SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 8, 2018
Sienna Biopharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
30699 Russell Ranch Road, Suite 140
Westlake Village, CA 91362
(Address of principal executive offices, including Zip Code)
Registrants telephone number, including area code: (818) 629-2256
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))
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 ☒
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.
On November 8, 2018, Sienna Biopharmaceuticals, Inc. (the Company) announced its financial results for the third quarter ended September 30, 2018. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K, including the attached Exhibit 99.1, is being furnished and shall not be deemed to be filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
|99.1||Press Release dated November 8, 2018.|
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: November 8, 2018||Sienna Biopharmaceuticals, Inc.|
|By:||/s/ Timothy K. Andrews|
|Name:||Timothy K. Andrews|
|Title:||General Counsel and Secretary|
Sienna Biopharmaceuticals® Reports Third Quarter 2018 Financial Results
WESTLAKE VILLAGE, Calif., Nov. 8, 2018 Sienna Biopharmaceuticals, Inc. (NASDAQ:SNNA), a clinical-stage medical dermatology and aesthetics company, today reported the Companys financial results for the third quarter of 2018.
We are pleased to report the results of our third quarter, said Frederick C. Beddingfield III, MD, PhD, President and Chief Executive Officer of Sienna Biopharmaceuticals®. August 1 marked the completion of Siennas first full year as a public company, and we continue to execute on our plans to bring innovative topical therapies to dermatology and aesthetics practitioners and their patients. Our team is excited, optimistic and focused, working toward clinical data this quarter from our Phase 2b trial with SNA-120 (pegcantratinib) in pruritus associated with psoriasis, as well as our Phase 1/2 exploratory trial with SNA-125 in atopic dermatitis and the first of our pivotal trials with SNA-001 for the reduction of unwanted light-pigmented hair.
Siennas pipeline currently includes multiple clinical-stage programs:
(from the Companys Topical by Design platform)
SNA-120 for the treatment of pruritus associated with psoriasis and the underlying psoriasis; Phase 2b top-line results expected in the fourth quarter of 2018
SNA-125 for the treatment of atopic dermatitis; Phase 1/2 results expected in the fourth quarter of 2018
SNA-125 for the treatment of psoriasis; continued progression to Phase 2
(from the Companys Topical Photoparticle Therapy platform)
SNA-001 for the reduction of light-pigmented hair
pivotal results with the 1064 nm wavelength laser expected in the fourth quarter of 2018
pivotal results with the 810 nm and with the 755 nm wavelength lasers expected in the first quarter of 2019
Selected Financial Results
Total operating expenses for the three months ended Sept. 30, 2018, were approximately $16.6 million, which includes research and development (R&D) expenses totaling approximately $12.1 million and general and administrative (G&A) expenses totaling approximately $4.4 million. Total operating expenses for the three months ended Sept. 30, 2017, were approximately $14.3 million, which included R&D expenses totaling approximately $9.4 million and G&A expenses totaling approximately $4.9 million. The year-over-year increase in R&D expenses was due primarily to increased development costs related to the initiation of clinical trials for SNA-120 and for SNA-125 and increased manufacturing costs related to SNA-125, offset by a reduction in costs related to the ongoing pivotal trials for SNA-001 and a reduction in manufacturing costs related to SNA-120. The year-over-year decrease in G&A expenses was due primarily to a $1.8 million non-cash decrease in the fair value of the contingent consideration liability related to the Companys acquisition of Creabilis plc in December 2016 and a reduction in legal fees, offset by an increase in personnel costs and an increase in costs related to being a public company.
Total operating expenses for the nine months ended Sept. 30, 2018, were approximately $56.7 million, which includes R&D expenses totaling approximately $40.8 million and G&A expenses totaling approximately $15.9 million. Total operating expenses for the nine months ended Sept. 30, 2017, were approximately $34.6 million, which included R&D expenses totaling approximately $21.0 million and G&A expenses totaling approximately $13.6 million. The year-over-year increase in R&D expenses was due primarily to increased development costs related to the initiation of clinical trials for SNA-120 and for SNA-125, increased manufacturing costs related to SNA-125 and increased costs related to early stage research activities, offset by a reduction in costs related to the ongoing pivotal trials for SNA-001. The year-over-year increase in G&A expenses was due primarily to an increase in personnel costs, an increase in expenses related to marketing research and an increase in costs related to being a public company, offset by a $1.6 million non-cash decrease in the fair value of the contingent consideration liability related to the Companys acquisition of Creabilis plc in December 2016 and a reduction in consulting and legal fees.
Cash burn during the three months ended Sept. 30, 2018, was approximately $15.9 million. Cash burn during the nine months ended Sept. 30, 2018, was approximately $46.1 million. Siennas cash and cash equivalents as of Sept. 30, 2018, totaled approximately $64.0 million.
About Sienna Biopharmaceuticals®
Sienna Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on bringing innovations in biotechnology to the discovery, development and commercialization of first-in-class, targeted, topical products in medical dermatology and aesthetics. The Companys objective is to develop a unique, diversified, multi-asset pipeline of topical therapies that enhance the health, appearance and quality of life of dermatology and aesthetics patients. Sienna® is led by a management team with extensive experience in product development and commercialization at several leading dermatology, aesthetics and biotechnology companies.
For more information, visit the Companys website at www.SiennaBio.com.
This press release contains forward-looking statements, including but not limited to statements regarding the anticipated timing of clinical data readouts from Siennas development programs. Such forward-looking statements involve substantial risks and uncertainties that could cause Siennas clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the pharmaceutical drug and medical device development processes, including regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing pharmaceutical drug and medical device products, Siennas ability to successfully protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations and the availability or commercial potential of Siennas drug candidates. Sienna undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Siennas most recent Annual Report on Form 10-K and any subsequent current and periodic reports filed with the Securities and Exchange Commission.
Sienna Biopharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
|Three Months Ended
|Nine Months Ended
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense), net
Net loss before taxes
Income tax benefit
Per share information:
Net loss, basic and diluted1
Basic and diluted weighted average shares outstanding2
1 Diluted net loss per share is the same as basic net loss per share, as the effects of potentially dilutive securities are antidilutive during periods of net loss.
2 As of Sept. 30, 2018, there were 21,140,101 shares of common stock outstanding.
Sienna Biopharmaceuticals, Inc.
Selected Consolidated Balance Sheet Data
|September 30, 2018||December 31, 2017|
Cash and cash equivalents
Total current liabilities
Total stockholders equity
Caroline Van Hove
Sienna Biopharmaceuticals, Inc.
30699 Russell Ranch Road, Suite 140, Westlake Village, CA 91362
Office 818-629-2256 | Fax 818-706-1214