8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): August 8, 2017

Dermira, Inc.

(Exact Name of the Registrant as Specified in Its Charter)

Delaware

(State or Other Jurisdiction of Incorporation)

000-36668	27-3267680
(Commission File Number)	(IRS Employer Identification No.)
275 Middlefield Road, Suite 150 Menlo Park, California	94025
(Address of Principal Executive Offices)	(Zip Code)

(650) 421-7200

(Registrant’s Telephone Number, Including Area Code)

(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):

☐ 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 1.01 Entry into a Material Definitive Agreement.

On August 8, 2017 (the “Execution Date”), Dermira, Inc. (“Dermira”) entered into a license agreement (the “Agreement”) with F. Hoffmann-La Roche Ltd and Genentech, Inc. (together, “Roche”) pursuant to which Dermira will obtain exclusive, worldwide rights to develop and commercialize lebrikizumab, a bivalent, monospecific, monoclonal, monoepitopic and humanized IgG4 antibody targeting interleukin 13, for atopic dermatitis and all other indications, except Roche will retain exclusive rights to develop and promote lebrikizumab for interstitial lung disease (the “Retained Field”) and certain rights to use lebrikizumab for internal research purposes and for in vitro diagnostic purposes.

The Agreement includes the following terms, among others:

• The Agreement will become effective on the second business day following the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (“HSR”) (such date, the “Effective Date”) .

• Dermira will have the following payment obligations under the Agreement:

• an initial payment of $80 million to Roche within thirty (30) days after the Effective Date;

• a $25 million payment within thirty (30) days after the earlier of September 15, 2018 or the achievement of 50% enrollment in Dermira’s first Phase 2 clinical study of lebrikizumab;

• a $30 million payment within thirty (30) days after the earlier of December 15, 2018 or the achievement of 100% enrollment in Dermira’s first Phase 2 clinical study of lebrikizumab;

• a $40 million payment within thirty (30) days after the initiation of Dermira’s first Phase 3 clinical study of lebrikizumab;

• up to an additional $50 million in payments upon the achievement of milestones related to submission of applications for regulatory approval of lebrikizumab (other than for the Retained Field) in certain territories;

• up to an additional $160 million in payments upon the achievement of milestones related to the first commercial sale of lebrikizumab (other than for the Retained Field) in certain territories;

• up to an additional $1.025 billion in payments based on the achievement of certain thresholds for annual net sales of lebrikizumab (other than for the Retained Field) ranging from $250 million to $3 billion, with each such potential milestone payment representing between 15% and 20% of the applicable net sales threshold; and

• royalty payments representing a range of percentages of tiers of corresponding ranges of annual net sales of lebrikizumab (other than for the Retained Field) that begins in the high single-digits for the first annual net sales tier and increases up to the high teens for annual net sales in excess of $3 billion.

• Royalty payment obligations with respect to a given country will commence on the date of the first commercial sale of lebrikizumab (other than for the Retained Field) in such country and end on the later of the date that is (a) ten (10) years after the date of the first commercial sale of lebrikizumab (other than for the Retained Field) in such country, (b) the expiration of the last to expire valid claim of the applicable licensed compound patent rights, Dermira patent rights or joint patent rights in such country covering the use, manufacturing, import, offering for sale, or sale of lebrikizumab (other than for the Retained Field) in such country, (c) the expiration of the last to expire valid claim of the applicable licensed non-compound patent rights in such country covering the use, import, offering for sale, or sale of the product in such country, or (d) the expiration of the last to expire regulatory exclusivity conferred by the applicable regulatory authority in such country for lebrikizumab (other than for the Retained Field).

• Roche will receive the net sales of lebrikizumab in the Retained Field less certain amounts associated with Dermira’s costs.

• Dermira will be solely responsible for its development costs (including all regulatory interactions and conducting and funding of any clinical trials) and commercialization of lebrikizumab (other than in the Retained Field).

• Roche or its designees will manufacture, if required, and supply to Dermira lebrikizumab drug substance and drug product pursuant to the terms of a supply agreement to be entered into by the parties. Subject to certain conditions, Roche will have the right to transfer its manufacture and supply responsibilities under the Agreement to Dermira by providing written notice to Dermira. Notwithstanding any such transfer, Roche will retain the right to manufacture the compound and product to exercise its retained rights, including for its own development purposes in the Retained Field, provided that Roche may not (a) enable or license any Roche know-how to a third party to manufacture the compound other than subcontractors performing such manufacturing for use by Roche or Dermira under the Agreement, (b) manufacture a biosimilar product for sale or use in any country until the earlier of four (4) years after the expiration of the royalty term in the country of the first commercial sale of the product (other than for the Retained Field) or the end of the Agreement term, or (c) license any Roche know-how that is disclosed by Roche to Dermira under the Agreement to a third party to manufacture a biosimilar product in any country until the earlier of five (5) years after the expiration of the royalty term in the country of the first commercial sale of the product (other than for the Retained Field) or the end of the Agreement term.

• Roche’s rights under this Agreement in the Retained Field will be relinquished to Dermira (the “Roche Reversion”): (a) at Roche’s election at any time following 30 days’ prior written notice to Dermira; or (b) automatically if at any time in a period of eighteen (18) consecutive months Roche is not conducting an active clinical study of lebrikizumab or recurring, bona fide activities aimed at receiving regulatory approval for the compound in the Retained Field, provided that such automatic reversion may not occur within three (3) years of the Effective Date or following regulatory approval for the compound in the Retained Field. Upon the occurrence of the Roche Reversion, all of Roche’s rights and all of Dermira’s obligations each with respect to the Retained Field will automatically expire, Dermira’s payment obligations that had been limited to indications outside the Retained Field will apply to all indications, and where the “first commercial sale” had applied to the first commercial sale other than for the Retained Field, the “first commercial sale” will apply to the first commercial sale in any indication.

• Subject to certain conditions and limitations: (a) Dermira will have the right to sublicense the rights granted to it under the Agreement; (b) either party may terminate the Agreement in the event of an uncured breach of material obligations by, or certain insolvency events of, the other party or if expiration or termination of the waiting period under HSR has not occurred within six (6) months of the Execution Date; and (c) Dermira may terminate the Agreement at any time, on a country-by-country basis, upon six (6) months’ prior written notice before the first commercial sale of lebrikizumab (other than for the Retained Field) or upon nine (9) months prior written notice after the first commercial sale of the product (other than for the Retained Field).

• Neither party may assign the Agreement or any part thereof prior to the occurrence of both (a) the Roche Reversion and (b) the first commercial sale of lebrikizumab (other than for the Retained Field), without the prior written approval of the other party, which shall not to be unreasonably withheld, conditioned or delayed. Following the occurrence of both the Roche Reversion and the first commercial sale of lebrikizumab (other than for the Retained Field), Dermira may assign the Agreement without Roche’s prior consent in the context of a merger, acquisition, sale or other transaction involving all or substantially all of Dermira’s assets. A party consummating a change of control transaction will provide written notice to the other party within agreed time periods prior to or following completion of the change of control transaction.

• Roche shall indemnify Dermira for losses arising out of (a) Roche’s breach of any obligation, representation, warranty, covenant or agreement made by it under the Agreement, (b) development, manufacture or promotion of lebrikizumab in or for the Retained Field, including the sale of lebrikizumab by Dermira for use in the Retained Field, (c) Roche’s exercise of certain retained rights, development by Roche in the Retained Field, and promotion by Roche in the Retained Field, or (d) the manufacture of lebrikizumab by or on behalf of Roche.

• Dermira shall indemnify Roche for losses arising out of (a) Dermira’s breach of any obligation, representation, warranty, covenant or agreement made by it under the Agreement, or (b) Dermira’s of development, manufacture, use, handling, storage, sale or other disposition of lebrikizumab (including product liability claims and infringement of third party patents).

• The Agreement contains customary representations and warranties made by both parties.

• Following the Effective Date and subject to earlier termination, the Agreement will remain in effect until no royalty or other payment obligations under this Agreement are or may become due.

The foregoing summary of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the Agreement, which will be filed as an exhibit to Dermira’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2017.

Item 7.01 Regulation FD Disclosure.

Dermira anticipates the following corporate milestones in the second half of 2017:

• Submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis.

• Launch of Dermira’s hyperhidrosis disease awareness campaign.

Dermira anticipates the following corporate milestones in the first quarter of 2018:

• Announcement of topline results from CLAREOS-1 and CLAREOS-2, the Phase 3 clinical trials investigating the safety and efficacy of olumacostat glasaretil in patients with acne vulgaris.

• Initiation of a Phase 2b dose-ranging study assessing lebrikizumab in adult patients with moderate-to-severe atopic dermatitis, subject to the expiration or termination of waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as amended, which Dermira anticipates will occur in the third quarter of 2017, and successful program transfer from Roche.

Dermira anticipates the following corporate milestones in the second half of 2018:

• Commercial launch of Cimzia^® (certolizumab pegol) for the treatment of moderate-to-severe chronic plaque psoriasis, subject to approval by the FDA of the supplemental Biologics License Application submitted by UCB Pharma S.A. to the FDA in July 2017.

• Commercial launch of glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis, subject to approval by the FDA of the NDA which Dermira anticipates submitting to the FDA in the second half of 2017.

The foregoing disclosures constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. You should refer to the section entitled “Risk Factors” set forth in Dermira’s annual and quarterly reports and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. The forward-looking statements speak only as of the date of this Current Report on Form 8-K. Dermira undertakes 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.

The information in this Item 7.01 is furnished pursuant to Item 7.01 of Form 8-K, and is not deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibits is not incorporated by reference in any filing of Dermira under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any filings.

Item 8.01 Other Events.

On August 8, 2017, Dermira issued a press release announcing its entry into the Agreement. The press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number	Description of Exhibit
99.1	Press release dated August 8, 2017.

SIGNATURE

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: August 8, 2017	By:	/s/ Andrew L. Guggenhime
		Andrew L. Guggenhime Chief Operating Officer and Chief Financial Officer

EXHIBIT INDEX

Exhibit Number	Description of Exhibit
99.1	Press release dated August 8, 2017.

EX-99.1

Exhibit 99.1

Dermira Enters into Agreement to License Exclusive, Worldwide

Rights to Lebrikizumab

• Dermira plans to develop and commercialize lebrikizumab, a monoclonal antibody targeting IL-13, for moderate-to-severe atopic dermatitis

• Initiation of a Phase 2b clinical study is expected in the first quarter of 2018

• Management will host webcast and conference call today at 5:30 a.m. PT / 8:30 a.m. ET

MENLO PARK, Calif., August 8, 2017 – Dermira, Inc. (NASDAQ: DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today announced that it has entered into a licensing agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (together Roche). Pursuant to the agreement, Dermira will obtain exclusive, worldwide rights to develop and commercialize lebrikizumab, a monoclonal antibody targeting interleukin 13 (IL-13), for atopic dermatitis and all other indications, except Roche will retain certain rights, including exclusive rights to develop and promote lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis.

Under the terms of the agreement, Dermira will make an initial payment of $80 million to Roche and payments totaling $55 million in 2018. Dermira will also be obligated to make additional payments upon the achievement of certain milestones, comprising $40 million upon the initiation of Dermira’s first Phase 3 clinical study, up to $210 million upon the achievement of regulatory and first commercial sale milestones in certain territories and up to $1.025 billion based on the achievement of certain thresholds for net sales of lebrikizumab for indications other than interstitial lung disease. Upon potential regulatory approval, Dermira will make royalty payments representing percentages of net sales that range from the high single-digits to the high teens. The effectiveness of the agreement is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as amended (HSR).

“Atopic dermatitis is one of the most common skin diseases in the world, affecting millions of adults and children, and moderate to severe forms of this condition present a tremendous burden for patients,” said Tom Wiggans, chairman and chief executive officer of Dermira. “We believe atopic dermatitis is one of the greatest unmet needs in dermatology, and lebrikizumab, if successfully developed and approved, could represent a meaningful advancement in the treatment of this disease. The addition of this program to our development portfolio represents an important step toward our goal of building a leading medical dermatology company dedicated to delivering differentiated, new therapies to the millions of patients living with chronic skin conditions.”

Dermira plans to initiate a Phase 2b dose-ranging study assessing lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2018. The objective of the Phase 2b dose-ranging study will be to optimize the dose of lebrikizumab for the design of a Phase 3 program. Preliminary design elements of the Phase 2b dose-ranging study include evaluating a loading dose and higher dose regimens of lebrikizumab than were explored in previous atopic dermatitis studies.

“Lebrikizumab is a potent and specific inhibitor of IL-13 with a differentiated mechanism of action and attractive pharmacokinetic properties,” said Eugene Bauer, M.D., chief medical officer of Dermira. “Data from preclinical and clinical studies, including pharmacokinetic and pharmacodynamic results from early clinical experience in atopic dermatitis, are encouraging and suggest higher doses of lebrikizumab could lead to greater efficacy in atopic dermatitis, while potentially offering a less frequent and therefore more convenient dosing regimen relative to existing therapies. If successfully developed, we believe that lebrikizumab could be a best-in-class IL-13 inhibitor and could have a best-in-disease profile.”

The transaction is expected to close in the third quarter of 2017 subject to the expiration or termination of the waiting period under HSR. Upon the close, Dermira expects to record a charge related to the acquisition of in-process research and development for a total of $135 million, consisting of the $80 million initial payment and $55 million of payments due in 2018. In addition, Dermira estimates it will incur up to $10 million in operating expenses in 2017 for costs related to transferring the lebrikizumab program to Dermira and preparing for the initiation of the Phase 2b dose-ranging study. Including the payments to Roche and costs related to the program, Dermira anticipates that it will spend approximately $200 million to obtain the topline results for the Phase 2b study. Assuming the close of the transaction, Dermira anticipates that its cash and cash equivalents and investments would be sufficient to meet its anticipated cash requirements into the first half of 2019, consistent with previously issued financial guidance.

Leerink Partners, LLC acted as financial advisor, and King & Spalding LLP and Fenwick & West LLP acted as legal counsel to Dermira, Inc.

Webcast and Conference Call Information

Dermira will host a webcast and conference call today to review details of the agreement beginning at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time. Analysts and investors can participate in the conference call by dialing (877) 359-9508 for domestic callers and +1 (224) 357-2393 for international callers using the conference ID# 67835410. The webcast can be accessed live on the Investor Relations page of Dermira’s website, http://investor.dermira.com, and will be available for replay for 30 days following the call. A telephone replay of the call will be available by dialing (855) 859-2056 for domestic callers or +1 (404)-537-3406 for international callers and entering the conference code: 67835410.

About Lebrikizumab and Phase 2 Exploratory Clinical Studies

Lebrikizumab is a novel, humanized monoclonal antibody designed to specifically block the action of IL-13, a cytokine that is a central pathogenic mediator in atopic dermatitis. Two exploratory Phase 2 clinical studies, TREBLE and ARBAN, evaluated the safety and efficacy of lebrikizumab in adult patients with moderate-to-severe atopic dermatitis. TREBLE was a double-blind, placebo-controlled study that evaluated the safety and efficacy of lebrikizumab in combination with topical corticosteroids. ARBAN was an open-label study designed to assess the safety of lebrikizumab as a monotherapy, with an exploratory assessment of efficacy. In both studies, clinical improvements were observed in patients treated with lebrikizumab. Adverse event rates were generally similar between treatment groups in each trial and most were mild or moderate in severity. Additional studies are needed to fully assess the potential benefits and risks of lebrikizumab.

About Atopic Dermatitis

Atopic dermatitis is the most common and severe form of eczema, a chronic inflammatory condition that can present as early as childhood and continue into adulthood. A moderate-to-severe form of the disease is characterized by rashes on the skin that often cover much of the body and can include redness, cracking, dryness and intense, persistent itching. Moderate-to-severe atopic dermatitis has a profound negative impact on patients’ mental and physical functioning, limiting their activities and health-related quality of life. Patients with moderate-to-severe atopic dermatitis have reported a larger impact on quality of life than patients with psoriasis.

About Dermira

Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s pipeline includes three late-stage product candidates that could have a profound impact on the lives of patients: CIMZIA^® (certolizumab pegol), for which marketing applications have been submitted for potential approval for the treatment of moderate-to-severe chronic plaque psoriasis, in collaboration with UCB Pharma S.A.; glycopyrronium tosylate (formerly DRM04), which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com.

In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/Dermira-inc) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.

Dermira^® is a registered trademark owned by Dermira, Inc.

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, and Section 21E of the Securities Exchange Act of 1934, as amended, 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 statements with respect to: effectiveness of the agreement and expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as amended; Dermira’s plan to develop and commercialize lebrikizumab for moderate-to-severe atopic dermatitis; the expected timing for initiation of a Phase 2b dose-ranging study of lebrikizumab for moderate-to-severe atopic dermatitis; the potential payments by Dermira to Roche, including the initial payment, payments in 2018, payment upon initiation of Dermira’s first Phase 3 clinical study of lebrikizumab, payments based on achievement of regulatory and first commercial sale milestones, milestone payments based on the achievement of certain thresholds for net sales and royalty payments representing percentages of net sales; lebrikizumab potentially representing a meaningful advancement in the treatment of atopic dermatitis if successfully developed and approved; Dermira’s goal of building a leading medical dermatology company dedicated to delivering differentiated, new therapies to the millions of patients

living with chronic skin conditions; the objective and design elements of the planned Phase 2b dose-ranging study; the potential that higher doses of lebrikizumab could lead to greater efficacy in atopic dermatitis while potentially offering a less frequent and therefore more convenient dosing regimen relative to existing therapies; the possibility of lebrikizumab becoming a best-in-class IL-13 antibody and having a best-in-disease profile if successfully developed; lebrikizumab potentially playing an important role in addressing the unmet need for certain conditions, including atopic dermatitis; the anticipated timing for closing of the transaction; the charge related to the acquisition of in-process research and development expected to be recorded upon the closing; estimated operating expenses in 2017 for costs related to transferring the lebrikizumab program to Dermira and preparing for the initiation of the Phase 2b dose-ranging study; estimated spend to obtain the topline results for the Phase 2b study; and the expectation that Dermira’s cash and cash equivalents and investments will be sufficient to meet its anticipated cash requirements into the first half of 2019. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause 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 design, implementation and outcomes of Dermira’s clinical trials; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; the outcomes of future meetings with regulatory agencies; and Dermira’s ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes 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.

Contacts:

Media:

Erica Jefferson

Senior Director, Head of Corporate Communications

650-421-7216

media@dermira.com

Investors:

Ian Clements, Ph.D.

Vice President, Investor Relations

650-422-7753

investor@dermira.com

Robert H. Uhl

Westwicke Partners

Managing Director

858-356-5932

robert.uhl@westwicke.com