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Equity Research Jnapodano@Zacks.Com October 5, 2010 Jason Napodano, CFA 312-265-9421 Equity Research [email protected] www.zacks.com 111 North Canal Street, Chicago, IL 60606 INVO Bioscience (IVOB-OTC) IVOB: INVOcell Launched In Canada UPDATE Through Exclusive Agreement This morning INVO Bio announced its INVOcell device has been launched in Canada through an exclusive distribution agreement with Invaron Pharma. We see this as a significant near-term opportunity for the company. Outperform Current Recommendation The INVOcell device has been elegantly designed to Prior Recommendation N/A provide several advantages when compared to Date of Last Change 05/24/2010 interuterine insemination (IUI) or in vitro fertilization (IVF). These advantages include lower risk of ovarian Current Price (10/05/10) $0.08 hyperstimulation syndrome, lower risk of anesthesia complications, and wider applicability and availability for Target Price $0.25 infertile couples. New reimbursement policies in Canada should help drive uptake of INVOCell over the next several years. SUMMARY DATA 52-Week High $0.51 Risk Level Above Average 52-Week Low $0.03 Type of Stock Small-Growth One-Year Return (%) -83.80 Industry Med-Biomed/Gene Beta -0.96 Zacks Rank in Industry 45 of 138 Average Daily Volume (sh) 121,134 ZACKS ESTIMATES Shares Outstanding (mil) 63 Market Capitalization ($mil) $3 Revenue (in millions of $) Short Interest Ratio (days) N/A Q1 Q2 Q3 Q4 Year Institutional Ownership (%) N/A Insider Ownership (%) N/A (Mar) (Jun) (Sep) (Dec) (Dec) 2009 0.04 A 0.02 A 0.00 A 0.01 A 0.06 A Annual Cash Dividend $0.00 2010 0.02 A 0.01 A 0.02 E 0.02 E 0.07 E Dividend Yield (%) 0.00 2011 0.10 E 2012 0.16 E 5-Yr. Historical Growth Rates Sales (%) N/A Earnings per Share Earnings Per Share (%) N/A (EPS is operating earnings before non recurring items) Q1 Q2 Q3 Q4 Year Dividend (%) N/A (Mar) (Jun) (Sep) (Dec) (Dec) 2009 $0.01 A -$0.01 A -$0.06 A -$0.00 A -$0.09 A P/E using TTM EPS N/A 2010 $0.01 A -$0.01 A -$0.01 E -$0.01 E -$0.01 E P/E using 2010 Estimate N/A 2011 -$0.03 E P/E using 2011 Estimate N/A 2012 -$0.03 E Zacks Projected EPS Growth Rate - Next 5 Years % N/A Zacks Rank 3 © Copyright 2010, Zacks Investment Research. All Rights Reserved. WHAT S NEW INVOcell Launched In Canada On October 5, 2010, INVO Biosciences announced that it has signed an agreement with Canadian-based Invaron Pharmaceuticals for the exclusive distribution of INVOcell in Canada. We believe this could represent a meaningful near-term revenue driver for INVO Bio given the growing infertility rates and Canada and recently implemented reimbursement policy that dramatically improves patient access to assisted reproductive procedures. INVO Bio received Health Canada Regulatory Approval in 2009. The device is CE Mark approved in Europe and Canada and conforms to all consumer health and safety requirements. INVOcell is currently marketed and sold in Austria, Cameroon, Columbia, the Dominican Republic, Guatemala, Nicaragua, Pakistan, Panama, Peru, Spain, Togo, Turkey, and Venezuela. Regulatory procedure is underway in additional areas including China, Russia, and India. There are approximately 27 fertility centers in Canada licensed to perform assisted reproductive procedures. INVO Bio s more natural alternative to IVF is an attractive option for the estimated 1 million infertile couples in Canada. Plus, with approval and now distribution in place, the door is open to the estimated 8 million infertile couples in the U.S. and 10 million Europe to travel to Canada should they chose to seek INVOcell. Recently, the provincial government of Quebec has initiated the funding of up to three assisted reproductive cycles for residents of the province. Fertility centers in Quebec are currently administering approximately 1,850 cycles annually. By 2014 provincial officials predict that the annual number of embryo-implant cycles administered will grow to between 7,000 and 10,000 in the Quebec province alone due to the new reimbursement policy. INVO Bio s INVOcell device represents an excellent low start-up-cost alternative to help these centers meet the potential surge in demand for assisted reproductive procedures. INVESTMENT THESIS Sales of the INVOcell device have underwhelmed to date. Management continues to run into the problem where existing IVF centers are viewing the INVOcell device as a competitive threat. These centers, due to the difficult economic environment, are seeing demand decline significantly. However, most IVF centers still have a backlog, albeit smaller, as the number of infertile couples seeking treatment continues to rise. Instead of viewing INVOcell as a competitive threat, if these centers viewed the product as a low-cost alternative to target a significant population of the infertile couples currently not being treated by IVF, sales of INVOcell would soar. This is management s chief goal in the coming quarters to work with the doctors and the IVF centers, and educate them on how INVOcell can help expand their business and grow their revenues. However, this costs money; money to attend conferences, travel to IVF centers and meet with doctors in South America, Europe, and Asia, and to educate and train potential users on INVOcell. This is money the company did not have to spend in the second quarter, and that is why we believe sales disappointed. If the company can secure funding in the next few months, we expect the situation to improve. We note that the company plans to attend the American Society of Reproductive Medicine (ASRM) in late-October 2010 in Denver, CO. This could be a significant opportunity to increase education and awareness in the U.S. for the INVOcell device. Looking For Funding As of June 30, 2010, INVO BioSciences reported only $571 in cash on the balance sheet. Operating burn for the second quarter was $108k, one of the lowest in a while and further evidence of the lack of marketing and promotional spending during the quarter. We believe the company needs an estimated $250k to fund operations in the third quarter, and another $300 to $400k for the fourth quarter. During the second quarter, the company funded operations by issuing convertible notes and restricted stock. We expect this to continue in the third and fourth quarter. In August 2010, the company raised $50k by issuing 1.25 million shares of common stock to Mazuma Funding of New York, a private investor. The company used the proceeds to pay off a $50k working line of credit with Century Bank. We anticipate future PIPE deals to come, however the overall dilution through the end of the year should be less than 10%. Zacks Investment Research Page 2 www.zacks.com The company is also looking to tap its reserve equity financing (REF) agreement with AGS Capital Group LLC. INVO Bio and AGS entered into the REF in October 2009, which allows the company to issue common stock for cash consideration of up to $10 million. We expect that INVO to access this REF in the fourth quarter. The opportunity exists for the company to secure funding from the Federal R&D Tax Credit. These options include either a tax credit for R&D expenses, or a research grant that would pay for up to 50% of the total research or related expenses for new product development. We estimate that INVO could qualify for a federal research grant between $500k and $1 million to fund the U.S. regulatory trial for INVOcell. Management has applied for these funds and expects to hear back in September or October. Finally, management is in discussions with potential development and commercialization partners in Europe, Asia, and the U.S. These talks may be early-stage, but the potential exists that something gets done to provide additional funding for expansion of the marketing and promotional effort behind INVOcell in 2011. We highlight the recent agreement with Invaron Pharmaceuticals in Canada as a positive step forward on INVOcell distribution. Management is currently in the process of launching INVO around the world. The device is ISO-13485 certified and CE Mark approved for sale in Europe and Canada. Key markets where the device is available include Canada, Austria, Columbia, Pakistan, Peru, Brazil, and Argentina. For these territories where registration has been complete, management has signed distribution partners and is working with physicians to train them on the procedure. The company is in talks with potential distribution partners in India, China, Russia, and South Africa. Management just recently got some good news from the State Food and Drug (SFDA) agency in China, classifying INVOcell as a Class 2 medical device without requiring a human clinical trial. The next step for potential marketing in China is for management to secure a Certificate of Free Sale for a European contract manufacturer, which will allow for marketing in China through the company s distribution partner, Progressive Group. In the U.S., INVO Bioscience has completed the first step for medical device companies who manufacture Class 2 devices and the filing of a Premarket Notification with the FDA. The FDA has reviewed the 510(k) application and requested human clinical trial. INVO is currently focusing on the international market while is seeks funds to conduct the U.S. registration program. We believe this program could begin in 2011 once funds are secured, perhaps in the form of a federal grant. According to the European Society of Human Reproduction and Embryology (ESHRE), in 2007 there were an estimated 150 million couples worldwide with infertility. Based on the significant limitations discussed above for IUI and IVF, only around 0.5% seek treatment, leaving an estimated 149 million couples untreated.
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