Innocoll, Inc. Announces Second Quarter 2015 Financial And Operating Results And Updates Late-Stage Product Portfolio Progress

ATHLONE, Ireland, Aug. 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 and six months ended June 30, 2015.

"We continued to execute on our objectives during the second quarter," said Tony Zook, Chief Executive Officer of Innocoll. "Both Cogenzia Phase 3 trials are now dosing patients and we expect to complete enrollment before the end of the first quarter of 2016. We were awarded QIDP status for Cogenzia, which confers a number of potential benefits including Fast Track designation and priority review by the FDA. This may move forward the projected PDUFA action date and the potential commercial launch by several months. We also received feedback from the FDA for our XaraColl Phase 3 program and anticipate patient enrollment in both Phase 3 studies to begin before the end of the third quarter of 2015. Finally, we continued our transition to a commercial-stage pharmaceutical company by strengthening the management team with the appointments of Rich Fante, Chief Commercial Officer and Head of Commercial and Business Development and Pepe Carmona as our CFO, effective September 1. We are excited about maintaining our momentum for the rest of the year."

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 effective September 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 additional FDA 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: Innocoll reported a net loss attributable to ordinary shareholders of €24.7 million, or €15.0 per share ($1.27 per ADS), for the three months ended June 30, 2015, compared to a loss of €14.0 million, or €79.2 per share for the three months ended June 30, 2014.

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 ($0.50 per ADS), for the three months ended June 30, 2015, compared to a loss of €3.6 million, or €20.2 per share, for the three months ended June 30, 2014. The GAAP and non-GAAP diluted loss per share for the three months ended June 30, 2015 included finance expense of €1.7 million, consisting foreign exchange losses in the quarter.

Weighted average shares outstanding increased from 0.18 million during the three months ended June 30, 2014 to 1.66 million during the three months ended June 30, 2015, respectively, primarily as a result of the conversion of preference shares into ordinary shares and pre-IPO and IPO equity issuances in 2014, and our follow-on offering in the second quarter of 2015.

Revenues: Revenues were €0.6 million for the three months ended June 30, 2015 as compared to €1.3 million for the three months ended June 30, 2014, a decrease of 57%. This decrease was primarily due to a decrease in sales to Jazz Pharmaceuticals/EUSA Pharma of CollatampG®, our gentamicin implant for the treatment and prevention of post-surgical infection, following Jazz Pharmaceuticals' sale of its EUSA Pharma division in March 2015.

Research and Development (R&D) Expenses: R&D expenses were €4.4 million for the three months ended June 30, 2015 as compared to €0.5 million for the three months ended June 30, 2014. R&D expenses in the three months ended June 30, 2015 included €3.8 million in external clinical research costs, which consisted primarily of expenses incurred in connection with the initiation of our Phase 3 Cogenzia® efficacy trials, the completion of our Phase 3 pivotal XaraColl® pharmacokinetic study, and the initiation of our Phase 3 XaraColl® efficacy trials. R&D expenses are expected to continue to increase going forward as the company advances the clinical development of its products.

General and Administrative (G&A) Expenses: G&A expenses were €3.5 million for the three months ended June 30, 2015 as compared to €2.7 million for the three months ended June 30, 2014. G&A expenses in the three months ended June 30, 2015 and June 30, 2014 included €0.5 million and €1.1 million respectively in non-cash charges for stock-based compensation. Excluding such charges for stock-based compensation, G&A expenses for the three months ended June 30, 2015 were €3.0 million as compared to €1.6 million for the three months ended June 30, 2014. The increase in G&A is primarily due to the incremental expenses incurred in connection with becoming a public company in the third quarter of 2014, and to our continued infrastructure build out to support clinical programs and commercialization.

Finance Expense: Finance expense was €16.1 million for the three months ended June 30, 2015 as compared to an expense of €10.6 million for the three months ended June 30, 2014. Finance expense in each quarter consisted primarily of non-cash items due to the increase in the value of liabilities associated with options issued to pre-IPO investors outstanding at the end of each quarter, as well as foreign exchange gains or losses. In the three months ended June 30, 2015, finance expense included a €14.4 million increase of value of liabilities associated with options and foreign exchange losses of €1.7 million.