Brickell Biotech Reports Second Quarter 2020 Financial Results and Provides Corporate Update
Brickell Biotech reported significant progress in developing sofpironium bromide for primary axillary hyperhidrosis. Key highlights include positive Phase 3 results in Japan and plans to initiate U.S. pivotal studies in Q4 2020. Financial results for Q2 2020 showed cash and equivalents at $21.6 million, down from $2.6 million in revenue a year prior. Research expenses fell to $2.7 million, but the net loss increased to $5.1 million. The company also confirmed Kaken is expected to receive regulatory approval in Japan by Q4 2020.
- Completed Phase 3 long-term safety study with no serious adverse events.
- Positive Phase 3 pivotal study results in Japan with all endpoints achieved.
- Plans to initiate U.S. Phase 3 program for sofpironium bromide gel in Q4 2020.
- Raised $18.7 million through equity offering for R&D and operational costs.
- Revenue decreased to $0.6 million from $2.6 million year-over-year.
- Net loss increased to $5.1 million in Q2 2020 compared to $3.7 million in Q2 2019.
- General and administrative expenses rose to $3.0 million, driven by increased professional fees.
Positive data from the Sofpironium Bromide Phase 3 pivotal study in Japan presented in Q2 2020 by development partner, Kaken
Kaken to receive regulatory decision in Japan for sofpironium bromide gel as early as the fourth quarter of 2020
Brickell plans to initiate its U.S. pivotal Phase 3 program in the fourth quarter of 2020
BOULDER, Colo., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced financial results for the second quarter ended June 30, 2020 and provided a corporate update.
“We announced several milestones during the first half of 2020 that strengthened our ability to execute our strategy to develop sofpironium bromide as a treatment for primary axillary hyperhidrosis in the U.S. and in Japan. Most notable are the successful completion of our U.S. Phase 3 long-term safety study, the positive Phase 3 pivotal study results in Japan for sofpironium bromide presented in June by our Japanese development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”), and an equity financing for net proceeds of
Business and Recent Developments
- In July 2020, Brickell completed the analysis of its 12-month Phase 3 open-label long-term safety study, in 300 subjects 9 years and older with primary axillary hyperhidrosis, sofpironium bromide gel,
5% and15% . The study results confirmed that sofpironium bromide gel, at both concentrations, was safe and generally well tolerated, which was consistent with the earlier Phase 2 clinical trial results. No treatment-related serious adverse events were observed. Brickell expects to release additional details at an upcoming scientific forum.
- In June 2020, Brickell announced positive Phase 3 pivotal study results in Japan from Kaken. All primary and secondary efficacy endpoints of the study were achieved and sofpironium bromide was safe and generally well tolerated. The study evaluated a total of 281 Japanese patients randomized 1:1 to apply sofpironium bromide gel,
5% (SB) or vehicle gel (placebo) to the axillae (i.e., underarm) for 42 days. These study results were presented as part of the Late-Breaking Research Program during the American Academy of Dermatology (AAD) Virtual Meeting Experience. - In January 2020, Kaken announced submission of a new drug application in Japan requesting approval to manufacture and market sofpironium bromide gel,
5% for primary axillary hyperhidrosis based on the positive Phase 3 data. - In June 2020, Brickell completed an equity offering resulting in net proceeds of approximately
$18.7 million . The Company anticipates using the proceeds from the offering for research and development, including clinical trials, working capital, and general corporate purposes.
Upcoming Milestones
- Plan to initiate the U.S. Phase 3 pivotal program for sofpironium bromide gel,
15% in the fourth quarter of 2020. The planned program will be comprised of two pivotal Phase 3 trials to evaluate approximately 350 subjects per trial with primary axillary hyperhidrosis in the U.S. The first Phase 3 study is expected to begin in the fourth quarter of 2020. - Expect Kaken to receive regulatory decision for sofpironium bromide gel,
5% in Japan, as early as the fourth quarter of 2020. Under the agreement with Kaken, Brickell is entitled to receive commercial milestone payments, as well as tiered royalties based on a percentage of net sales of sofpironium bromide in Japan.
Financial Results
The Company reported cash and cash equivalents and marketable securities of
Revenue was
Research and development expenses were
General and administrative expenses were
Total other income, net was
Brickell’s net loss was
Conference Call and Webcast Information
Brickell’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13706625. A live webcast of the conference call can be accessed through the “Investors” tab on the Brickell Biotech website at http://www.brickellbio.com. A replay will be available on this website shortly after conclusion of the event for 90 days.
About Sofpironium Bromide
Sofpironium bromide is a proprietary new molecular entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action topically and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. This proposed mechanism of action may allow for highly effective doses to be used while limiting systemic side effects. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida. Sofpironium bromide is not approved for use in any country at this time.
About Hyperhidrosis
Hyperhidrosis is a life-altering medical condition where a person sweats more than the body requires to regulate its temperature. More than 15 million people, or
About Brickell
Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell’s pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell’s strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit http://www.brickellbio.com.
Cautionary Note Regarding Forward-Looking Statements
Any statements made in this press release relating to future financial, business and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, the anticipated timing, scope, design and/or results of future clinical trials, the expected timing and/or results of regulatory approvals and prospects for commercializing any of Brickell’s product candidates, including in Japan, the United States or any other country, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Brickell, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, ability to obtain adequate financing to advance product development (including the U.S. Phase 3 pivotal program for sofpironium bromide), potential delays for any reason in product development, regulatory changes, unanticipated demands on cash resources, any disruption to its business caused by the current COVID-19 pandemic, interruptions, delays or negative determinations on Kaken’s new drug application under review, and other risks associated with developing, and obtaining regulatory approval for and commercializing novel therapeutics.
Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell’s filings with the United States Securities and Exchange Commission (SEC), which are available at http://www.sec.gov (or at http://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.
1Doolittle et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 2016; 308: 743-749.
2 Fujimoto et al. Epidemiological study and considerations of focal hyperhidrosis in Japan. J Dermatol 2013; 40: 886-90.
Brickell Investor Contact:
Dan Ferry
LifeSci Advisors
(617) 430-7576
daniel@lifesciadvisors.com
Brickell Biotech, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||||
| Collaboration revenue | $ | 607 | $ | 2,573 | $ | 1,653 | $ | 6,065 | |||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 2,712 | 4,229 | 5,376 | 10,248 | |||||||||||||||
| General and administrative | 3,021 | 1,323 | 5,502 | 3,389 | |||||||||||||||
| Total operating expenses | 5,733 | 5,552 | 10,878 | 13,637 | |||||||||||||||
| Loss from operations | (5,126 | ) | (2,979 | ) | (9,225 | ) | (7,572 | ) | |||||||||||
| Investment and other income, net | 7 | 4 | 3 | 10 | |||||||||||||||
| Interest expense | — | (660 | ) | — | (884 | ) | |||||||||||||
| Change in fair value of derivative liability | — | (11 | ) | — | (11 | ) | |||||||||||||
| Change in fair value of warrant liability | — | (8 | ) | — | 223 | ||||||||||||||
| Net loss | (5,119 | ) | (3,654 | ) | (9,222 | ) | (8,234 | ) | |||||||||||
| Reduction (accretion) of redeemable convertible preferred stock to redemption value | — | (163 | ) | — | 10,356 | ||||||||||||||
| Net income (loss) attributable to common stockholders | $ | (5,119 | ) | $ | (3,817 | ) | $ | (9,222 | ) | $ | 2,122 | ||||||||
| Net income (loss) per common share attributable to common stockholders, basic | $ | (0.43 | ) | $ | (6.48 | ) | $ | (0.87 | ) | $ | 3.60 | ||||||||
| Net loss per common share attributable to common stockholders, diluted | $ | (0.43 | ) | $ | (6.48 | ) | $ | (0.87 | ) | $ | (4.46 | ) | |||||||
| Weighted-average shares used to compute net income (loss) per share attributable to common stockholders, basic | 11,819,152 | 589,001 | 10,595,960 | 589,001 | |||||||||||||||
| Weighted-average shares used to compute net loss per share attributable to common stockholders, diluted | 11,819,152 | 589,001 | 10,595,960 | 1,845,467 | |||||||||||||||
Brickell Biotech, Inc.
Selected Financial Information
Condensed Consolidated Balance Sheet Data
(amounts in thousands)
(unaudited)
| June 30, 2020 | December 31, 2019 | ||||||
| Cash and cash equivalents | $ | 21,570 | $ | 7,232 | |||
| Marketable securities, available-for-sale | — | 4,497 | |||||
| Prepaid expenses and other current assets | 5,736 | 6,240 | |||||
| Total assets | 27,430 | 18,144 | |||||
| Total liabilities | 7,520 | 10,570 | |||||
| Total stockholders’ equity | 19,910 | 7,574 | |||||
FAQ
What are Brickell Biotech's Q2 2020 financial results?
When will Brickell Biotech initiate its U.S. Phase 3 study for sofpironium bromide?
What were the results of the Phase 3 study for sofpironium bromide in Japan?
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What strategic partnerships does Brickell Biotech have?
