Added shares @ BIEL
Took advantage of todays weak hands an added another 1M shares to my war chest!
Another Historical Review on my notes back in 2009 from a conference call are fun to read knowing how far we have come and where we are going...like a fine wine it takes some patience!
Trial Presentation – Dr. David Genecov, M.D., FACS-FAAP – Leading surgeon especially in Wound Care was a lead investigatore on Evaluating the ActiPatch on Plantar Fasiitis (Heel Pain). A condition that is difficult for people to walk. The trial evaluated the Actipatch at night with Placebo vs. active prdt. Treated Patients for 7 days…..looked at 55 patients….another 20 Patient will be evaluated soon. Trial has gone thru IRB. Very Solid Trial. Trending shows that on Day 4, there is a decrease of pain with less medication. Typically using over the counter medication for pain. The Dr. had a Personal story –Tylenol….Issues with kidneys. His father used Tylenol for back pain…..ended up with Kidney failure due to the drugs. He believes that this product would had prevented this side affect. He will have a publication for the trial by the end of the year. He has had a few physician colleagues interested in his trial and patient’s response. The company will have access to the data for FDA filing very soon.
Allay Patch User. Dr. Aria (Mispelled?) MD – LA She shared her personal experience on the Allay Patch. She had several issues with her conditions only able to use Tylenol but then used Midol which helped but led to chronic gastritis. She started using the actipatch about two months ago. She says PMS basically stops her from doing anything for about 2 or 3 days a month. She has to plan her life around her periods that are so painful. Can’t travel and she needs to stay home. So glad she found it. On the first day of using the actipatch, she noticed benefit in a couple of hours. Still had some pain, but much better. By the second day, the pain was almost completely gone. By the third day, the pain was gone. On a scale of 1-10, PMS pain without patch is a 10. After 4-5 hours of use, pain is a 5 on the first day. By second day, pain is a 0. (Joel mentioned on a Scale is 1-10.)
International Distribution. – Update – Expanding Western Europe. They will be distributing to Germany and Spain. Biggest Market is Germany in Europe. Making progress in Italy and Canada. Plan to ramp up distribution in Europe and Asia markets.
Status of FDA filings – Will have Actipatch. Have a demand for clinical studies. A lot investigators coming to the company to participate. Pushing hard for a clinical study on cesarian section Blindness study. Hernia study. Company will be slowing down the amt of trials since they want to focus on what is on the table today.. June 15 for Allay Period Patch. Planning to hear from FDA very soon. They will file for general surgery indication. Doing this will leap frog a FDA filings for a Global Muscular Skeleton Back pain. Pushing Company wants to put product on Walgreens etc. Dr. Genecov, M.D., FACS-FAAP trial is the key to these top indications.
Market Stats – Carrie Synder – Independent Consultant for BIEL– Comprehensive study published at the end of THIS week. Market research study. Will file on BIEL. The Study will show thatthese products could potential reach into the BILLIONS of dollars if the penetration is large but will be conservative on the potential for today’s discussion. Mentioned the Global Pain Surgeryarea could have 4 -5 % growth with 3 -4 billion market place. This represents 37% of pain relief market She shared 4 areas of focus 1. Cesarean Market. Mothers don’t No drugs due to concerns about Nursing 1.2 mill C sections performed in the US.. 20 % penetration equals $13.4 millions 2. Cosmetic Market. Breast Augmentation – Small market to reconstructive surgery. 6.6 million procedures representing about 20 % of the market . Equals about$ 66 million in US only. 3.Menstrual Pain Relief – Million of woman. Huge market 50 mill women 10 mill users 5 % Users = Market share potential is $80 million per year. 4. Lower back Pain – Biggest market to Muscular Skeletal - Last year had 16 mill patients which at 10% market share equal $65 million potential annual. Just summary for US = 225 million per year….for US. IF you market for world with US accts could equal 500 million ann. revs. Worldwide: $1-$2 billion/year. These are conservative. Huge returns. She's giving very conservative estimates on markets. This is for United States only. There is very little competition out there. Especially given that BIEL has patent to portable PEMF therapy.
Tylenol Press and FDA Panel review – July 3rd Panel – Brought in a panel of scientist and docs to review this with FDA. Number 1 cause is liver failure. Suggested to pull off Extra Strength Tylenol off the market and decrease – Had score of 39 before panel to 16 acceptance score a few days after the panel recommendations. Market is trying to position against Tylenol. Drug free solution. Patent is key to their products. Have applied for a second patent for large scope of indications.
Financials – 80% recent Q’s to Company are about financial picture. Now $910K covertures Debt to $50,000 convertible is down below 50K. Convertibility Debt Free. Down size has been dilution. Downside has been dilution and now they say they are looking in rearview window with dilution. Company is not concerned with liquidity. Won’t raise significant cash and think stock is still undervalued. Improvements in gross margins similar to any pharmaceutical company and as volumes up cost per unit will go down.
Company has been keeping expenses down as well Cost of capital has dropped. Gross Margin on the prdts. Improvement to manufacturing process. As the volumes move up….the Gross Margins will drop. Company has done a great job on controlling cost. Breaking even now. Export/Import Bank – have a guarantee by US government to help BIEL on exports. Cost of Capital is very low. Nice profits moving forward. Hire two brand managers to help BIEL markets.
Top priority is the clinical studies. Many of the trials are finishing. Dr. Genecov, M.D., FACS-FAAP Data is pivotal and a key for the indication on back pain. Large market. Further looking to Muscular Skeleton indication. They top priority is to “Rewrite the thought of How to Manage Pain” .
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