Innocoll AG Announces Second Quarter 2015 Financial and Operating Results and Updates Late-Stage Product Portfolio Progress
ATHLONE,
“We continued to execute on our objectives during the second quarter,” said
Second Quarter 2015 and Recent Highlights
- Announced results of the pivotal PK study that supports use of the 300 mg dose of XaraColl for Phase 3 studies in post-operative pain.
-
Received feedback from the
FDA for our XaraColl Phase 3 program. Both studies will be run in parallel using the 300 mg dose. -
Raised
$16.1 million in net proceeds in a follow-on equity offering. - Dosed the first patients in both the COACT-1 and COACT-2 Phase 3 studies of Cogenzia in diabetic foot infections.
-
Announced that Cogenzia was granted Qualified Infectious Disease Product (QIDP) status by the
U.S. Food and Drug Administration . -
Appointed
Jose (Pepe) Carmona as Chief Financial Officer effectiveSeptember 1 -
Appointed
Rich Fante as Chief Commercial Officer and Head of Business Development
Clinical Program Update
XaraColl®
-
Feedback regarding our proposed Phase 3 plan administering the 300 mg dose has been received from the
FDA . Two identical U.S. Phase 3 studies will test the 300 mg dose versus placebo with a primary endpoint of the 24-hour Summed Pain Intensity Difference rather than the integrated endpoint that we initially contemplated. The trials are expected to begin dosing patients during the third quarter of 2015.
Cogenzia®
-
Two identical Phase 3 trials will be conducted in the U.S., EU and
Australia and are enrolling patients. Patient enrollment is expected to be completed before the second quarter of 2016. Topline data from these studies are anticipated to be available in the third quarter of 2016. -
QIDP status was granted by the U.S.
FDA . Cogenzia is now eligible for additionalFDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and an additional five-year extension of market exclusivity.
CollaGUARD®
- A clinical program is under development for CollaGUARD to support approval in the U.S. We anticipate finalizing the details on this program before the end of 2015.
Second Quarter 2015 Financial Results
Net Loss Available to Ordinary Shareholders:
Non-GAAP diluted loss excluding stock-based compensation and certain non-cash finance or other income was €9.8 million or €5.9 per share (
Weighted average shares outstanding increased from 0.18 million during the three months ended
Revenues: Revenues were €0.6 million for the three months ended
Research and Development (R&D) Expenses: R&D expenses were €4.4 million for the three months ended
General and Administrative (G&A) Expenses: G&A expenses were €3.5 million for the three months ended
Finance Expense: Finance expense was €16.1 million for the three months ended
Cash Position
As of
For further financial information for the period ending
Conference Call
To participate in the conference call, please dial 877-407-4018 (domestic) or 201-689-8471 (international) and ask for the “
An archived webcast recording and telephone replay will be available on the
About
For more information, please visit www.innocollinc.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-IFRS/non-GAAP Financial Measures
To supplement our unaudited consolidated financial statements prepared in accordance with IFRS, we disclose certain non-IFRS, or 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 which 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, which is a non-IFRS financial measure, is intended as a supplemental measure of our performance that is not required by, or presented in accordance with, IFRS. 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 IFRS. 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 future expectations, plans and prospects, including statements about the development of our product candidates, such as the timing, conduct and outcome of our Phase 3 clinical trials of Xaracoll for the treatment of post-operative pain and Cogenzia for the adjuvant treatment of diabetic foot infections, and clinical studies of CollaGUARD, our barrier for the prevention of post-surgical adhesions, and related anticipated
Tables to follow
INNOCOLL AG | ||||||
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (UNAUDITED) | ||||||
Three | Six | |||||
Three months | months | Six months | months | |||
ended | ended | ended | ended | |||
06/30/15 | 06/30/14 | 06/30/15 | 06/30/14 | |||
Thousands of Euros (except where indicated in US$, and share and share data) | ($’000) | (€’000) | (€’000) | ($’000) | (€’000) | (€’000) |
Revenue | $637 | €569 | €1,316 | $1,326 | €1,185 | €2,601 |
Cost of sales | (1,307) | (1,168) | (1,391) | (2,835) | (2,534) | (2,943) |
Gross loss | (670) | (599) | (75) | (1,509) | (1,349) | (342) |
Research and development expenses | (4,967) | (4,439) | (539) | (10,305) | (9,210) | (1,047) |
General and administrative expenses | (3,969) | (3,547) | (2,689) | (7,097) | (6,343) | (4,791) |
Other operating (expense)/income – net | — | — | (39) | — | — | 42 |
Loss from operating activities – continuing operations | (9,606) | (8,585) | (3,342) | (18,911) | (16,902) | (6,138) |
Finance expense | (18,050) | (16,132) | (10,617) | (14,757) | (13,189) | (12,250) |
Other income/(expense) | — | — | 75 | (1) | (1) | 75 |
Loss before income tax | (27,656) | (24,717) | (13,884) | (33,669) | (30,092) | (18,313) |
Income tax | (27) | (24) | (66) | (62) | (55) | (86) |
Loss for the period – all attributable to equity holders of the company | (27,683) | (24,741) | (13,950) | (33,731) | (30,147) | (18,399) |
Other comprehensive income: | ||||||
Currency translation adjustment | 203 | 181 | (38) | (444) | (397) | (43) |
Total comprehensive loss for the period | $(27,480) | €(24,560) | €(13,988) | $(34,175) | €(30,544) | €(18,442) |
Basic and diluted loss per share | $(16.7) | €(15.0) | €(79.2) | $(21.4) | €(19.1) | €(170.7) |
Basic and diluted loss per ADS | $(1.3) | €(1.1) | €(6.0) | $(1.6) | €(1.4) | €(12.9) |
INNOCOLL AG | ||||||
NON-GAAP NET EARNINGS (UNAUDITED) | ||||||
Three | Six | |||||
Three months | months | Six months | months | |||
ended | ended | ended | ended | |||
06/30/15 | 06/30/14 | 06/30/15 | 06/30/14 | |||
Numerator for non-GAAP loss per share -Thousands of Euros (except where indicated in US$, and share and share data) |
($’000) |
(€’000) |
(€’000) |
($’000) |
(€’000) |
(€’000) |
Net loss – basic | $(27,683) | €(24,741) | €(13,950) | $(33,731) | €(30,147) | €(18,399) |
Share based payments | 578 | 517 | 1,118 | 1,191 | 1,064 | 1,601 |
Fair value expense on warrants | 16,135 | 14,420 | 9,272 | 19,311 | 17,259 | 9,272 |
Non-GAAP net loss – basic and diluted | (10,970) | (9,804) | (3,560) | (13,229) | (11,824) | (7,526) |
Denominator – number of shares: | ||||||
Weighted-average shares outstanding – basic and diluted | 1,655,403 | 1,655,403 | 176,083 | 1,579,757 | 1,579,757 | 107,796 |
Loss per share: | ||||||
Basic and diluted | $(6.6) | €(5.9) | €(20.2) | $(8.4) | €(7.5) | €(69.8) |
Loss per ADS: | ||||||
Basic and diluted | $(0.5) | €(0.5) | €(1.5) | $(0.6) | €(0.6) | €(5.3) |
INNOCOLL AG | |||
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION | |||
at June 30, 2015 and December 31,2014 | |||
Thousands of Euros (except where indicated in US$) | 06/30/15 | 06/30/15 | 12/31/14 |
(unaudited) | (unaudited) | ||
($’000) | (€’000) | (€’000) | |
Assets | |||
Property, plant and equipment | $2,059 | €1,840 | €1,238 |
Total non-current assets | 2,059 | 1,840 | 1,238 |
Inventories | 1,475 | 1,318 | 1,118 |
Trade and other receivables | 3,974 | 3,552 | 761 |
Cash and cash equivalents | 52,249 | 46,697 | 45,616 |
Total current assets | 57,698 | 51,567 | 47,495 |
Total assets | 59,757 | 53,407 | 48,733 |
Equity | |||
Share capital | 1,932 | 1,727 | 1,503 |
Share premium | 152,343 | 136,154 | 122,084 |
Capital contribution | 809 | 723 | 723 |
Other reserves | 13,891 | 12,415 | 12,415 |
Currency translation reserve | (1,140) | (1,019) | (622) |
Accumulated share compensation reserve | 6,952 | 6,213 | 5,149 |
Accumulated deficit | (153,138) | (136,865) | (106,718) |
Total equity attributable to equity holders of the company | 21,649 | 19,348 | 34,534 |
Liabilities | |||
Warrant liability | 27,411 | 24,498 | 7,239 |
Defined pension liability | 69 | 62 | 61 |
Total non-current liabilities | 27,480 | 24,560 | 7,300 |
Trade and other payables | 8,038 | 7,184 | 5,055 |
Deferred income | 2,581 | 2,307 | 1,835 |
Current taxes payable | 9 | 8 | 9 |
Total current liabilities | 10,628 | 9,499 | 6,899 |
Total liabilities | 38,108 | 34,059 | 14,199 |
Total equity and liabilities | 59,757 | 53,407 | 48,733 |
INNOCOLL AG | |||
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (UNAUDITED) | |||
Six | Six | Six | |
months | months | months | |
ended | ended | ended | |
Thousands of Euros (except where indicated in US$) | 06/30/15 | 06/30/15 | 06/30/14 |
($’000) | (€’000) | (€’000) | |
Operating activities loss for the period | $(33,730) | €(30,147) | €(18,399) |
Adjustments for: | |||
Finance (income)/expense | 14,757 | 13,189 | 12,250 |
Depreciation/impairment of property, plant & equipment | 170 | 153 | 137 |
Income tax expense | 62 | 55 | 86 |
Loss on the sale of fixed assets | 1 | 1 | (75) |
Share based payment | 1,191 | 1,064 | 1,601 |
Foreign exchange gains | (253) | (226) | 10 |
Operating cash outflows before movements in working capital | (17,802) | (15,911) | (4,390) |
Decrease in inventory | (224) | (200) | 580 |
Increase in trade and other receivables | (3,123) | (2,791) | (1,126) |
Increase in trade and other payables | 2,382 | 2,129 | 2,174 |
Increase/(decrease) in deferred income and defined benefit pension liability | 529 | 473 | (623) |
Income taxes paid | (63) | (56) | (86) |
Net cash used in operating activities | (18,301) | (16,356) | (3,471) |
Cash flows from investing activities: | |||
Purchases of property, plant and equipment | (846) | (756) | (293) |
Interest received | (6) | (5) | — |
Proceeds on sale of Fixed Assets | — | — | 75 |
Net cash used in investing activities: | (852) | (761) | (218) |
Cash inflows from financing activities: | |||
Proceeds from issue of shares | 15,994 | 14,294 | 12,497 |
Net cash inflows from financing activities | 15,994 | 14,294 | 12,497 |
Net decrease in cash and cash equivalents | (3,159) | (2,823) | 8,808 |
Cash and cash equivalents at the beginning of the period | 51,040 | 45,616 | 2,692 |
Effect of foreign exchange rate changes | 4,368 | 3,904 | 33 |
Cash and cash equivalents at the end of the period | $52,249 | €46,697 | €11,533 |
CONTACT: Corporate:Denise Carter Executive Vice President Business Development and Corporate Affairs (215) 765-0149 dcarter@innocollinc.com Investor Contact:Russo Partners, LLC Robert E. Flamm , Ph.D. (212) 845-4226 robert.flamm@russopartnersllc.com