8-K
Valion Bio, Inc. (VBIO)
UNITED STATESSECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORTPURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest eventreported): August 15, 2022
TIVIC HEALTH SYSTEMS, INC.
(Exact name of registrant as specified in itscharter)
| Delaware | 001-41052 | 81-4016391 |
|---|---|---|
| (State or other jurisdictionof incorporation) | (CommissionFile Number) | (IRS EmployerIdentification No.) |
25821 Industrial Blvd., Suite 100
Hayward, CA 94545
(Address of principal executive offices, includingzip code)
Registrant’s telephone number, includingarea code: (888) 276-6888
N/A (Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol(s) | Name of each exchangeon which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | TIVC | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02 | Results of Operations and Financial Condition |
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The information provided below in “Item 7.01 - Regulation FD Disclosure” of this Current Report on Form 8-K is incorporated by reference into this Item 2.02.
| Item 7.01 | Regulation FD Disclosure |
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On August 15, 2022, Tivic Health Systems, Inc. (the “Company”) issued a press release regarding the Company’s financial results for its second fiscal quarter ended June 30, 2022. A copy of that press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.
In addition, on August 15, 2022, the Company began using a new corporate presentation. A copy of that corporate presentation is furnished as Exhibit 99.2 hereto and incorporated herein by reference. A copy of the presentation is also available on the Company’s website located at https://tivichealth.com/investor/.
The information set forth under Item 7.01 of this Current Report on Form 8-K (“Current Report”), including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibits 99.1 and 99.2, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.
Forward-Looking Statements
This Current Report, including Exhibits 99.1 and 99.2 attached hereto, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.
Forward-looking statements in this Current Report, including Exhibits 99.1 and 99.2 attached hereto, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission, reports to the stockholders of the Company and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Securities and Exchange Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.
| Item 9.01 | Financial Statements and Exhibits. |
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| (d) | Exhibits. |
| --- | --- |
| Exhibit<br><br> <br>No. | Description |
| --- | --- |
| 99.1 | Press Release, dated August 15, 2022. |
| 99.2 | Corporate Presentation, dated August 2022 |
| 104 | Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: August 15, 2022
| TIVIC HEALTH SYSTEMS, INC. | |
|---|---|
| By: | /s/ Veronica Cai |
| Name: Veronica Cai | |
| Title: Chief Financial Officer |
Exhibit 99.1
Tivic Health Reports Strong Growth in Second Quarter 2022 Financial Results
265% growth in unit sales throughdirect-to-consumer channels,97% overall revenue growth vs. Q2 2021
SAN FRANCISCO BAY AREA, CA — (Business Wire) – August 15, 2022 – Tivic Health® Systems, Inc. (“Tivic Health”, Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today announced its financial results for the quarter ended June 30, 2022.
Jennifer Ernst, CEO of Tivic Health commented, “Our second quarter results demonstrate clear traction on the three pillars of the strategy we laid out last November – increasing direct-to-consumer revenue, reducing cost of goods and seeding our product pipeline.”
Q2 Financial Highlights
| • | 97% increase in revenue from $268 thousand in Q2 2021 to $528 thousand in<br>Q2 2022. |
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| • | 265% increase in unit sales through our direct-to-consumer channels from<br>Q2 2021. |
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| • | Reduction in average per unit cost of sales from $97.18 to $90.26, despite<br>increased variable costs due to higher shipping, fulfillment and transaction fees. |
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Q2 Corporate Highlights
| • | Significant progress made on elements of supply chain to support cost improvements<br>and scaling. |
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| • | The 60-person randomized sham-controlled clinical trial for post-operative<br>pain reduction is ongoing. |
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| • | Market studies on a promising new indication for migraines were completed. |
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| • | New patent issued, bringing Tivic Health’s patent portfolio to 5 issued<br>patents, 18 pending, and 96 claims. |
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Financial Review for the Three Months Ended June 30, 2022
| • | For the second quarter of 2022, revenue increased $260 thousand,<br>or 97%, primarily due to a 44% increase in unit sales and the optimization of existing sales channels. Units sold through our direct-to-consumer<br>channels increased 265% compared to the second quarter of 2021. |
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| • | For the second quarter of 2022, cost of sales was $403 thousand<br>compared to $301 thousand for the same period in 2021, an increase of $102 thousand, or 34%. The increase was primarily due to higher<br>sales volume. |
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| • | For the second quarter 2022, research and development expenses<br>were $497 thousand, a $305 thousand increase from $192 thousand for the same period in 2021. This increase was primarily due to increased<br>headcount and increased costs for product research and design. |
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| • | Sales and marketing expenses were $1.1 million for the three<br>months ended June 30, 2022, compared to $345 thousand for the same period in 2021, representing an increase of $780 thousand. The increase<br>in sales and marketing expenses were due primarily to upgrading and optimizing e-commerce infrastructure, testing new advertising vehicles,<br>expanding our co-operative marketing programs with channel partners and other strategic marketing investments. |
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| • | General and administrative expenses were $1.5 million for the three months<br>ended June 30, 2022, compared to $485 thousand for the same period in 2021, representing an increase of $1.0 million. The increase was<br>primarily attributable to increased headcount, legal and professional fees, D&O insurance costs and increased fees and professional<br>services that are required for public company standards. |
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| • | These increases resulted in a net loss of<br>$3.0 million for Q2 2022, compared to $1.1 million in Q2 2021. |
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| • | As of June 30, 2022, cash and short-term<br>investments balance was $9.0 million. |
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Financial Review for the Six Months Ended June 30, 2022
| • | For the six months ended June 30, 2022, revenue increased $365 thousand, or 62%, compared to the same period<br>in 2021, primarily due to a 36% increase in unit sales. |
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| • | For the six months ended June 30, 2022, cost of sales was $760 thousand compared to $602 thousand for the<br>same period in 2021, an increase of $158 thousand, or 26%. The increase was primarily driven by higher sales volume in 2022. |
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| • | For the six months ended June 30, 2022, research and development expenses were $898 thousand, a $508 thousand<br>increase from $390 thousand for the same period in 2021. The increase is primarily due to increased headcount and costs related to additional<br>investments in product candidate research and design. |
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| • | Sales and marketing expenses were $1.8 million for the six<br>months ended June 30, 2022, compared to $645 thousand for the same period in 2021, representing an increase of $1.2 million. The increase<br>for the six-months ended June 30, 2022 was due primarily to the expansion of our sales and marketing efforts. |
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| • | General and administrative expenses were $2.7 million for the six months ended<br>June 30, 2022, compared to $1.0 million for the same period in 2021, representing an increase of $1.7 million. The increase was<br>primarily attributable to increased headcount, legal and professional fees, D&O insurance costs, increased rent and increased fees<br>and professional services that are required for public company standards. |
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Conference Call:
Management will host a conference call and webcast on Monday, August 15, 2022, at 1:30 PM PT / 4:30 PM ET to discuss the company’s second quarter 2022 financial results and provide a business update.
The conference call will be available via telephone by dialing toll free 877-545-0320 local callers; or 973-528-0002 for international callers and using Participant Access Code: 492379.
The conference call will also be available via Webcast link: https://www.webcaster4.com/Webcast/Page/2865/46308
An audio replay of the call will be available from the “Recent Press” page on the Tivic Health website at https://tivichealth.com/investor/.
About Tivic Health
Tivic Health Systems, Inc. is a commercial-phase health technology company delivering non-invasive bioelectronic treatments that provide consumers a choice in the treatment of inflammation and related conditions. For more information visit https://tivichealth.com @TivicHealth.
Forward-Looking Statements
This press release may contain “forward-lookingstatements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, containedin this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified bythe use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,”or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-lookingstatements are based on Tivic Health Systems, Inc.’s current expectations and are subject to inherent uncertainties, risks, andassumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events thatmay not prove to be accurate. Additional information concerning Tivic Health and its business, including a discussion of factors thatcould materially affect the company operating results, is contained in the company’s Annual Report on Form 10-K for the yearended December 31, 2021, filed with the Securities and Exchange Commission on March 31, 2022, under the heading “Risk Factors,”as well as the company’s subsequent filings with the Securities and Exchange Commission. Forward-looking statements containedin this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except asrequired by applicable law.
Contact:
Media Contact:
Cheryl Delgreco
Cheryl.Delgreco@tivichealth.com
617-429-6749
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Tivic Health Systems, Inc.
Condensed Balance Sheets (Unaudited)
June 30, 2022 and December 31, 2021
(in thousands, except share and per share data)
| December 31, | |||||
|---|---|---|---|---|---|
| 2021 | |||||
| ASSETS | |||||
| Current assets | |||||
| Cash and cash equivalents | 9,049 | $ | 12,975 | ||
| Accounts receivable, net | 92 | 92 | |||
| Inventory, net | 833 | 429 | |||
| Prepaid expenses and other current assets | 398 | 793 | |||
| Total current assets | 10,372 | 14,289 | |||
| Property and equipment, net | 13 | 11 | |||
| Right-of-use assets, operating lease | 607 | 687 | |||
| Other assets | 34 | 49 | |||
| Total assets | 11,026 | $ | 15,036 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current liabilities | |||||
| Accounts payable | 1,915 | $ | 789 | ||
| Other accrued expenses | 293 | 267 | |||
| Operating lease liability, current | 170 | 163 | |||
| Total current liabilities | 2,378 | 1,219 | |||
| Operating lease liability | 461 | 545 | |||
| Total liabilities | 2,839 | 1,764 | |||
| Commitments and contingencies | |||||
| Stockholders’ equity | |||||
| Preferred stock, 0.0001 par value, 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2022 and December 31, 2021 | — | — | |||
| Common stock, 0.0001 par value, 200,000,000 shares authorized; 9,621,484 and 9,715,234 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 1 | 1 | |||
| Additional paid in capital | 32,990 | 32,817 | |||
| Accumulated deficit | (24,804 | ) | (19,546 | ) | |
| Total stockholders’ equity | 8,187 | 13,272 | |||
| Total liabilities and stockholders’ equity | 11,026 | $ | 15,036 |
All values are in US Dollars.
Tivic Health Systems, Inc.
Condensed Statements of Operations (Unaudited)
Three and Six Months Ended June 30, 2022 and 2021
(in thousands, except share and per share data)
| Three Months Ended | Six Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| June 30, | June 30, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenue | $ | 528 | $ | 268 | $ | 956 | $ | 591 | ||||
| Cost of sales | 403 | 301 | 760 | 602 | ||||||||
| Gross profit (loss) | 125 | (33 | ) | 196 | (11 | ) | ||||||
| Operating expenses: | ||||||||||||
| Research and development | 497 | 192 | 898 | 390 | ||||||||
| Sales and marketing | 1,125 | 345 | 1,809 | 645 | ||||||||
| General and administrative | 1,521 | 485 | 2,747 | 1,066 | ||||||||
| Total operating expenses | 3,143 | 1,022 | 5,454 | 2,101 | ||||||||
| Loss from operations | (3,018 | ) | (1,055 | ) | (5,258 | ) | (2,112 | ) | ||||
| Other income (expense): | ||||||||||||
| Interest expense | — | (223 | ) | — | (497 | ) | ||||||
| Change in fair value of derivative liabilities | — | 28 | — | 1 | ||||||||
| Other income | — | 156 | — | 158 | ||||||||
| Total other income (expense) | — | (39 | ) | — | (338 | ) | ||||||
| Net loss | $ | (3,018 | ) | $ | (1,094 | ) | $ | (5,258 | ) | $ | (2,450 | ) |
| Net loss per share - basic and diluted | $ | (0.32 | ) | $ | (0.46 | ) | $ | (0.55 | ) | $ | (1.04 | ) |
| Weighted-average number of shares - basic and diluted | 9,621,484 | 2,374,479 | 9,668,100 | 2,354,589 |
Exhibit 99.2
1 2022 August INVESTOR PRESENTATION NASDAQ: TIVC Electrons as Medicine
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 strategy and plans and objectives of management for future operations, including, among others, statements regarding our expected growth, acquisition strategies, investments, and future capital expenditures are all forward looking statements . Without limiting the generality of the foregoing, words such as “may,” “will,” “should,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “target,” “project,” “might,” “plan,” “predict” or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward - looking statements . We caution you that any such forward - looking statements are not guarantees of future performance, and are subject to risks, assumptions and uncertainties that are difficult to predict and beyond our ability and control . Although we believe that the expectations reflected in these forward - looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward - looking statements . Any differences could be caused by a number of factors, including but not limited to : our anticipated needs for working capital ; our ability to secure additional financing ; regulatory or legal developments in the United States and other countries ; our expectation regarding timing, costs, conduct and development of our product candidates ; supply chain constraints ; and our efforts to expand our products and business . Many of the important factors that will determine these results are beyond our ability to control or predict . Accordingly, you should not place undue reliance on any such forward - looking statements . Any forward - looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward - looking statement, whether as a result of new information, future developments or otherwise . New factors emerge from time to time, and it is not possible for us to predict which will arise . We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward - looking statements . In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject . These statements are based upon information available to us as of the date made, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information . These statements are inherently uncertain, and you are cautioned not to place undue reliance upon these statements . Unless otherwise indicated, information contained in this presentation concerning our industry, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third - party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data, and our experience in, and knowledge of, such industry and markets, which we believe to be reasonable . In addition, projections, assumptions and estimates of the future performance of the industry in which we operate, and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, which could cause results to differ materially from those expressed in the estimates made by the independent parties and by us . This presentation shall not constitute an offer to sell or the solicitation of an offer to buy our securities . FORWARD LOOKING STATEMENTS
3 Investment Highlights TIVIC HEALTH: FOUNDED 2016 32,000 Units Sold 2 FDA Clearances + CE Mark Over 2 3 5 18 500 + IPO PEER - REVIEWED PUBLICATIONS REGULATORY CLEARANCES ISSUED PATENTS PATENTS PENDING 4 - AND 5 - STAR PRODUCT REVIEWS NOVEMBER 2021 Growth company in the emerging area of noninvasive bioelectronic medicine Strong science backing FDA Approved / CE marked, award - winning product for sinus pain, pressure & congestion Extensible platform with potential applications in migraine and other indications ClearUP is the first commercial product, demonstrated management's scientific and commercial capabilities, delivering product from founding to launch in 3 years Direct consumer engagement accelerating sales traction Non - invasive bioelectronic platform offers effective therapeutic solutions with high safety profile, low - risk, and broad application 153% Year - over - year DTC unit growth
4 THE BIG IDEA The body is an electro chemical system. Electrons can be used as medicine. Bioelectronic medicine treats disease by tuning the electrical signals carried along the neural (nerve) pathways. 4 Bioelectronic medicine “represents a multi - billion - dollar opportunity, … [and has the] potential to become a pillar of medical treatment.” Bioelectronics ‘jump - start the next wave of device therapeutics. October 2019
5 Moving from implants to non - invasive 1960s Pacemakers 2010s Sleep Apnea, Rheumatoid Arthritis 1990s Deep Brain, Spinal Cord 2020s Non - Invasive Bioelectronics • Bioelectronics historically required implanted, invasive technology • Tivic Health has delivered non - invasive ways to tune neural signals • Non - invasive = Shorter development time, lower risk, broader applicability INVASIVE NON - INVASIVE BIOELECTRONICS TRAJECTORY
6 TIVIC HEALTH’S FIRST PLATFORM FOR Non - invasive 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 treatment zones, personalize therapeutic stimulation
7 K182025 CE 704687 DEN200006 ISSUED PATENTS almost 100 claims 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 Medicine Double - blind, sham - controlled, randomized trial. Reductions in pain and congestion vs. sham 10 minutes after treatment. Published: International Forum of Allergy & Rhinology ROBUST FOUNDATIONS
8 PRODUCT & 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 orldwide Approved product in market PRODUCT / PRODUCT LINE THERAPEUTIC AREA DISCOVERY /R&D CLINICAL FEASIBILITY PIVOTAL STUDY REGULATORY CLEARANCE COMMERCIAL DISTRIBUTION CONTENT PARTNERS ClearUP Ʀ Sinus Pain and Congestion npdPP Post - Operative Pain npdMI Migraine Sinus Pain and Congestion (ClearUP) $8B estimated US market, global opportunity (1) Extensible platform (1) Market research study of 600 people with recurring sinus conditions. Company - sponsored research conducted by Research America. PIPELINE
9 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, winner of numerous innovation awards • Available through Tier 1 online retailers, average 4+ star ratings • $149 list price (scheduled price increase to $169 in September) FIRST COMMERCIAL PRODUCT IN MARKET Featured on … … and more “ Changed my life! “Unbelievable” “Godsend” “Amazing!”
10 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 2 200M US adults experience at least monthly. 1 27% would consider purchase @ $149. 2 = $8.0B US Market 2 Large Markets, Significant Growth Opportunity MARKET SIZE CE Mark Secured for International Growth Sinus Pain, Pressure & Congestion from any cause Global problem. Future growth opportunity secured by existing regulatory clearance. ClearUP is indicated for use for temporary relief of sinus pain from allergic rhinitis (US FDA), for temporary relief of moderate to severe congestion (US FDA), and for temporary relief of sinus pain, pressure and congestion (CE Mark). (1) Data from publicly available information that has not been independently verified by the Company. (2) Market research study of 600 people with recurring sinus conditions. Company sponsored research conducted by Research America .
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 / impractical • Not portable • $706M US market OTC Drugs Dominate Sinus Care … but 90% of sufferers interested in treatments that decrease use of drugs 1 (1) Market research study of 600 people with recurring sinus conditions. Company - sponsored research conducted by Research America. COMPETITIVE LANDSCAPE Intranasal Steroids • Powerful drug • Burning, stinging, nose bleeds, headache, nausea, vomiting, diarrhea, sore throat, dizziness, cough
12 82% preferred ClearUP to existing 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 clinical studies and post - market surveillance. (1) Data from a 71 - person double - blind, randomized, controlled clinical study conducted by Stanford Medicine.
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. Reduction in pain and congestion, 10 - minutes after first use. #p = 0.007; *p = 0.008; two - tailed unpaired t - test comparing Sham vs. ClearUP RESULTS PUBLISHED IN CLINICAL: PEER - REVIEWED PUBLICATION Runner - Up Best Clinical Manuscript Effective for 74% of users 10 minutes after use Clinically meaningful reduction in pain and congestion 10 minutes after 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 comparing pre - treatment vs. post - treatment Continued improvement with regular use CLINICAL: PEER - REVIEWED PUBLICATION 4 - week open - label study showed continued reduction in pain and congestion with daily use; also showed durable effect , relief present at 6 hours after treatment. Continued week - over - week reduction in symptoms ▼ 43.3% Reduction in Pain ▼ 44.3% Reduction in Congestion RESULTS PUBLISHED IN Effective for 88% of users after 4 weeks of use
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 activation mediates pain CLINICAL: MECHANISM OF ACTION Pain Low - level current applied to sensory trigeminal nerves markedly reduces pain 1 2 . Mandel, Yossi, et al . "Vasoconstriction by electrical stimulation : new approach to control of non - compressible hemorrhage . " Scientific reports 3 . 1 ( 2013 ) : 1 - 7 . 3 . Franco, O . S . , et al . “Effects of different frequencies of transcutaneous electrical nerve stimulation on venous vascular reactivity . ” Brazilian Journal of Medical and Biological Research 47 . 5 ( 2014 ) : 411 - 418 . 4 . Malm, L . “Stimulation of sympathetic nerve fibres to the nose in cats . ” Acta otolaryngologica 75 . 2 - 6 ( 1973 ) ; 519 - 526 . 5 . Fischer, Laurent, et al . “Adrenergic and non - adrenergic vasoconstrictor mechanisms in the human nasal mucosa . ” Rhinology 31 . 1 ( 1993 ) : 11 - 15 . Congestion Activation of sympathetic nerve fibers promotes rapid release of norepinephrine and vasoconstriction. 2 - 4 Vasoconstriction reduces swelling, increases air flow, and decreases congestion. 5 The mechanism described has been reviewed by the FDA in conjunction with FDA Clearances. The exact mechanism of action for ClearUP has not been definitively proven. Sympathetic nerve activation relieves congestion. Trigeminal nerve activation mediates pain Sympathetic nerve activation relieves congestion.
16 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 AWARENESS Digital, cable, and CTV video advertising, social media, SEO, content marketing Currently available at … and others Buy Now • Proven model in consumer marketing • Focus for 2022 scaling • Consumer engagement part of our DNA • Contributes to success of both OTC and potential prescription products
17 2023+: Additional Channel Growth Opportunity 2022: Optimize and scale highest margin channels MARKET DEVELOPMENT Early Traction Expedited Development Sept 2016 – Sept 2019 2020 - 2021 2022+ • Optimizing website and D2C channels • Scaling - up advertising to drive sales, capture market share • Expanding social media, content marketing x Tier 1 sales relationships in place x Over 23,000 units sold x 500+ 4 - and 5 - star ratings x 3 years from founding to product sales of FDA - cleared medical device Early traction shows high - growth opportunities in D2C 2023+ 74% of target customers expect to purchase on - line, 65% from manufacturer’s website 1 o Healthcare professional (HCP) referrals o In - store o International (1) Market research study of 600 people with recurring sinus conditions. Company sponsored research conducted by Research America .
18 FINANCIALS Operating results • ClearUP revenue increased 62% year over year primarily due to 36% increase in unit sales • Variable cost of sales increased 44% year over year primarily due to increase in unit sales and increased shipping, fulfillment and transactional costs • Fixed cost of sales decreased 33% primarily due to increase in unit sales and refinement of manufacturing and distribution processes Six Months Ended June 30, ($ in thousands) 2022 2021 Revenues $ 956 $ 591 Direct to consumer 905 357 Retail 170 286 Returns & Warranty Reserves (119) (52) Cost of Sales 760 602 Variable 667 463 Fixed 93 139 Gross Profit (Loss) 196 (11) Net loss $ (5,258) $ (2,450)
19 Common Stock as of July 28, 2022 9,677,734 Options and warrants 1,557,780 Fully Diluted Shares 11,235,514 Single class of shares FINANCIALS • $9.0M cash at the end of Q2 2022 • No debt • IPO in November 2021 to broaden investor reach, build consumer engagement and sales infrastructure and broaden product pipeline
20 2022 Directions INVESTING FOR GROWTH Broaden ClearUP market penetration • Upgrade ecommerce infrastructure, online website design and branding • Optimize and expand advertising and public relations • Increase support for social media and digital Improve ClearUP gross margin • Increase % of sales through direct channels • Launch second generation with improved cost structure, lower cost manufacturing • Higher volume absorbing fixed & allocated costs Expand product pipeline • Clinical research to validate migraine and post - operative pain management opportunities • Evaluation of potential merger, acquisition & licensing opportunities Build Tivic as trusted brand for non - invasive bioelectronic medicine
21 Experienced, Execution - oriented Leadership 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 Scientific Officer, Ph.D. Neuroscientist, Asst. Prof. of Medicine, UCSF. Pfizer, EMD Serono. Named to 40 under 40, Silicon Valley Business Journal. Four prior neuromodulation products. Veronica Cai Chief Financial Officer, CPA 25 years broad - based public and private company finance and accounting leadership for high - growth medical and life science companies. Prior experience at RefleXion Medical, Catalyst Bioscience, Zogenix . Previously served at Ernst & Young and at the PCAOB. Ryan Sabia Chief Operations Officer Global sales, marketing, and operations for omnichannel and ecommerce growth companies. Background in both health and consumer products. 2021 Female Founders 100 Top 25 Women in Consumer Healthtech.
22 Experienced Board of Directors Dean Zikria Global Strategy, J&J, Pfizer, Allergy/Asthma Chief Commercial Officer, Intuity Medical. Commercial leadership Pfizer, J&J. Healthcare Strategy at Accenture, Deloitte. Growth leadership in Asthma & Allergy. MBA, Rutgers. BS, Biology, Rutgers. Karen Drexler Public Board Member, Compensation Chair, Nominating & Governance Chair Board of ResMed (NYSE: RSMD), OutSet Medical (NASDAQ: OM) and VIDA Diagnostics. Sale of companies to Roche, J&J. MBA, Stanford; BSE Princeton University. Sheryle Bolton Hult Faculty, Board Chair, Audit Committee Chair Experienced public company CEO. International Board Member and serial entrepreneur. Prior leadership of successful neuroscience IPO. Merrill Lynch Capital Markets. MBA, Harvard Business School. INDEPENDENT DIRECTORS
23 Summary TIVIC HEALTH FDA - cleared product in high - growth sector. Established Tier 1 channels growing. Large available market. Clinical validation with leading institutions, peer - reviewed publications. Regulatory clearances for both US and international sales. Robust IP portfolio, recently issued patents. Extensible platform with multiple product opportunities. Growth strategy built for 21 st century. Experienced leadership , with public company growth experience.
24 24 Jennifer Ernst CEO, Tivic Health jennifer.ernst@tivichealth.com