UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of report (date of earliest event reported): November 12, 2014
DERMIRA, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-36668 |
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27-3267680 |
(State or other jurisdiction of |
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(Commission File Number) |
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(I.R.S. Employer |
2055 Woodside Road |
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Redwood City, California |
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94061 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrants telephone number, including area code: (650) 421-7200
Not Applicable
(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 (see General Instruction A.2 below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On November 12, 2014, Dermira, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2014. The press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto are being furnished pursuant to Item 2.02 of Form 8-K and will 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 that section, nor will it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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Press release of Dermira, Inc., dated November 12, 2014 |
SIGNATURES
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.
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DERMIRA, INC. | |
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Date: November 12, 2014 |
By: |
/s/ Andrew L. Guggenhime |
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Name: Andrew L. Guggenhime | |
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Title: Chief Operating Officer and Chief Financial Officer |
Exhibit 99.1
Dermira Reports Third Quarter 2014 Financial Results and Provides Corporate Update
REDWOOD CITY, Calif., November 12, 2014 Dermira, Inc. (NASDAQ: DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated medical dermatology products to dermatologists and their patients, today reported financial results for the quarter ended September 30, 2014.
With the clinical advancement of our three late-stage product candidates, the addition of key executives, and the successful completion of our initial public offering, 2014 has been a pivotal year for Dermira, said Tom Wiggans, chief executive officer of Dermira. We are excited to be entering 2015 with momentum and a highly strengthened capital position as we continue to build Dermira into a leading innovator in the large and underserved medical dermatology market. We look forward to the dosing of the first patient in our Phase 3 Cimzia program and to further clinical advancement of our other product candidates.
Operational Highlights and Clinical Pipeline Update
· Completed initial public offering and Series C financing. In October 2014, Dermira completed its initial public offering (IPO) of 7,812,500 shares of common stock at an offering price of $16 per share. Concurrent with the offering, Dermira also sold through a private placement 468,750 shares of its common stock to UCB S.A., an existing stockholder, at the IPO price. Proceeds from the IPO and concurrent private placement totaled approximately $120.3 million, net of underwriting discounts, commissions and offering-related transaction costs. Prior to the IPO, in August 2014, Dermira completed a Series C financing for net proceeds of $48.8 million. In aggregate, Dermira raised net proceeds of $169.1 million pursuant to these financings.
· Cimzia® (certolizumab pegol) for psoriasis. In September 2014, Dermira and its partner, UCB, filed an investigational new drug (IND) application for Cimzia for the treatment of moderate-to-severe plaque psoriasis with the FDA. Dermira anticipates the initiation of patient enrollment in its Phase 3 program of Cimzia in psoriasis during the first half of 2015.
· DRM04 (topical anticholinergic) for hyperhidrosis. In August 2014, Dermira successfully completed a 198-patient, randomized, double-blind, vehicle-controlled Phase 2b dose-ranging study in primary axillary hyperhidrosis of a topical formulation of an anticholinergic agent that has been approved for systemic administration in other indications (referred to as the topical formulation of the reference agent). In the study, significant reductions in sweat production and improvements in other efficacy endpoints were observed in patients treated with select doses of the reference agent compared to vehicle. Also during the third quarter, Dermira completed enrollment in its ongoing, second Phase 2b study assessing the efficacy, safety and pharmacokinetics of DRM04, the topical formulation of the reference agent and vehicle. Data from this study, which enrolled approximately 100 patients with primary axillary hyperhidrosis, are expected during the first half of 2015. If successful, Dermira plans to initiate a Phase 3 program for DRM04 during the second half of 2015.
· DRM01 (topical sebum inhibitor) for acne. In June 2014, Dermira completed a 108-patient, randomized, double-blind, vehicle-controlled Phase 2a study with DRM01 conducted in Canada that demonstrated significant reductions in the signs and symptoms of acne. Dermira remains on track to file an IND application with the FDA and initiate Phase 2b clinical development for DRM01 during the first half of 2015.
Third Quarter 2014 Financial Results
· For the quarter ended September 30, 2014, Dermira reported a net loss of $7.8 million compared to a net loss for the quarter ended September 30, 2013 of $4.7 million.
· Total operating expenses for the quarter ended September 30, 2014 were $7.7 million as compared to $4.6 million for the third quarter of 2013.
· Research and development expenses for the third quarter of 2014 were $6.0 million versus $3.6 million for the third quarter of 2013. This increase was primarily due to higher development costs for DRM04 and Cimzia and increased headcount.
· General and administrative expenses during the quarter ended September 30, 2014 were $1.7 million compared to $1.0 million for the same period in 2013. This increase was primarily related to increased headcount.
· As of September 30, 2014, Dermira had cash and cash equivalents of $50.8 million, debt of $1.9 million, and 16.3 million common and preferred shares outstanding. The September 30, 2014, cash and cash equivalents balance and shares outstanding totals do not include the impact of the $120.3 million in net proceeds received and 8.3 million shares issued in connection with the Companys October 2014 IPO and concurrent private placement.
About Dermira
Dermira is a specialty biopharmaceutical company focused on bringing innovative and differentiated medical dermatology products to dermatologists and their patients. Dermiras portfolio of five product candidates targets significant market opportunities and includes three late-stage product candidates, Cimzia (certolizumab pegol), in development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe plaque psoriasis; DRM04, a topical treatment for hyperhidrosis; and, DRM01, a topical sebum inhibitor for the treatment of acne. Dermira is headquartered in Redwood City, California. For more information, please visit www.dermira.com.
Forward-Looking Statements
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the safe harbor created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including with respect to planned next steps in the clinical development of our product candidates. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the outcomes of our clinical trials, our dependence on third party clinical research organizations, manufacturers and suppliers, our ability to obtain regulatory approval for our product candidates, the costs of our development programs, our ability to obtain necessary additional capital, market acceptance of our potential products, our ability to develop and maintain collaborations and license products and intellectual property, the impact of competitive products and therapies including generics and biosimilars, our ability to manage the growth and complexity of our organization, our ability to maintain, protect and enhance our intellectual property, and our ability to continue to stay in compliance with applicable laws and regulations. You should refer to the risks set forth in Part II, Item 1A, Risk Factors in the Companys Quarterly Report on Form 10-Q and other filings the Company makes with the Securities and Exchange Commission from time to time for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. We undertake no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
Dermira Contact
Andrew Guggenhime
Chief Operating Officer and Chief Financial Officer
650.421.7200
Investor Contact
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
Dermira, Inc.
Selected Consolidated Statements of Operations Data
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2014 |
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2013 |
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2014 |
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2013 |
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Operating expenses: |
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Research and development |
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$ |
6,028 |
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$ |
3,619 |
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$ |
19,676 |
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$ |
12,397 |
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General and administrative |
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1,688 |
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1,009 |
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5,240 |
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3,214 |
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Total operating expenses |
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7,716 |
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4,628 |
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24,916 |
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15,611 |
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Loss from operations |
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(7,716 |
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(4,628 |
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(24,916 |
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(15,611 |
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Interest and other income (expense), net |
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(84 |
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(37 |
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(118 |
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(25 |
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Interest expense |
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(47 |
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(114 |
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Net loss |
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$ |
(7,847 |
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$ |
(4,665 |
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$ |
(25,148 |
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$ |
(15,636 |
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Net loss per share, basic and diluted |
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$ |
(8.66 |
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$ |
(5.57 |
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$ |
(27.93 |
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$ |
(19.40 |
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Weighted-average common shares used to compute net loss per share, basic and diluted |
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906,239 |
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836,876 |
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900,350 |
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806,137 |
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Dermira, Inc.
Selected Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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September 30, |
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December 31, |
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2014 |
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2013 |
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Cash and cash equivalents |
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$ |
50,845 |
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$ |
22,144 |
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Working capital |
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43,624 |
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17,973 |
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Total assets |
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59,616 |
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26,871 |
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Bank term loan, current and non-current |
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1,937 |
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1,919 |
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Convertible preferred stock |
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113,414 |
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59,588 |
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Accumulated deficit |
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(75,922 |
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(50,774 |
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Total stockholders deficit |
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(74,310 |
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(49,803 |
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Note: The balance sheet data exclude the impact of the Companys initial public offering (IPO) and concurrent private placement that were completed in October 2014, in connection with which the Company issued a total of 8,281,250 shares and raised total estimated net proceeds of $120.3 million.