ImmuCell Corporation · NASDAQ:ICCC
ImmuCell — Investor Presentation (August 2016)
43 slides from ImmuCell's investor presentation, August 2016
Slide 1: Investor Presentation August 2016
ImmuCell developers of NASDAQ: ICCC Investor Presentation August 2016
Slide 2: Forward-Looking Statements
Forward-Looking Statements Safe Harbor Statement: This presentation contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating t
Slide 3: Table of Contents
Table of Contents Core Presentation: 1) Company and Market Overview………………………………………..…………….....4-7 2) First Defense ® for Calves – Dairy and Beef…….….…………….…………..……..8-15 3) Mast Out ® for Dairy Cows …………………...………………. ……………………..16-28 Supporting Information: 4) Financial Review(1)…………………………..………………………
Slide 4: Company Overview
Company Overview • Founded: 1982, IPO: 1987, Secondary Offering: February 2016 • ImmuCell Corporation (NASDAQ: ICCC) is an animal health company that is focused on improving animal health and productivity from the “Calf to the Cow” • We aim to capitalize on the significant growth in sales of First D
Slide 5: Company Overview (continued)
Company Overview (continued) • Product sales for Q2 2016 and FY 2015 were $2.4M and $10.2M, respectively. • (LPS)/EPS for Q2 2016 and FY 2015 were ($0.00) and $0.38, respectively. • Cash and investments balance of $10.8M at June 30, 2016. • Stockholders’ equity of $16.3M at June 30, 2016. • Game cha
Slide 6: Improve the Food Chain with Less Antibiotics
Improve the Food Chain with Less Antibiotics The common denominator between our commercial product, First Defense®, (for newborn dairy and beef calves) and Mast Out® (for dairy cows) is that both products increase efficiency of food production with less antibiotics. (NASDAQ: ICCC) 6
Slide 7: Market Overview
Market Overview • ImmuCell’s products are currently focused on the North American dairy and beef cattle markets, although significant market opportunities exist in other international territories. Number of Dairy & Beef Cows (in thousands) Dairy Beef Total Markets currently served: United States 9,3
Slide 8: First Defense for Calves – Dairy and Beef
ImmuCell First Defense® for Calves – Dairy and Beef
Slide 9: First Defense: Provides Immediate Immunity to Newborn Calves
First Defense® : Provides Immediate Immunity™ to Newborn Calves • Newborn calves have naïve immune systems • Colostrum (first milk) consumption immediately after birth is the only way to provide critically important antibodies that allow calves time to fully develop their own immunity • First Defens
Slide 10: Scours: Leading Calf Disease Risk
Scours: Leading Calf Disease Risk Rampant, uncontrolled diarrhea in newborn calves primarily caused by: • E. coli • Coronavirus • Rotavirus • Cryptosporidium • Salmonella Scours is an economic drain in three ways: 1. Calf losses • Death 2. Treatment costs • Antibiotics, rehydration fluids, and incre
Slide 11: Scours: Cost to the U.S. Dairy and Beef Industries
Scours: Cost to the U.S. Dairy and Beef Industries Estimated annual scours-related costs to the dairy industry: ~$329 million(1) Estimated annual scours-related costs to the beef industry: ~$412 million(1) Total estimated annual scours-related costs to the calf industry: ~$741 million(1) (1)See Appe
Slide 12: Growing Share of Growing Market
Growing Share of Growing Market Growth is attributable primarily to: 1. Successful efforts by our expanded sales and marketing team 2. Continued strong beef prices 3. Interrupted supply to the market by a competitor # Treatment Doses 3,000,000 2,500,000 22% 26% 32% 38% 2,000,000 1,500,000 78% 68% 62
Slide 13: Estimate of U.S. Market Size
Estimate of U.S. Market Size Number of calves that are diagnosed • Scours incidence rate: Approximately 23% w/scours annually (8,501,000 / 37,054,000) suggesting the use rate Dairy 2,647,000 of scours preventatives could grow significantly as producers adopt preventative protocols over Beef + 5,854,
Slide 14: Competitive Product Comparison
Competitive Product Comparison USDA Claims Product Mode-of-Action E. coli Corona Rota First Defense® Two-part: delivers bovine antibodies to the gut that are (ImmuCell) absorbed into the bloodstream X X (1) Forces calf to mount an immune response to a vaccine to Calf-Guard® develop protective antibo
Slide 15: Sales Strategy to Increase Market Share in a Growing Market
Sales Strategy to Increase Market Share in a Growing Market • By adding two new regional sales managers to our team in the third quarter of 2014, we now support our distributors with five regional sales managers (1) reporting to our vice president of sales and marketing. • Growing sales force commun
Slide 16: Mast Out for Dairy Cows
ImmuCell Mast Out® for Dairy Cows
Slide 17: Mastitis: Leading Cause of Economic Harm to the Dairy Industry
Mastitis: Leading Cause of Economic Harm to the Dairy Industry $2 Billion • Mastitis – A potentially fatal mammary gland infection – The single largest economic harm to the dairy industry – $2 billion per year in the U.S. alone • Antibiotic treatments are available on the market, but milk from treat
Slide 18: Nisin, our Active Pharmaceutical Ingredient
Nisin, our Active Pharmaceutical Ingredient • Nisin is a bacteriocin (a compound produced by bacteria that kill other bacteria) that has potent antibacterial activity against many Gram-positive pathogens • This peptide is naturally-derived from a proprietary strain of Lactococcus lactis • Crude prep
Slide 19: Cost of "Dumped" Milk Associated with All Traditional Antibiotics
Cost of “Dumped” Milk Associated with All Traditional Antibiotics Range in costs per cow associated with milk discard for products with clinical mastitis disease claims Treatment Discard Average Cost of Brand Name Company Total Dump Days Days (4) Days (4) Dumped Milk(1) Dariclox Merck 1.5 2 3.5 $ 39
Slide 20: Subclinical Mastitis in Lactating Dairy Cows
Subclinical Mastitis in Lactating Dairy Cows • A cow infected with subclinical mastitis is “stuck between a rock and a hard place” because the dairy farmer KNOWS she is sick but cannot JUSTIFY the cost of “dumped” milk required to treat her. • Subclinical mastitis is a chronic infection that should
Slide 21: Mast Out Treats Subclinical Mastitis
Mast Out® Treats Subclinical Mastitis • Mast Out® is a Nisin-based intramammary treatment for subclinical (infected, but still producing saleable milk) mastitis in lactating cows. • Subclinical mastitis is predominantly Gram-positive (clinical mastitis is about 50% Gram-positive and 50% Gram-negativ
Slide 22: Mast Out: Novel Alternative to Traditional Antibiotics
Mast Out®: Novel Alternative to Traditional Antibiotics Value Proposition of Mast Out® • Zero milk discard and zero meat withhold (in • Game changer, making treatment of subclinical the United States) mastitis economically feasible • Higher quality of milk by having lower • The FDA has warned that t
Slide 23: Mast Out: Product label claims
Mast Out®: Product label claims • The mastitis market today is dominated by Zoetis, Merck and Boehringer Ingelheim. All of these traditional antibiotics are sold subject to milk discard and meat withhold requirements. • We have met our development objective of establishing disease claims that are si
Slide 24: Potential Mast Out Sales in U.S. Market
Potential Mast Out® Sales in U.S. Market The critical assumptions underlying these figures are as follows: Potential U.S. Market Sales (U.S. dollars) • Treatment of subclinical mastitis only. Availability of highly efficacious product option $36.1 with zero milk withdrawal will shift treatment in fa
Slide 25: Pharmaceutical-grade Nisin Plant
Pharmaceutical-grade Nisin Plant • Construction of a Nisin pilot plant in our 56 Evergreen Drive (Portland, ME) facility was completed during Q3 2014. This pilot plant allows us to: 1) expand our process knowledge and controls; 2) establish operating ranges for critical process parameters; 3) optimi
Slide 26: Conceptual Drawing of Commercial-Scale Nisin Plant
Conceptual Drawing of Commercial-Scale Nisin Plant (NASDAQ: ICCC) 26
Slide 27: Status of NADA Technical Sections
Status of NADA Technical Sections Development Item Date Completed Environmental Impact Technical Section Complete Letter from the FDA Q3 2008 Target Animal Safety (TAS) Technical Section Complete Letter from the FDA Q2 2012 Effectiveness Technical Section Complete Letter from the FDA Q3 2012 Human F
Slide 28: Remaining Development Milestones to NADA Approval
Remaining Development Milestones to NADA Approval First quarter of 2016 Secure financing First quarter of 2016 Initiate design and permitting for commercial-scale Nisin plant Third quarter of 2016 Initiate construction of building shell for commercial-scale Nisin plant Mid 2017 Achieve FDA approval
Slide 29: Financial Review
ImmuCell Financial Review
Slide 30: Investment Highlights
Investment Highlights As of June 30, 2016: As of August 9, 2016: • Cash and Investments: $10.8M • Stock price: $7.99 • $2.59 per share • Net Working Capital: $11.9M • 52-week range: $5.60-$10.92 • $2.85 per share • Shares Outstanding: 4.2M • Total Stockholders’ Equity: $16.3M • $3.90 per share • Mar
Slide 31: Consistent Annual Total Sales Growth
Consistent Annual Total Sales Growth $12.0 Total Product Sales $10.23 $10.0 $ in Millions $8.0 $7.60 $6.01 $6.0 $5.39 $5.36 $5.11 $4.0 $2.0 $0.0 Year Ended Year Ended Year Ended Year Ended Year Ended Six Months 12/31/11 12/31/12 12/31/13 12/31/14 12/31/15 Ended 06/30/16 (NASDAQ: ICCC) 31
Slide 32: First Defense Sales Growth
First Defense® Sales Growth • Positive sales growth of First Defense® for 21 quarters out of the last 23 quarters % Growth in Sales of First Defense® Product Line Compared to the Same Quarters of the Previous Years 70% 60% 50% Q1 40% Q2 30% Q3 20% 10% Q4 0% FY -10% YTD -20% -30% 2010 vs 2009 2011 vs
Slide 33: Net (Loss) Income
Net (Loss) Income Year ended December 31, 2011 2012 2013 2014 2015 Six Months Ended $1,213,239 June 30, 2016 $1,400,000 EPS = $0.38 $1,200,000 $1,000,000 $800,000 $443,292 $600,000 EPS=$0.11 $400,000 $89,512 $117,395 EPS = $0.03 EPS = $0.04 $200,000 $0 ($200,000) ($167,159) LPS = ($0.06) ($400,000)
Slide 34: Appendix
ImmuCell Appendix
Slide 35: Economics of Dairy Industry
Economics of Dairy Industry • The value of a dairy bull calf increased from near zero to $300 to $400, and more recently decreased to $50 to $250 • We saw an improved milk price and an overall improvement in Milk-to-Feed Price Ratio during 2014 • This positive trend did not continue during 2015 or i
Slide 36: U.S. Sales and Marketing Territories
Your Calf Crew™ U.S. Sales and Marketing Territories Michaela Spring Michelle Philibeck Matt Hutchins Sales & Marketing Regional Manager Sales & Marketing Regional Manager Sales & Marketing Regional Manager Western Region Midwestern Region Eastern Region 319-431-1150 920-213-7588 937-243-4211 msprin
Slide 37: Scours: Cost to the U.S. Dairy and Beef Industries
Scours: Cost to the U.S. Dairy and Beef Industries Dairy Beef Scours Related Cost to Dairy Industry Calf Deaths $119 million – Calf Deaths Calf Deaths $45 million – Scours Treatments Deaths prior to weaning 6.4% Deaths prior to weaning 7.8% % of above deaths from scours 14.2% $90 million – Reduced W
Slide 38: Customer Testimonials
Customer Testimonials “First Defense® is like an insurance policy that pays for itself in spades. Say you cut your death loss from, conservatively, 8 to 2 percent. If you have 300 calves a month, that’s 12 more calves a month or 144 calves a year more that you are able to raise. That fuels the growt
Slide 39: Additional Mastitis-Related Marketed Products
Additional Mastitis-Related Marketed Products • Wipe Out® Dairy Wipes – Wipe Out® contains a naturally safe antimicrobial that attacks bacteria on contact. The use of an antimicrobial to clean and sanitize the teat area before and after milking has been proven to reduce the incidence of mastitis in
Slide 40: Key Publications Related to the Subclinical Mastitis Market Opportunity
Key Publications Related to the Subclinical Mastitis Market Opportunity Santman-Berends, IM. (2012, May), Incidence of subclinical mastitis in Dutch dairy heifers in the first 100 days in lactation and associated risk factors, J Dairy Science, 95(5): 2476- 2484. Roesch, M. (2007, February), Subclini
Slide 41: Animal Health Industry
Animal Health Industry Animal Health Companies Animal Health Companies (cont.) Diagnostics and Services Companies Aratana Therapeutics (PETX) Virbac AH (VIRP) Abaxis (ABAX) Bayer AH (BAYRY) Zivo Bioscience (ZIVO)(2) Advanced Animal Diagnostics (Private) Boehringer Ingelheim AH (Private) Zoetis (ZTS)
Slide 42: Company Leadership
Company Leadership Executive Management Team Board of Directors • Michael F. Brigham • Michael F. Brigham – President and CEO – President and CEO – Director since 1999 – Officer since 1991 – Appointed CEO in 2000 • Joseph H. Crabb, Ph.D. – Vice President and Chief Scientific Officer • Joseph H. Crab
Slide 43: Contact Information
Contact Information Investor Relations ImmuCell Corporation Lytham Partners, LLC NASDAQ: ICCC ICCC@lythampartners.com Michael Brigham Robert Blum President and CEO Joseph Diaz Joe Dorame Adam Lowensteiner (NY) 56 Evergreen Drive Portland, ME 04103 (602) 889-9700 – Phoenix (207) 878-2770 (646) 829-97