30, 2016 as compared to $10.3 million for the six
months ended June 30, 2015. R&D expenses in the six months
ended June 30, 2016 included $23.6 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 the XARACOLL
NDA.
General and Administrative (G&A)
Expenses: G&A expenses were $13.4 million for the six
months ended June 30, 2016 as compared to $7.6 million for the six
months ended June 30, 2015. Excluding stock-based
compensation charges, G&A expenses for the six months ended
December 30 2016 were $9.4 million as compared to $5.9 million for
the six months ended June 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 build out to
support clinical programs, and the initiation of our
pre-commercialization investment.
Other Operating Income/(Expense): Other income
was $3.5 million for the six months ended June 30, 2016 as compared
to an expense of $14.5 million for the six months ended June 30,
2015. Other income in the six months ended June 30, 2016 consisted
primarily of non-cash items due to the fair value income of
investor options outstanding, partially offset by interest on the
company’s existing loan with the European Investment Bank (EIB).
Other expense in the six months ended June 30, 2015 consisted
primarily of $19.1 million fair value expense of investor options
outstanding, partially offset by foreign exchange gains of $4.6
million.
Cash Position
As of June 30, 2016, cash and cash equivalents
totaled $53.8 million compared to $22.7 million as of March 31,
2016. The cash and cash equivalents position includes the $37.4
million net proceeds from the public equity follow-on and $11.2
million from the drawdown of the second tranche of the European
Investment Bank loan.
We expect that our rate of expenses will
decrease significantly following the completion of our pivotal
studies for XARACOLL, as our clinical studies for COGENZIA come to
a conclusion, and as we complete the expansion of our Saal, Germany
manufacturing facility. We plan to manage our resources to extend
the cash runway for at least a year and until after the anticipated
XARACOLL NDA approval, expected in the third quarter of 2017.
For further financial information for the
quarter ended June 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 second quarter financial results
and provide a business update.
To participate in the conference call, please
dial 877-407-4018 (domestic) or 201-689-8471 (international) and
ask for the "Innocoll second 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: 89801826. The telephone replay will be available until 11:59
p.m. ET on August 24, 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 wound
and/or 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; COGENZIA
(INL-002), a gentamicin-collagen topical matrix for the adjuvant
treatment of diabetic foot infections; 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
investor options 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 and our other product candidates;
our interpretation of the data and results from our clinical
trials; our plans for, and the expected timing of, our XARACOLL NDA
submission with the FDA; 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
expectations regarding future events, including statements
regarding the therapeutic benefit and safety profile of XARACOLL,
plans and prospects, including statements about the development of
our product candidates and the timing, conduct, enrollment and
outcome of our clinical studies, the availability and receipt of
data from those studies, our ability to sell any approved products,
the risk that the FDA may not accept 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;
our plans to develop and manufacture XARACOLL, COGENZIA and our
other product candidates; our ability to secure Fast Track priority
review for COGENZIA; our ability to successfully progress our
clinical programs and achieve important key milestones; our receipt
of top-line data for COGENZIA's in accordance with the timeframe
presented; our ability to successfully and timely complete the
expansion of our manufacturing facility in Saal, Germany; our
ability to provide physicians and patients with innovative new
therapeutic options developed from our technology platform; our
ability to timely submit, and have accepted for publication,
XARACOLL data through an NDA; our ability to ramp up commercial
capabilities and realize benefits from new hires; our ability
to timely complete studies, and the timing of our ability to submit
a full IDE package with the Pilot (Feasibility) Clinical Study for
COLLAGUARD; the results of clinical trials for XARACOLL, COGENZIA
and our other product candidates; the timing of, and our ability to
obtain, regulatory approval of XARACOLL, COGENZIA and our other
product candidates; our manufacturing and marketing capabilities;
the timing of, and our ability to obtain, regulatory approvals for
the expansion of our manufacturing facility; the sufficiency of
cash resources and need for additional financing, 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. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we
make. 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 |
|
Six |
|
Six |
| |
|
|
|
|
|
|
months |
|
months |
|
months |
|
months |
| |
|
|
|
|
|
|
ended |
|
ended |
|
ended |
|
ended |
| |
|
|
|
|
|
|
06/30/16 |
|
06/30/15 |
|
06/30/16 |
|
06/30/15 |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Thousands of US$ (except share and share
data) |
|
|
($'000) |
|
($'000) |
|
($'000) |
|
($'000) |
|
|
| Revenue |
|
$ |
|
1,305 |
|
$ |
|
629 |
|
$ |
|
2,864 |
|
$ |
|
1,323 |
|
| Cost of
sales |
|
|
|
(1,878 |
) |
|
|
(1,291 |
) |
|
|
(3,589 |
) |
|
|
(2,829 |
) |
| Gross
loss |
|
|
|
(573 |
) |
|
|
(662 |
) |
|
|
(725 |
) |
|
|
(1,506 |
) |
| Research
and development expenses |
|
|
|
(10,608 |
) |
|
|
(4,906 |
) |
|
|
(25,576 |
) |
|
|
(10,277 |
) |
| General and
administrative expenses |
|
|
|
(6,042 |
) |
|
|
(4,179 |
) |
|
|
(13,428 |
) |
|
|
(7,589 |
) |
| Loss from
operating activities - continuing operations |
|
|
(17,223 |
) |
|
|
(9,747 |
) |
|
|
(39,729 |
) |
|
|
(19,372 |
) |
| Other
income/(expense) |
|
|
|
4,257 |
|
|
|
(17,830 |
) |
|
|
3,540 |
|
|
|
(14,517 |
) |
|
Loss before income tax |
|
|
|
(12,966 |
) |
|
|
(27,577 |
) |
|
|
(36,189 |
) |
|
|
(33,889 |
) |
| Income tax
benefit/(expense) |
|
|
|
117 |
|
|
|
(27 |
) |
|
|
286 |
|
|
|
(62 |
) |
|
Loss for the period - all attributable to equity
holders |
|
|
|
|
|
|
|
|
| of
the company |
|
|
|
(12,849 |
) |
|
|
(27,604 |
) |
|
|
(35,903 |
) |
|
|
(33,951 |
) |
|
Other comprehensive (loss)/income: |
|
|
|
|
|
|
|
|
|
| Currency
translation adjustment |
|
|
|
(65 |
) |
|
|
200 |
|
|
|
55 |
|
|
|
(451 |
) |
|
Total comprehensive loss for the period |
|
$ |
|
(12,914 |
) |
$ |
|
(27,404 |
) |
$ |
|
(35,848 |
) |
$ |
|
(34,402 |
) |
| Basic and
diluted loss per share |
|
$ |
|
(0.53 |
) |
$ |
|
(1.24 |
) |
$ |
|
(1.50 |
) |
$ |
|
(1.60 |
) |
|
|
| INNOCOLL HOLDINGS PLC |
|
|
|
| NON-GAAP NET EARNINGS
(UNAUDITED) |
|
|
|
| |
Three |
|
Three |
|
Six |
|
Six |
| |
|
months |
|
months |
|
months |
|
months |
| |
|
ended |
|
ended |
|
ended |
|
ended |
| |
|
06/30/16 |
|
06/30/15 |
|
06/30/16 |
|
06/30/15 |
|
Numerator for non-GAAP loss per share -Thousands
of |
|
| US$ (except share and share data) |
|
|
|
($'000) |
|
($'000) |
|
($'000) |
|
($'000) |
|
|
| Net loss -
basic |
|
$ |
|
(12,849 |
) |
$ |
|
(27,604 |
) |
$ |
|
(35,903 |
) |
$ |
|
(33,951 |
) |
| Share based
payments |
|
|
2,102 |
|
|
|
829 |
|
|
|
4,013 |
|
|
|
1,705 |
|
| Fair value
(gain)/expense on warrants |
|
|
(4,318 |
) |
|
|
15,937 |
|
|
|
(4,418 |
) |
|
|
19,134 |
|
| Non-GAAP
net loss - basic and diluted |
|
|
(15,065 |
) |
|
|
(10,838 |
) |
|
|
(36,308 |
) |
|
|
(13,112 |
) |
|
Denominator - number of shares: |
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding - basic and diluted |
|
|
24,353,498 |
|
|
|
22,311,004 |
|
|
|
24,007,703 |
|
|
|
21,225,693 |
|
|
Loss per share: |
|
|
|
|
|
|
|
|
| Basic and
diluted |
|
$ |
|
(0.62 |
) |
$ |
|
(0.49 |
) |
$ |
|
(1.51 |
) |
$ |
|
(0.62 |
) |
| |
|
|
|
|
|
|
|
| INNOCOLL HOLDINGS PLC |
|
| CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL
POSITION |
|
| at June 30, 2016 and December 31,2015 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
| Thousands of
US$ |
|
|
|
|
|
06/30/16 |
|
12/31/15 |
|
|
| |
(unaudited) |
|
| |
($'000) |
|
($'000) |
|
|
Assets |
|
$ |
|
$ |
|
|
|
Current assets |
|
|
|
|
|
| Cash and
cash equivalents |
|
|
53,795 |
|
|
|
42,186 |
|
|
| Trade and
other receivables |
|
|
4,938 |
|
|
|
4,567 |
|
|
|
|
Inventories |
|
|
2,094 |
|
|
|
1,808 |
|
|
|
| Deferred
taxation |
|
|
317 |
|
|
|
- |
|
|
| Total
current assets |
|
|
61,144 |
|
|
|
48,561 |
|
|
| Property,
plant and equipment |
|
|
9,664 |
|
|
|
4,199 |
|
|
| Total
non-current assets |
|
|
9,664 |
|
|
|
4,199 |
|
|
|
Total assets |
|
$ |
|
70,808 |
|
$ |
|
52,760 |
|
|
|
Liabilities |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
| Trade and
other payables |
|
$ |
|
19,289 |
|
$ |
|
14,411 |
|
|
|
| Deferred
income |
|
|
1,849 |
|
|
|
2,219 |
|
|
|
| Current
taxes payable |
|
|
191 |
|
|
|
20 |
|
|
| Deferred
taxation |
|
|
- |
|
|
|
263 |
|
|
|
Total current liabilities |
|
|
21,329 |
|
|
|
16,913 |
|
|
| Interest
bearing loans and borrowings |
|
|
28,878 |
|
|
|
16,400 |
|
|
| Warrant
liability |
|
|
7,080 |
|
|
|
11,498 |
|
|
| Defined
benefit pension liability |
|
|
50 |
|
|
|
49 |
|
|
|
Total non-current liabilities |
|
|
36,008 |
|
|
|
27,947 |
|
|
|
Total liabilities |
|
|
57,337 |
|
|
|
44,860 |
|
|
|
Equity |
|
|
|
|
|
| Share
capital |
|
|
323 |
|
|
|
1,943 |
|
|
| Additional
paid -in capital |
|
|
216,419 |
|
|
|
173,353 |
|
|
| Currency
translation reserve |
|
|
(1,189 |
) |
|
|
(1,244 |
) |
|
| Treasury
shares |
|
|
(27 |
) |
|
|
- |
|
|
| Accumulated
deficit |
|
|
(202,055 |
) |
|
|
(166,152 |
) |
|
| Total
equity attributable to equity holders of the company |
|
|
13,471 |
|
|
|
7,900 |
|
|
|
Total liabilities and equity |
|
$ |
|
70,808 |
|
$ |
|
52,760 |
|
|
| |
|
|
|
|
| INNOCOLL HOLDINGS PLC |
|
| CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
(UNAUDITED) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
Three |
|
Three |
|
Six |
|
Six |
|
| |
|
|
|
|
|
|
months |
|
months |
|
months |
|
months |
|
| |
|
|
|
|
|
|
ended |
|
ended |
|
ended |
|
ended |
|
| Thousands of
US$ |
|
|
|
|
|
06/30/16 |
|
06/30/15 |
|
06/30/16 |
|
06/30/15 |
|
| |
|
($'000) |
|
($'000) |
|
($'000) |
|
($'000) |
|
|
Operating activities loss for the period |
|
$ |
|
(12,849 |
) |
$ |
|
(27,604 |
) |
$ |
|
(35,903 |
) |
$ |
|
(33,951 |
) |
|
| Adjustments
for: |
|
|
|
|
|
|
|
|
|
| Other
(income)/expense |
|
|
(4,257 |
) |
|
|
17,830 |
|
|
|
(3,540 |
) |
|
|
14,517 |
|
|
| Income tax
(benefit)/expense |
|
|
(117 |
) |
|
|
27 |
|
|
|
(286 |
) |
|
|
62 |
|
|
| Loss on the
sale of fixed assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
|
| Non-cash
items |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of property, plant & equipment |
|
|
113 |
|
|
|
87 |
|
|
|
208 |
|
|
|
170 |
|
|
| Share based
payment |
|
|
2,102 |
|
|
|
829 |
|
|
|
4,013 |
|
|
|
1,705 |
|
|
| Foreign
exchange gains/(losses) |
|
|
35 |
|
|
|
(99 |
) |
|
|
(65 |
) |
|
|
(258 |
) |
|
|
Operating cash outflows before movements in working
capital |
|
|
(14,973 |
) |
|
|
(8,930 |
) |
|
|
(35,573 |
) |
|
|
(17,754 |
) |
|
| Increase in
inventories |
|
|
(206 |
) |
|
|
(314 |
) |
|
|
(286 |
) |
|
|
(118 |
) |
|
|
Decrease/(increase) in trade and other receivables |
|
|
15 |
|
|
|
(1,069 |
) |
|
|
(371 |
) |
|
|
(3,051 |
) |
|
| Increase in
trade and other payables |
|
|
1,089 |
|
|
|
1,787 |
|
|
|
4,878 |
|
|
|
1,901 |
|
|
|
(Decrease)/increase in deferred income and defined benefit pension
liability |
|
|
(116 |
) |
|
|
29 |
|
|
|
(369 |
) |
|
|
348 |
|
|
| Income
taxes paid |
|
|
(68 |
) |
|
|
(27 |
) |
|
|
(124 |
) |
|
|
(65 |
) |
|
| Net
cash used in operating activities |
|
|
(14,259 |
) |
|
|
(8,524 |
) |
|
|
(31,845 |
) |
|
|
(18,739 |
) |
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
| Purchases
of property, plant and equipment |
|
|
(3,082 |
) |
|
|
(704 |
) |
|
|
(5,497 |
) |
|
|
(841 |
) |
|
| Interest
received |
|
|
1 |
|
|
|
(30 |
) |
|
|
8 |
|
|
|
(2 |
) |
|
| Net
cash used in investing activities: |
|
|
(3,081 |
) |
|
|
(734 |
) |
|
|
(5,489 |
) |
|
|
(843 |
) |
|
|
Cash inflows from financing activities: |
|
|
|
|
|
|
|
|
|
| Proceeds
from issue of shares |
|
|
37,403 |
|
|
|
15,992 |
|
|
|
37,406 |
|
|
|
15,992 |
|
|
| Proceeds
from interest bearing loans & borrowings |
|
|
11,240 |
|
|
|
- |
|
|
|
11,240 |
|
|
|
- |
|
|
| Net
cash inflows from financing activities |
|
|
48,643 |
|
|
|
15,992 |
|
|
|
48,646 |
|
|
|
15,992 |
|
|
| Net
decrease in cash and cash equivalents |
|
|
31,303 |
|
|
|
6,734 |
|
|
|
11,312 |
|
|
|
(3,590 |
) |
|
| Cash and
cash equivalents at the beginning of the period |
|
|
22,743 |
|
|
|
45,578 |
|
|
|
42,186 |
|
|
|
55,382 |
|
|
| Effect of
foreign exchange rate changes |
|
|
(251 |
) |
|
|
(60 |
) |
|
|
297 |
|
|
|
460 |
|
|
|
Cash and cash equivalents at the end of the
period |
|
$ |
|
53,795 |
|
$ |
|
52,252 |
|
$ |
|
53,795 |
|
$ |
|
52,252 |
|
|
| |
|
|
|
|
|
|
|
|
| INNOCOLL HOLDINGS PLC |
|
| RECONCILIATION OF NON-GAAP NET LOSS TO NEAREST
COMPARABLE GAAP MEASURE (UNAUDITED) |
|
|
|
| |
Three |
|
Three |
|
Six |
|
Six |
|
| |
|
months |
|
months |
|
months |
|
months |
|
| |
|
ended |
|
ended |
|
ended |
|
ended |
|
| |
|
06/30/16 |
|
06/30/15 |
|
06/30/16 |
|
06/30/15 |
|
| |
|
| Thousands of
US$ |
|
|
|
|
|
($'000) |
|
($'000) |
|
($'000) |
|
($'000) |
|
|
|
| Net loss
attributable to equity holders of the company |
$ |
|
(12,849 |
) |
$ |
|
(27,604 |
) |
$ |
|
(35,903 |
) |
$ |
|
(33,951 |
) |
|
|
| Share based
payments |
|
|
2,102 |
|
|
|
829 |
|
|
|
4,013 |
|
|
|
1,705 |
|
|
|
| Fair value
(gain)/expense on warrants |
|
|
(4,318 |
) |
|
|
15,937 |
|
|
|
(4,418 |
) |
|
|
19,134 |
|
|
|
| Non-GAAP
net loss |
|
|
(15,065 |
) |
|
|
(10,838 |
) |
|
|
(36,308 |
) |
|
|
(13,112 |
) |
|
|
| |
|
|
|
|
|
|
|
|
|
|
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 Mar 2024 to Apr 2024
Innocoll AG (NASDAQ:INNL)
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From Apr 2023 to Apr 2024
