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Oculus Offers 2HCY12 Business Update

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Oculus Innovative Sciences, Inc. (Nasdaq: OCLS) a healthcare company that designs, produces and markets innovative, safe and effective anti-infective medical devices while also developing multiple drug candidates, today provided a market update for the second half of 2012.

Financial Update/EBITDAS Profitability Expected During FY 2014

Total revenue was $8.6 million in the six months ended September 30, 2012, compared to $6.6 million in the same period last year with product revenue growing at 32% over the same period last year. Operating loss minus non-cash expenses (EBITDAS) for these six months was $235,000 compared to $1.2 million in the same period last year. If adjusted for one-time severance costs of $410,000 relating to the transaction with Oculus partner, More Pharma, Oculus would have been EBITDAS profitable for the first half of FY 2013. The company's cash position as of September 30, 2012 was $8.3 million.

Oculus management believes the combination of the growing revenue, especially in the United States, and reduced operating expenses in Mexico, should result in consistent EBITDAS profitability sometime in fiscal year 2014, excluding expenses directly related to clinical drug trials. Once realized, Oculus will then target cash flow breakeven, which will be facilitated by continued revenue growth and maintenance of reduced cash operating expenses. Management provided product revenue growth guidance of up to 25% for the full fiscal year 2013, compared to the same period last year.

Revenue Growth

Oculus management anticipates sustainable revenue growth as a result of the following domestic partnerships:

* U.S. sales of Oculus' dermatology products and expansion of product lines will provide the greatest near-term revenue boost with revenue growth guidance of 40% to 60% for full fiscal year 2013. * Animal healthcare partner, Innovacyn, Inc., provided Oculus with revenue growth of 36% in the first half of FY 2013. The company has provided guidance of up to 20% revenue growth for FY 2013. 

The company's international sales are expected to grow as a result of additional drug and device approvals in both India and China in Q4 FY 2013 with commercialization to follow in Q1 FY 2014. Oculus will update guidance as these initiatives move forward.  

Scar Study

Oculus completed patient enrollment for its scar management trial. This trial is being conducted based on an FDA-reviewed protocol to support the company's pending FDA 510(k) clearance for management of hypertrophic and keloid scars. The company expects to announce top line data from this trial in early calendar year 2013. Upon successful completion of the clinical trial and anticipated FDA clearance, AmDerma/Quinnova will reimburse Oculus for the cost of the trial and will introduce another innovative Microcyn-based product into the U.S. dermatology market. This is part of Oculus' strategy to provide partners with growing and robust product pipelines for their respective markets.

Two FY 2013 Licensing Agreements

Oculus' partner, More Pharma, assumed all Microcyn-based product marketing and sales responsibilities in South America and the Caribbean as of August 2012. In addition to an upfront payment of $5.1 million to Oculus, More Pharma's 200-person marketing/sales team has assumed all product marketing/sales in Mexico, while also pursuing further regulatory approvals and subsequent commercialization in other Latin American countries. Oculus believes long-term sales will grow at a much greater pace as these regulatory approvals are secured. More Pharma's 200-person marketing/sales team has assumed all product marketing/sales in Mexico as of August 2012. As a result of this successful transition the company eliminated its marketing and sales team in that region, thus lowering its SG&A expenses by $2.8 million per annum.

Secondly, Oculus signed a licensing agreement with AmDerma/Quinnova to develop and commercialize Oculus' novel proprietary Microcyn® Technology drug compounds for major dermatological conditions, including acne. The exclusive agreement includes licensing of the dermatology compounds in the United States and India. The product formulation is nearing finalization. AmDerma/Quinnova will be responsible for the development costs for the acne formulation as well as other dermatological compounds. 

Future Planned Partnerships

Duplicating the successful blueprint of the FY 2013 partnerships, Oculus is working to secure a series of CE mark approvals for use of its various product formulations in the treatment of wounds and dermatology indications. The added CE mark approvals will provide a significant opportunity for potential partners to quickly commercialize and penetrate the European markets in FY 2014.   

Posted-In: News Guidance

 

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