LA JOLLA, Calif., Aug. 19, 2013 (GLOBE NEWSWIRE) -- Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the "Company") (OTCBB:INNV) (http://www.innovuspharma.com) announced today a corporate mid-year update covering Company activities, expected near-term events and comments on recent market conditions, as follows:
2013 has been a transformative year for Innovous Pharma as we refined our business objectives, expanded our management team, continued to build a strong and global pipeline, secured financing for the company, increased liquidity of our stock, signed multiple commercial distribution agreements for two of our products and generated revenues.
The Company corporate objectives for 2013 are as follows:
Expand Management Team
The Company has put together a very seasoned and experienced management team with an excellent track record of product development, partnering, commercial operations and growth.
On January 22, 2013, Innovus appointed Bassam Damaj, Ph. D. to serve as its President and Chief Executive Officer and a member of the Board of Directors. Dr. Damaj replaced Vivian Liu, who continues to serve on the Board of Directors. Dr. Damaj has brought a surge of energy to the Company and has helped to re-focus and execute on the Company's goals. Before joining Innovus, Dr. Damaj served as President and Chief Executive Officer of Apricus Biosciences, Inc., (Nasdaq:APRI) from December 2009 until November 2012. At Apricus Bio, Dr. Damaj was responsible for the approval of its lead drug Vitaros, a treatment for erectile dysfunction and for the major commercial partnerships done with Takeda, Sandoz-Novartis, Abbott, Bracco and others.
On February 19, 2013, Robert Verfurth was hired as Innovus' Vice President of Sales and Marketing. Mr. Verfurth is responsible for the sales and marketing efforts of the Company's pipeline. Mr. Verfurth was most recently a part of the marketing and sales team at Apricus Biosciences. Prior to Apricus, until mid 2012, Mr. Verfurth was Vice President, US Sales-West for Becton Dickinson Diagnostics and served as Vice President, US Sales and Support for the molecular diagnostic start-up GeneOhm Sciences beginning in 2005. Prior to GeneOhm, Mr. Verfurth held a number of commercial roles, including Vice President of Sales at both Prometheus Laboratories and Dianon.
On May 28, 2013, Morgan Brown, C.P.A., M.B.A. joined Innovus as Executive Vice President and Chief Financial Officer with responsibility for finance, accounting, human resources, information technology and investor relations. Mr. Brown brings with him more than 20 years of financial and accounting experience and has worked with the small management team to lay the groundwork for a future up listing to NASDAQ. Prior to joining Innovus, Mr. Brown served in a similar capacity at World Heart Corporation (Nasdaq:WHRT), a medical device company, from August 2009 until August 2012. Prior to his position at World Heart, Mr. Brown served as Chief Financial Officer at CRI Lifetree, a full-service CRO, and at NPS Pharmaceuticals, Inc., a biotech company.
Rounding out the senior management team, on July 22, 2013, Innovus invited Randy Berholtz, Esq. to act as corporate Secretary and legal consultant. Mr. Berholtz has an impressive resume, working most recently as Executive Vice President, General Counsel, and Secretary at Apricus Biosciences, Inc. (Nasdaq: APRI). Mr. Berholtz has served in many leadership roles with various life science companies, including ACON Laboratories, Inc., IngleWood Ventures, L.P., and Nanogen, Inc. The Company looks forward to having his expertise available to assist with complex legal issues and corporate governance.
In June 2013 Innovus formed and appointed the first member, Robert E. Hoffman, to its Business and Finance Advisory Board. The Company plans to utilize the Business and Finance Advisory Board members' experience and backgrounds for strategic planning and industry insight. As the first member, Mr. Hoffman's broad financial experience in the biopharmaceuticals sector makes him a valuable resource for the current management team at Innovus. Currently, Mr. Hoffman is Senior Vice President, Finance and Chief Financial Officer of Arena Pharmaceuticals, Inc. (Nasdaq:ARNA).
Secure Financing for its On-Going Operations and Increase Cash Reserves
During the six months ended June 30, 2013, the Company worked hard to secure financing for its growth and ongoing operations. To date we have secured close to $1.2M in notes and equity financing mainly from our President & CEO. The Company is also in discussion to secure non-dilutive funding from on-going commercial and distribution partnerships for its products.
Secure "Clean" Audit Opinion on the Company's 2012 Annual Financial Statements
The going concern assumption in the Generally Accepted Auditing Standards SAS 59, The Auditor's Consideration of an Entity's Ability to Continue as a Going Concern, requires an auditor to evaluate conditions or events that raise questions about an entity's ability to continue as a going concern. Typically, if an auditor has concerns about a firm's ability to continue as a going concern, the audit opinion will contain a paragraph outlining issues with this assumption. In the Company's 10-K report for the year ended December 31, 2012, the Company's auditors did not include any such going concern paragraph in their audit opinion.
"Having the going concern issue removed from our audit opinion for the first time in many years is a significant accomplishment for our relatively new management team, further affirming our continued success in the execution of the Company's goals," noted Dr. Bassam Damaj. "Having the going concern opinion removed not only validates our business strategy but also instills further trust in our management team by our shareholders, as well as, with the numerous pharmaceutical companies, which we are in active partnership discussions with at this present time."
Build a Strong and Global Pipeline in Large Markets
Building a strong and global pipeline was an important priority in 2013. Innovus has built a strong pipeline in the sexual dysfunction, arthritis, cough and cold and acne therapeutic areas. In the sexual dysfunction area, the Company acquired the ex-US rights to the patented CIRCUMserum™ product to help with reduced penile sensitivity ("RPS") in circumcised men and diabetic patients. CIRCUMserum works by making the skin more sensitive with the continuous use of the product. In a patient use study, over 80% of users responded positively and were satisfied. To bolster our sexual dysfunction franchise, Innovus developed a proprietary treatment for premature ejaculation ("PE"), a very large market targeting over 30% of men. The product, EjectDelay™, is based on the active drug benzocaine which delays ejaculation by over 4 minutes in clinical trials. The Company is actively looking for additional products to complement its sexual dysfunction franchise.
The Company developed multiple other products: Apeaz™ for arthritis, Xyralid™ for hemorrhoids, zinc cough and cold lozenges and Innovus Acne Care for acne. The arthritis and hemorrhoids products are topical. Apeaz is based on the strong anti-inflammatory methyl salicylate which has been shown to repair damaged tissues in mouse studies in addition to the effective pain management it provides. Over 21 million people suffer from arthritis in the US and it is a continuously growing market. Xyralid is based on the active drug lidocaine which works by anesthetizing inflamed tissue. Over 50 million worldwide hemorrhoid procedures are done per year for a condition that affects more than 50% of people over 50 years in United States.
Launch Three of its OTC or Consumer Healthcare Products
Innovus launched CIRCUMserum, a consumer healthcare product for reduced penile sensitivity, in May 2013 and expects to launch EjectDelay, an FDA compliant OTC gel for premature ejaculation, and Apeaz, an FDA compliant OTC cream for arthritis pain relief, in the fourth quarter of 2013. In order to facilitate the respective launches of these products, Innovus has entered into co-promotion agreements with companies such as Consortia to promote within the United States, including outside sales reps. Additionally, Innovus plans to enter into license and distribution agreements with ex-US licensees for these products. Finally, Innovus launched the www.ejectdelay.com website and plans to launch other product specific websites in the future. Customers are expected to be able to purchase Innovus products online.
Begin Generating Revenue from Product Sales
We plan to start generating revenue through the signing of multiple commercial partnerships for EjectDelay and CIRCUMserum outside the United States during the second half of 2013.
Sign Commercial Partnerships for its Products
The Company is pursuing an aggressive commercial partnering and distribution strategy ex-US and plans to sign multiple commercial agreements during the second half of 2013.
In summary, we are committed to driving topline performance with growth products in key geographies, advancing and augmenting our pipeline and aggressively managing our cost base. By doing these things well, we will preserve the ability to invest in our future, potentially start to generate strong cash flow and drive shareholder value and return over both the short and long term. For more information, go to: www.innovuspharma.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995:
With the exception of the historical statements, statements contained in this release, including statements regarding the expected results of the studies, may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are generally identifiable by the use of the words "believes," "views," "expects," "projects," "hopes," "could," "will," "intends," "should," "estimate," "would," "may," "anticipates," "plans", "target", "goal" or the negative of these words or other variations on these words or comparable terminology. These forward-looking statements are subject to a number of risks and uncertainties that may, individually or collectively, cause actual results to differ materially from those contained in the forward-looking information, and are based on the current expectations, estimates, forecasts and projections of Innovus Pharma. Many of the risks and uncertainties are outside the control of Innovus Pharma including Innovus Pharma's ability to continue to retain and recruit talented individuals to fill out its management team, board of directors and advisory board; Innovus Pharma's ability secure future financing to support its on-going business needs, increase its cash reserves and to launch its product portfolio; Innovus Pharma's ability obtain an unqualified audit opinion on its financial statements in the future; Innovus Pharm's ability to enter into commercial agreements for its product portfolio; and, Innovus Pharma's ability to launch and begin generating revenues from its product portfolio. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in Innovus Pharma's most recent annual report on Form 10-K and its other filings with the SEC. Copies of these filings are available from the SEC's website or the "Investors" section of Innovus Pharma's website at innovuspharma.com. Forward-looking statements contained in this press release speak only as of the date hereof. Except as required by law, Innovus Pharma undertakes no obligation to publicly release the results of any revisions or updates to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
Innovus Pharma Contact: Kevin Holmes Chesapeake Group T: 410-825-3930