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
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 pending FDA 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
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.
Cash Position
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.
Conference Call
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.
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