Apellis Pharmaceuticals (APLS) 2025 Conference May 27, 2025 02:30 PM ET Speaker0 Hey, good afternoon, everyone. I'm happy to have Appellis as the next fireside chat. So we have Cedric Francois with us, CEO and Tim Sullivan, CFO. And recognizing that you are a broader C3 complement inhibitor company, I am stating the obvious that this is an ophthalmology conference. And so maybe we can just start out and level set and talk about your ophthalmology franchise, the commercial prospects, the pipeline pursuits an ...

2 Second Quarter 2021 Financial Results Conference Call August 9, 2021 Apellis Participants CEDRIC FRANCOIS, M.D., Ph.D. Co-Founder & Chief Executive Officer ADAM TOWNSEND Chief Commercial Officer FEDERICO GROSSI, M.D., Ph.D. Chief Medical Officer TIM SULLIVAN Chief Financial Officer Forward-Looking Statements Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking stateme ...

DERBY and OAKS Phase 3 Top-Line Results Conference Call September 9, 2021 Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Apellis' interpretation of results from the OAKS and DER ...

Leaders in Complement January 2022 Forward-looking statements Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "wo ...

Group 1 - The market is highlighting the free cash flow (FCF) potential of Syfovre and Empaveli, with Syfovre projected to exceed $1 billion in annual sales despite initial rollout challenges due to infection reports [1] - The firm faced difficulties in launching Syfovre, but the outlook for its sales remains strong, indicating a recovery in market confidence [1] - A holistic investment approach is emphasized, considering both top-down and bottom-up valuation techniques, with a focus on capital structure and debt covenants impacting equity valuation [1]

Summary of Apellis Pharmaceuticals Conference Call Company Overview - **Company**: Apellis Pharmaceuticals (APLS) - **Event**: Bank of America Healthcare Conference - **Date**: May 13, 2025 - **Speakers**: Cedric Francois (CEO), Tim Sullivan (CFO) Key Points Industry Context - Discussion on the impact of recent executive orders related to drug pricing, particularly the "most favored nation" clause, which may affect Medicare pricing for Apellis' products [4][5][6] - Monitoring of tariff situations and their potential impact on gross margins [9] Product Insights - **Cyfoviry**: - Patients are responsible for approximately 20% copay, around $400 per injection [11][12] - A significant drop in funding from charitable foundations has affected patient access, leading to increased sample usage by physicians [14][15][19] - Despite challenges, there was a 4% quarter-over-quarter growth in patient treatments from Q4 to Q1 [19] - The company is only treating about 10% of the geographic atrophy patient population, indicating substantial unmet demand [20] Competitive Landscape - Apellis has gained market share against competitors, with a shift from 40% to 55% in new patients treated for Cyfoviry compared to 45% for the competitor [32][33] - Differentiation in efficacy and dosing frequency (every other month) is cited as a key driver for market share gains [34] Financial Health - Apellis ended the quarter with $358 million in cash, sufficient to reach profitability without needing to raise additional capital [45] Upcoming Launches - **C3G Program**: - Launch expected in August, targeting a patient population of approximately 5,000 [46][47] - Promising data showing 70% of patients had no trace of disease after six months of treatment [49] - Administered subcutaneously twice a week, similar to PNH [50] Future Directions - Plans to leverage learnings from previous product launches to ensure a strong market entry for C3G [56] - Ongoing development of a siRNA program in geographic atrophy, aiming to synchronize treatments for improved patient outcomes [58][59] - Two phase three trials in nephrology are set to begin in the second half of the year [60] Marketing and Awareness - A direct-to-consumer (DTC) campaign featuring Henry Winkler has shown early success in driving patient awareness and engagement [66][71] Guidance and Market Outlook - The company is cautious about providing sales guidance until after the C3G launch, given the recent challenges faced with Cyfoviry [62] Miscellaneous - Apellis has received recognition for its advertising campaigns, indicating effective marketing strategies [67][71] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting Apellis Pharmaceuticals' strategic positioning, product performance, and future growth potential in the biotech industry.

Core Viewpoint - Apellis Pharmaceuticals reported disappointing first-quarter 2025 results, with a wider loss per share and lower revenues than expected, leading to a significant drop in share price [1][2][5] Financial Performance - The company incurred a loss of 74 cents per share, exceeding the Zacks Consensus Estimate of a loss of 36 cents, and a loss of 54 cents in the same quarter last year [1] - Total revenues for the first quarter were $166.8 million, missing the Zacks Consensus Estimate of $192 million and down from $172.3 million in the prior year [1][2] - Syfovre sales were $130.2 million, a 5% decline year over year, and missed the Zacks Consensus Estimate of $156.9 million [3][4] - Empaveli recorded sales of $19.7 million, down 23% from the previous year, also missing estimates [7] Market Position and Product Performance - Syfovre is the market leader in geographic atrophy (GA) with over 60% market share, and new patient starts increased to 55% by late April [4] - The company delivered over 82,000 commercial vials and nearly 10,000 samples of Syfovre to doctors in the reported quarter [4] Revenue Streams and Expenses - Licensing and other revenues increased by 83% year over year to $16.9 million [8] - Research and development expenses rose by 2% to $86.4 million, while selling, general, and administrative expenses remained flat at $129.3 million [8] Cash Position - As of March 31, 2025, Apellis had cash, cash equivalents, and marketable securities totaling $358.4 million, down from $411.3 million at the end of 2024 [9] Pipeline Developments - Apellis is awaiting FDA decision on a supplemental new drug application for systemic pegcetacoplan, with a decision expected on July 28, 2025 [10][11] - The company plans to initiate two pivotal phase III studies of Empaveli in the second half of 2025 [12] - A mid-stage multi-dose study of siRNA candidate APL-3007 in combination with Syfovre is also planned for the second quarter of 2025 [13]

Core Insights - Apellis Pharmaceuticals, Inc. reported a revenue of $166.8 million for Q1 2025, reflecting a year-over-year decline of 3.2% and a significant EPS of -$0.74 compared to -$0.54 a year ago, indicating a worsening financial performance [1] - The revenue fell short of the Zacks Consensus Estimate of $192.44 million by 13.33%, and the EPS also missed the consensus estimate of -$0.36 by 105.56% [1] Revenue Breakdown - Product revenue was reported at $149.90 million, which is 8.1% lower than the year-ago quarter and below the average estimate of $181.79 million from 10 analysts [4] - Licensing and other revenue reached $16.90 million, exceeding the average estimate of $13.31 million and showing a year-over-year increase of 82.7% [4] - Specific product revenues included EMPAVELI at $19.73 million, below the average estimate of $23.67 million, and SYFOVRE at $130.17 million, which also fell short of the $156.94 million average estimate [4] Stock Performance - Over the past month, shares of Apellis Pharmaceuticals have returned +2.3%, underperforming compared to the Zacks S&P 500 composite's +10.6% change [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Financial Data and Key Metrics Changes - In Q1 2025, Cifovri net product revenue was $130 million, which was down due to inventory dynamics and funding shortages at third-party co-pay assistance programs [12][14][23] - Cifovri injection demand grew 4% quarter over quarter, indicating a positive trend in market demand despite revenue shortfalls [8][12] - The company ended Q1 2025 with $358 million in cash and cash equivalents, indicating a strong liquidity position to fund operations towards profitability [17] Business Line Data and Key Metrics Changes - Cifovri maintained over 60% market share in geographic atrophy, with new patient starts exceeding 50% in Q1 and reaching 55% by late April [9][17] - Empavedi generated $20 million in net product revenue in Q1, with high compliance rates of 97% and a consistent safety profile [23] - The supplemental NDA for Empavedi was accepted by the FDA with a PDUFA date of July 28, indicating a significant upcoming launch opportunity [10][11] Market Data and Key Metrics Changes - The geographic atrophy market is expected to see continued but modest growth, with Cifovri positioned as a market leader [9] - The U.S. commercial opportunity for C3G and iCMPGN is estimated at 5,000 patients, with expectations for Empavedi to be used across all patient groups [22] Company Strategy and Development Direction - The company aims to capitalize on strong physician demand for Cifovri and is preparing for the launch of Empavedi in C3G and iCMPGN [24] - Strategic initiatives include enhancing disease state awareness and ensuring seamless access to treatment upon approval [20][22] - The company is focused on maintaining financial discipline while driving revenue growth and delivering meaningful treatments to patients [24] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the market, including funding shortages impacting demand but expressed confidence in the long-term growth potential of Cifovri [6][8] - The company is optimistic about the upcoming launch of Empavedi and its potential to transform treatment in C3G and iCMPGN [24] - Management emphasized the importance of transitioning patients from samples to commercial doses to mitigate the impact of co-pay assistance program funding issues [113] Other Important Information - The company welcomed Craig Wheeler to its Board of Directors, highlighting his extensive experience in the biopharmaceutical industry [25] - The management is closely monitoring tariff situations and is prepared to take steps to mitigate any adverse impacts [17] Q&A Session Summary Question: Clarification on Q1 volume dynamics - Management clarified that Q1 saw a 4% growth in injections, with a drawdown of inventory impacting the number of vials delivered [30][34] Question: Expectations for copay assistance underfunding - Management does not expect the copay assistance underfunding issue to be resolved soon, but they are working to transition patients from samples to commercial doses [36][38] Question: Sales guidance considerations - Management indicated that they are not likely to provide sales guidance this year due to recent dynamics affecting the market [50][52] Question: Payer landscape post-label update - Management confirmed that Cifovri maintains preferred positioning with several large Medicare Advantage plans, and no significant changes were noted post-competitor label update [60] Question: Launch plans for C3G and ICMPGN - Management is actively profiling accounts and building relationships with key physician accounts in preparation for the launch of Empavedi [117]