Innocoll AG Announces First Quarter Financial and Operating Results
ATHLONE,
“I am pleased to report that we have made significant progress against the major deliverables we set out last quarter,” said
First Quarter 2015 and Recent Highlights
-
Appointed
James Tursi , M.D., as chief medical officer, a seasoned pharmaceutical executive with extensive experience developing drugs across a number of therapeutic areas. He will be responsible for managing all clinical development programs, medical affairs and safety for the Company. - Announced results of Phase 3 pivotal XaraColl® pharmacokinetic study that are expected to support use of the 300 mg dose for Phase 3 clinical studies in post-operative pain.
-
Secured €25 million loan commitment from the
European Investment Bank (EIB). -
Raised
$16.1 million in net proceeds in a follow-on equity offering.
Clinical Program Update
XaraColl®
-
U.S. Phase 3 studies are expected to be initiated before the end of the second quarter of 2015 and a contract research organization has been selected. Pending
FDA acceptance of the study design, these trials are expected to run in parallel with first patients enrolled during the third quarter of 2015. The studies are expected to evaluate the safety and efficacy of a 300 mg dose of XaraColl® vs. placebo. Topline data from these studies are anticipated to be available in early 2016 pendingFDA feedback.
Cogenzia®
- Two identical U.S. and European Phase 3 trials have been initiated and patient enrollment is expected to begin by the end of the second quarter of 2015. Topline data from these studies are anticipated to be available in the middle of 2016.
CollaGUARD®
- The Company has ongoing pilot clinical studies to evaluate CollaGUARD® in different surgical procedures. The goal of these studies is to generate data that will be used to finalize our pivotal clinical protocol to obtain PMA approval in the U.S. The data will also be used to support the use of CollaGUARD® in countries where the product is already approved.
Manufacturing Update
First 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 €2.0 million or €1.3 per share (
Weighted average shares outstanding increased from 0.04 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 €4.8 million for the three months ended
General and Administrative (G&A) Expenses: G&A expenses were €2.8 million for the three months ended
Finance and Other Income: Finance and other income was €2.9 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 | |||
Three months | months | ||
ended | ended | ||
03/31/15 | 03/31/14 | ||
Thousands of Euros (except where indicated in US$, and share and share data) | ($’000) | (€’000) | (€’000) |
Revenue | $ 663 | € 616 | € 1,285 |
Cost of sales | (1,470) | (1,366) | (1,552) |
Gross loss | (807) | (750) | (267) |
Research and development expenses | (5,133) | (4,771) | (508) |
General and administrative expenses | (3,009) | (2,797) | (2,102) |
Other operating income – net | — | — | 81 |
Loss from operating activities – continuing operations | (8,949) | (8,318) | (2,796) |
Finance income/(expense) | 3,166 | 2,943 | (1,633) |
Other income | (1) | (1) | — |
Loss before income tax | (5,784) | (5,376) | (4,429) |
Income tax | (33) | (31) | (20) |
Loss for the period – all attributable to equity holders of the company | (5,817) | (5,407) | (4,449) |
Other comprehensive income: | |||
Currency translation adjustment | (622) | (578) | 5 |
Total comprehensive loss for the period | $ (6,439) | € (5,985) | € (4,444) |
Basic and diluted loss per share | $ (3.9) | € (3.6) | € (114.8) |
Basic and diluted loss per ADS | $ (0.3) | € (0.3) | € (8.7) |
INNOCOLL AG | |||
NON-GAAP NET EARNINGS (UNAUDITED) | |||
Three | |||
Three months | months | ||
ended | ended | ||
03/31/15 | 03/31/14 | ||
Numerator for non-GAAP loss per share -Thousands of Euros (except where indicated in US$, and share and share data) | ($’000) | (€’000) | (€’000) |
Net loss – basic | $ (5,817) | € (5,407) | € (4,449) |
Share based payments | 589 | 547 | 483 |
Fair value expense on warrants | 3,054 | 2,839 | — |
Non-GAAP net loss – basic and diluted | (2,174) | (2,021) | (3,966) |
Denominator – number of shares: | |||
Weighted-average shares outstanding – basic and diluted | 1,503,271 | 1,503,271 | 38,750 |
Loss per share: | |||
Basic and diluted | $ (1.5) | € (1.3) | € (102.4) |
Loss per ADS: | |||
Basic and diluted | $ (0.1) | € (0.1) | € (7.7) |
INNOCOLL AG | |||
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION | |||
at March 31, 2015 and December 31,2014 | |||
Thousands of Euros (except where indicated in US$) | 03/31/15 | 03/31/15 | 12/31/14 |
(unaudited) | (unaudited) | ||
($’000) | (€’000) | (€’000) | |
Assets | |||
Property, plant and equipment | $ 1,386 | € 1,288 | € 1,238 |
Total non-current assets | 1,386 | 1,288 | 1,238 |
Inventories | 1,162 | 1,080 | 1,118 |
Trade and other receivables | 2,903 | 2,698 | 761 |
Cash and cash equivalents | 45,577 | 42,362 | 45,616 |
Total current assets | 49,642 | 46,140 | 47,495 |
Total assets | 51,028 | 47,428 | 48,733 |
Equity | |||
Share capital | 1,617 | 1,503 | 1,503 |
Share premium | 131,350 | 122,084 | 122,084 |
Capital contribution | 778 | 723 | 723 |
Other reserves | 13,357 | 12,415 | 12,415 |
Currency translation reserve | (1,291) | (1,200) | (622) |
Accumulated share compensation reserve | 6,128 | 5,696 | 5,149 |
Accumulated deficit | (120,634) | (112,125) | (106,718) |
Total equity attributable to equity holders of the company | 31,305 | 29,096 | 34,534 |
Liabilities | |||
Warrant liability | 10,842 | 10,077 | 7,239 |
Defined pension liability | 67 | 62 | 61 |
Total non-current liabilities | 10,909 | 10,139 | 7,300 |
Trade and other payables | 6,252 | 5,812 | 5,055 |
Deferred income | 2,554 | 2,374 | 1,835 |
Current taxes payable | 8 | 7 | 9 |
Total current liabilities | 8,814 | 8,193 | 6,899 |
Total liabilities | 19,723 | 18,332 | 14,199 |
Total equity and liabilities | 51,028 | 47,428 | 48,733 |
INNOCOLL AG | |||
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (UNAUDITED) | |||
Three | Three | Three | |
months | months | months | |
ended | ended | ended | |
Thousands of Euros (except where indicated in US$) | 03/31/15 | 03/31/15 | 03/31/14 |
($’000) | (€’000) | (€’000) | |
Operating activities loss for the period | $ (5,817) | € (5,407) | € (4,449) |
Adjustments for: | |||
Finance (income)/expense | (3,166) | (2,943) | 1,633 |
Depreciation/impairment of property, plant & equipment | 79 | 74 | 93 |
Income tax expense | 33 | 31 | 20 |
Loss on the sale of fixed assets | 1 | 1 | — |
Share based payment | 589 | 547 | 483 |
Foreign exchange gains | (147) | (137) | (2) |
Operating cash outflows before movements in working capital | (8,428) | (7,834) | (2,222) |
Decrease in inventory | 42 | 39 | 335 |
Increase in trade and other receivables | (2,084) | (1,937) | (577) |
Increase in trade and other payables | 813 | 756 | 1,177 |
Increase/(decrease) in deferred income and defined benefit pension liability | 581 | 540 | (352) |
Income taxes paid | (37) | (34) | (20) |
Net cash used in operating activities | (9,113) | (8,470) | (1,659) |
Cash flows from investing activities: | |||
Purchases of property, plant and equipment | (137) | (127) | (160) |
Interest received | 27 | 25 | — |
Net cash used in investing activities: | (110) | (102) | (160) |
Cash inflows from financing activities: | |||
Proceeds from issue of shares | — | — | 48 |
Net cash inflows from financing activities | — | — | 48 |
Net decrease in cash and cash equivalents | (9,223) | (8,572) | (1,771) |
Cash and cash equivalents at the beginning of the period | 49,078 | 45,616 | 2,692 |
Effect of foreign exchange rate changes | 5,722 | 5,318 | 1 |
Cash and cash equivalents at the end of the period | $ 45,577 | € 42,362 | € 922 |
CONTACT: Corporate:Denise Carter Executive Vice President Business Development and Corporate Affairs (215) 765-0149 Investor Contact:Russo Partners, LLC Robert E. Flamm , Ph.D. (212) 845-4226 robert.flamm@russopartnersllc.com