Brickell Biotech, Inc. (BBI) Q1 2021 Earnings Conference Call May 13, 2021 4:30 PM ET Company Participants Garth Russell - Investor Relations, LifeSci Advisors Robert Brown - Chief Executive Officer Deepak Chadha - Chief R&D Officer Bert Marchio - Chief Financial Officer Conference Call Participants Leland Gershell - Oppenheimer & Company Operator Greetings, and welcome to the Brickell Biotech Inc. First Quarter 2021 Financial Results Call. At this time, all participants are in a listen-only mode. A questio ...

[Forward-Looking Statements](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) The report includes forward-looking statements about future financial performance and clinical development, subject to significant risks and uncertainties - The report contains forward-looking statements regarding future financial performance, clinical trials, and commercialization, subject to significant risks detailed in the Risk Factors section[8](index=8&type=chunk)[9](index=9&type=chunk) [Risk Factors Summary](index=4&type=section&id=RISK%20FACTORS%20SUMMARY) The company's business relies on sofpironium bromide's success, facing risks from clinical trials, competition, third-party reliance, financing, and COVID-19 - The company's business is highly dependent on the successful development, regulatory approval, and commercialization of its lead product candidate, **sofpironium bromide**[14](index=14&type=chunk) - Key risks include challenges in **Phase 3 trials**, potential side effects, competition, reliance on partners, and the need for **additional financing**[14](index=14&type=chunk) - The **COVID-19 pandemic** poses a significant risk to financial condition, operations, and clinical trials[15](index=15&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements and management's discussion of its financial condition and operations [Financial Statements (Unaudited)](index=6&type=section&id=ITEM%201.%20Financial%20Statements%20(Unaudited)) Q1 2021 saw decreased revenue and increased net loss due to higher R&D expenses, while cash improved from financing activities Condensed Consolidated Balance Sheet Data (in thousands) | Metric | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $34,781 | $30,115 | | Total current assets | $38,778 | $33,604 | | Total assets | $38,851 | $33,634 | | Total current liabilities | $9,381 | $6,353 | | Total liabilities | $9,707 | $6,499 | | Total stockholders' equity | $29,144 | $27,135 | Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Total revenue | $17 | $1,046 | | Research and development | $6,052 | $2,664 | | General and administrative | $2,967 | $2,481 | | Loss from operations | $(9,002) | $(4,099) | | Net loss | $(9,005) | $(4,103) | | Net loss per share | $(0.15) | $(0.45) | Condensed Consolidated Statements of Cash Flows (in thousands) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,891) | $(6,610) | | Net cash provided by (used in) investing activities | $(40) | $4,500 | | Net cash provided by financing activities | $10,597 | $2,005 | | Net increase (decrease) in cash | $4,666 | $(105) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company advances sofpironium bromide through Phase 3 trials; Q1 2021 revenue decreased, R&D expenses rose, and current cash is sufficient for the next 12 months [Our Clinical Programs](index=23&type=section&id=Our%20Clinical%20Programs) Brickell conducts two U.S. Phase 3 studies for sofpironium bromide, with topline results expected in Q4 2021, and Kaken launched the product in Japan in November 2020 - The company initiated two U.S. pivotal **Phase 3 clinical trials** (Cardigan I and Cardigan II) for sofpironium bromide gel, 15% in late 2020[87](index=87&type=chunk)[88](index=88&type=chunk) - **Topline results** from the Cardigan studies are expected in **Q4 2021**, intended to support a U.S. New Drug Application (NDA) submission in 2022[89](index=89&type=chunk) - In Japan, partner Kaken received regulatory approval for sofpironium bromide gel, 5% (brand name **ECCLOCK®**) in September 2020 and launched commercial sales in **November 2020**[95](index=95&type=chunk)[97](index=97&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Q1 2021 revenue decreased by **$1.0 million**, R&D expenses rose by **$3.4 million**, resulting in a **$9.0 million** net loss, more than double Q1 2020 Comparison of Operations (in thousands) | Metric | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Revenue | $17 | $1,046 | | Research and development expenses | $(6,052) | $(2,664) | | General and administrative expenses | $(2,967) | $(2,481) | | Net loss | $(9,005) | $(4,103) | - The decrease in revenue was primarily because a **$15.6 million R&D payment** from Kaken was fully accounted for by Q3 2020, with Q1 2021 revenue consisting of initial royalties from Kaken's sales in Japan[128](index=128&type=chunk) - The **$3.4 million increase in R&D expenses** was mainly due to increased clinical costs associated with the Phase 3 Cardigan studies, which began in Q4 2020[129](index=129&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2021, the company held **$34.8 million** in cash, sufficient for 12 months, with **$10.6 million** net cash from Q1 2021 financing activities - The company had cash and cash equivalents of **$34.8 million** as of March 31, 2021[131](index=131&type=chunk) - Management believes that current cash and cash equivalents are sufficient to fund operations for at least the **next 12 months** from the report's issuance date[132](index=132&type=chunk) - Net cash provided by financing activities increased to **$10.6 million** in Q1 2021 from **$2.0 million** in Q1 2020, mainly due to higher proceeds from the exercise of warrants[137](index=137&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Brickell Biotech is exempt from providing disclosures about market risk - The company is a smaller reporting company and is not required to provide disclosures about market risk[138](index=138&type=chunk) [Controls and Procedures](index=32&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2021, with no significant changes in internal control over financial reporting - Disclosure controls and procedures were effective as of **March 31, 2021**, based on evaluation by the principal executive and financial officers[141](index=141&type=chunk) - No significant changes in internal control over financial reporting occurred during the three months ended **March 31, 2021**[142](index=142&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides other information, including legal proceedings, risk factors, equity securities, and exhibits [Legal Proceedings](index=34&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings that would adversely affect its business - As of the filing date, the company is not a party to any material legal proceedings[145](index=145&type=chunk) [Risk Factors](index=34&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces substantial risks, primarily its dependence on sofpironium bromide's success, covering business operations, financial stability, regulatory, strategic, third-party, and IP challenges [Risks Related to Business Operations](index=34&type=section&id=Risks%20Related%20to%20Business%20Operations) Business operations risks include heavy reliance on sofpironium bromide's success, clinical trial failures, side effects, competition, partner dependence, and COVID-19 impacts - The company's business is highly dependent on the successful financing, clinical development, regulatory approval, and commercialization of its lead asset, **sofpironium bromide**[147](index=147&type=chunk) - The **COVID-19 pandemic** could delay or interrupt clinical trials, participant recruitment, manufacturing, and regulatory review[172](index=172&type=chunk)[173](index=173&type=chunk) - Sofpironium bromide, if approved, will face significant competition from existing treatments like **OTC antiperspirants**, **BOTOX®**, and **Qbrexza®**[177](index=177&type=chunk)[178](index=178&type=chunk) [Risks Related to Liquidity, Financial Matters and Common Stock](index=45&type=section&id=Risks%20Related%20to%20Our%20Liquidity,%20Financial%20Matters%20and%20Our%20Common%20Stock) Financial risks include the critical need for **additional capital**, high **stock price volatility**, potential **illiquidity**, and **Nasdaq delisting** risk if minimum bid price requirements are not met - The company will need to raise substantial **additional financing** to fund operations and the NDA submission for sofpironium bromide, which may not be available on favorable terms[195](index=195&type=chunk) - The company's stock price has been and may continue to be highly **volatile**, facing a risk of **delisting from Nasdaq** if it fails to meet continued listing requirements[200](index=200&type=chunk)[209](index=209&type=chunk) - The exercise of outstanding stock options and warrants will **dilute** the ownership of existing stockholders[206](index=206&type=chunk) [Risks Related to Legal, Regulatory, and Compliance Matters](index=50&type=section&id=Risks%20Related%20to%20Legal,%20Regulatory,%20and%20Compliance%20Matters) Regulatory risks include the possibility of failing to obtain U.S. approval, extensive post-approval review, product liability lawsuits, and compliance with complex healthcare laws - The company may never obtain U.S. regulatory approval for its product candidates and will be subject to extensive and continued regulatory review and compliance obligations post-approval[213](index=213&type=chunk) - The company faces inherent risk of **product liability claims** from clinical testing and potential commercialization, with potentially inadequate insurance coverage[220](index=220&type=chunk) - The company is subject to strict healthcare laws (e.g., **Anti-Kickback Statute**, **False Claims Act**), with non-compliance potentially leading to significant penalties and exclusion from federal healthcare programs[231](index=231&type=chunk) [Risks Related to Strategic Matters](index=56&type=section&id=Risks%20Related%20to%20Strategic%20Matters) The strategy to in-license or acquire additional product candidates carries risks of high cost, management distraction, and potential failure due to competition and development - The strategy to in-license and acquire additional product candidates could impact liquidity, increase expenses, and distract management[234](index=234&type=chunk) - Failure to successfully in-license, acquire, and develop additional product candidates would impair the company's ability to grow[235](index=235&type=chunk) [Risks Related to Dependence on Third Parties](index=57&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) The company's complete reliance on third-party contractors for manufacturing and distribution creates risks in quality control, capacity, pricing, and supply chain stability - The company relies completely on **third-party contractors** for manufacturing and distribution of clinical drug supplies, including sole-source suppliers[243](index=243&type=chunk) - Manufacturing and supply are complex and technically challenging, with potential for failure in **quality control**, scaling up, and distribution[249](index=249&type=chunk) [Risks Related to Intellectual Property](index=60&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Intellectual property risks include challenges in obtaining, maintaining, and enforcing patent rights for sofpironium bromide globally, with potential for invalidation or limited lifespan - The company's success depends on its ability to obtain, maintain, and enforce patent and other intellectual property protections for **sofpironium bromide**[252](index=252&type=chunk) - Protecting intellectual property rights throughout the world is difficult, as laws and enforcement vary significantly by country[260](index=260&type=chunk) - The company could lose important license rights if it fails to comply with its obligations under intellectual property license agreements[266](index=266&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=65&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported by the company during the period - None reported[277](index=277&type=chunk) [Defaults Upon Senior Securities](index=65&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company - Not applicable[278](index=278&type=chunk) [Mine Safety Disclosures](index=65&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[279](index=279&type=chunk) [Other Information](index=65&type=section&id=ITEM%205.%20Other%20Information) No other information was reported by the company - None reported[280](index=280&type=chunk) [Exhibits](index=65&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents, agreements, and officer certifications

Company & Product Overview - Brickell Biotech's sofpironium bromide (SB) is a novel topical treatment for primary axillary hyperhidrosis, currently in Phase 3 clinical trials in the U S [5] - SB gel, 5% (ECCLOCK®) is approved and commercially launched in Japan by Kaken Pharmaceutical for primary axillary hyperhidrosis [5] - The company estimates a large market opportunity of over 15 million people in the U S alone suffering from hyperhidrosis [5, 9] - In Japan, the estimated market opportunity represents approximately 12.7% of the population [5, 8] Clinical Trial Results & Development - U S Phase 2b study showed statistically significant response for SB gel, 15% in Gravimetric Sweat Production (GSP) change from baseline [16] - All doses in the U S Phase 2b study demonstrated statistically significant responses for HDSM-Ax improvement [16] - In the U S Phase 2b study, subjects reporting at least one adverse event ranged from 15.8% in the vehicle group to 51.9% in the SB 15% group [18] - Kaken's Japan Phase 3 study achieved statistically significant results for primary and secondary efficacy endpoints with SB gel, 5% [25] Market & Therapeutic Context - Hyperhidrosis affects 8.8% of individuals aged 18-39 and 17.1% of those aged 12-17 in the U S [11] - Approximately 51% of U S hyperhidrosis sufferers have consulted a healthcare professional, with about 23% currently receiving treatment [11]

Brickell Biotech, Inc. (BBI) Q4 2020 Earnings Conference Call March 9, 2021 4:30 PM ET Company Participants Dan Ferry - Investor Relations, LifeSci Advisors Robert Brown - Chief Executive Officer Deepak Chadha - Chief R&D Officer Bert Marchio - Chief Financial Officer Andy Sklawer - COO Conference Call Participants Thomas Flaten - Lake Street Capital Markets Leland Gershell - Oppenheimer Operator Greeting. And welcome to the Brickell Biotech Inc. Fourth Quarter and Full Year 2020 Financial Results Call. At ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-21088 BRICKELL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 93-0948554 (State or other jurisdiction of incorpo ...

♡ BrickellBio ©2020 Brickell Biotech, Inc. All rights reserved 1 NASDAQ: BBI Company Overview Presentation Making Fresh Tracks in Dermatology® December 2020 Forward-Looking Statements Ø This presentation contains forward-looking statements that involve substantial risk and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation other than statements of historical fact, including statements regarding our str ...

Brickell Biotech, Inc. (BBI) Q3 2020 Earnings Conference Call November 12, 2020 4:30 PM ET Company Participants Dan Ferry - Investor Relations, LifeSci Advisors Robert Brown - Chief Executive Officer Deepak Chadha - Chief R&D Officer Michael Carruthers - Chief Financial Officer Conference Call Participants Thomas Flaten - Lake Street Capital Markets Trevor Howard - Oppenheimer Operator Greeting. And welcome to the Brickell Biotech Inc. Third Quarter 2020 Financial Results Call. At this time, all participant ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 5777 Central Avenue, Boulder, CO 80301 (Address of principal executive offices) (Zip Code) (720) 505-4755 (Registrant's telephone number, including are ...

♡ BrickellBio Corporate Presentation, © 2020 1 NASDAQ: BBI Company Overview Presentation Making Fresh Tracks in Dermatology® August 2020 Forward-Looking Statements Ø This presentation contains forward-looking statements that involve substantial risk and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation other than statements of historical fact, including statements regarding our strategy, future operat ...

Financial Data and Key Metrics Changes - As of June 30, 2020, the company reported $21.6 million in cash, cash equivalents, and marketable securities, having used $4.7 million in cash during Q2 2020 [31] - The net loss for Q2 2020 was $5.1 million, compared to $3.7 million for Q2 2019, attributed to decreased revenue and a $1 million accrual for future milestone payments [32][33] - Revenue recognized in Q2 2020 was $600,000, down from $2.6 million in the same period in 2019, primarily due to the conclusion of prior clinical studies [33][35] - R&D expenses totaled $2.7 million in Q2 2020, down from $4.2 million in Q2 2019, reflecting the completion of earlier studies [36] - G&A expenses increased to $3 million in Q2 2020 from $1.3 million in Q2 2019, mainly due to higher public company operating costs [37] Business Line Data and Key Metrics Changes - The company achieved several milestones for its lead asset, sofpironium bromide, including the completion of a 12-month Phase III open label safety study in the US and positive Phase III results from its partner Kaken Pharmaceuticals in Japan [9][10] - The Phase III pivotal study in Japan met all primary and secondary efficacy endpoints, demonstrating significant improvements in hyperhidrosis symptoms [15][16] Market Data and Key Metrics Changes - Kaken Pharmaceuticals is expected to receive a regulatory decision on their NDA for sofpironium bromide gel 5% in Japan as early as Q4 2020, with Brickell entitled to milestone payments and royalties from sales [23][24] Company Strategy and Development Direction - The company plans to initiate a Phase III pivotal program for sofpironium bromide in the US in Q4 2020, consisting of two trials with approximately 350 subjects each [25][26] - The strategy includes focusing on the safety and efficacy of a 15% concentration of sofpironium bromide gel [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to conduct the upcoming studies despite potential COVID-19 impacts, citing the short duration of patient engagement in the studies [51][53] - There is cautious optimism regarding Kaken's regulatory interactions in Japan, with expectations for a typical 12-month approval timeline [56] Other Important Information - The company completed a public offering in June 2020, raising net proceeds of $18.7 million to support the advancement of its clinical programs [28] Q&A Session Summary Question: What does a 2-point reduction on the primary endpoint mean for patients? - A 2-point shift on the HDSM-Ax scale indicates a move from severe to mild or moderate hyperhidrosis, significantly improving quality of life for patients [40][42] Question: How does the PRO scale compare to Qbrexza? - The HDSM-Ax scale is a multi-domain 5-point scale requiring a 2-point shift, while Qbrexza uses an 11-point scale requiring a 4-point shift, indicating different measurement approaches [45] Question: How dependent is the study initiation on COVID-19? - The timeline is somewhat dependent on COVID-19, but there is confidence in the ability to start the study due to the short duration and geographic variance of study sites [51][53] Question: Is the second study initiation gated by enrollment pace in the first study? - The focus is currently on starting the first study, with no guidance provided on the second study's initiation at this time [54] Question: How is Kaken's regulatory dialogue with authorities? - Kaken has had regular interactions with regulatory authorities in Japan, and the process appears to be proceeding according to plan [56]