Gurnet Point L.P. enters into agreement to acquire Innocoll Holdings plc

Transaction Unanimously Supported by Innocoll Board and Key Shareholders

CAMBRIDGE, Mass. & ATHLONE, Ireland--(BUSINESS WIRE)--Gurnet Point L.P., a healthcare investment fund, and Innocoll Holdings plc (NASDAQ:INNL), a global pharmaceutical and medical device company, today announced that they have reached an agreement on the terms of a recommended offer. Under the recommended offer, Gurnet Point will acquire Innocoll for $1.75 per share in cash, and up to $4.90 in cash from a contingent value right (CVR), for a total potential per share value of up to $6.65 or up to approximately $209 million in aggregate. The initial cash consideration of $1.75 represents a premium of approximately 120 percent to the closing price per Innocoll Share on March 10, 2017, the last dealing day prior to the date on which the anomalous movement in Innocoll’s shares commenced (and a premium of approximately 28 percent to the closing price per Innocoll Share on March 15, 2017, the day prior to Innocoll initiating the commencement of the offer period).

During the offer period, Gurnet Point plans to provide a term loan of $10 million to give Innocoll additional resources needed for the continued development of XARACOLL within the post-operative pain market. Innocoll believes that the loan will provide it with the additional capital needed to prepare for the re-submission of the XARACOLL new drug application (“NDA”) to the U.S. Federal Drug Administration (“FDA”) in order to achieve the milestones related to the CVR.

This transaction builds on Gurnet Point’s strategy of investing in life science, medical technology and healthcare service companies. Since its initial NASDAQ public offering in 2014, Innocoll has leveraged its proprietary collagen-based technology to successfully complete two Phase 3 studies for XARACOLL, Innocoll’s late-stage surgically implantable and bioresorbable collagen matrix. XARACOLL was developed to provide sustained post-operative pain relief through controlled delivery of bupivacaine at the surgical site.

Innocoll noted that its Board had explored a sale of the company, to achieve its goal of bringing XARACOLL to market, as well as keeping the company independent and funding the over $100 million required to fund operations through 2019 from raising equity or debt. The “go-it-alone” option was dismissed due to the potential for significant shareholder dilution and execution risk. A potential license for XARACOLL in the United States was also investigated, but no suitable partner has been found.

“Having studied a number of strategic options over the past several months, our Board and management team believe this strategic transaction will give Innocoll access to the financial resources it needs to pursue its goals of bringing XARACOLL through its development to commercialization, and address important unmet medical needs in the post-operative pain market. We believe that the combined leadership of the two companies, supported by Gurnet Point’s financial strength, will better position Innocoll to pursue a successful filing and subsequent commercialization of XARACOLL,” said Jonathan Symonds, Chairperson of Innocoll. “The Innocoll directors unanimously support the offer, which represents a significant premium to the recent share price. In addition, the CVR allows shareholders to participate in the continued development of XARACOLL without further investment."

The directors of Innocoll and major shareholders, including holdings managed by Fortress, Morgan Stanley, Sofinnova and Unique Technologies, have provided irrevocable undertakings to vote in favor of the scheme. In total, management, directors and shareholders have provided irrevocable undertakings representing 46% of the issued ordinary share capital of Innocoll. Details of these irrevocable undertakings, including the circumstances in which they cease to be binding, are set out in the announcement pursuant to Rule 2.5 of the Irish Takeover Rules made by Gurnet Point, Gurnet Bidco and Innocoll today.

“Gurnet Point intends to work with Innocoll’s team to help bring XARACOLL to market by infusing substantial additional capital for its continued development and regulatory approval. We have great respect for Tony Zook and his team at Innocoll and look forward to investing in the business and assisting with the approval of XARACOLL and its commercialization,” said Christopher Viehbacher, Managing Partner at Gurnet Point Capital.

Innocoll had expected to receive FDA approval of XARACOLL this year. On December 29, 2016, Innocoll announced that it had received a Refusal to File Letter from the FDA for XARACOLL. Among other points, the FDA indicated that XARACOLL should be characterized as a drug-device combination product and that additional clinical and nonclinical information on XARACOLL may be required. To provide this information, Innocoll proposes to conduct an additional short-term pharmacokinetic study and several short-term non-clinical toxicology and biocompatibility studies.

The Innocoll directors believe that, if adequately financed and successful, such studies may be completed in time for an end of year re-submission of the XARACOLL NDA. Data from these studies, along with additional manufacturing information required to address the new combination product designation by the FDA and other chemistry, manufacturing and control activities, are also expected to be included in the re-submission.

If the re-submitted NDA is accepted by the FDA, thereby allowing XARACOLL to ultimately be approved, the Innocoll directors believe that Innocoll could be in a position to commercialize XARACOLL by the end of 2018.

Terms of the Transaction

The transaction, which is valued at up to approximately $209 million (including the maximum amount payable upon achievement of the CVR milestones listed below), is expected to be implemented by means of a court-sanctioned scheme of arrangement under Irish law or, with the consent of the Irish Takeover Panel, a takeover offer if Gurnet Bidco so chooses. Innocoll's Board of Directors intends to recommend unanimously that Innocoll shareholders vote or procure votes in favor of the Transaction.

Under the terms of the acquisition, each CVR represents the right to receive a specified amount of cash payments, with each payment conditioned upon the achievement of certain events, called CVR Payment Events.

These CVR Payment Events are:

• First CVR Payment Event: Gurnet Bidco will pay $0.70 in cash per CVR if on or before December 31, 2018, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following open abdominal Hernia repair.
• Second CVR Payment Event: Gurnet Bidco will pay an additional $1.33 in cash per CVR if, on or before December 31, 2018, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following Soft Tissue repair (and not limited to hernia repair).
• Third CVR Payment Event: If the milestone is met, Gurnet Bidco will either pay: $1.00 in cash per CVR if, on or before December 31, 2019, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following Hard Tissue repair; or, if not $0.60 in cash per CVR if, after December 31, 2019 but on or before June 30, 2020, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following Hard Tissue repair.
• Fourth CVR Payment Event: If the milestone is met, Gurnet Bidco will either pay: $1.87 in cash per CVR if global net sales of XARACOLL exceed $60 million in any four consecutive Calendar Quarters ending on or prior to December 31, 2019; or, if not, $1.00 in cash per CVR if global net sales of XARACOLL exceed $60 million in any four consecutive Calendar Quarters ending on or prior to March 31, 2020.
• In the event that none of the CVR Payment Events occur by the relevant dates, then the CVR will have no value. The minimum payment of the CVR is zero and the maximum payment is $4.90 in cash per Innocoll Share.

About Gurnet

Gurnet Point is a healthcare investment fund led by Christopher Viehbacher, managing partner, Gurnet Point Capital. Gurnet Point is based in Cambridge, Massachusetts, USA, and invests in life sciences and medical technologies as well as healthcare services across all stages of development through to commercialization.

About Innocoll

Innocoll is a global, commercial stage specialty pharmaceutical and medical device company with late stage development programs targeting areas of significant unmet medical need. Innocoll’s shares are listed for trading on the NASDAQ under the symbol “INNL.” Innocoll utilizes its proprietary collagen-based technology platform to develop biodegradable and fully bioresorbable products and product candidates which can be broken down by the body without the need for surgical removal or topical application. Using its proprietary processes at its manufacturing facility, Innocoll derives and purifies bovine and equine collagen and then utilizes its technology platform to incorporate the purified collagen into its topical and implantable products. Innocoll’s proprietary processes and technologies also enable it to control the texture, consistency, drug elution dynamics, resorption time and other physical characteristics of the finished product. All of Innocoll’s native collagen products – from extraction/purification of type-1 collagen through final delivery form – are manufactured at its certified, integrated plant in Saal, Germany.

General

This summary should be read in conjunction with the full text of the Rule 2.5 announcement, being the formal transaction announcement made by Gurnet Point, Gurnet Bidco and Innocoll earlier today. The Rule 2.5 announcement and this announcement will be made available on a Gurnet Point website for the purposes of the Acquisition (www.GurnetPointLPOffer.com) and on Innocoll’s website (www.Innocoll.com). Certain capitalized words used in this announcement and not defined have the meaning given to such words in the Rule 2.5 announcement. The bases and sources set out in the Rule 2.5 announcement have been used in this announcement, unless otherwise stated or the context otherwise requires. Certain figures included in this announcement have been subjected to rounding adjustments.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION.

Important Additional Information for U.S. Investors and Where to Find It

Innocoll intends to file the Scheme Document, which will also constitute the proxy statement of Innocoll (the “Proxy Statement”), with the SEC and mail a copy to Innocoll Shareholders in advance of the Scheme Meeting and the EGM and in connection with the Acquisition and the Scheme. INNOCOLL SHAREHOLDERS ARE URGED TO READ THE SCHEME DOCUMENT/PROXY STATEMENT AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT INNOCOLL, THE ACQUISITION, THE SCHEME AND RELATED MATTERS. Innocoll Shareholders will be able to obtain free copies of the Scheme Document/Proxy Statement and other documents filed with or furnished to the SEC by Innocoll through the website maintained by the SEC at www.sec.gov. In addition, Innocoll Shareholders will be able to obtain free copies of the Scheme Document/Proxy Statement on www.Innocoll/com/investors.

Participants in the Solicitation

Innocoll, Gurnet Point and Gurnet Bidco and certain of its respective directors and executive officers and employees may be considered participants in the solicitation of proxies from the shareholders of Innocoll in respect of the transactions contemplated by the Scheme Document/Proxy Statement. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the shareholders of Innocoll in connection with the proposed transactions, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the Proxy Statement when it is filed with the SEC. Information regarding Innocoll’s directors and executive officers is contained in Innocoll’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 which is filed with the SEC. Information concerning the interests of Innocoll’s participants in the solicitation, which may, in some cases, be different than those of Innocoll’s shareholders generally will be set forth in the Proxy Statement relating to the transaction when it becomes available.

No Offer or Solicitation

This announcement is for information purposes only and is not intended to and does not constitute an offer to purchase, sell, subscribe for or exchange, or the solicitation of an offer to purchase, sell, subscribe for or exchange or an invitation to purchase, sell, subscribe for or exchange any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the Acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. The Acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer Document), which will contain the full terms and conditions of the Acquisition, including details of how to vote in respect of the Acquisition. Any decision in respect of, or other response to, the Acquisition, should be made only on the basis of the information contained in the Scheme Document (of, if applicable, the Takeover Offer Document). No offer of securities shall be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements included in this announcement are forward-looking and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements can typically be identified by the use of forward-looking terminology, such as “expects”, “believes”, “may”, “will”, “could”, “should”, “intends”, “plans”, “predicts”, “envisages”, “estimates”, “forecast”, “outlook”, “guidance”, “possible”, “projects”, “potential” or “anticipates” or other similar words and expressions and include, without limitation, any projections relating to results of operations and financial conditions of either Gurnet Point, Gurnet Bidco or Innocoll and their respective subsidiary undertakings from time to time, as well as plans and objectives for future operations, expected future revenues, financing plans, expected expenditures, expected synergies and divestments relating to Gurnet Point, Gurnet Bidco or Innocoll and discussions of Gurnet Point’s, Gurnet Bidco’s or Innocoll’s business plan. All forward-looking statements in this announcement made by Gurnet Point and / or Gurnet Bidco are based upon information known to Gurnet Point and / or Gurnet Bidco on the date of this announcement and all forward-looking statements in this announcement made by Innocoll are based upon information known to Innocoll on the date of this announcement. Except as expressly required by law, Gurnet Point, Gurnet Bidco and Innocoll disclaim any intent or obligation to update or revise these forward-looking statements. None of Gurnet Point, Gurnet Bidco or Innocoll undertake any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, save as may be required by law.

Statements under the Irish Takeover Rules

The directors of Gurnet Bidco and the managers of Waypoint International GP LLC (in its capacity as general partner of Gurnet Point) accept responsibility for the information contained in this announcement, other than the information relating to Innocoll, the Innocoll Group and the Innocoll directors and members of their immediate families, related trusts and persons connected with them, for which the Innocoll directors accept responsibility. To the best of the knowledge and belief of the directors of Gurnet Bidco and the managers of Waypoint International GP LLC (in its capacity as general partner of Gurnet Point) (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

The Innocoll directors accept responsibility for the information contained in this announcement relating to Innocoll, the Innocoll Group and the Innocoll directors and members of their immediate families, related trusts and persons connected with them, except for statements made by Gurnet Point and Gurnet Bidco in respect of Innocoll. To the best of the knowledge and belief of the Innocoll directors (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

Evercore Partners International LLP (“Evercore”), which is authorized and regulated in the United Kingdom by the Financial Conduct Authority, is acting as Financial Adviser exclusively for Gurnet Point and Gurnet Bidco and no one else in connection with the Acquisition and the other matters referred to in this announcement, and will not regard any other person as its client in relation to the Acquisition and the other matters referred to in this announcement and will not be responsible to anyone other than Gurnet Point and / or Gurnet Bidco for providing the protections afforded to clients of Evercore, nor for providing advice in relation to the Acquisition or the other matters referred to in this announcement. Neither Evercore nor any of its subsidiaries, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Evercore in connection with this announcement, any statement contained herein or otherwise.

Piper Jaffray & Co. (“Piper Jaffray”), which is a securities broker-dealer registered with the U.S. Securities and Exchange Commission (“SEC”) and subject to regulation by the SEC and the Financial Industry Regulatory Authority (“FINRA”), is acting as financial adviser exclusively for Innocoll and for no one else in connection with the Acquisition and the other matters referred to in this announcement, and will not be responsible to anyone other than Innocoll for providing the protections afforded to clients of Piper Jaffray or for providing advice in relation to the Acquisition or any other matters referred to in this announcement.

Disclosure Requirements under the Irish Takeover Rules

Persons interested in 1% or more of any relevant securities in Innocoll may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013. See the Rule 2.5 announcement of earlier today for further details.

No Profit Forecast / Asset Valuation

No statement in this announcement is intended to constitute a profit forecast for any period, nor should any statements be interpreted to mean that earnings, earnings per share, losses or losses per share will necessarily be greater or lesser than those for the relevant preceding financial periods for any of Innocoll, Gurnet Point or Gurnet Bidco as appropriate. No statement in this announcement constitutes an asset valuation.

Contacts
 

Enquiries:
Gurnet Point and Gurnet Bidco
Evercore (Financial Adviser to Gurnet Point and Gurnet Bidco)
Francois Maisonrouge
John Honts Tel: +1 212 857 3100
Edward Banks Tel: +44 (0) 20 7653 6000
or
Abernathy MacGregor (Press Inquiries)
Tom Johnson Tel: +1 212 371 5999
tbj@abmac.com
or
Innocoll
Tel: Jose (Pepe) Carmona, Chief Financial Officer
pcarmona@innocoll.com
Piper Jaffray (Financial Adviser to Innocoll)
Peter Day Tel: + 1 617 654 0772
Peter Lombard Tel: + 1 617 654 0751
Michael Burton-Williams Tel: + 1 212 284 6126

Innocoll announces regulatory path forward after receiving formal FDA Type A meeting minutes regarding its XARACOLL® (bupivacaine HCl collagen-matrix implant) New Drug Application

ATHLONE, Ireland -- Innocoll Holdings plc (NASDAQ:INNL) ("Innocoll" or the "Company"), a global, commercial-stage, specialty pharmaceutical and medical device company, today announced receipt of formal Type A Meeting minutes from the United States Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for XARACOLL (bupivacaine HCl collagen-matrix implant).  XARACOLL is the company’s product in development for the treatment of postsurgical pain.

Innocoll received a Refusal to File (RTF) Letter from the FDA in December 2016 pertaining to the XARACOLL NDA initially submitted on October 31, 2016.  In the RTF letter, the FDA indicated among other things, that XARACOLL should be characterized as a drug/device combination, which would require that the Company submit additional information.  During the Type A meeting, representatives of the FDA, after reviewing information provided by Innocoll to address matters raised in the RTF letter, provided guidance which was confirmed in the formal FDA meeting minutes.  The minutes serve as the official record of the FDA response to our proposal to address certain issues raised in the RTF by conducting an additional short-term pharmacokinetic study and several short-term non-clinical toxicology and biocompatibility studies. Innocoll believes, if adequately financed and successful, such studies may be completed in time for a resubmission of the NDA at the end of 2017.  Data from these studies, along with additional manufacturing information required to address the new combination product designation and other chemistry, manufacturing and control (CMC) issues, are expected to be included in the resubmission.  The acceptability of this data and other data that we reviewed with FDA during the meeting will be evaluated by the FDA during its review of the resubmission.

“I am pleased that we have clarified the data needed to address the questions raised in the RTF letter. With the official minutes from the FDA now in hand, we believe that we have a path forward for a possible resubmission of the XARACOLL NDA by the end of 2017, assuming adequate financing to commence the proposed studies, and further assuming positive results,” said Tony Zook, CEO of Innocoll.


About XARACOLL®

XARACOLL is Innocoll’s late-stage surgically implantable and bioresorbable collagen matrix developed to provide sustained postsurgical pain relief through controlled delivery of bupivacaine at the surgical site.


About Innocoll Holdings plc

Innocoll is a global, commercial stage specialty pharmaceutical and medical device company with late stage development programs targeting areas of significant unmet medical need. Innocoll utilizes its proprietary collagen-based technology platform to develop biodegradable and fully bioresorbable products and product candidates which can be broken down by the body without the need for surgical removal or topical application.

Innocoll Holdings plc Announces Fourth Quarter and Full-Year 2016 Financial and Operating Results and Provides Corporate Update

ATHLONE, Ireland -- Innocoll Holdings plc (Nasdaq:INNL), a global, commercial stage, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need announced financial and operating results for the three months and full year ended December 31, 2016. Innocoll manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based biodegradable and fully bioresorbable technology platform.

“In 2016, Innocoll successfully achieved milestones, but also faced challenges.  On the one hand, XARACOLL achieved positive pivotal results in Phase 3 trials and we were able to substantially finalize the expansion of our manufacturing facility in Saal, Germany. On the other hand, COGENZIA did not achieve statistical significance in improving clinical cure in diabetic foot infections (DFI) and XARACOLL received the Refusal-to-File letter from the U.S. Food and Drug Administration (FDA)," said Tony Zook, Chief Executive Officer of Innocoll. “In February 2017, we attended a Type-A meeting with representatives of the FDA to review pathways forward following our receipt of the Refusal-To-File letter.  During the meeting, we proposed a plan to conduct an additional short-term Pharmacokinetic study and several short-term non-clinical studies, which we believe will allow us to submit a revised NDA to the FDA by the end of 2017.  If the formal minutes from the Type-A meeting, which we expect to receive at the end of this month, confirm that the FDA agrees with our plan, we would submit a revised NDA to the FDA soon after the completion of the additional studies, assuming adequate financing to commence the proposed studies, and further assuming positive results."

Innocoll plans to update investors with additional information about the outcome of its Type A meeting shortly after receiving formal written FDA minutes. In the interim, Innocoll intends to continue to explore strategic options to maximize value to its shareholders.

Fourth Quarter 2016 and Recent Updates

• Substantially finalized expansion of its Saal, Germany manufacturing facility.
• Following receipt of the XARACOLL Refusal to File Letter in December, 2016, in January 2017, Innocoll requested a Type A meeting with the FDA, which was held in late February 2017. At the meeting, management presented a plan for a path forward, including an additional short-term Pharmacokinetic study and several short-term non-clinical studies, which assuming FDA concurrence, adequate financing and further positive trial results, could enable Innocoll to submit a revised NDA for XARACOLL in the latter part of 2017.

Fourth Quarter 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll reported a net loss attributable to ordinary shares of $3.8 million, or $0.13 per share, for the fourth quarter of 2016, compared to a loss of $7.7 million, or $0.33 per share for the fourth quarter of 2015.

Non-GAAP diluted loss excluding nonrecurring items was $7.6 million or $0.26 per share, for the fourth quarter of 2016, compared to a loss of $16.9 million or $0.72 per share, for the fourth quarter of 2015.

The weighted average number of ordinary shares outstanding increased from 23.5 million in the fourth quarter of 2015 to 29.7 million in the fourth quarter of 2016, primarily as a result of the follow-on public offering in the second quarter of 2016.

Revenues: Revenues were $0.6 million for the fourth quarter of 2016 as compared to $0.9 million for the fourth quarter of 2015. This decrease was primarily due to lower sales to EUSA Pharma of CollatampG®.

Research and Development (R&D) Expenses: R&D expenses were $4.7 million for the fourth quarter of 2016 as compared to $11.7 million for the fourth quarter of 2015. R&D expenses in the fourth quarter of 2016 included $3.7 million in external clinical research expenses, which was primarily driven by the finalization of our Phase 3 Cogenzia efficacy trials.

General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the fourth quarter of 2016 as compared to $6.1 million for the fourth quarter of 2015. Excluding stock-based compensation charges, G&A expenses for the fourth quarter of 2016 were $2.6 million as compared to $5.7 million for the fourth quarter of 2015. The decrease in G&A excluding stock-based compensation was primarily due to reduction in discretionary expenses and prior year expenses relating to the company’s re-domiciliation to Ireland.

Other Operating Income: Other operating income was $7.1 million for the fourth quarter of 2016 as compared to $10.9 million for the fourth quarter of 2015. Other income in the fourth quarter of 2016 consisted primarily of fair value income of warrants outstanding and foreign exchange gains, partially offset by accrued interest on the company’s existing loan with the European Investment Bank (EIB). Other income in the fourth quarter of 2015 consisted primarily of $9.7 million fair value income of warrants outstanding.

Full Year 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll reported a net loss attributable to ordinary shareholders of $57.0 million, or $2.12 per share, for the year ended December 31, 2016, compared to a loss of $50.9 million, or $2.28 per share for the year ended December 31, 2015. 

Non-GAAP diluted loss excluding nonrecurring items was $59.1 million or $2.20 per share, for the year ended December 31, 2016, compared to a loss of $42.8 million, or $1.92 per share, for the year ended December 31, 2015. 

The weighted average number of ordinary shares outstanding increased from 22.3 million during the year ended December 31, 2015, to 26.9 million during the year ended December 31, 2016, primarily as a result of the follow-on public offering in the second quarter of 2016.

Revenues:  Revenues were $4.4 million for the year ended December 31, 2016 as compared to $2.9 million for year ended December 31, 2015.  This increase was primarily due to an increase in sales to EUSA Pharma of Collatamp G, our gentamicin implant for the treatment and prevention of post-surgical infection.

Research and Development (R&D) Expenses:  R&D expenses were $38.7 million for the year ended December, 31 2016 as compared to $29.8 million for the year ended December 31, 2015. R&D expenses in the year ended December 31, 2016 included $34.8 million in external clinical research expenses, which was primarily due to the completion of our pivotal Phase 3 studies of XARACOLL and Cogenzia. R&D expenses are expected to significantly decrease going forward.

General and Administrative (G&A) Expenses:  G&A expenses were $25.4 million for the year ended December 31, 2016 as compared to $19.7 million for the year ended December 31, 2015.   Excluding stock-based compensation charges, G&A expenses for the year ended December 31 2016 were $16.9 million as compared to $15.7 million for the year ended December 31, 2015. The increase in G&A, excluding stock-based compensation, was primarily due to our continued infrastructure build out to support clinical programs and expenses related to the company’s re-domiciliation to Ireland.

Other Operating Income: Other operating income was $10.0 million for the year ended December 31, 2016 as compared to $1.6 million for the year ended December 31, 2015. Other income for the year ended December 31, 2016 consisted primarily of non-cash items due to the fair value income of warrants outstanding and foreign exchange gains, partially offset by accrued interest on the company’s existing loan with the EIB. Other expense for the year ended December 31, 2015 consisted primarily of foreign exchange gains of $5.6 million, partially offset by fair value expense of warrants outstanding of $4.0 million.

Cash Position

As of December 31, 2016, cash and cash equivalents totalled $15.8 million compared to $30.4 million as of September 30, 2016. For further financial information for the period ending December 31, 2016, please refer to the financial statements appearing at the end of this release.

In management's opinion, Innocoll's anticipated expenditures during the next 12 months to advance its current operations, including plans to conduct further studies to enable it to submit a revised NDA for XARACOLL and to develop CollaGUARD will be greater than the amount of its current cash and cash equivalents.  The Company may not be able to generate revenues from the sale of XARACOLL until the end of 2018, if at all.

Innocoll's need for additional capital will vary depending on a variety of circumstances, including, for example, if it is required to conduct additional tests not currently contemplated, the level and timing of regulatory approval, as well as the extent to which it chooses to establish collaboration, co-promotion, distribution or other similar agreements for its products and product candidates. Moreover, changing circumstances may cause it to spend cash significantly faster than it currently anticipates, and it may need to spend more cash than currently expected because of circumstances beyond its control.

To the extent that Innocoll's capital resources are insufficient to meet its future operating and capital requirements, it will need to finance its cash needs through public or private equity offerings, debt financings, corporate collaboration and licensing arrangements, or strategic alternatives.

About Innocoll Holdings plc

Innocoll is a global, specialty pharmaceutical company with late stage development programs that is dedicated to engineering better medicines to help patients get better. Its proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to surgery sites, they are designed to provide a range of benefits. Its late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain and CollaGUARD (INL-003), a barrier for the prevention of post-surgical adhesions.

Innocoll's currently approved products include: CollaGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet.  All of its native collagen products — from extraction/purification of type-1 collagen through final delivery form — are manufactured at its certified, integrated plant in Saal, Germany.

For more information, please visit www.innocoll.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.

Innocoll Holdings Announces Statement re: Possible Offer

ATHLONE, Ireland -- The Board of Innocoll Holdings plc (“Innocoll” or the “Company”) (NASDAQ:INNL) notes anomalous movements in Innocoll’s share price this week and confirms that it is in discussions which may or may not lead to an offer for the entire issued share capital of the Company.

Management has been investigating and continues to investigate strategic options for the Company to maximise shareholder value. There can be no certainty that this will lead to an offer for Innocoll or any of its share capital nor as to the terms on which an offer, if any, might be made. The Company has participated in a Type A meeting with the United States Food and Drug Administration ("FDA") regarding the re-submission to the FDA for approval of XARACOLL. It expects to receive the minutes of the Type A meeting before the end of March and will make a further announcement at that time. 

A further announcement will be made when appropriate.

ENQUIRIES

Innocoll Holdings plc

Jose (Pepe) Carmona, Chief Financial Officer
pcarmona@innocoll.com

Piper Jaffray & Co

Peter Day, Managing Director
Peter.c.day@pjc.com

Peter Lombard, Managing Director
peter.a.lombard@pjc.com

Michael Burton-Williams, Principal
michael.g.burton-williams@pjc.com

Innocoll Receives Refusal to File Letter from U.S. FDA for XARACOLL® (bupivacaine HCl collagen-matrix implants) New Drug Application

ATHLONE, Ireland - Innocoll (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company, today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) for XARACOLL, the company’s product candidate for the treatment of postsurgical pain.

Upon preliminary review, the FDA determined that the application, which was submitted in October 2016, was not sufficiently complete to permit a substantive review.  In the Refusal to File letter, the FDA indicated among other things, that XARACOLL should be characterized as a drug/device combination, which would require that the Company submit additional information.  The company will request a Type A meeting with the FDA to respond to several issues believed to be addressable and seek clarification of what additional information, if any, will be required.  Additional details will be disclosed in the future after discussions with the FDA.

“We expect to work with the FDA over the coming weeks in an effort to address the open issues and to define a path forward for a successful re-filing of our application at the earliest point in time,” said Tony Zook, CEO of Innocoll.

About XARACOLL® 
XARACOLL® is a surgically implantable and bioresorbable bupivacaine-collagen matrix that utilizes our CollaRx® proprietary collagen-based delivery technology and is being developed to provide sustained postsurgical pain relief directly into the surgical site. XARACOLL is also designed to reduce the need for systemic opioids and their associated risks.

About Innocoll Holdings plc
Innocoll is a global, specialty pharmaceutical company with late stage development programs that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing large unmet medical needs, including: XARACOLL for the treatment of postsurgical pain and COLLAGUARD (INL-003), a barrier for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®.

Innocoll Holdings plc Announces Third Quarter 2016 Financial and Operating Results and Provides Corporate Update

ATHLONE, Ireland -- Innocoll Holdings plc (INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical needs, today announced financial and operating results for the three months ended September 30, 2016. Using our proprietary collagen-based technology platform, we manufacture and supply a range of biodegradable and fully bioresorbable pharmaceutical products and medical devices that are precision-engineered for targeted use.

“As we recently announced, Innocoll achieved an exciting, new milestone with the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for XARACOLL for the treatment of post-surgical pain,” said Tony Zook, Chief Executive Officer of Innocoll. “We anticipate an FDA acceptance of the NDA, for review, by the end of this year, and with a target Prescription Drug User Fee Act (PDUFA) action date in late August 2017, this achievement will take us another step closer to the approval and launch of XARACOLL in potentially less than one year. In preparation, our Saal Germany based manufacturing facility has completed its construction phase, and we are on schedule to undergo pre-approval inspections soon. In addition to progressing XARACOLL, we were also pleased to announce the advancement of COLLAGUARD upon successful demonstration of medical safety in its pre-clinical studies, which cleared the way for our submission of an Investigational Device Exemption (IDE) this month for the prevention of post-surgical adhesions. The COLLAGUARD program is an ideal complement to XARACOLL, which we believe will position Innocoll competitively in the hospital segment. We reported earlier this month that while COGENZIA showed trends of clinical improvement as adjunct treatment of Diabetic Foot Infections (DFIs), the top-line results did not reach statistical significance for the primary endpoint. We will continue to assess all strategic options to bring these much needed new products to the market and the medical community. We plan to manage our cash runway until after the anticipated XARACOLL NDA approval, expected in the third quarter of 2017, and we feel confident about our ability to finance the commercialization of XARACOLL as well as our pipeline”.

Third Quarter 2016 and Recent Highlights

• Submitted an NDA for XARACOLL to the FDA for the treatment of postsurgical pain
• FDA acceptance anticipated by the end of 2016, with a target PDUFA action date in late August 2017.
• Presented supportive pharmacokinetic data at American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, in October.
• Medical publication and presentation of full Phase 3 data are targeted for 2Q 2017. Also under preparation to be published next year are the results of our Health Economics (HECON) study, demonstrating the health economic benefits of using XARACOLL.
• Assessment of strategic options around product development continues, as well the planning and preparation for commercialization has ramped up.
• Advanced COLLAGUARD (INL-003), a collagen film being developed as a medical device implanted at the time of surgery for the prevention of postsurgical adhesions
• Completed pre-clinical studies that demonstrated safety as a surgical adhesion barrier in preclinical studies.
• The positive data support filing of an IDE this quarter, 4Q 2016. Thereafter, a Pilot (Feasibility) Study, for the prevention of post-surgical adhesions in patients undergoing open myomectomy, could be initiated next year, assuming the availability of resources to fund the study.
• Announced that Phase 3 clinical trials for COGENZIA showed trends toward clinical response, but top-line data did not achieve statistical significance in improving clinical cure in DFIs.
• The two COACT Phase 3 clinical trials in patients with moderate to severe DFIs studied COGENZIA administered in conjunction with the standard of care (SOC): systemic antibiotics and wound therapy. Based on top-line data, the COGENZIA plus SOC arm did not meet its primary endpoint of clinical cure of infection after 28 days versus placebo plus SOC or versus SOC alone.
• While Innocoll continues to analyze the results, and there were trends toward clinical response in the COGENZIA and placebo collagen-matrix arms, the top-line data suggests that neither COACT-1 nor COACT-2 achieved statistical significance.
• COGENZIA and the placebo collagen-matrix were well tolerated, and the incidence of overall adverse events was similar across all three treatment arms.
• Continued expansion of Saal manufacturing facilities on schedule with successful completion of key stages
• New Quality Control Laboratories approved and operational.
• On-time completion of the CMC Sections and submission of the XARACOLL NDA to the FDA.
• Construction phase of the commercial manufacturing area completed.  Site qualification/validation activities on target for completion prior to year-end.
• Successful completion of a EU “Notified Body” medical device inspection.
• Continuing efforts in preparation for Pre-approval Inspection by FDA.  Initial 3rd Party, ex-FDA compliance audit completed.

Third Quarter 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll Holdings plc reported a net loss attributable to its ordinary shares of $17.2 million, or $0.58 per share, for the third quarter of 2016, compared to a loss of $9.1 million, or $0.39 per share, for the third quarter of 2015.

Non-GAAP basic and diluted net loss excluding non-cash expense with respect to share-based compensation and fair value gains and losses on warrants was $15.2 million or $0.51 per share, for the third quarter of 2016, compared to a loss of $12.5 million or $0.53 per share, for the third quarter of 2015.

The weighted average number of ordinary shares outstanding increased from 23.4 million in the third quarter of 2015 to 29.7 million in the third quarter of 2016, primarily as a result of Innocoll's follow-on public offering in the second quarter of 2016. The total number of shares outstanding as at September 30, 2016 was 29.7 million.

Revenues: Revenues were $0.9 million for the third quarter of 2016 compared to $0.7 million in the third quarter of 2015. This increase was primarily due to an increase in sales to EUSA Pharma of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, following the stabilization of the EUSA Pharma business following the transfer from Jazz Pharmaceuticals.

Research and Development (R&D) Expenses: R&D expenses were $8.4 million for the third quarter of 2016 compared to $7.7 million for the third quarter of 2015. R&D expenses in the third quarter of 2016 included $7.5 million in external clinical research expenses, which was primarily driven by our Phase 3 COGENZIA efficacy trials. R&D expenses are expected to decrease significantly in the future as the company concludes the COGENZIA clinical studies and files its NDA for XARACOLL.         

General and Administrative (G&A) Expenses: G&A expenses were $7.1 million for the third quarter of 2016 compared to $6.0 million for the third quarter of 2015. Excluding share-based compensation charges, G&A expenses for the third quarter of 2016 were $4.9 million, as compared to $4.2 million for the third quarter of 2015. The increase in G&A, excluding stock-based compensation, was primarily due to our continued infrastructure to support clinical programs and some pre-commercialization investment.

Other Operating (Expense)/Income: Other expense was $0.6 million for the third quarter of 2016 compared to other income of $5.2 million for the third quarter of 2015. Other expense in the third quarter of 2016 consisted primarily of accrued interest on the company’s existing loan with the European Investment Bank (EIB) and foreign exchange losses, partially offset by the fair value income of warrants outstanding. Other income in the third quarter of 2015 consisted primarily of $5.2 million fair value income of investor options outstanding.

Nine Month 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll Holdings plc reported a net loss attributable to its ordinary shareholders of $53.1 million, or $2.05 per share, for the nine months ended September 30, 2016, compared to a loss of $43.1 million, or $1.96 per share, for the nine months ended September 30, 2015. 

Non-GAAP basic and diluted loss excluding non-cash expense with respect to share-based compensation and fair value gains and losses on warrants was $51.5 million or $1.99 per share, for the nine months ended September 30, 2016, compared to a loss of $25.6 million, or $1.17 per share, for the nine months September 30, 2015. 

The weighted average number of Innocoll ordinary shares outstanding increased from 21.9 million during the nine months ended September 30, 2015, to 25.9 million during the nine months ended September 30, 2016, primarily as a result of Innocoll’s follow-on public offering in the second quarter of 2016. The total number of shares outstanding at September 30, 2016 was 29.7 million.

Revenues: Revenues were $3.8 million for the nine months ended September 30, 2016 compared to $2.0 million for nine months ended September 30, 2015. This increase was primarily due to an increase in sales to EUSA Pharma of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, following the stabilization of the EUSA Pharma business following the transfer from Jazz Pharmaceuticals.

Research and Development (R&D) Expenses:  R&D expenses were $34.0 million for the nine months ended September 30, 2016 compared to $18.0 million for the nine months ended September 30, 2015. R&D expenses in the nine months ended September 30, 2016 included $31.1 million in external clinical research expenses, which was primarily due to ramp-up and completion of our Phase 3 XARACOLL efficacy trials and the ramp-up of our Phase 3 COGENZIA efficacy trials. R&D expenses are expected to decrease significantly in the future as the company concludes the COGENZIA clinical studies and files its NDA for XARACOLL.

General and Administrative (G&A) Expenses:  G&A expenses were $20.6 million for the nine months ended September 30, 2016 compared to $13.6 million for the nine months ended September 30, 2015.  Excluding share-based compensation charges, G&A expenses for the nine months ended September 30 2016 were $14.3 million compared to $10.0 million for the nine months ended September 30, 2015. The increase in G&A, excluding stock-based compensation, was primarily due to $2.2 million of one-off expenses related to the re-domiciliation of the company to Ireland, our continued infrastructure to support clinical programs, and some pre-commercialization investment.

Other Operating Income/(Expense): Other income was $2.9 million for the nine months ended September 30, 2016 compared to an expense of $9.3 million for the nine months ended September 30, 2015. Other income in the nine months ended September 30, 2016 consisted primarily of non-cash items due to the fair value income of warrants outstanding, partially offset by accrued interest on the company’s existing loan with the EIB and foreign exchange losses. Other expense in the nine months ended September 30, 2015 consisted primarily of $13.9 million fair value expense of warrants outstanding, partially offset by foreign exchange gains of $4.6 million.

Cash Position

As of September 30, 2016, cash and cash equivalents totaled $30.4 million compared to $53.8 million as of June 30, 2016. 

We expect that our rate of expenses will decrease significantly as our clinical study for COGENZIA concluded and as we finalise completion of the expansion of our Saal, Germany manufacturing facility. We plan to manage our resources to extend the cash runway until after the anticipated XARACOLL NDA approval, expected in the third quarter of 2017.

For further financial information for the quarter ended September 30, 2016, please refer to the financial statements appearing at the end of this release.

About Innocoll Holdings plc

Innocoll is a global, specialty pharmaceutical company with late stage development programs that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain and COLLAGUARD (INL-003), a barrier for the prevention of post-surgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet.  All of our native collagen products — from extraction/purification of type-1 collagen through final delivery form — are manufactured at our certified, integrated plant in Saal, Germany.

For more information, please visit www.innocoll.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.

Contact:

Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com

Jeannie Sorenson, M.D.
Vice President, Investor Relations
(314) 458-7355
jsorenson@innocoll.com

Innocoll Announces Top-Line Data From Phase 3 Trials With COGENZIA and NDA Submission for XARACOLL

• COACT-1 and COACT-2 Phase 3 clinical trials for COGENZIA did not achieve statistical significance in improving clinical cure in diabetic foot infections (DFI)
• New Drug Application (NDA) for XARACOLL submitted to the U.S. Food and Drug Administration (FDA) for the treatment of postsurgical pain
• COLLAGUARD pre-clinical safety studies completed; IDE submission on track for later this month
• Conference call on top-line results scheduled for Friday, November 4, 2016 at 8:30 a.m. Eastern Daylight Time

ATHLONE, Ireland -- Innocoll Holdings plc (NASDAQ:INNL) a global, commercial-stage, specialty pharmaceutical company, today announced that  based on top-line data from its COACT-1 and COACT-2 Phase 3 clinical trials of COGENZIA (gentamicin collagen topical matrix) in patients  with moderate to severe diabetic foot infections administered in conjunction with systemic antibiotics and wound therapy, the standard of care (SOC), did not meet their primary endpoint of clinical cure of infection after 28 days versus either placebo plus SOC or SOC alone. 

While there were trends toward clinical response (clinical cure plus improvement) in the COGENZIA arm and the placebo collagen-matrix arm, neither COACT-1 nor COACT-2 achieved statistical significance on their shared primary endpoint of clinical cure after 28 days.  While Innocoll continues to analyze the clinical results, the top-line data suggests that the addition of gentamicin delivered topically through COGENZIA, in conjunction with SOC, does not confer sufficient additional clinical benefit over the placebo, administered with SOC, or SOC alone.  

COGENZIA and the placebo collagen-matrix were well-tolerated in both studies.  Incidence of overall adverse events was similar across all three treatment arms in the COACT-1 and COACT-2 studies, respectively.

Innocoll also announced the submission of a New Drug Application (NDA) for XARACOLL (bupivacaine HCl collagen-matrix implants) to the U.S. Food and Drug Administration (FDA) for the treatment of postsurgical pain.  The submission was based upon the successful results of the MATRIX trials which showed statistically significant differences in the primary endpoint, the sum of pain intensity in both studies, as well as statistically significant reductions in opioid use and other secondary endpoints.

Finally, Innocoll announced the pre-clinical safety studies for COLLAGUARD (INL-003) have been completed.  COLLAGUARD is a collagen film being developed as a medical device for the prevention of postsurgical adhesions implanted at the time of surgery.  Innocoll is preparing to submit an Investigational Device Exemption (IDE) later this month.

“Having multiple late-stage product opportunities has always underpinned the value of Innocoll,” said Innocoll CEO Tony Zook.  “The submission of the XARACOLL NDA with potential commercialization in 2017 and the progress of the registration program for COLLAGUARD positions Innocoll competitively in the hospital segment.  We will also continue to assess all strategic options to bring these needed therapies to the market.”  

About COGENZIA

COGENZIA is a topical gentamicin collagen-matrix patch that utilizes our COLLARX® proprietary collagen-based delivery technology and was under development to provide topical anti-infective efficacy in combination with systemic antibiotic therapy and standard ulcer care in patients with diabetic foot infections (DFI). 

About COACT-1 and COACT-2

COACT-1 and COACT-2 Phase 3 studies are two identical, randomized, placebo-controlled, blinded studies that enrolled 1,136 patients at 160 separate centers in the United States, Europe and Australia.  The primary objective was to determine the effect of COGENZIA in combination with systemic antibiotic therapy compared to placebo matrix and no matrix, both in combination with systemic antibiotic therapy on diabetic patients’ clinical outcome in the treatment of infected foot ulcers.  Patients were randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (1) daily application of a topical gentamicin collagen-matrix patch, (2) daily application of a topical placebo-matrix patch or (3) no-matrix, in the ratio 2:1:1.  Patients were treated up to 28 days and returned to the clinic weekly for safety and efficacy assessments. Final efficacy assessments used in the primary efficacy analyses were obtained at the first follow-up visit approximately 10 days after treatment was stopped. The remaining follow-up visits occurred at approximately 30, 60 and 90 days after treatment stopped.   The primary endpoint is the percent of patients achieving resolution of all clinical signs and symptoms of infection at the first follow-up visit per the judgment of each treating clinician using the 2012 IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections.

The study design was in agreement with the FDA under a special protocol assessment (SPA) and COGENZIA was granted a Qualified Infectious Disease Product (QIDP) designation for a potential priority review of 6 months for approval in addition to expanding the marketing exclusivity to 8 years.

About Innocoll

Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines. Our proprietary, biocompatible, and biodegradable collagen-based products are engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of treatment benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postsurgical pain; COGENZIA, a topical gentamicin collagen-matrix patch for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships. All of our collagen products—from extraction/purification of Type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

For more information, please visit www.innocoll.com.

Ongoing Pipeline Studies

On May 25, 2016 Innocoll announced that two placebo-controlled Phase 3 pivotal studies evaluating XARACOLL® (bupivacaine HCl collagen-matrix implants) each achieved the primary endpoint as a postsurgical pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in treatment effect for pain reduction and opioid reduction. Based on these results, Innocoll has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA).

Additionally, a clinical program is under development for COLLAGUARD (INL-003), a collagen barrier for the prevention of postsurgical adhesions, to support approval in the U.S. The nonclinical program has been completed and Innocoll is preparing to submit an Investigational Device Exemption (IDE) later this year.

For more information, please visit www.innocoll.com.

Innocoll Holdings plc Announces Second Quarter 2016 Financial and Operating Results and Provides Corporate Update

ATHLONE, Ireland, Aug. 17, 2016 -- Innocoll Holdings plc (Nasdaq:INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical needs, today announced financial and operating results for the three months and six months ended June 30, 2016. Using our proprietary collagen-based technology platform, we manufacture and supply a range of biodegradable and fully bioresorbable pharmaceutical products and medical devices that are precision-engineered for targeted use.

“I am pleased that in the second quarter, we continued to make solid progress in advancing our clinical programs, delivering on important key milestones,” said Tony Zook, Chief Executive Officer of Innocoll. “XARACOLL achieved positive pivotal results in Phase 3 trials, and we are now preparing to submit an NDA to the FDA for the treatment of post-operative pain. Our second Phase 3 drug candidate COGENZIA, for the treatment of diabetic foot infections, completed enrollment of its two clinical trials in late June, with top-line data expected in the early fourth quarter of this year. We also advanced COLLAGUARD, for the prevention of surgical adhesions, into pre-IDE studies as planned. The expansion of our manufacturing facility in Saal, Germany, continues to make headway. The Government of Upper Bavaria has approved our new laboratories for use, and we expect to complete the construction phase of the Saal facility’s commercial manufacturing area this quarter. We have started to ramp up our commercial infrastructure as well by hiring additional talent with deep experience in launching successful pharmaceutical products. Our vision is to provide physicians and patients with innovative new therapeutic options developed from our technology platform, thus serving unmet medical needs while simultaneously increasing shareholder value, and we will continue to work hard on those commitments.”

Second Quarter 2016 and Recent Highlights

• Announced positive pivotal data in two Phase 3 clinical trials for XARACOLL, which demonstrated highly statistically significant results as a long-acting anesthetic in the reduction of surgical pain following hernia repair. Full analysis of the data will be submitted for medical publication and to the U.S. Food and Drug Administration (FDA) through an NDA for the treatment of post-operative pain, by early 4Q 2016.
• Completed enrollment in two Phase 3 clinical studies studying COGENZIA in diabetic foot infections. Top line data from these studies are anticipated in the early fourth quarter of this year, followed closely by an NDA submission if the data is positive. COGENZIA’s QIDP designation provides potential eligibility for Fast Track priority review.
• Started non-clinical studies for COLLAGUARD, with data expected later this quarter. Assuming positive results and availability of resources, filing of an IDE package is expected to follow.
• Received approval from Government of Upper Bavaria of new quality-controlled laboratories at Saal facility. On track to complete the construction phase of the commercial manufacturing area in the third quarter of 2016, with qualification / validation activities targeted for the fourth quarter of this year.  Activities initiated to prepare for pre-approval inspection by the FDA after submission of the XARACOLL NDA.
• Continued to ramp up on commercial capabilities, including exceptional hires in Suzanne Delaney (formerly of GlaxoSmithKline) as Vice President of Sales and Ken Graham (formerly of Bayer) as Vice President of Managed Markets. Each brings nearly 25 years of pharmaceuticals sales and marketing experience from previous leadership roles, with successful launches of multiple widely recognized pharmaceutical brand drugs.
• Strengthened our financial position through the additions of cash totaling approximately $49 million to the balance sheet in June. The drawdown of the second tranche from the European Investment Bank (EIB) added $11.2 million, following positive Phase 3 data for XARACOLL. In addition, Innocoll’s completion of a public offering of ordinary shares raised gross proceeds of approximately $40 million. At June 30, 2016, cash and equivalents totaled $53.8 million, compared to $22.7 million as of March 31, 2016. The company plans to manage its resources to extend the cash runway for at least a year and until after the anticipated XARACOLL NDA approval, the company’s priority, expected in the third quarter of 2017.

Second Quarter 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll Holdings plc reported a net loss attributable to its ordinary shares of $12.8 million, or $0.53 per share of Innocoll Holdings plc, for the second quarter of 2016, compared to a loss of $27.6 million, or $1.24 per share of Innocoll Holdings plc, for the second quarter of 2015.

Non-GAAP diluted net loss excluding non-cash expense with respect to share-based compensation and fair value gains and losses on investor options was $15.1 million or $0.62 per share of Innocoll Holdings plc, for the second quarter of 2016, compared to a loss of $10.8 million or $0.49 per share of Innocoll Holdings plc, for the second quarter of 2015.

The weighted average number of ordinary shares outstanding increased from 22.3 million in the second quarter of 2015 to 24.4 million in the second quarter of 2016, primarily as a result of Innocoll Holdings plc’s follow-on public offering in the second quarter of 2016. The total number of shares outstanding as at June 30, 2016 was 29.7 million.

Revenues: Revenues were $1.3 million for the second quarter of 2016 as compared to $0.6 million in the second quarter of 2015. This increase was primarily due to an increase in sales to EUSA Pharma of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, following the stabilization of the EUSA Pharma business following the transfer from Jazz Pharmaceuticals.

Research and Development (R&D) Expenses: R&D expenses were $10.6 million for the second quarter of 2016 as compared to $4.9 million for the second quarter of 2015. R&D expenses in the second quarter of 2016 included $9.6 million in external clinical research expenses, which was primarily driven by our Phase 3 COGENZIA efficacy trials and the conclusion of our Phase 3 XARACOLL efficacy trials. R&D expenses are expected to decrease significantly in the future as the company concludes the COGENZIA clinical studies and files the XARACOLL NDA.        

General and Administrative (G&A) Expenses: G&A expenses were $6.0 million for the second quarter of 2016 as compared to $4.2 million for the second quarter of 2015. Excluding stock-based compensation charges, G&A expenses for the second quarter of 2016 were $3.9 million as compared to $3.4 million for the second quarter of 2015. The increase in G&A, excluding stock-based compensation, was primarily due to our continued infrastructure build out to support clinical programs and the initiation of our pre-commercialization investment.

Other Operating Income/(Expense): Other income was $4.3 million for the second quarter of 2016 as compared to other expense of $17.8 million for the second quarter of 2015. Other income in the second quarter consisted primarily of non-cash items due to the fair value income of investor options outstanding and foreign exchange gains, partially offset by interest on the company’s existing loan with the European Investment Bank (EIB). Other expense in the second quarter of 2015 consisted primarily of $15.9 million fair value expense of investor options outstanding and foreign exchange losses of $1.9 million.

Six Month 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll Holdings plc reported a net loss attributable to its ordinary shareholders of $35.9 million, or $1.50 per share of Innocoll Holdings plc, for the six months ended June 30, 2016, compared to a loss of $34.0 million, or $1.60 per share of Innocoll Holdings plc for the six months ended June 30, 2015. 

Non-GAAP diluted loss excluding non-cash expense with respect to share-based compensation and fair value gains and losses on investor options was $36.3 million or $1.51 per share of Innocoll Holdings plc, for the six months ended June 30, 2016, compared to a loss of $13.1 million, or $0.62 per share of Innocoll Holdings plc, for the six months June 30, 2015. 

The weighted average number of Innocoll Holdings plc ordinary shares outstanding increased from 21.2 million during the six months ended June 30, 2015, to 24.0 million during the six months ended June 30, 2016, primarily as a result of Innocoll Holdings plc’s follow-on public offering in the second quarter of 2016. The total number of shares outstanding as at June 30, 2016 was 29.7 million.

Revenues: Revenues were $2.9 million for the six months ended June 30, 2016 as compared to $1.3 million for six months ended June 30, 2015. This increase was primarily due to an increase in sales to EUSA Pharma of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, following the stabilization of the EUSA Pharma business following the transfer from Jazz Pharmaceuticals.

Research and Development (R&D) Expenses:  R&D expenses were $25.6 million for the six months ended June 30, 2016 as compared to $10.3 million for the six months ended June 30, 2015. R&D expenses in the six months ended June 30, 2016 included $23.6 million in external clinical research expenses, which was primarily due to ramp-up and completion of our Phase 3 XARACOLL efficacy trials and the ramp-up of our Phase 3 COGENZIA efficacy trials. R&D expenses are expected to decrease significantly in the future as the company concludes the COGENZIA clinical studies and files the XARACOLL NDA.

General and Administrative (G&A) Expenses:  G&A expenses were $13.4 million for the six months ended June 30, 2016 as compared to $7.6 million for the six months ended June 30, 2015.  Excluding stock-based compensation charges, G&A expenses for the six months ended December 30 2016 were $9.4 million as compared to $5.9 million for the six months ended June 30, 2015. The increase in G&A, excluding stock-based compensation, was primarily due to $2.2 million of one-off expenses related to the re-domiciliation of the company to Ireland, our continued infrastructure build out to support clinical programs, and the initiation of our pre-commercialization investment.

Other Operating Income/(Expense): Other income was $3.5 million for the six months ended June 30, 2016 as compared to an expense of $14.5 million for the six months ended June 30, 2015. Other income in the six months ended June 30, 2016 consisted primarily of non-cash items due to the fair value income of investor options outstanding, partially offset by interest on the company’s existing loan with the European Investment Bank (EIB). Other expense in the six months ended June 30, 2015 consisted primarily of $19.1 million fair value expense of investor options outstanding, partially offset by foreign exchange gains of $4.6 million.

Cash Position

As of June 30, 2016, cash and cash equivalents totaled $53.8 million compared to $22.7 million as of March 31, 2016. The cash and cash equivalents position includes the $37.4 million net proceeds from the public equity follow-on and $11.2 million from the drawdown of the second tranche of the European Investment Bank loan.

We expect that our rate of expenses will decrease significantly following the completion of our pivotal studies for XARACOLL, as our clinical studies for COGENZIA come to a conclusion, and as we complete the expansion of our Saal, Germany manufacturing facility. We plan to manage our resources to extend the cash runway for at least a year and until after the anticipated XARACOLL NDA approval, expected in the third quarter of 2017.

For further financial information for the quarter ended June 30, 2016, please refer to the financial statements appearing at the end of this release.

Conference Call

Innocoll management will host a conference call today at 8:30 a.m. ET to discuss second quarter 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 second quarter financial results conference call." A live webcast of the call can be accessed under "Events and Presentations" in the Investors section of the Company's website at www.innocoll.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: 89801826. The telephone replay will be available until 11:59 p.m. ET on August 24, 2016.

About Innocoll Holdings plc

Innocoll is a global, specialty pharmaceutical company with late stage development programs that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain; COGENZIA (INL-002), a gentamicin-collagen topical matrix for the adjuvant treatment of diabetic foot infections; and COLLAGUARD (INL-003), a barrier for the prevention of post-surgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet.  All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

For more information, please visit www.innocoll.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-GAAP Financial Measures

This press release includes certain numerical measures that are or may be considered “non-GAAP financial measures” under the SEC’s Regulation G. “GAAP” refers to generally accepted accounting principles in the United States. The reconciliations of such measures to the most comparable GAAP figures, in accordance with Regulation G, are included herein.

To supplement our unaudited consolidated financial statements prepared in accordance with U.S. GAAP, we disclose certain 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 investor options 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 that 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 is intended as a supplemental measure of our performance. 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 U.S. GAAP. 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.

Innocoll Holdings plc Announces the Completion of Enrollment in Two Pivotal Phase 3 Clinical Trials of COGENZIA for the Treatment of Diabetic Foot Infections

ATHLONE, Ireland, June 23, 2016 (GLOBE NEWSWIRE) -- Innocoll Holdings plc (INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need, today announced the completion of enrollment of patients in its two pivotal phase 3 trials, COACT-1 and COACT-2, to evaluate the safety and efficacy of COGENZIA (INL-002), a proprietary collagen matrix with gentamicin, in the treatment of diabetic foot infections (DFIs). The company anticipates announcing top line data from these studies in the third quarter or early fourth quarter of 2016, with an NDA submission with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) submission with the European Medicines Agency to follow if data are positive. COGENZIA’s QIDP designation provides potential eligibility for Fast Track designation and priority review by the FDA.

These two phase 3 trials are identical in design, with COACT-1 being conducted solely in the U.S. and COACT-2 in Europe, Australia, and the U.S. The primary endpoint is to demonstrate that for moderate and severe DFIs, COGENZIA as an adjunct to systemic antibiotics and standard wound care, improves the rate of clinical cure, which is evaluated by a clinician 10 days after completion of treatment.  Patients are followed for up to an additional 90 days to assess various secondary endpoints, including pathogen eradication, ulcer closure, safety, and health economic components such as reduced rates of hospitalizations and amputations. “We are excited to reach this key milestone, which brings us closer to our objective of developing COGENZIA to help cure diabetic foot infections. We believe that COGENZIA has the potential to fill a critical need for a more effective therapy. If the results are positive, we will have two products in commercialization by the end of 2017, subject to regulatory approvals. These results are a demonstration of the strength of our organization in delivering on our commitments,” said Tony Zook, Chief Executive Officer of Innocoll.

Last month, Innocoll reported positive phase 3 results for XARACOLL as a long-acting anesthetic in the reduction of post-operative pain and total opioid use in patients undergoing hernia repair. With Innocoll's recent financing activities, the company expects that available cash will extend through the anticipated NDA submission for XARACOLL and until its anticipated approval in the second half of 2017. Innocoll is now moving forward with the build-up of its pre-commercialization plans to be prepared to launch its proprietary products by the end of 2017.

About Innocoll Holdings plc

Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain; INL-002 (COGENZIA), a gentamicin-collagen topical matrix for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of post-surgical adhesions.

Our current products include: COLLAGUARD®, COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet.  All of our native collagen products — from extraction/purification of type-1 collagen through final delivery form — are manufactured at our plant in Saal, Germany.

For more information, please visit www.innocoll.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.

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 and the timing, conduct, enrollment and outcome of our clinical studies, the availability of data from those studies, our ability to sell any approved products, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "goal," "objective", "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. 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. Such risks and uncertainties include, among others, those related to success of our COACT-1 and COACT-2 trials in demonstrating the safety and efficacy of COGENZIA in the treatment of DFIs; the timing and submission of an NDA or MAA for COGENZIA; our receipt of positive results for the COACT-1 or COACT-2 trials that achieve primary or secondary endpoints; COGENZIA's eligibility for fast track designation and priority review by the FDA; the ability of COGENZIA to improve the rate of clinical cure in moderate and severe DFIs; COGENZIA's ability to significantly increase the success rate and reduce the incidence of complications and sequelae; the timing for COGENZIA's product approval, if any; whether COGENZIA will be the first topical antibiotic indicated for the treatment of moderate or severe DFIs; our ability to successfully build-up pre-commercialization plans in preparation for a product launch by the end of 2017; the timing and costs involved in developing and commercializing our products and product candidates; the timing for clinical trials and results, delays in potential approvals by FDA; availability of data and results from such trials, timing and expectations for regulatory approvals; the size and growth of the potential markets for our product candidates and our ability to serve those markets; our manufacturing and marketing capabilities; the timing of, and our ability to obtain, regulatory approvals for the expansion of our manufacturing facility; regulatory developments in the United States and foreign countries; our ability to obtain and maintain the scope, duration and protection of our intellectual property rights; or other actions and factors discussed in the "Risk Factors" section of our Annual Report on Form 20-F for the year ended December 31, 2015, and our other reports filed with the Securities and Exchange Commission. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.  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.  We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contact:

Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com

Jeannie Sorenson, M.D.
Vice President, Investor Relations
(314) 458-7355
jsorenson@innocoll.com

Innocoll Holdings plc Announces Pricing of Public Offering of Ordinary Shares

ATHLONE, Ireland, June 16, 2016  -- Innocoll Holdings plc (Nasdaq:INNL), a global, specialty pharmaceutical and medical device company with late stage development programs targeting areas of significant unmet medical need, today announced that it has priced an underwritten public offering of 5,725,000 ordinary shares at a price to the public of $7.00 per ordinary share, for aggregate gross proceeds to the Company of approximately $40.1 million.  All of the ordinary shares in the offering are being sold by Innocoll.  Certain of our officers and directors have agreed to purchase ordinary shares in the offering at the public offering price.  In addition, Innocoll has granted the underwriters of the offering a 30-day option to purchase up to an additional 858,750 ordinary shares in connection with the offering to cover over-allotments.  The offering is expected to close on June 22, 2016, subject to customary closing conditions.

Morgan Stanley is acting as lead book-running manager, Piper Jaffray & Co. is acting as joint book-running manager, Stifel is acting as lead manager, and FBR and Janney Montgomery Scott are acting as co-managers for the offering. 

The Company expects to receive net proceeds from the offering, after deducting underwriting discounts and commissions and other expenses payable by it, of approximately $37.0 million. 

The shares are being offered by the Company pursuant to an effective shelf registration statement on Form F-3, as amended, previously filed with the Securities and Exchange Commission (the "SEC").  A preliminary prospectus supplement and an accompanying base prospectus related to the offering were filed with the SEC on June 13, 2016. The final prospectus supplement will be filed with the SEC.  When available, copies of the final prospectus supplement and the accompanying base prospectus relating to this offering may also be obtained by contacting Morgan Stanley, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at (800) 747-3924, or by email at prospectus@pjc.com, or by accessing the SEC's website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Innocoll Holdings plc

Innocoll is a global, commercial-stage specialty pharmaceutical and medical device company. The company's late stage product candidate pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain; INL-002, a gentamicin-collagen topical matrix for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of post-surgical adhesions.

Forward-Looking Statements

This press release contains forward-looking statements, including those relating to the use of proceeds from the sale of ordinary shares and the expected closing of the offering.  Forward-looking statements are generally statements that are not historical facts, and can be identified by the words "anticipate," "believe," "estimate," "expect," "intend," "goal," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors.  These risks and uncertainties include, without limitation, our ability to successfully complete the offering, the volatility of our stock price may prevent shares purchased in the offering from being resold at or above the price paid for them, purchasers of shares in the offering will suffer immediate and substantial dilution, we may use the proceeds from the offering in ways that may not enhance our operating results or the market price of our ordinary shares, and other risks and uncertainties which are discussed in more detail in our Annual Report on Form 20-F for the year ended December 31, 2015, filed on March 17, 2016, and our other reports filed with the SEC.  We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law.

Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com

Jeannie Sorenson, M.D.
Vice President, Investor Relations
(314) 458-7355
jsorenson@innocoll.com

Innocoll Announces XARACOLL® (bupivacaine-collagen bioresorbable implant) Meets Primary Endpoint in Both Pivotal Phase 3 Trials in Postoperative Pain Relief

• First long-acting, opioid-sparing, local analgesic to meet primary endpoints of Phase 3 clinical trials in hernia repair
   
• Data supports on-schedule NDA filing this year
   
• Results validate the Innocoll technology platform
   
• Conference call and webcast on top-line results scheduled for today at 8:30 a.m. Eastern Daylight Time

ATHLONE, Ireland, May 25, 2016 (GLOBE NEWSWIRE) --  Innocoll (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company, today announced that two placebo-controlled Phase 3 pivotal studies evaluating XARACOLL® (bupivacaine-collagen bioresorbable implant) each achieved the primary endpoint as a postoperative pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in treatment effect for pain reduction and opioid reduction.

The primary efficacy endpoint, the sum of pain intensity over 24 hours (SPI24) comparing XARACOLL to placebo, met statistical significance in both the MATRIX-1 (p=0.0004) and MATRIX-2 (p<0.0001) studies. These highly statistically significant results make XARACOLL the first long-acting, opioid-sparing, local analgesic to meet primary endpoints of Phase 3 clinical trials in hernia repair, a highly painful and commonly performed surgery.

A key secondary endpoint in the MATRIX trials was the sum of pain intensity over 48 hours (SPI48). The pooled data of the two MATRIX studies were statistically significant for this endpoint (p=0.0033). MATRIX-2 achieved a statistically significant result (p=0.0270), and MATRIX-1 trended toward, but did not achieve statistical significance (p=0.0568).

Another key secondary endpoint was the sum of pain intensity over 72 hours (SPI72). The pooled data of the two MATRIX studies for this endpoint were statistically significant, although neither individual study achieved statistical significance for SPI72.

The MATRIX studies also looked at multiple opioid-sparing secondary endpoints. Both trials demonstrated that XARACOLL significantly reduces total opioid consumption and significantly increases the time prior to the first use of opioids. To preserve the company’s plan to publish the full analysis of the Phase 3 MATRIX studies at future medical meetings and in peer-reviewed publications, further details regarding secondary endpoints will not be released at this time. 

XARACOLL was well tolerated in both studies. Incidence of overall adverse events was similar to the placebo arm of each study. There were no XARACOLL-related serious adverse events. Opioid-related adverse events were higher in the placebo arms of both studies.

Based on these results, Innocoll plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) this year.

“We are very pleased by these positive top-line results for XARACOLL,” said Innocoll CEO Tony Zook. “These two successful postoperative pain studies validate our proprietary collagen-based technology platform. We are committed to filing our NDA this year and bringing this innovative new treatment to market. Our manufacturing expansion and commercial readiness activities are on-track to support an anticipated launch in 2017.”

XARACOLL, a surgically implantable and bioresorbable bupivacaine-collagen matrix, is applied through a simple insertion into the incision and is being developed to provide sustained pain relief by delivering bupivacaine HCl directly at the site of surgical trauma. Bupivacaine HCl is a local anesthetic with a well-characterized safety and efficacy profile. The data collected on the MATRIX-1 and MATRIX-2 studies show that the use of our XARACOLL proprietary collagen implant as a delivery vehicle for bupivacaine HCl appeared to be safe.

“Available therapies for postoperative pain relief are heavily reliant on opioids, which may cause costly and problematic side effects, and further subject patients to long-term opioid use and abuse,” said Harold S. Minkowitz, MD, Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, TX. “XARACOLL’s success in a commonly performed and highly painful surgery suggests that XARACOLL could become an important option for the surgical and anesthesia communities in addressing patient satisfaction with pain management options and the need for opioid-sparing approaches to pain reduction.” 

Webcast and Conference Call Today, May 25, 2016, at 8:30 a.m. Eastern Daylight Time

The Innocoll management team will host a webcast and conference call to discuss the top-line results at 8:30 a.m. ET on May 25, 2016. Interested parties may access the webcast through the Investors section of our website, direct through the registration link, or by dialing 1-877-407-4018 (toll-free); 1-201-689-8471 (international); 1-800-904-100 (Ireland toll-free) and referencing the confirmation number 13638130. A replay of the call will be available on the Innocoll website later in the day, and the replay will be available for approximately one month following the call.

About XARACOLL® 

XARACOLL® is a surgically implantable and bioresorbable bupivacaine-collagen matrix that utilizes our CollaRx® proprietary collagen-based delivery technology and is being developed to provide sustained postoperative pain relief directly into the surgical site. XARACOLL is also designed to reduce the need for systemic opioids and their associated risks.

About Postoperative Pain

Postoperative pain is a complex response to tissue trauma during surgery that stimulates hypersensitivity of the central nervous system, resulting in pain within the surgical cavity and in other areas directly affected by the surgical procedure (incision site). The current standard of care relies heavily on the use of opioids supplemented by other classes of pain medications, the combination of which is known as multi-modal pain therapy. However, according to a survey published in the journal of Anesthesia & Analgesia and a 2014 Decision Resources Postoperative Pain Survey, 75 percent of patients receiving standard treatments still report inadequate postoperative pain relief and 79 percent of patients report adverse events from these medications. Given the negative side effects of opioids in particular, there is increasing focus on treatments that reduce opioid use in the treatment of postoperative pain.

About MATRIX-1 and MATRIX-2

MATRIX-1 and MATRIX-2 Phase 3 studies are two identical, randomized, placebo-controlled, double-blinded studies to investigate the safety and efficacy of a surgically implantable and bioresorbable bupivacaine-collagen matrix in treating acute postoperative pain associated with hernia repair. Each study enrolled over 300 patients aged 18 and older in the United States (U.S.). Patients with a unilateral inguinal hernia undergoing open hernioplasty were randomized in a 2:1 ratio to one of two treatment groups per study: three 100 mg XARACOLL matrices for a total dose of 300 mg of bupivacaine HCl or three placebo matrices. The matrices were placed at multiple layers within the hernia repair site in order to provide local levels of bupivacaine HCl directly at the location of surgical trauma. All patients received 650 mg of acetaminophen three times a day and could receive rescue opioids as needed. The primary efficacy endpoint was the sum of pain intensity (SPI) over 24 hours comparing the XARACOLL matrix to placebo. Safety was evaluated through the collection of adverse events through 30 days postoperatively.

About Innocoll

Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain; INL-002, a gentamicin-collagen topical matrix for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of post-surgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Pioneer, Biomet 3i and Biomet. All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

For more information, please visit www.innocoll.com.

Ongoing Pipeline Studies

Innocoll is also conducting two identical Phase 3 trials, one in the U.S. (COACT-1) and the second in the U.S., Europe and Australia (COACT-2), to evaluate the safety and efficacy of INL-002, a topical gentamicin administered via our proprietary collagen matrix, in patients with diabetic foot infections. The primary endpoint is the percent of patients achieving resolution of all clinical signs and symptoms of infection, evaluated by the clinician 10 to 14 days after completion of treatment, compared to placebo arms. Top-line data from these studies are anticipated to be available later in 2016.

INL-002 received QIPD designation for the adjunctive treatment of moderate and severe diabetic foot infection from the FDA.

Additionally, a clinical program is under development for INL-003, a collagen barrier for the prevention of post-surgical adhesions, to support approval in the U.S. The nonclinical program is ongoing and will be completed and reported prior to the filing of an IDE application planned for second half of 2016, with the Pilot (Feasibility) Clinical Study to be initiated immediately thereafter, upon availability of financial resources. For more information on our pipeline studies, please visit www.innocoll.com/products.aspx.

Forward-looking Statements

Any statements in this press release about our ongoing development of XARACOLL and our other product candidates; our interpretation of the data and results from our MATRIX-1 and MATRIX-2 clinical trials; our plans for, and the expected timing of, our XARACOLL NDA submission with the FDA; our plans to develop and commercialize XARACOLL and its market potential; the potential therapeutic and other benefits of XARACOLL and our other product candidates; Innocoll's current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of XARACOLL, plans and objectives for present and future clinical trials and results of such trials, the risk that the FDA may not accept pooled data, plans and objectives for regulatory approval 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. Such forward-looking statements involve substantial risks and uncertainties including, but not limited to, the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of XARACOLL and may require us to conduct additional clinical trials; XARACOLL may not receive regulatory approval or be successfully commercialized, including as a result of the FDA's or other regulatory authorities' decisions regarding labeling and other matters that could affect its availability or commercial potential; our plans to develop and manufacture XARACOLL; the size and growth of the potential markets for XARACOLL and our ability to serve those markets; our manufacturing and marketing capabilities; or other actions and factors discussed in the "Risk Factors" section of our Annual Report on Form 20-F for the year ended December 31, 2015, which is on file with the Securities and Exchange Commission. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. 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. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

The scientific information discussed in this news release related to Innocoll's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com

Jeannie Sorenson, M.D.
Vice President, Investor Relations
(314) 458-7355
jsorenson@innocoll.com 

Media Contact:
Shelly Orlacchio
(215) 564-3200, ext 118
Sorlacchio@Gobraithwaite.com 

Innocoll Holdings plc Appoints Lesley Russell, MBChB, MRCP, as Chief Medical Officer

ATHLONE, Ireland - Innocoll Holdings plc (Nasdaq:INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need, today announced that Lesley Russell, MBChB, MRCP, has been appointed chief medical officer. Dr. Russell will be responsible for managing all clinical development programs as well as medical and regulatory affairs for the company.

“Lesley’s background in drug development and regulatory experience at both emerging and established biopharmaceutical companies is an excellent fit for us as we progress toward commercialization. Her experience to further develop our programs and articulate them to the FDA will be a critical aspect of our success,” said Tony Zook, chief executive officer of Innocoll. “We expect that she will be a significant contributor to our anticipated label expansion and product life cycle plans for XARACOLL and COGENZIA, the COLLAGUARD clinical development plan, and future product candidates that we expect to emerge from our collagen drug formulation platform.”

Dr. Russell has extensive experience managing the development of pharmaceuticals and biologics across a wide range of therapeutic areas, dosage forms and formulations on a global scale. Most recently, she was chief operating officer and chief medical officer at TetraLogic Pharmaceuticals where she advanced the company’s lead candidate into Phase 2 clinical trials in parallel with the company’s initial public offering. Prior to this role, Dr. Russell held senior executive research and development positions at a number of biopharmaceutical companies including Teva Pharmaceuticals, Cephalon, Inc., and US Bioscience/Medimmune Oncology. In these roles, she managed staff responsible for a variety of functions including regulatory strategy development, clinical research, medical affairs and data management. She is a member of the boards of directors for AMAG Pharmaceuticals and Endocyte Pharmaceuticals. Dr. Russell obtained her medical degree from the University of Edinburgh, Scotland.

“Innocoll’s collagen platform has the potential to generate product candidates into the future beyond the two late-stage candidates that will complete Phase 3 studies this year and a third that will soon enter Phase 3 development,” said Dr. Russell. “I am looking forward to working with the team as the company advances through planned commercialization of its lead candidates and generates new candidates to sustain growth for the long-term.”

About Innocoll Holdings PLC

Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines to help patients get better. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColL for the treatment of postoperative pain; INL-002, a gentamicin-collagen topical matrix for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of post-surgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Biomet 3i and Biomet. All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

For more information, please visit www.innocoll.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.

Innocoll Holdings plc Announces Fourth Quarter and Full-Year 2015 Financial and Operating Results and Provides Corporate Update

ATHLONE, Ireland -- Innocoll Holdings plc (INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need announced financial and operating results for the three months and full year ended December 31, 2015. We manufacture and supply a range of pharmaceutical products and medical devices using our proprietary collagen-based biodegradable and fully bioresorbable technology platform.

“We have successfully performed against the commitments we made at the beginning of 2015," said Tony Zook, Chief Executive Officer of Innocoll. “Our Phase 3 programs for INL-001, or XaraColl, and INL-002, or Cogenzia, initiated on schedule and all four trials are on track to deliver results on time and on budget. We re-domiciled the company to Ireland, which will enable us to be competitive with other NASDAQ listed companies, while we continue to enjoy our Irish tax residency. We recently had a pre-IDE meeting with the FDA to discuss the INL-003, or CollaGUARD, path toward approval and we are preparing to begin the required non-clinical studies in the second quarter. I expect 2016 to be a transformative year for Innocoll and, together with our experienced leadership team, we are preparing Innocoll to successfully transition to a commercial stage company”.

Fourth Quarter 2015 and Recent Highlights

• Appointed Charles Katzer as Global Supply / Procurement.
• Announced plans in December to move the company’s domicile to Ireland from Germany; completed re-domiciliation on March 16 to become an Irish-incorporated company, Innocoll Holdings plc. Transitioned NASDAQ listing via the exchange of ADSs of our predecessor, Innocoll AG, for ordinary shares of Innocoll Holdings plc, listed directly on NASDAQ under the same “INNL” trading symbol.

Clinical Program Update

INL-001 (XaraColl®)

• Patients continue to be recruited and treated in two identical U.S. Phase 3 trials, MATRIX-1 and MATRIX-2, to evaluate the 300 mg dose versus placebo in patients undergoing abdominal hernia repair. The primary endpoint is 24-hour Summed Pain Intensity. Secondary endpoints include 48 and 72-hour pain relief and opioid use. Topline data from these studies are anticipated to be available in the second quarter and an NDA submission is anticipated by the end of the third quarter of 2016.

INL-002 (Cogenzia®)

• Patients continue to be recruited and dosed in two identical Phase 3 trials, one in the U.S. (COACT-1) and the second in the U.S. and Europe (COACT-2), to evaluate the safety and efficacy of topical gentamicin administered via a collagen matrix in patients with diabetic foot infections. The primary endpoint is “clinical cure” at the test of cure, which will be evaluated by the clinician 10 days post completion of treatment. Topline data from these studies are anticipated to be available in the third quarter of 2016 and we anticipate an NDA submission by the fourth quarter of 2016 under its designation of QIDP, which provides potential access to priority review and eligibility for Fast Track priority review designation by the FDA.

INL-003 (CollaGUARD®)

• A clinical program is under development for CollaGUARD to support approval in the U.S.A. for which a constructive pre-IDE meeting was held with FDA in the first quarter of 2016. We agreed upon a non-clinical program of two small studies, an infectivity study and a burst study. Both studies are anticipated to be completed and reported prior to the filing of a full IDE package in the third quarter of 2016, with the Pilot (Feasibility) Clinical Study to be initiated immediately thereafter, upon availability of resources.

Fourth Quarter 2015 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll AG reported a net loss attributable to its ordinary shares of €6.2 million, or €3.5 per share of Innocoll AG ($0.29 per ADS, converted at an exchange rate as of December 31, 2015), for the fourth quarter of 2015, compared to a loss of €4.2 million, or €2.9 per share of Innocoll AG ($0.24 per ADS) for the fourth quarter of 2014. Each ADS of Innocoll AG represented 1/13.25 of an ordinary share of Innocoll AG, prior to our termination of Innocoll AG's ADS facility.

Non-GAAP diluted net loss excluding nonrecurring items was €15.5 million or €8.7 per share of Innocoll AG ($0.72 per ADS), for the fourth quarter of 2015, compared to a loss of €2.0 million or €1.4 per share of Innocoll AG ($0.11 per ADS), for the fourth quarter of 2014.

The number of Innocoll AG ordinary shares outstanding increased from 1.46 million in the fourth quarter of 2014 to 1.77 million in the fourth quarter of 2015, primarily as a result of Innocoll AG's follow-on public offering in the second quarter of 2015.

Revenues: Revenues were €0.8 million for the fourth quarter of 2015 and fourth quarter of 2015.

Research and Development (R&D) Expenses: R&D expenses were €10.7 million for the fourth quarter of 2015 as compared to €1.3 million for the fourth quarter of 2014. R&D expenses in the fourth quarter of 2015 included €9.7 million in external clinical research expenses, which was primarily driven by the ramp-up of our Phase 3 XaraColl and Cogenzia efficacy trials.

General and Administrative (G&A) Expenses: G&A expenses were €6.5 million for the fourth quarter of 2015 as compared to €4.3 million for the fourth quarter of 2014. Excluding stock-based compensation charges, G&A expenses for the fourth quarter of 2015 were €5.2 million as compared to €2.0 million for the fourth quarter of 2014. The increase in G&A excluding stock-based compensation was primarily due to our continued infrastructure build out to support clinical programs, initiation of our pre-commercialization investment and expenses related to the company's re-domiciliation to Ireland.

Other Operating Income/(Expense): Other operating income was €1.7 million for the fourth quarter of 2015 as compared to €0.0 million for the fourth quarter of 2014. The income in the fourth quarter of 2015 was primarily driven by the reversal of the impairment of certain plant and equipment in earlier years which the company is now utilizing as part of its expansion of manufacturing facilities in Saal, Germany.

Finance Income/(Expense): Finance income was €9.9 million for the fourth quarter of 2015 as compared to €2.1 million for the fourth quarter of 2014. Finance expense in each quarter consisted primarily of non-cash items due to the decrease 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.

Full Year 2015 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll AG reported a net loss attributable to its ordinary shareholders of €43.1 million, or €25.6 per share of Innocoll AG ($2.10 per ADS, converted at an exchange rate as of December 31, 2015), for the year ended December 31, 2015, compared to a loss of €20.7 million, or €28.1 per share of Innocoll AG ($2.31 per ADS) for the year ended December 31, 2014.

Non-GAAP diluted loss excluding nonrecurring items was €38.5 million or €22.9 per share of Innocoll AG ($1.90 per ADS), for the year ended December 31, 2015, compared to a loss of €9.3 million, or €12.6 per share of Innocoll AG ($1.03 per ADS), for the year ended December 31, 2014.

The number of Innocoll AG ordinary shares outstanding increased from 0.74 million during the year ended December 31, 2014, to 1.69 million during the year ended December 31, 2015, primarily as a result of the conversion of preferred shares into Innocoll AG ordinary shares and the follow-on public offering in the second quarter of 2015.

Revenues: Revenues were €2.6 million for the year ended December 31, 2015 as compared to €4.5 million for year ended December 31, 2014. 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

Research and Development (R&D) Expenses: R&D expenses were €26.9 million for the year ended December, 31 2015 as compared to €3.3 million for the year ended December 31, 2014. R&D expenses in the year ended December 31, 2015 included €23.8 million in external clinical research expenses, which was primarily due to the completion of our pivotal pharmacokinetics and safety study of XaraColl and the initiation and running of our Phase 3 Cogenzia and 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 €19.0 million for the year ended December 31, 2015 as compared to €11.7 million for the year ended December 31, 2014. Excluding stock-based compensation charges, G&A expenses for the year ended December 31 2015 were €14.2 million as compared to €6.6 million for the year ended December 31, 2014. The increase in G&A, excluding stock-based compensation, was primarily due to our continued infrastructure build out to support clinical programs, initiation of our pre-commercialization investment and expenses related to the company re-domiciliation to Ireland.

Other Operating Income/(Expense): Other operating income was €3.9 million for the year ended December 31, 2015 as compared to €0.0 million for the year ended December 31, 2014. The income in the year ended December 31, 2015 was primarily driven by the reversal of the impairment of certain plant and equipment in earlier years.

Finance Income/(Expense): Finance income was €1.4 million for the year ended December 31, 2015 as compared to finance expense of €4.5 million in the year ended December 31, 2014. Finance income in the year ended December 31, 2015 consisted primarily of €5.1 million in foreign exchange gains, partially offset by €3.7 million fair value expense of investor options outstanding. Finance expense in the year ended December 2014 included €6.3 million fair value expense of investor options outstanding, and €3.1 million interest on convertible preferred shares, partially offset by €4.7 million in foreign exchange gains.

Cash Position

As of December 31, 2015, cash and cash equivalents totaled €38.7 million ($42.2 million, converted at an exchange rate as of December 31, 2015) compared to €34.8 million as of September 30, 2015 ($39.0 million, converted at an exchange rate as of September 30, 2015). In addition, the company has available to it up to €10 million in loan commitments from the European Investment Bank (EIB), which will become available if the company achieves primary end points for either of the XaraColl or Cogenzia studies.

Our rate of expenses will continue to increase as we advance our planned clinical trials of XaraColl, Cogenzia and CollaGUARD and expanding our manufacturing facility in Saal, Germany. As a result, we will be required to seek additional sources of capital during the next 12 months or restrict certain of our expenditures to conserve capital and extend our resources.

For further financial information for the period ending December 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, translated at a rate of $1.0887 per euro, the exchange rate as of December 31, 2015.

Conference Call

Innocoll management will host a conference call today at 8:30 a.m. EDT to discuss Fourth quarter and full-year 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 fourth 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.innocoll.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: 13632174. The telephone replay will be available until midnight EDT on March 21, 2016.

About Innocoll

Innocoll is dedicated to making better happen—better ways for patients to recover from surgeries and better ways to treat limb-threatening infections. We strive to engineer better medicines to help patients get better.

Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits.

Our robust, late-stage product pipeline is focused on addressing a number of significant unmet medical needs: INL-001, a bupivacaine-collagen bioresorbable implant (Phase III), is being studied to provide better postoperative analgesia; INL-002, a gentamicin-collagen topical matrix (Phase III), is being investigated as a topical treatment to better treat diabetic foot infections; and INL-003, a bioresorbable collagen film surgical adhesion barrier (approved ex-US), is scheduled to enter clinical trials in the US for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, and Biomet. All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

Innocoll is a global company operating in Europe and the US, with plans to further partner in other high- potential areas around the world.

For more information, please visit www.innocoll.com.

Innocoll AG Appoints Charles Katzer as Head of Manufacturing and Technical Operations

ATHLONE, Ireland -- Innocoll AG (NASDAQ:INNL) announced that Charles Katzer has been appointed head of Manufacturing and Technical Operations effective immediately. The addition of this role to the senior management team is part of its strategic plan to transition Innocoll into a commercial-stage, fully-integrated specialty pharmaceutical company.

“2016 is anticipated to be an important transitional year for Innocoll,” said Tony Zook, chief executive officer of Innocoll. “We expect to announce results of our two Phase 3 trials of XaraColl for the treatment of post-operative pain in the second quarter of 2016. Results of our two Phase 3 trials of Cogenzia for treatment of diabetic foot infections are expected to be announced in the third quarter of 2016. Both products are anticipated to receive marketing approval in 2017 and, thus, will require a manufacturing ramp-up that is already in progress. We have already initiated pre-commercial activities for both candidates. The addition of Chuck adds his skills and experience in manufacturing, QA/QC, supply chain management and related activities to our team and will help us make both XaraColl and Cogenzia commercial successes.”

Throughout Mr. Katzer’s over 40-year career, he has been responsible for the leadership and direction of manufacturing, quality operations, product & process development, supply chain operations, and engineering functional disciplines in the biopharmaceutical industry. Most recently, he was the senior vice president of technical operations of Auxilium Pharmaceuticals, where he was responsible for the overall leadership and direction of manufacturing, supply chain, process development, among other activities, for Auxilium’s products. Prior to his tenure at Auxilium, Mr. Katzer was responsible for a variety of operational activities including manufacturing, QA/QC and process development at a number of biopharmaceutical companies including Discovery Laboratories, Medimmune Vaccines, US Bioscience, Immunomedics and Rhone-Poulenc Rorer. Mr. Katzer received his B.S. in Zoology from the University of Wisconsin.

“Innocoll’s collagen matrix technologies, as evidenced by its advanced product pipeline, are platforms that provide significant potential to make medicines work better, and, therefore, offer ideal opportunities for long-term successful pharmaceutical product development and commercial success,” said Mr. Katzer. “I’m am looking forward to contributing to this success and to participate in the growth of the company in 2016 and beyond.”

About Innocoll AG

Innocoll is dedicated to making better happen—better ways for patients to recover from surgeries and better ways to treat limb-threatening infections. We strive to engineer better medicines to help patients get better.

Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits.

Our robust, late-stage product pipeline is focused on addressing a number of significant unmet medical needs: INL-001, a bupivacaine-collagen bioresorbable implant (Phase III), is being studied to provide better postoperative analgesia; INL-002, a gentamicin-collagen topical matrix (Phase III), is being investigated as a topical treatment to better cure diabetic foot infections; and INL-003, a bioresorbable collagen film surgical adhesion barrier (approved ex-US), is scheduled to enter clinical trials in the US for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, and Biomet. All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

Innocoll is a global company operating in Europe and the US, with plans to further partner in other high- potential areas around the world.

For more information, please visit www.innocoll.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.

Corporate:

Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com

Investor Contact:

Russo Partners, LLC
Robert E. Flamm, Ph.D.
(212) 845-4226
robert.flamm@russopartnersllc.com

Innocoll AG Announces Plan to Move Corporate Domicile to Ireland

ATHLONE, Ireland - Innocoll AG (NASDAQ:INNL) today announced that its supervisory board has unanimously approved a plan to move the company's legal domicile from Germany to Ireland.

We expect Innocoll to have a transformative year in 2016. Our two lead product candidates are well advanced in their Phase 3 efficacy trials. We expect the Phase 3 data from XaraColl and Cogenzia to be available in the first half and in the third quarter of 2016, respectively. We expect to commence a clinical program in the US for CollaGUARD, our third product in the pipeline, which helps fight post-surgical adhesions, after a pre-submission meeting planned for the first quarter of 2016 with the FDA. We intend to build commercial capabilities in the U.S. to effectively support our brands, and we will evaluate the benefits of select partnerships or co-promotions outside the U.S. Finally, we have started to expand our manufacturing capabilities in our facility in Saal, Germany, in order to supply our late-stage products.

The re-domicile to Ireland is a critical strategic step that will help us capitalize on our strategic initiatives and enhance our corporate profile as there are significant potential benefits of having our publicly-traded parent incorporated in Ireland. It will provide us with greater flexibility in structuring our equity issuances and other financing transactions. Also, the re-domicile will help eliminate certain burdensome formalities and costs to the company and our shareholders. Finally, it positions the company to have better access to the global financial market, and enable us to continue to further attract and retain talent.

The proposed move to a jurisdiction like Ireland will put Innocoll in line with the majority of the NASDAQ listed peers in our sector while preserving Innocoll AG's current Irish tax residency without impacting Innocoll's operations.

"We believe that our proposed corporate re-domicile is in the best interest of Innocoll and our shareholders," said Tony Zook, chief executive officer of Innocoll. "We believe this move will enable Innocoll to benefit from advantages offered by Irish corporate law and provide important economic and operational benefits for our company."

Innocoll's proposed re-domicile will be achieved through a cross border merger under European Union law pursuant to which Innocoll AG will merge into Innocoll Holdings plc, an Irish shell company, the ordinary shares of which will be exchanged for those of Innocoll AG (including those shares underlying existing ADSs on a 1:1 basis). Upon completion of the transaction, Innocoll Holdings plc intends to list its shares directly on NASDAQ under the same "INNL" trading symbol currently used by Innocoll. Innocoll Holdings plc will be the sole surviving entity after the merger and will assume all of the assets and liabilities of Innocoll AG.

The proposed change in domicile is subject to approval from Innocoll's shareholders at an extraordinary general meeting anticipated to occur in January 2016, the final approval of Innocoll's management board, and the satisfaction of other customary closing conditions. If approved, the re-domicile merger and share exchange are expected to close in March 2016.

Innocoll Holdings plc will file a Registration Statement on Form F-4 with the Securities and Exchange Commission which will contain a prospectus relating to the re-domicile merger, including the share exchange. Upon completion of the transaction, Innocoll Holdings plc will remain subject to the reporting, disclosure and governance requirements of the NASDAQ and the SEC.

About Innocoll AG

Innocoll is dedicated to making better happen—better ways for patients to recover from surgeries and better ways to treat limb-threatening infections. We strive to engineer better medicines to help patients get better.

Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits.

Our late-stage product pipeline is focused on addressing a number of significant unmet medical needs: INL-001, a bupivacaine-collagen bioresorbable implant (Phase III), is being studied to provide better postoperative analgesia; INL-002, a gentamicin-collagen topical matrix (Phase III), is being investigated as a topical treatment to better cure diabetic foot infections; and INL-003, a bioresorbable collagen film surgical adhesion barrier (approved ex-US), is scheduled to enter clinical trials in the US for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, and Biomet. All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

Innocoll is a global company operating in Europe and the US, with plans to further partner in other high- potential areas around the world.

For more information, please visit www.innocoll.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.

Innocoll AG Announces First Patient Dosed in the XaraColl MATRIX-2 Phase 3 Study for the Treatment of Postoperative Pain

ATHLONE, Ireland - 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 that the first patient was dosed in the MATRIX-2 (Multisite Assessment of PosToperative PainReduction wIth XaraColl) Phase 3 study for the treatment of postoperative pain following open hernioplasty with mesh using XaraColl, Innocoll's surgically implantable and bioresorbable bupivacaine-collagen matrix.

The MATRIX-2 Phase 3 study is the second of two identical randomized, placebo-controlled, double-blinded studies to investigate the safety and efficacy of a surgically implantable and resorbable bupivacaine-collagen matrix. The MATRIX-1 study had its first patient enrolled last month. Each study is expected to enroll approximately 300 patients aged 18 and older in the United States. Patients with a unilateral inguinal hernia undergoing open hernioplasty with mesh placement will be treated in one of two arms per study: three 100 mg XaraColl matrices for a total dose of 300 mg of bupivacaine hydrochloride or three placebo matrices. The matrices are placed at the site of the hernia repair in order to provide local levels of bupivacaine directly at the location of surgical trauma.

The primary efficacy endpoint is the sum of pain intensity difference (SPID) over 24 hours comparing the XaraColl matrix to placebo. Additional endpoints include the SPID at 48 and 72 hours as well as total opioid use at 24, 48 and 72 hours. Safety will be evaluated through the collection of adverse events through 30 days postoperatively.

Enrollment for both studies is expected to complete in the first quarter of 2016 and topline results from the studies are expected in the second quarter of 2016.

Postoperative pain management is a serious concern for surgeons and patients. In the U.S., approximately 750,000 hernia operations are performed annually. Effective postoperative pain control is an essential component of the care of the surgical patient. Inadequate pain control, apart from being inhumane, may result in increased morbidity or mortality. While opioids are very effective analgesics, opioids also carry with them many undesirable potential side effects: sedation, respiratory depression, nausea and vomiting, hypotension and bradycardia, pruritus, and inhibition of bowel function.

XaraColl acts locally following implantation at the surgical site to provide sustained pain relief by delivering appropriate concentrations of bupivacaine directly at the site of surgical trauma for up to 72 hours. Bupivacaine is a long acting local anesthetic with a well-characterized safety and efficacy profile. The XaraColl collagen matrix helps deliver that local pain relief for up to 72 hours.

"We remain committed to delivering our late-stage portfolio and realizing the potential of these exciting therapeutics for the physicians and patients they serve," said Tony Zook, Chief Executive Officer. "With the dosing of the first patient in our MATRIX-2 study, we continue to execute on the deliverables we set for ourselves. Both the Cogenzia and XaraColl Phase 3 programs are fully underway and before the close of the year, we also hope to have discussions with the FDA to advance CollaGuard."

More information on the study will be posted at www.clinicaltrials.gov.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.

Innocoll AG Announces Departure of Chief Medical Officer

ATHLONE, Ireland -- Innocoll AG (NASDAQ:INNL) announced that James P. Tursi, M.D., will depart Innocoll to pursue another opportunity. Dr. Tursi will remain with Innocoll until September 21, 2015.

"James has done a great job advancing our lead assets into advanced clinical development during his tenure at Innocoll," said Tony Zook chief executive officer of Innocoll. "Phase 3 clinical trials for both Cogenzia and XaraColl are actively recruiting patients. The U.S clinical program plans for CollaGUARD are in place and we anticipate initiating interactions with the FDA to discuss them in the fourth quarter. Although we are disappointed by his leaving, we credit James with completing the key groundwork that is enabling us to focus on clinical trial execution for Cogenzia and XaraColl and moving toward discussions of our CollaGUARD clinical plan with regulators. We are in good position while we search for his successor. We wish James well in his next career role."

Dr. Tursi joined Innocoll in March 2015. His initial priorities upon assuming the position were to initiate the Phase 3 programs for Cogenzia and XaraColl and to finalize the U.S. clinical program plans for CollaGUARD. Both the Cogenzia and XaraColl Phase 3 programs began recruiting patients in 2015 as planned. Interactions with regulators on the CollaGUARD pivotal trial proposed program are on track to begin in the fourth quarter of 2015.

"I appreciate the challenge and opportunity to work with the team on advancing Innocoll's late stage clinical pipeline," said Dr. Tursi. "I leave Innocoll with the conviction that the company's key clinical programs will continue to progress as anticipated and that the team is fully prepared to execute on its objectives. I wish the Innocoll team the best as they bring needed medicines to patients."

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.

Innocoll AG Announces First Patient Dosed in the XaraColl MATRIX-1 Phase 3 Study for the Treatment of Postoperative Pain

ATHLONE, Ireland, -- Innocoll AG (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 that the first patient was dosed in the MATRIX-1 (Multisite Assessment of PosToperative Pain Reduction wIth XaraColl) Phase 3 study for the treatment of postoperative pain following open hernioplasty with mesh using XaraColl, Innocoll's surgically implantable and bioresorbable bupivacaine-collagen matrix.

Postoperative pain management is a serious concern for surgeons and patients. According to Life Science Database, there are over 76 million surgeries performed annually in the US with approximately 1.4 million being hernia operations. Effective postoperative pain control is an essential component of the care of the surgical patient. Inadequate pain control, apart from being inhumane, may result in increased morbidity or mortality. While opioids are very effective analgesics, opioids also carry with them many undesirable potential side effects: sedation, respiratory depression, nausea and vomiting, hypotension and bradycardia, pruritus, and inhibition of bowel function.

XaraColl acts locally following implantation at the surgical site and is intended to provide sustained pain relief by delivering appropriate concentrations of bupivacaine directly at the site of surgical trauma for up to 72 hours. Bupivacaine is a long acting local anesthetic with a well-characterized safety and efficacy profile. The XaraColl collagen matrix helps deliver that local pain relief for up to 72 hours.

"Postoperative pain management is critical for a successful result of nearly any surgical procedure. When pain is adequately controlled, patients have a better experience." said Dr. James Tursi, Chief Medical Officer at Innocoll. "A better experience for the patient means a better experience for the surgeon. Importantly, the ability to limit or reduce exposure to opioids may enable patients to avoid opioid related side effects and potentially opioid related complications."

The MATRIX-1 Phase 3 study is one of two identical randomized, placebo-controlled, double-blinded studies to investigate the safety and efficacy of a surgically implantable and resorbable bupivacaine-collagen matrix. The second Phase 3 study, MATRIX-2 is expected to start later this quarter. Each study is expected to enroll approximately 300 patients age 18 and older in the United States. Patients with a unilateral inguinal hernia undergoing open hernioplasty with mesh placement will be treated in one of two arms per study: three 100 mg XaraColl matrices for a total dose of 300 mg of bupivacaine hydrochloride or three placebo matrices. The matrices are placed at the site of the hernia repair in order to provide local levels of bupivacaine directly at the location of surgical trauma.

The primary efficacy endpoint is the sum of pain intensity difference (SPID) over 24 hours comparing the XaraColl matrix to placebo. Additional endpoints include the SPID at 48 and 72 hours as well as total opioid use at 24, 48 and 72 hours. Safety will be evaluated through the collection of adverse events through 30 days postoperatively.

To qualify for the study, patients must have a planned (non-emergent) unilateral inguinal hernioplasty (open laparotomy, tension-free technique) to be performed according to standard surgical technique under general anesthesia. Following screening and determination of eligibility, study participants will be assigned to one of two groups. Patients will be treated with implantation of three 100 mg XaraColl matrices (total dose 300 mg) or three placebo matrices. Pain measurements will be recorded at predetermined intervals over the first 72 hours following implantation of the matrices. Enrollment is expected to complete in the first quarter of 2016 and topline results from the study are expected in the second quarter of 2016.

More information on the study will be posted at www.clinicaltrials.gov.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl(R) for the treatment of post-operative pain; Cogenzia(R) for the adjuvant treatment of diabetic foot infections; and CollaGUARD(R), a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp(R) G, Septocoll(R), RegenePro(R), Collieva(R), CollaCare(R), Collexa(R), and Zorpreva(TM), which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx(R), Collatamp(R), CollaGUARD(R), Collieva(R), CollaCare(R), Collexa(R), Cogenzia(R) LidoColl(R), LiquiColl(R), Septocoll(R), and XaraColl(R) are registered trademarks, and CollaPress(TM), DermaSil(TM), Durieva(TM), and Zorpreva(TM) are trademarks of the company.

Innocoll AG Appoints Rich Fante as Chief Commercial Officer and Head of Business Development

ATHLONE, Ireland -- Innocoll AG (NASDAQ:INNL) announced that Rich Fante has been appointed Chief Commercial Officer and Head of Business Development effectiveAugust 20, 2015. The addition of this role to the senior management team is an additional step in the transition of the company to a commercial-stage, fully-integrated specialty pharmaceutical company.

"Our two lead product candidates, Cogenzia and XaraColl, are rapidly progressing in advanced clinical development so we need the additional skills and experience to finalize and execute on our commercial strategies for both products in the near-term," said Tony Zook, Chief Executive Officer of Innocoll. "The addition of Rich Fante to our executive team adds the critical skills and commercial experience we need to ensure commercial success. Cogenzia, currently in Phase 3 trials, recently received Qualified Infectious Disease Product (QIDP) designation from the FDA, which may lead to a priority review and accelerated time to market. We also anticipate initiating Phase 3 trials for XaraColl this quarter. Both sets of pivotal trials are expected to read out data in 2016. Rich's joining the team is timely."

Mr. Fante has deep experience in the management and execution of commercial product strategies in the pharmaceutical industry. Most recently, he was founder and president of RF Consulting, a firm that assists emerging biopharmaceutical companies in their commercialization efforts. Prior to founding RF Consulting, Mr. Fante spent over nineteen years at AstraZeneca pharmaceuticals in the United States, where he served a number of rolls, most recently as President of its U.S. business, CEO North America and Regional Vice President of the Americas. During his tenure at AstraZeneca, the company became the second largest pharmaceutical company in the U.S. He helped to build some of the most successful brands in pharmaceutical industry history including Nexium®, Crestor®, Symbicort®, Arimidex®, Seroquel® and Prilosec®. Before joining AstraZeneca in January 1995, Mr. Fante began his career in pharmaceutical sales and marketing as a sales representative followed by brand management at Lederle Laboratories. Mr. Fante has served as Board Chairman of the National Pharmaceutical Council and was a member of the Institute of Medicine of the National Academies of Science Roundtable on Value and Science. Mr. Fante is currently a non-executive director of the privately held biotech company Inhibikase Therapeutics, Inc. Mr. Fante received his B.A. in Biology from Princeton University and his M.B.A. from University of North Carolina at Chapel Hill.

"Innocoll's late stage product pipeline represents an ideal opportunity to begin to engage with the market," said Mr. Fante. "The promise of the company's products and the experience of the leadership team are a clear combination of factors for commercial success, and I'm pleased to be in the position to make a contribution to the company's transition."

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.

Innocoll AG Appoints Jose Carmona as Chief Financial Officer

Appointment is effective on September 1, 2015

Gordon Dunn will continue as Vice President, Finance Director, Europe

ATHLONE, Ireland -- Innocoll AG (NASDAQ:INNL) today announced that Jose (Pepe) Carmona, previously the Chief Financial Officer of a division of Alcon, a Novartiscompany, has been appointed Chief Financial Officer effective September 1, 2015. Gordon Dunn, Innocoll's current Chief Financial Officer, will continue with the company as Vice President, Finance Director, Europe. The executive changes were made to add further commercialization experience to the senior management team as the company prepares to transition to a fully-integrated specialty pharmaceutical company.

"As Innocoll continues to execute on the transition of the organization, it is essential that our leadership team has the skills and experience required to successfully lead a commercial-stage company," said Tony Zook, Chief Executive Officer of Innocoll. "Jose's extensive background with major pharmaceutical and personal care companies is the skill set that will help propel the company to its next stage in its development. We very much thank Gordon for his contributions as CFO and appreciate his continued commitment to the company by heading our European financial operations."

Mr. Carmona has over 19 years of experience applying his extensive management skills toward the financial operations of commercial-stage companies. Most recently he served as Chief Financial Officer of Alcon Europe, Middle East & Africa, a division of Novartis, and prior to that he held numerous financial management positions with increasing responsibility within Novartis. Before joining Novartis in 2003, Mr. Carmona held senior management positions for several divisions of Proctor and Gamble in Latin America. Mr. Carmona received his B.S. in Industrial and Civil Engineering from Universidad Tecnica Federico Santa Maria in Valparaiso, Chile, and his M.B.A. from Columbia Business School in New York City.

"I am very pleased to be joining Innocoll at such an exciting stage in its development," said Mr. Carmona. "The company could face a rapid transition from a clinical development-stage company to a company with multiple self-marketed products in the very near term. It will be a momentous time at Innocoll and I look forward to contributing to the company's continued success."

Mr. Dunn added, "I am extremely proud of what we accomplished at Innocoll during my tenure as the company's CFO. We raised the capital necessary to build a strong drug formulation platform and set the stage for commercialization. I look forward to working with Pepe who will apply his commercial-stage experience toward moving the company to the next level at exactly the right time in the company's development."

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.