UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM8-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): February 28, 2017
DERMIRA, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-36668 | 27-3267680 | ||
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification Number) |
275 Middlefield Road, Suite 150 | ||
Menlo Park, California | 94025 | |
(Address of Principal Executive Offices) | (Zip Code) |
Registrant’s 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 Form8-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):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule14a-12 under the Exchange Act (17 CFR240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule14d-2(b) under the Exchange Act (17 CFR240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule13e-4(c) under the Exchange Act (17 CFR240.13e-4(c)) |
Item 2.02 | Results of Operations and Financial Condition. |
On February 28, 2017, Dermira, Inc. (“Dermira”) issued a press release announcing its financial results for the quarter and year ended December 31, 2016. The press release is being furnished as Exhibit 99.1.
The information furnished in this Current Report under the Item 2.02 and Exhibit 99.1 attached hereto are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 8.01 | Other Events. |
Olumacostat Glasaretil (formerly DRM01)
The tables below indicate the absolute and percentage change in inflammatory acne lesion count, absolute and percentage change innon-inflammatory acne lesion count and the Investigator’s Global Assessment (“IGA”) response rate (³2-point improvement) at weeks 4, 8 and 12 for patients who participated in Dermira’s olumacostat glasaretil (“OG”) Phase 2b clinical trials, which were designed to evaluate the safety and efficacy of OG in adult patients withmoderate-to-severe facial acne vulgaris.
Absolute and Percent Change in Inflammatory Acne Lesion Count
Week 4 | Week 8 | Week 12 | ||||||||||||||||||||||||||||||||||||||||||
Dose | Absolute Change | p-value | Percent Change | p-value | Absolute Change | p-value | Percent Change | p-value | Absolute Change | p-value | Percent Change | p-value | ||||||||||||||||||||||||||||||||
7.5% OG (twice daily) n=101 | -9.2 | Not significant | -33.7 | Not significant | -12.3 | 0.050 | -45.6 | 0.046 | -15.0 | 0.001 | -55.6 | <0.001 | ||||||||||||||||||||||||||||||||
7.5% OG (once daily) n=110 | -8.6 | Not significant | -31.8 | Not significant | -12.8 | 0.012 | -47.5 | 0.014 | -14.5 | 0.004 | -53.3 | 0.004 | ||||||||||||||||||||||||||||||||
4.0% OG (once daily) n=106 | -8.7 | Not significant | -32.7 | Not significant | -12.3 | 0.040 | -45.9 | 0.036 | -14.6 | 0.003 | -54.8 | 0.002 | ||||||||||||||||||||||||||||||||
Vehicle (combined once/twice daily) n=102 | -7.2 | -26.7 | -9.7 | -36.1 | -10.7 | -40.0 |
Absolute and Percent Change inNon-Inflammatory Acne Lesion Count
Week 4 | Week 8 | Week 12 | ||||||||||||||||||||||||||||||||||||||||||
Dose | Absolute Change | p-value | Percent Change | p-value | Absolute Change | p-value | Percent Change | p-value | Absolute Change | p-value | Percent Change | p-value | ||||||||||||||||||||||||||||||||
7.5% OG (twice daily) n=101 | -8.6 | Not significant | -22.7 | Not significant | -12.5 | 0.035 | -34.6 | 0.042 | -17.5 | <0.001 | -47.8 | <0.001 | ||||||||||||||||||||||||||||||||
7.5% OG (once daily) n=110 | -7.7 | Not significant | -20.8 | Not significant | -11.9 | | Not significant | | -31.2 | | Not significant | | -13.4 | 0.050 | -36.6 | 0.152 | ||||||||||||||||||||||||||||
4.0% OG (once daily) n=106 | -8.3 | Not significant | -23.3 | Not significant | -13.3 | 0.012 | -35.4 | 0.029 | -15.3 | 0.004 | -42.1 | 0.014 | ||||||||||||||||||||||||||||||||
Vehicle (combined once/twice daily) n=102 | -6.8 | -16.5 | -8.7 | -24.4 | -9.3 | -28.7 |
IGA Response Rate (³2-Point Improvement)
Week 4 | Week 8 | Week 12 | ||||||||||||||||||||||
Dose | Percent | p-value | Percent | p-value | Percent | p-value | ||||||||||||||||||
7.5% OG (twice daily) n=101 | 4.1 | Not significant | 16.8 | 0.002 | 25.9 | 0.004 | ||||||||||||||||||
7.5% OG (once daily) n=110 | 2.8 | Not significant | 9.6 | Not significant | 19.2 | 0.063 | ||||||||||||||||||
4.0% OG (once daily) n=106 | 3.2 | Not significant | 13.3 | 0.014 | 21.6 | 0.024 | ||||||||||||||||||
Vehicle (combined once/twice daily) n=102 | 2.3 | 3.5 | 9.8 |
Glycopyrronium Tosylate (formerly DRM04)
The tables below indicate the Axillary Sweating Daily Diary (ASDD) response rate (³4-point improvement) and absolute change in sweat production at weeks 1, 2, 3 and 4 for patients who participated in Dermira’s glycopyrronium tosylate (“GT”)ATMOS-1 andATMOS-2 Phase 3 clinical trials, which were designed to assess the safety and efficacy of GT relative to vehicle.
ASDD Response Rate (³4-Point Improvement)
(n=) | Week 1 | Week 2 | Week 3 | Week 4 | ||||||||||||||||||||||||||||||||||||||||||||
Dose | ATMOS-1 | ATMOS-2 | ATMOS-1 | ATMOS-2 | ATMOS-1 | ATMOS-2 | ATMOS-1 | ATMOS-2 | ATMOS-1 | ATMOS-2 | ||||||||||||||||||||||||||||||||||||||
3.75 GT (once daily) | 229 | 234 | 22.9 | % | 29.0 | % | 47.1 | % | 53.8 | % | 53.2 | % | 61.0 | % | 52.8 | % | p<0.001 | 66.1 | % | p<0.001 | ||||||||||||||||||||||||||||
Vehicle (once daily) | 115 | 119 | 5.3 | % | 4.2 | % | 19.9 | % | 18.1 | % | 26.1 | % | 26.7 | % | 28.3 | % | 26.9 | % |
Absolute Change in Sweat Production (mg/5 minutes)
(n=) | Week 1 | Week 2 | Week 3 | Week 4 | ||||||||||||||||||||||||||||||||||||||||||||
Dose | ATMOS-1 | ATMOS-2 | ATMOS-1 | ATMOS-2 | ATMOS-1 | ATMOS-2 | ATMOS-1 | ATMOS-2 | ATMOS-1 | ATMOS-2 | ||||||||||||||||||||||||||||||||||||||
3.75 GT (once daily) | 229 | 234 | -75.5 | -108.0 | -85.7 | -111.4 | -88.9 | -110.3 | -104.9 | 0.065 | -110.3 | <0.001 | ||||||||||||||||||||||||||||||||||||
Vehicle (once daily) | 115 | 119 | -58.0 | -56.8 | -71.5 | -86.0 | -90.8 | -85.6 | -91.9 | -92.2 | ||||||||||||||||||||||||||||||||||||||
3.75 GT (once daily) | 220 | -96.2 | * | 0.001 | ||||||||||||||||||||||||||||||||||||||||||||
Vehicle (once daily) | 110 | -90.6 | * |
* | The average reduction in sweat production was 104.9 mg in patients treated with GT as compared to 91.9 mg in vehicle-treated patients based on the overall dataset from theintent-to-treat population (p=0.065). As outlined in thepre-specified statistical analysis plan submitted to the U.S. Food and Drug Administration, a sensitivity analysis was conducted that led to the exclusion of an analysis center with extreme outlier data for the gravimetric measurement of sweat. This analysis center consisted of 14 patients, of whom nine were treated with GT and five received vehicle only. Following the exclusion of this analysis center, patients treated with GT demonstrated an average reduction in sweat production of 96.2 mg as compared to 90.6 mg in patients who received the vehicle only (p=0.001). |
Cimzia
The table below indicates the proportion of patients achieving an improvement of at least 90% in the clinical grading scale called the Psoriasis Area and Severity Index (PASI 90 response) in Dermira’s CimziaCIMPASI-1 andCIMPASI-2 Phase 3 clinical trials, which were designed to demonstrate the superiority of treatment with Cimzia relative to placebo, and the change from baseline in the Dermatology Life Quality Index (“DLQI”) for patients who participated in the trials, at week 16.
PASI 90 Response Rate and Change from Baseline in DLQI at Week 16
PASI 90 Response Rate Percentage | Change from Baseline in DLQI | |||||||||||||||||||||||||||||||||||||||||||||||
CIMPASI-1 | CIMPASI-2 | CIMPASI-1 | CIMPASI-2 | CIMPASI-1 | CIMPASI-2 | |||||||||||||||||||||||||||||||||||||||||||
Dose | (n=) | Percent | p-value | Percent | p-value | Baseline | (LSM Change ± SE)* | p-value | Baseline | (LSM Change ± SE)* | p-value | |||||||||||||||||||||||||||||||||||||
Cimzia 400 mg (once every two weeks) | 88 | 87 | 43.6 | <0.0001 | 55.4 | <0.0001 | 13.1 | -10.2 | <0.0001 | 14.2 | -10.0 | <0.0001 | ||||||||||||||||||||||||||||||||||||
Cimzia 200 mg (loading dose of 400 mg at weeks 0, 2 and 4 followed by 200 mg every two weeks for an additional 12 weeks) | 95 | 91 | 35.8 | <0.0001 | 52.6 | <0.0001 | 13.3 | -9.3 | <0.0001 | 15.2 | -10.4 | <0.0001 | ||||||||||||||||||||||||||||||||||||
Placebo (once every two weeks) | 51 | 49 | 0.4 | 4.5 | 13.9 | -3.3 | 12.9 | -3.8 |
* | Least squares mean ± standard error. |
Executive Compensation
The following table provides information regarding all plan andnon-plan compensation awarded to, earned by or paid to Dermira’s principal executive officer, principal financial officer and the three other most highly compensated executive officers serving as such at December 31, 2016 (the “Named Executive Officers”) for all services rendered in all capacities during the year ended December 31, 2016:
Name and Principal Position | Salary | Equity Awards(1) | Non-Equity Incentive Plan Compensation(2) | Total | ||||||||||||
Thomas G. Wiggans | $ | 500,000 | $ | 3,685,971 | $ | 312,500 | $ | 4,498,471 | ||||||||
Andrew L. Guggenhime | $ | 367,430 | $ | 1,458,960 | $ | 183,715 | $ | 2,010,105 | ||||||||
Eugene A. Bauer, M.D. | $ | 360,750 | $ | 1,075,050 | $ | 157,828 | $ | 1,593,628 | ||||||||
Luis Peña | $ | 358,719 | $ | 1,389,905 | $ | 156,925 | $ | 1,905,549 | ||||||||
Christopher Griffith | $ | 284,900 | $ | 441,416 | $ | 106,838 | $ | 833,154 |
(1) | The amounts reported in the “Equity Awards” column represent the grant date fair value of the stock options and restricted stock units granted to the Named Executive Officers during the year ended December 31, 2016 as computed in accordance with Accounting Standards Codification Topic 718. The assumptions used in calculating the grant date fair value of the equity awards reported in this column are set forth in Notes 2 and 12 to the audited consolidated financial statements included in Dermira’s annual report on Form10-K for the year ended December 31, 2016. Note that the amounts reported in this column reflect the accounting cost for these equity awards, and do not correspond to the actual economic value that may be received by our Named Executive Officers therefrom. |
(2) | The amounts reported in the“Non-Equity Incentive Plan Compensation” column represent bonuses earned by the Named Executive Officers under Dermira’s incentive compensation guidelines recommended by Dermira’s compensation committee and approved by Dermira’s board of directors for the year ended December 31, 2016. Under the guidelines, Mr. Wiggans was entitled to a target bonus of up to 50% of his base salary, Mr. Guggenhime was entitled to a target bonus of up to 40% of his base salary, Dr. Bauer and Mr. Peña were entitled to a target bonus of up to 35% of their respective base salary and Mr. Griffith was entitled to a target bonus of up to 30% of his base salary. In February 2017, Dermira’s board of directors determined the actual amounts of the incentive bonuses for the year ended December 31, 2016 based on Dermira’s achievement of corporate objectives. Bonuses of approximately 125% of the target bonuses were paid to the Named Executive Officers based on Dermira’s achievement of corporate objectives. |
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit | Description | |
99.1 | Dermira Inc. Press Release dated February 28, 2017 |
SIGNATURES
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.
DERMIRA, INC. | ||||||
Date: February 28, 2017 | By: | /s/ Andrew L. Guggenhime | ||||
Name: | Andrew L. Guggenhime | |||||
Title: | Chief Operating Officer and Chief Financial Officer |
EXHIBIT INDEX
Exhibit | Description | |
99.1 | Dermira, Inc. Press Release dated February 28, 2017 |