EX-99.2 3 d722390dex992.htm EX-99.2 EX-99.2

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Lebrikizumab P2b Topline Results March 18, 2019 Exhibit 99.2


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This presentation contains "forward-looking" statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our business strategy, objectives and opportunities; the size of the atopic dermatitis market, the successful completion of, and timing expectations for the receipt and announcement of efficacy and safety data from our Phase 2b lebrikizumab clinical trial, timing of initiation of a Phase 3 lebrikizumab program. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements, including, but not limited to, those related to our dependence on third-party clinical research organizations, manufacturers, suppliers and distributors; our ability to obtain necessary additional capital; market acceptance of our product; the impact of competitive products and therapies; our ability to attract and retain key employees; the costs of our commercialization plans and development programs; the design, implementation and outcomes of our clinical trials; 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 section entitled “Risk Factors” set forth in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings we make with the Securities and Exchange Commission (SEC) 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. You should not rely upon forward-looking statements as predictions of future events. Neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update any forward-looking statements after the date of this presentation except as may be required by law. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Projections, assumptions and estimates of the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. We use our website (www.dermira.com), LinkedIn page (www.linkedin.com/company/dermira-inc-), Instagram account and corporate Twitter account (@DermiraInc) as channels of distribution of information about our company, product candidates, planned announcements, attendance at upcoming conferences and other matters. Such information may be deemed material information and we may use these channels to comply with our disclosure obligations under Regulation FD. Therefore, investors should monitor our website, LinkedIn page, Twitter account and Instagram page in addition to following our SEC filings, press releases, public conference calls and webcasts. Forward-Looking Statements


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Executive Summary Clinical profile has the potential to significantly alter the treatment landscape in AD Selective inhibition of IL-13 with lebrikizumab could be the best approach to treating AD All three doses of lebrikizumab met primary endpoint with statistical significance Robust dose-dependent efficacy across multiple measures Well-tolerated with safety profile consistent with prior studies Results warrant rapid advancement to Phase 3 program; planned by end of 2019 after End-of-Phase 2 meeting with FDA


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Lebrikizumab offers a differentiated mechanism of action that has the potential to be a best-in-disease therapy for treating AD IL-13/IL-4 class is a validated, targeted approach Biologic atopic dermatitis therapy is a large and growing market Predicted to be as large as approximately $14.8 billion by 20251 Need for new, differentiated therapies Phase 2b study confirms thesis that lebrikizumab may potentially offer a compelling combination of efficacy, safety, tolerability, convenience and ease-of-use Lebrikizumab: Compelling Investment Thesis Phase 2b topline results announced on March 18, 2019 Planned Phase 3 initiation by end of 2019, after End-of-Phase 2 meeting; expect topline data first half 20212 1. Decision Resources (2017); 2. Estimate provided as of March 18, 2019. Expected topline results timing assumes Phase 3 initiation by year-end 2019


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Phase 2b Study to Optimize Product Profile Study objectives Optimize dosing regimen to enhance product profile Define monotherapy profile Screen Lebrikizumab 250 mg LD, followed by 125 mg Q4W Lebrikizumab 500 mg LD, followed by 250mg Q4W Lebrikizumab 500 mg LD (wk 0 & 2), followed by 250 mg Q2W Placebo Q2W Randomize (2:3:3:3) (n=280*) End of Treatment Baseline Week 16 Key inclusion criteria Adults with moderate-to-severe AD not adequately controlled with topicals or for whom topical treatment is medically inadvisable TCS washout prior to randomization Key endpoints (response rates at week 16) Primary endpoint Percent change in EASI Secondary endpoints include: ≥ 2-point reduction from baseline and a final IGA score of 0/1 EASI-50, EASI-75, EASI-90 Pruritus NRS Abbreviations: Q2W (every 2 weeks), Q4W (every 4 weeks), TCS (topical corticosteroids), IGA (Investigator Global Assessment), EASI (Eczema Area and Severity Index), NRS (numerical rating scale). Over the 16-week period, approximately 56% in the placebo arm discontinued compared to approximately 22% across the lebrikizumab dosing arms. Study Design:


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Study Protocol Key Inclusion criteria Chronic AD has been present for ≥1 year before screening visit EASI score ≥16 at screening and baseline visits IGA score of 3 or 4 (scale of 0 to 4) at screening and baseline visits ≥10% body surface area (BSA) of AD involvement at screening and baseline visits Statistical analysis considerations Statistical tests were two sided and performed at the 0.05 level of significance The primary method of handling missing efficacy data was the Markov Chain Monte Carlo (MCMC) multiple imputation Rescue treatment Patients were permitted rescue therapy, including topical corticosteroids, in all arms recommended by the investigator If patients used systemic therapy, they had to discontinue the treatment Approximately 13% and 35% received rescue therapy in the treatment and placebo arms, respectively


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Select Baseline Disease Characteristics Dermira data on file 125 mg Q4W (n=73) 250 mg Q4W (n=80) 250 mg Q2W (n=75) Placebo (n=52) EASI Score n 73 80 75 52 Mean 29.852 26.146 25.477 28.903 SD 13.5174 10.1346 11.2057 11.7900 IGA (%) n 73 80 75 52 3 - Moderate 43 (58.9%) 54 (67.5%) 53 (70.7%) 32 (61.5%) 4 - Severe 30 (41.1%) 26 (32.5%) 22 (29.3%) 20 (38.5%) BSA n 73 80 75 52 Mean 45.5 41.1 39.4 46.5 SD 24.49 20.89 21.49 22.68 Pruritus Score n 68 77 69 49 Mean 7.6 7.1 7.6 7.4 SD 1.98 2.44 1.87 2.42 DLQI Score n 72 80 75 52 Mean 14.5 14.2 14.1 14.1 SD 7.10 7.66 6.94 7.07


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Primary Endpoint: EASI Improvement p = 0.0165 p = 0.0022 p = 0.0005


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Efficacy: Investigators Global Assessment p = 0.0392 p = 0.0023 Response Rate (% of Patients)


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Efficacy: EASI-75 p = 0.0021 p = 0.0005 Response Rate (% of Patients)


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Efficacy: EASI-90 p = 0.0062 p = 0.0006 Response Rate (% of Patients)


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Pruritis: NRS, >4 Point Improvement p = 0.1067 p = 0.0008 Response Rate (% of Patients) All data reported are observed values.


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Adverse Events: Lebri Was Well Tolerated Most Frequent Adverse Events Placebo (n=52) 125mg Lebri Q4W (n=73) 250mg Lebri Q4W (n=80) 250mg Lebri Q2W (n=75) All Lebri (n=228) Upper Respiratory Tract Infection 3 (5.8%) 6 (8.2%) 9 (11.3%) 2 (2.7%) 17 (7.5%) Nasopharyngitis 2 (3.8%) 4 (5.5%) 2 (2.5%) 9 (12.0%) 15 (6.6%) Fatigue 0 0 4 (5.0%) 0 4 (1.8%) Headache 3 (5.8%) 2 (2.7%) 1 (1.3%) 4 (5.3%) 7 (3.1%) Injection Site Pain 1 (1.9%) 0 3 (3.8%) 4 (5.3%) 7 (3.1%) Herpes Zoster 0 0 1 (1.3%) 1 (1.3%) 2 (0.9%) Herpes Infections 0 2 (2.7%) 2 (2.5%) 1 (1.3%) 5 (2.2%) Conjunctivitis 0 1 (1.4%) 3 (3.8%) 2 (2.7%) 6 (2.6%) Dermira data on file


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Dupilumab Profile Can Be Improved Upon Endpoints Dupilumab – SOLO 11 Dupilumab – SOLO 21 Dupilumab – P2b2 Efficacy IGA: Score of 0 to 1, “Clear” or “Almost Clear” 38% vs. 10%  36% vs. 8% 30% vs. 2% Improvement in EASI Score 72% vs. 38% 67% vs. 31% 71% vs. 20% EASI-50 69% vs. 25% 65% vs. 22% 78% vs. 30% EASI-75 51% vs. 15% 44% vs. 12% 53% vs. 12% EASI-90 36% vs 8% 30% vs. 7% 30% vs. 3% Pruritus Improvement (NRS): > 4 point Improvement 41% vs. 12% 36% vs. 10% NR % change in Peak Weekly Averaged Pruritus NRS 51% vs. 27% 47% vs. 18% 46% vs. 0.4% Safety and Tolerability Serious AE % AEs > 1% Incidence Serious AEs: 3% vs. 5% Injection Site Reaction: 10% vs. 5% Conjunctivitis: 10% vs. 2% Oral Herpes: 4% vs. 2% Oral Herpes simplex virus infection: 2% vs. 1% Data reported under SOLO 1 is combined safety from SOLO 1 and SOLO2 Serious AEs: 2% vs. 7% Injection Site Reaction: NR Conjunctivitis: 5% vs. 3% Oral Herpes: 5% vs. 0% Oral Herpes simplex virus infection: 3% vs. 0% Dosing Dosing Frequency and Loading loading dose of 2 injections (600mg) followed by a maintenance dose of 1 injection (300mg) given every two weeks (Q2W) loading dose of 2 injections (600mg) followed by a maintenance dose of 1 injection (300mg) given every two weeks (Q2W) loading dose of 2 injections (600mg) followed by a maintenance dose of 1 injection (300mg) given every two weeks (Q2W) 1. NEJM 2016;375:2335-48, 2. Lancet 2016; 387; 40-52


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Conclusions These data suggest that taking a selective approach to addressing IL-13 inhibition with lebrikizumab may be the best approach to treating AD Based on the compelling efficacy results observed, lebrikizumab may have the potential to be a truly differentiated therapy and may offer a best-in-disease treatment option for patients living with AD These data suggest that lebrikizumab may also be differentiated on its safety, tolerability and dosing profile Plan to have End-of-Phase 2 meeting with FDA and initiate Phase 3 program by end of 2019


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Thank You Company Contact: Ian Clements, PhD ian.clements@dermira.com ©2019 Dermira, Inc. All rights reserved. “Dermira” is a registered trademark in the United States and other countries. A trademark application for “Dermira” and logo is pending in the United States. All other service marks, trademarks and tradenames appearing in this presentation are the property of their respective owners. Solely for convenience, the trademarks and tradenames referred to in this presentation appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to these trademarks and tradenames. The information herein is for informational purposes only and represents the current view of Dermira, Inc. as of the date of this presentation (or as of an earlier date if specifically noted).