Valion Bio, Inc. · NASDAQ:VBIO
Valion Bio — Tivic Health Systems — Investor Presentation (December 2021)
24 slides from Valion Bio's investor presentation, Dec 8, 2021
Slide 1: Bioelectronic Medicine: Non-Invasively Targeting Immune System Responses
1 Bioelectronic Medicine NON - INVASIVELY TARGETING IMMUNE SYSTEM RESPONSES 2021 DECEMBER INVESTOR PRESENTATION
Slide 2: Forward-looking statements
2 This presentation contains forward - looking statements . All statements other than statements of historical facts contained in this presentation may be forward - looking statements . Statements regarding our future results of operations and financial position, economic performance, business strat
Slide 3: Management Introductions
3 Management Introductions LEADERSHIP TEAM Jennifer Ernst Chief Executive Officer, Co - founder, MBA Built Tivic Health from founding to IPO in 5 years. Took prior company (Thin Film Electronics) from 8 - person R&D team to $480MM market cap in < 5 years, as CEO of US subsidiary. Blake Gurfein Chief
Slide 4: Investment Highlights
4 Investment Highlights TIVIC HEALTH: FOUNDED 2016 23,000 Units Sold 2 FDA Clearances & CE Mark Over 2 3 4 18 500 + PEER - REVIEWED PUBLICATIONS REGULATORY CLEARANCES ISSUED PATENTS PATENTS PENDING 4 - AND 5 - STAR REVIEWS Commercial - phase in high - growth bioelectronics sector. FDA & CE cleared,
Slide 5: The Big Idea: Electrons as Medicine
5 THE BIG IDEA The body is an electro chemical system. Electrons can be used as medicine. 5 Bioelectronic medicine “represents a multibillion dollar opportunity, … [and has the] potential to become a pillar of medical treatment.”
Slide 6: Electrons as medicine: Bioelectronics' Origins
6 Electrons as medicine BIOELECTRONICS’ ORIGINS 1960s Pacemakers 2010s Sleep Apnea, Rheumatoid Arthritis 1990s Deep Brain, Spinal Cord 2020s Non - Invasive Bioelectronics • Bioelectronic medicine treats disease by tuning electrical signaling carried along neural (nerve) pathways. • Tivic Health focu
Slide 7: ClearUP: Clears congestion, stops sinus pain, non-invasively
7 Clears congestion, stops sinus pain, non - invasively. ClearUP ® • User glides tip along facial skin around cheek, nose, brow (sinus regions) for 5 minutes, twice daily and as needed. • Low - level pulsed current flows from tip, through sinus passages. • Launched late 2019. Available through Tier
Slide 8: Our Platform for Non-invasive Peripheral Nerve Stimulation
8 OUR PLATFORM FOR Non - invasive Peripheral Nerve Stimulation Programmable Parameters produce varied biological responses for different diseases and conditions Patented Form Factor enables low - level electrical current to penetrate deeply through tissue Proprietary Algorithms detect optimal treatm
Slide 9: Pipeline
9 PIPELINE Other Potential Use Cases Postoperative Pain following sinus surgery 600,000 FESS (sinus) surgeries annually in US, alternative to opioids Temporomandibular Joint Disorder (TMJ) Tinnitus Trigeminal Neuralgia Otitis Media / Ear Infection Migraine Headache 39M people in US, 1B people w orld
Slide 10: Robust Foundations: IP, Clearances, Publications
10 K182025 CE 704687 DEN200006 ISSUED PATENTS (issued in 2020 & 2021) 5 PATENTS PENDING 18 STRONG INTELLECTUAL PROPERTY THREE REGULATORY CLEARANCES PEER - REVIEWED PUBLICATIONS Open - label study. Continuous reduction in pain and congestion over 4 - weeks of at - home use. Published: Bioelectronic M
Slide 11: Competitive Landscape
11 Oral & Intranasal Decongestants Antihistamines • Treat itchiness • Not effective for congestion and pain • Headache, sleepiness, fatigue, dry mouth, and sore throat • Insomnia, nervousness, heart palpitations, headache, sweating, nausea, trembling, weakness, rebound Saline Irrigation • Messy / im
Slide 12: Strong Consumer Preference
12 82% preferred ClearUP to current treatments 1 STRONG CONSUMER PREFERENCE • No pills, no sprays, nothing in the nose • No drugs, no significant side effects reported 2 • Use any time, anywhere, whenever and as often as needed (2) Most common side effect: 0.02% reported mild skin irritation in clin
Slide 13: Fast-acting: Peer-reviewed publication
13 Maul XA, Borchard NA, Hwang PH, Nayak JV. Microcurrent technology for rapid relief of sinus pain: a randomized, placebo-controll ed, double-blinded clinical trial. Int Forum Allergy Rhinol. 2019;9:352 – 356. Fast - acting Double - blind, randomized, sham - controlled trial examined acute response
Slide 14: Continued Improvement With Regular Use
14 Goldsobel, A.B., Prabhakar, N. & Gurfein, B.T. Prospective trial examining safety and efficacy of microcurrent stimulation fo r t he treatment of sinus pain and congestion. Bioelectron Med 5, 18 (2019) doi:10.1186/s42234 - 019 - 0035 - x #p < 0.01; *p < 0.0001; two - tailed paired t - test compar
Slide 15: Multiple pathways relieve multiple symptoms
15 Multiple pathways relieve multiple symptoms 1 . Maul, Ximena A . , et al . "Microcurrent technology for rapid relief of sinus pain : a randomized, placebo-controlled, double-blinded clinical trial . " International forum of allergy & rhinology . Vol . 9 . No . 4 . 2019 . Trigeminal nerve activati
Slide 16: Large Markets, Significant Growth Opportunity
16 2019 Sinus Pain from allergies 2021 Moderate to Severe Congestion from any cause 50M monthly allergy sufferers. 1 90% experience sinus pain from allergic rhinitis. 2 27% would consider purchase @ $149. 2 = $1.8B US Market 200M US adults experience at least monthly. 1 27% would consider purchase @
Slide 17: Market Development: Future Channel Growth
17 Future Channel Growth Optimize and scale highest margin channels MARKET DEVELOPMENT Early Traction Expedited Development Sept 2016 – Sept 2019 2020 - 2021 2022+ • Optimize website and D2C channels • Scale - up advertising to drive sales, capture market share • Expand social media, content marketi
Slide 18: Omnichannel, multi-touchpoint approach
18 Tried - and - true omnichannel, multi - touchpoint approach DEMAND GENERATION BUILD CREDIBILITY / RETARGETTING 4 - & 5 - star reviews, clinical publications, value - added content (video content, blogs) DRIVE PURCHASE On - site advertising, co - operative marketing, seasonal promotions GENERATE A
Slide 19: Gen2 Architecture
19 New design built to deliver economies of scale GEN2 ARCHITECTURE • Fewer parts • Fully automated assembly for electronics • Estimated 5x increase to line output • Flexible design allows for future products on same architecture • High on - time production through 2020 & 2021 • Favorable supply agr
Slide 20: Financials
20 Twelve Months Ended December 31 Nine Months Ended September 30 (in thousands) FY 2020 FY 2019 Q1 - Q3 2021 Q1 - Q3 2020 Revenues $ 860 $ 420 $ 800 $ 489 Gross Profit (Loss) (225) (289) (104) (143) Operating Profit (Loss) (3,204) (3,643) (3,341) (2,399) 0 100 200 300 400 500 600 700 800 900 2019 F
Slide 21: Strong Cap Table & Balance Sheet
21 Common Stock (outstanding at IPO) 6,265,234 Common Stock (sold in IPO with overallotment) 3,450,000 Options and warrants 649,469 Fully Diluted Shares 10,364,703 Strong Cap Table & Balance Sheet FINANCIALS • IPO completed November 2021 with oversubscription: $15M+ net proceeds • No outstanding deb
Slide 22: 2022 Directions
22 2022 Directions INVESTMENTING FOR GROWTH Expand sales and marketing • Upgrade ecommerce infrastructure, online website design and branding • Optimize and expand advertising and public relations • Increase support for social media and digital Improve gross margin • Launch ClearUP Gen 2 product wit
Slide 23: Summary
23 Summary TIVIC HEALTH FDA - cleared product in high - growth sector. Established Tier 1 channels in place. 64% revenue growth 9 - Month YOY 2020 v. 2021. $8B estimated available market. Clinical validation with leading institutions, peer - reviewed publications. Regulatory clearances for both US a
Slide 24: Jennifer Ernst, CEO, Tivic Health
24 24 Jennifer Ernst CEO, Tivic Health jennifer.ernst@tivichealth.com
Tivic Health Systems — Investor Presentation (December 2021) on 6ix