Tailstorm - Investor Pitch Deck

Transcript

1. ’ Q4 2019 | Sales Presentation
2. Proprietary & Confidential 02
3. of shortages are injectable generic and drugs <$10 98% drugs are on the FDA’s short supply list 160+ of hospitals increased spending due to drug shortages 80% “Hospitals are facing a shortage on medications that are used every day. The situation is getting worse.” - American Hospital Association 2014 2015 2016 2017 2018 2019 NUMBER OF DRUGS ON SHORTAGE LIST
4. Low Profit Margins High Barrier to Entry Import & Shipping Costs Scarce Local Production The profit margins for these generic drugs are low, and most manufacturers would rather sell the profitable high value drugs. It is very expensive ($4m) and time consuming (3yrs) for manufacturers to obtain ANDA approval to manufacture generic drugs. The majority of US pharmaceutical supply is manufactured in India, which is far and costs a lot to ship. As of today, with most items in short supply there are either one or two manufacturers in the US. These manufacturers don’t have enough capacity to manage the country- wide problems of shortages. Lack of Generic Drug Manufacturers
5. Face Consolidation Unfortunately, most manufacturers will not be able to handle the additional expenses and will cease to exist next year Comply with New Standards This will cut profits considerably, and very few suppliers will be able to make a profit while complying with the new requirements 503B Manufacturers JAN 2020 - New GMP Standards New compliance standards will be enforced.
6. Increased Cost ›The shortages increase the demand, and with the increased demand, the prices for the drugs rise, making it harder for hospitals to obtain them. ›Added cost of obtaining drug alternatives. Safety is Compromised ›Pharma companies cut corners and get away with it because of the shortages. Interrupts Treatment ›Interruption to disease treatment, and medical procedure delays. ›Possible medication errors in prescribing alternative treatments. ›Lack of experience with dosing or preparation of required therapeutic alternatives.
7. Drug Shortages Various causes result in the shortage of generic drugs May 23, 2019 PharMEDium Hit With Permanent Injunction PharMEDium has been repeatedly cited by the FDA for safety concerns at its four manufacturing plants over the past dozen years. The injunction will be in effect until the FDA approves a corrective action by PharMEDium. Haste Due to the shortages, the safety standards are not being fully enforced Adverse Events This leads to the contamination of the drugs, causing illnesses and death
8. Higher production capacities, higher safety standards, more lives saved. Automation Higher Output Higher Safety Standards
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10. Proprietary & Confidential 10 Sterile Injectable Facility AZ Automation Higher Output Higher Safety Standards 503B 503B Pharma Co. (65 in existence) Medical Institutions (not retail) SELL
11. Proprietary & Confidential 11 Hospitals Doctors’ Offices
12. Proprietary & Confidential 12 Pharma Manufacturing Co. Founded in India TailStorm Founded in AZ Pharma Manufacturing Facility Setup in AZ TailStorm Generic Drug Sales Commence Mr. Viraj has been in the pharmaceutical manufacturing industry in India for 25 years. TailStorm was established in Arizona for selling high-value drugs ($10k+), working with insurance companies and hospitals for 4 years. We have been setting up the facility and making it ready for operation. We will begin mass production of low value drugs (<$10).
13. Proprietary & Confidential 13 Viraj Gandhi Promoter & Director ›25+ years in the pharmaceutical industry in India, Asia, and Europe ›Founded two successful pharma companies in India ›Involved in multiple other pharma related business ventures in the US ›US education Anuj Patodia Chief Executive Officer ›Investor director who owns & manages south India's leading affordable real estate projects. Mary Vilalona (CQM/OE, CQA) Director Quality Systems ›25+ years of quality assurance and management in pharmaceutical and medical device industries ›Led innovative company to first GMP compliant batch in 9 months. ›Led an unqualified facility to first commercial batch in under 2 years, with 13 site transfers and 13 ANDA new products in following 2.5 years
14. Proprietary & Confidential 14 – ’ Rashesh Dave Manager of Engineering ›Spent last 8 years as an engineer in India’s leading pharmaceutical design firm. ›Helped companies set up US FDA standard facilities in India while working at that company. Jose Guitterez Head of Manufacturing ›28 years experience in various facets of pharma manufacturing ›Last experience was at a 503B ›13 years working at Baxter, and 15 years as a consultant at a variety of manufacturing sites around the USA ›Led large team of 60+ people
15. Proprietary & Confidential 15 Dr. Richard Manch Chairman Chairman of the board & USA's leading hepatologist Dr. Sudhakar Reddy Board Member Arizona's #1 GI physician who also runs departments in multiple hospitals Dr. David Leff Board Member Arizona's top GI physician with relationships with leading hospitals in AZ & UT Dr. Shaleen Korch Board Member PHD In Biochemistry leading cancer research at Midwestern University
16. Proprietary & Confidential 16 – ’ Saurabh Shah Board Member Chief Investment Officer at Dyson Capital, a multi-family office with AUM >$1 billion. Anuj Patodia Board Member Investor director who owns & manages south India's leading affordable real estate projects. Viraj Gandhi Board Member ›25+ years in the pharmaceutical industry in India, Asia, and Europe ›Founded two successful pharma companies in India ›Involved in multiple other pharma related business ventures in the US ›US education
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18. Proprietary & Confidential 18 Full-scale CGMP Plant Not just a compounding facility Single Line Aqueous sterile injectable products manufactured in a single line Fully Automated Manufacturing facility Designed by the Best A leading pharmaceutical design firm
19. Proprietary & Confidential 19 300 workers 24,000 vials filled Labor intensive, low output Typical 503B
20. Proprietary & Confidential 20 Minimum labor, high output <20 workers 40,000 vials filled
21. Proprietary & Confidential 21 5-6 molecules Production at launch 20 molecules Phase 2 production 40k Vials / Day 1-50ml Injection Capacity (single-dose vials)
22. Proprietary & Confidential 22 * Pre filtration and Final filtration afterwards.
23. Proprietary & Confidential 23 EQUIPMENT VENDOR COUNTRY Filling Line Dara / NJNM Spain / USA Clean Room MRC UK / UAE WFI System Stilwell USA / Canada Terminal Sterilizer Micro Intl USA Modular Office & Lab Starrco USA EMS System Lighthouse USA Lab Equipment Various USA Infrastructure Contractor USA Top Tier Equipment Tailstorm has procured the equipment from local and reputable vendors. All of these vendors have been in business for more than 20 years, and have supplied solutions to leading pharma companies around the world.
24. Proprietary & Confidential 24 Quality Assurance Eliminate Human Error Specialist QA Team Control Variables Higher Standards › Due to automation, human error is eliminated › Our in-house quality assurance team are specialists for past 25 years › Competitors just use a pharmacist trained in administering medicine, not checking quality › We control all the variables in- house to ensure quality and safety › Competitors follow GMP to minimum extent (food product level). We are doing it as should be (pharma company level). This is more expensive.
25. Proprietary & Confidential 25 Reducing labor costs via automation to have more budget to spend on quality assurance Tailstorm (Automation + In-House Full Scale Laboratory) Competitors (Manual Labor) Manufacturing Budget We save money on manufacturing by utilizing automation, whereas competitors need to pay high costs for manual labor. Quality Budget Using the money saved on manufacturing costs, we are able to spend more money on quality assurance, whereas competitors must resort to cutting corners on quality. Total Cost Since the money saved on manufacturing is greater than the cost of quality assurance, our product still ends up being cheaper than the competitors’ products. $ $$$$ $$$ $ $$$$ $$$$$
26. Proprietary & Confidential 26 3 Main Raw Materials to Manufacture an Injection Water ›Main raw material in all injections; 95%-99% water. ›We make the water ready for injections in-house using our on-site Water for Injection (WFI) plant. ›This reduces the risk factor for the main ingredient. Glass Vials ›Product will be in direct contact with the glass vials, so quality is crucial. ›We buy ready-made FDA grade 1 vials that are fully compliant with US FDA from our trusted supplier. API ›Easy to find raw materials, freely available in the market. ›We buy all API from local US based manufacturers.
27. Proprietary & Confidential 27 Higher Production Volume Higher Quality Standards Compliant with New FDA Regulations Fresh Manufacturing Capacity › Our facility has >20 people producing 40k vials a day › Eliminate human error due to automation › Specialist quality assurance team › We control all the variables in-house to ensure quality and safety › We follow higher safety standards than competitors › We are already compliant with new USP 797 and revised CGMP expected to come into effect in 2020. › We address shortages by bringing in fresh manufacturing capacity (converting the product from powder to a sterile liquid).
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29. Proprietary & Confidential 29 FDA’s Short Supply List Tailstorm can manufacture any drug listed on the FDA’s short supply list, which includes 160+ drugs. Tailstorm will manufacture: › 20 molecules that appear most frequently on the list › Focus on generic injectables › Each molecule in different strength and pack sizes Category 1 Bulk Substances FDA’s list of "503B Category 1 Bulk Drug Substances Under Evaluation" included approximately 180 active ingredients. Tailstorm can produce any of these substances for use in hospitals and doctors’ offices. Find the full list here. Non Essentially Similar Drugs The 503B guidelines allow Tailstorm to make products that are commercially available, without filing an ANDA, as long as the product is not essentially similar to the commercially available product.
30. Proprietary & Confidential 30 – ’ PHASE 1- Q1 2020 STRENGTH PACK SIZE Lidocaine 1%, 2%, 4% 5 ml, 10 ml Bupivacaine 0.25%, 0.5% 5 ml, 10 ml Ketorolac 15 mg, 30 mg 2 ml, 4 ml Labetalol 20 mg 2 ml, 4 ml Sodium Chloride 23.4% 2 ml, 4 ml, 10ml Sodium Bicarbonate 8.4%, 4.2% 5 ml, 10 ml PHASE 2 - Q2 2020 STRENGTH PACK SIZE Calcium Chloride 10% 10 ml Dopamine 200 mg 5 ml 400 mg 10 ml Ropivacaine 0.2%, 0.5%, 1% 5 ml, 10 ml Atropine 0.1 mg/ml 10 ml Dextrose 50% 5 ml, 10 ml Diazepam 10 mg 2 ml 50 mg 10 ml PHASE 3- Q3 2020 STRENGTH PACK SIZE Dexamethasone - - - - - - Ondansetron - - - - - - Diltiazem - - - - - - Metoprolol Tartrate - - - - - - Dobutamine - - - - - - Amiodarone - - - - - - Nicardipine - - - - - -
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33. (602) 896-0454 info@tailstorm.com www.tailstorm.com