ATHLONE, Ireland, May 14, 2015 (GLOBE NEWSWIRE) -- Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops, manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced financial and operating results for the three months ended March 31, 2015.
"I am pleased to report that we have made significant progress against the major deliverables we set out last quarter," said Tony Zook, chief executive officer of Innocoll. "First, we successfully completed the XaraColl® pivotal pharmacokinetic Phase 3 study and we now are preparing to initiate Phase 3 trials in the U.S. Pending FDA acceptance of the study design, we expect to conduct both trials in parallel with patient enrollment expected to begin during the third quarter. Our parallel U.S. and European Cogenzia® Phase 3 trials are initiated with patient enrollment expected to begin by the end of the second quarter. We successfully completed an equity financing in April raising an additional $16.1 million (after deducting underwriting discounts and commissions and offering expenses), which enables us to move forward with the clinical programs for both XaraColl® and Cogenzia® in parallel. Second, we secured a loan commitment from the European Investment Bank to fund expansion of our manufacturing facility in Saal, Germany as well as the advancement of our late stage clinical development programs. This financing enables the company to build the manufacturing capacity needed to commercialize both XaraColl® and Cogenzia®."
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
- 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 pending FDA feedback.
- 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.
- 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.
Innocoll has developed multiple collagen delivery technologies that provide a variety of approaches to deliver therapeutics for specific patient conditions. These include the primary technologies CollaRx®, which is used in Cogenzia® and XaraColl®, and CollaFilm®, which is used in CollaGUARD®. All of the Company's products, both on the market and in clinical development, are manufactured at the Company's manufacturing facility in Saal, Germany. The Company secured a €25 million loan commitment from the EIB, part of which will be used to fund the expansion of the facility. The facility expansion, which is expected to be completed by the second half of 2016, will increase capacity up to seven-fold and position Innocoll for the anticipated launches of both XaraColl® and Cogenzia®.
First Quarter 2015 Financial Results
Net Loss Available to Ordinary Shareholders: Innocoll reported a net loss attributable to ordinary shareholders of €5.4 million, or €3.6 per share ($0.27 per ADS), for the three months ended March 31, 2015, compared to a loss of €4.4 million, or €114.8 per share, for the three months ended March 31, 2014.
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 ($0.11 per ADS), for the three months ended March 31, 2015, compared to a loss of €4.0 million, or €102.4 per share, for the three months ended March 31, 2014. The GAAP and non-GAAP diluted loss for the three months ended March 31, 2015 were both impacted by exceptional foreign exchange gains of €5.8 million in the quarter.
Weighted average shares outstanding increased from 0.04 million during the three months ended March 31, 2014 to 1.50 million during the three months ended March 31, 2015, respectively, primarily as a result of the conversion of preference shares into ordinary shares and pre-IPO and IPO equity issuances in 2014.
Revenues: Revenues were €0.6 million for the three months ended March 31, 2015 as compared to €1.3 million for the three months ended March 31, 2014, a decrease of 52%. This decrease was primarily due to a decrease in sales to Jazz Pharmaceuticals of CollatampG®, our gentamicin implant for the treatment and prevention of post-surgical infection. On March 20, 2015, Jazz Pharmaceuticals announced the sale of its division, which holds the rights to CollatampG® among other products, to a new company called EUSA Pharma, led by the original founder of the EUSA Pharma business that was acquired by Jazz in 2012.
Research and Development (R&D) Expenses: R&D expenses were €4.8 million for the three months ended March 31, 2015 as compared to €0.5 million for the three months ended March 31, 2014. R&D expenses in the three months ended March 31, 2015 included €4.2 million in external clinical research costs, which consisted primarily of expenses incurred in connection with the initiation of our Phase 3 Cogenzia® efficacy trials and the continuation of our Phase 3 pivotal XaraColl® pharmacokinetic study. R&D expenses are expected to increase going forward as the Company advances the clinical development of its products.
General and Administrative (G&A) Expenses: G&A expenses were €2.8 million for the three months ended March 31, 2015 as compared to €2.1 million for the three months ended March 31, 2014. G&A expenses in each of the three months ended March 31, 2015 and March 31, 2014, included €0.5 million in non-cash charges for stock-based compensation. Excluding such charges for stock-based compensation, G&A expenses for the three months ended March 31, 2015 were €2.3 million as compared to €1.6 million for the three months ended March 31, 2014. G&A expense is expected to increase going forward due to continued infrastructure build out to support clinical programs and commercialization.
Finance and Other Income: Finance and other income was €2.9 million for the three months ended March 31, 2015 as compared to an expense of €1.6 million for the three months ended March 31, 2014. Finance and other income or expense items in the first quarter of 2014 consisted primarily of non-cash items arising out of interest on convertible preferred shares outstanding. Finance and other income in the first quarter of 2015 consisted primarily of foreign exchange gains of €5.8 million partially offset by finance expense of €2.8 million due to increase in the value of liabilities associated with options issued to pre-IPO investors.
As of March 31, 2015, cash and cash equivalents totaled €42.4 million ($45.6 million) compared to €45.6 million ($55.4 million; converted at exchange rate at December 31, 2014) as of December 31, 2014. During March and April, 2015, the Company strengthened its cash position and capital resources by securing a €25 million loan commitment from the EIB, and raising $16.1 million in net proceeds from a follow-on equity offering. Following completion of the equity offering, existing cash and cash available to the Company under the EIB debt facility is expected to be sufficient to fund the Company's clinical programs and operational expenses through the first half of 2016 as well as to fully fund anticipated capital expenditure in connection with the expansion of the Company's manufacturing facility.
For further financial information for the period ending March 31, 2015, please refer to the financial statements appearing at the end of this release. As the financial statements are in euros, all amounts shown in U.S. dollars are for the convenience of the reader only, exchanged at a rate of €1.0759 per euro, the exchange rate as of March 31, 2015.
Innocoll management will host a conference call today at 8:30 a.m. EDT to discuss first quarter 2015 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 first quarter financial results conference call." A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.innocollinc.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: 13608017. The telephone replay will be available until midnight EDT on May 17, 2015.
About Innocoll AG
Innocoll is a global, commercial-stage, specialty pharmaceutical company. We develop and manufacture a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. Our late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® in Phase 3 development for the treatment of post-operative pain; Cogenzia® in Phase 3 for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. Our approved products include: CollaGUARD (Ex-US), CollatampG®, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of our products are made using Type 1 collagen and are manufactured in-house at our facility in Saal, Germany.
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.
"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 FDA pathways and approvals of our proposed clinical strategies, timing and adequacy of the completion of the expansion of our manufacturing facility, pre-commercial activities, the advancement of our earlier stage pipeline, future sales of CollatampG, CollaGUARD, RegenePro, Septocoll or other approved or marketed products, 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, including statements about the clinical trials of our product candidates. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in developing and commercializing our products and product candidates, the initiation and conduct of clinical trials, delays in potential approvals by FDA of the commencement of trials, availability of data from clinical trials, positive results from such trials and expectations for regulatory approvals, our scientific approach and general development progress, the availability or commercial potential of our product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the "Risk Factors" section of our Annual Report on Form 20-F for the year ended December 31, 2014, which is on file with the Securities and Exchange Commission. 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. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release."
Tables to follow
|CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (UNAUDITED)|
|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)|
|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)|
|Loss before income tax||(5,784)||(5,376)||(4,429)|
|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)|
|NON-GAAP NET EARNINGS (UNAUDITED)|
|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)|
|CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION|
|at March 31, 2015 and December 31,2014|
|Thousands of Euros (except where indicated in US$)||03/31/15||03/31/15||12/31/14|
|Property, plant and equipment||$ 1,386||€ 1,288||€ 1,238|
|Total non-current assets||1,386||1,288||1,238|
|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|
|Currency translation reserve||(1,291)||(1,200)||(622)|
|Accumulated share compensation reserve||6,128||5,696||5,149|
|Total equity attributable to equity holders of the company||31,305||29,096||34,534|
|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|
|Current taxes payable||8||7||9|
|Total current liabilities||8,814||8,193||6,899|
|Total equity and liabilities||51,028||47,428||48,733|
|CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (UNAUDITED)|
|Thousands of Euros (except where indicated in US$)||03/31/15||03/31/15||03/31/14|
|Operating activities loss for the period||$ (5,817)||€ (5,407)||€ (4,449)|
|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)|
|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 firstname.lastname@example.org