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Apellis(APLS) - 2023 Q1 - Earnings Call Presentation
2023-05-06 14:55
First Quarter 2023 Financial Results Conference Call May 4, 2023 Apellis Participants C E D R I C F R AN C O I S , M . D . , P h . D . Co-Founder, President & Chief Executive Officer AD A M T O W N S E N D Chief Commercial Officer C AR O L I N E B AU M A L , M . D . Chief Medical Officer T I M O T H Y S U L L I VAN Chief Financial Officer 2 APELLIS PROPRIETARY INFORMATION / FOR APELLIS USE ONLY Forward-looking statements Statements in this presentation about future expectations, plans and prospects, as well ...
Apellis(APLS) - 2023 Q1 - Quarterly Report
2023-05-03 16:00
Financial Performance - For the three months ended March 31, 2023, the company generated $18.4 million in net product revenue from sales of SYFOVRE and $20.4 million from EMPAVELI, totaling $38.8 million in net product revenue [128][130]. - Product revenue for Q1 2023 reached $38.8 million, a 220% increase from $12.1 million in Q1 2022, driven by EMPAVELI and SYFOVRE sales [174]. - Total revenue for Q1 2023 was $44.8 million, up 212% from $14.4 million in Q1 2022 [173]. - The company incurred net losses of $177.8 million for the three months ended March 31, 2023, compared to $138.9 million for the same period in 2022, with an accumulated deficit of $2.5 billion [137]. - Net loss for Q1 2023 was $177.8 million, a 28% increase from a net loss of $138.9 million in Q1 2022 [173]. - Interest income surged to $5.4 million in Q1 2023, compared to $0.1 million in Q1 2022, reflecting higher money market rates [181]. Cash and Funding - As of March 31, 2023, the company had cash and cash equivalents of $765.1 million, which is expected to fund operations at least into the first quarter of 2025 [136]. - The company expects to fund operating expenses and capital expenditures at least into the first quarter of 2025, based on current cash and anticipated sales [203]. - The company has financed operations through $1.6 billion in net proceeds from public offerings and $535.8 million from convertible notes [186]. - Net cash used in operating activities was $177.6 million for the three months ended March 31, 2023, compared to $111.6 million for the same period in 2022 [197][199]. - Net cash provided by financing activities was $391.1 million during the three months ended March 31, 2023, primarily from a follow-on common stock offering [200][201]. - The company may need to seek additional funding to support ongoing commercialization and development activities [205]. Expenses and Costs - The company anticipates significant increases in expenses related to commercialization and ongoing clinical trials [138]. - Research and development expenses are expected to increase as product candidate development programs progress, with costs primarily related to employee expenses and third-party agreements [164][167]. - General and administrative expenses are anticipated to increase to support ongoing research and development activities and potential commercialization of product candidates [168]. - Research and development expenses increased by 21% to $110.0 million in Q1 2023, compared to $90.9 million in Q1 2022 [179]. - General and administrative expenses rose by 99% to $102.1 million in Q1 2023, up from $51.2 million in Q1 2022 [180]. - Cost of sales increased to $7.8 million in Q1 2023 from $1.2 million in Q1 2022, primarily due to higher product sales volume [176]. - Significant commercialization expenses are anticipated for the product manufacturing, marketing, and sales of EMPAVELI and SYFOVRE [202]. Product Development and Collaborations - The company launched SYFOVRE in the United States in March 2023, targeting a market of over one million people affected by geographic atrophy [128]. - The company expects a decision from the European Medicines Agency on the marketing authorization application for intravitreal pegcetacoplan in early 2024 [129]. - The company is co-developing systemic pegcetacoplan for five indications in collaboration with Sobi, including C3 glomerulopathy and amyotrophic lateral sclerosis [132]. - The company plans to advance additional product candidates into clinical development in 2023, including an oral alternative pathway inhibitor and a novel compound for GA and wet AMD [134]. - The company has a development funding agreement with SFJ Pharmaceuticals Group, which includes potential payments of up to $60.0 million upon achieving specified development milestones [139]. - The company received a total of $250.0 million upfront from Sobi under a collaboration agreement, with potential milestone payments of up to $915.0 million and reimbursement of up to $80.0 million in development costs [158]. - The company earned a $50.0 million payment from Sobi related to the first regulatory and reimbursement milestone in Europe in March 2022 [159]. Debt and Liabilities - The company recognized a total of $149.7 million in net debt increase and net equity reduction upon adopting ASU 2020-06, which included reclassifications from equity to debt for the Convertible Notes [151]. - The effective interest rate used to determine the liability component of the 2019 and 2020 Convertible Notes was 10.5%, resulting in liabilities of $145.1 million and $204.5 million for the respective notes [150]. - The company entered into exchange agreements in January 2021, July 2021, and July 2022, resulting in a reduction of net debt by $122.8 million, $197.0 million, and $96.8 million respectively, and an increase in shares outstanding by 3,906,869, 5,992,217, and 3,027,018 shares [152][155][156]. - The company may redeem all or a portion of the Convertible Notes for cash on or after September 20, 2023, if the last reported sale price of common stock has been at least 130% of the conversion price for at least 20 trading days [148]. Market and Revenue Recognition - Product revenues are derived from sales of EMPAVELI and SYFOVRE in the United States, with revenue recognized upon satisfying performance obligations [160][161]. - Licensing and other revenue for Q1 2023 was $6.0 million, up from $2.3 million in Q1 2022, driven by product supply and royalty revenue from Sobi [175]. - The company expects continued impact on cost of sales as remaining pre-FDA approval inventory is sold [178]. - The company is closely monitoring credit risk related to deposits, particularly following the closure of Silicon Valley Bank, which held approximately 20% of the company's total cash [195]. - An immediate 10% change in interest rates would not have a material effect on the fair market value of the company's investment portfolio due to its low risk profile [208].
Apellis Pharmaceuticals (APLS) Presents at the Association for Research in Vision and Ophthalmology Annual Meeting - Slideshow
2023-05-01 10:41
Assessment of geographic atrophy progression in the phase 3 OAKS and DERBY trials Allen Chiang, Sujata Sarda, Mark Burch, Min Tsuboi, Daniel Jones, and Ramiro Ribeiro The Association for Research in Vision and Ophthalmology Annual Meeting New Orleans, USA April 23–27, 2023 Phase 3 OAKS and DERBY trials: Design and key criteria Patients with GA secondary to AMD 1258 patients at 232 sites combined Randomized 2:2:1:1 Pegcetacoplan monthly (N=419) Pegcetacoplan EOM (N=420) Sham monthly (N=208) Sham EOM (N=211) ...
Apellis(APLS) - 2022 Q4 - Annual Report
2023-02-20 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38276 | --- | --- | --- | |----------------------------------------------------------------------------|----------------------------- ...
Apellis(APLS) - 2022 Q3 - Earnings Call Transcript
2022-11-08 06:26
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q3 2022 Earnings Conference Call November 7, 2022 4:30 PM ET Company Participants Adam Townsend - Chief Commercial Officer Cedric Francois - Co-Founder, President & Chief Executive Officer Federico Grossi - Co-Founder & Chief Medical Officer Meredith Kaya - Senior Vice President, Investor Relations & Strategic Finance Timothy Sullivan - Chief Financial Officer Conference Call Participants Tazeen Ahmad - BAML Jon Miller - Evercore Anupam Rama - JPMorgan Philip Nade ...
Apellis(APLS) - 2022 Q3 - Quarterly Report
2022-11-06 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section covers the unaudited financial statements, management's analysis, market risk, and internal controls [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) For the nine months ended September 30, 2022, Apellis Pharmaceuticals reported total revenues of **$52.8 million**, a significant increase from **$6.3 million** in the prior year period, driven by EMPAVELI product sales, resulting in a net loss of **$486.2 million**, an improvement from **$598.4 million** in 2021, with **$708.6 million** in cash and equivalents and an accumulated deficit of **$2.1 billion** [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet highlights key financial positions including assets, liabilities, and equity as of September 30, 2022, and December 31, 2021 Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2022 (Unaudited) | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $584,189 | $640,192 | | Marketable securities | $124,364 | $60,358 | | Total current assets | $831,937 | $824,047 | | Total assets | $872,892 | $881,765 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $115,446 | $131,847 | | Long-term development liability | $340,142 | $345,151 | | Convertible senior notes | $92,663 | $189,024 | | Total liabilities | $565,476 | $683,103 | | Accumulated deficit | $(2,142,869) | $(1,656,688) | | Total stockholders' equity | $307,416 | $198,662 | [Condensed Consolidated Statements of Operations and Comprehensive Income/(Loss)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%2F(Loss)) This statement details the company's revenues, expenses, and net loss for the three and nine months ended September 30, 2022 and 2021 Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | 9 Months 2022 | 9 Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $17,676 | $5,314 | $45,439 | $5,937 | | Total revenue | $22,056 | $5,650 | $52,759 | $6,273 | | Research and development | $95,207 | $87,733 | $287,813 | $267,688 | | General and administrative | $78,406 | $45,763 | $192,795 | $135,309 | | Total operating expenses | $174,994 | $133,645 | $483,319 | $453,146 | | Net operating loss | $(152,938) | $(127,995) | $(430,560) | $(446,873) | | Net loss | $(191,269) | $(195,571) | $(486,181) | $(598,421) | | Net loss per share | $(1.75) | $(2.28) | $(4.65) | $(7.31) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes cash flows from operating, investing, and financing activities for the nine months ended September 30, 2022 and 2021 Cash Flow Summary for the Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(373,001) | $(450,627) | | Net cash (used in)/provided by investing activities | $(64,236) | $162,636 | | Net cash provided by financing activities | $381,605 | $8,278 | | Net decrease in cash, cash equivalents and restricted cash | $(56,307) | $(281,737) | | Cash, cash equivalents and restricted cash at end of period | $585,448 | $285,308 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies and events, including the company's liquidity position, deemed sufficient for at least the next twelve months - The company believes its cash, cash equivalents, and marketable securities of **$708.6 million** as of September 30, 2022, are sufficient to fund operations and capital expenditures for at least the next twelve months[33](index=33&type=chunk) Product Revenue, Net (in millions) | Period | Revenue | | :--- | :--- | | Three months ended Sep 30, 2022 | $17.7 | | Three months ended Sep 30, 2021 | $5.3 | | Nine months ended Sep 30, 2022 | $45.4 | | Nine months ended Sep 30, 2021 | $5.9 | - The development liability to SFJ Pharmaceuticals, related to funding for pegcetacoplan, stood at a carrying value of **$356.3 million** as of September 30, 2022, with payments due through 2027[54](index=54&type=chunk)[47](index=47&type=chunk)[48](index=48&type=chunk) - Through a series of exchange agreements in 2021 and 2022, the company significantly reduced its convertible debt, with the aggregate principal balance of Convertible Notes held by third parties at **$92.7 million** as of September 30, 2022[70](index=70&type=chunk)[77](index=77&type=chunk) - Under the Sobi collaboration, Apellis is entitled to tiered, double-digit royalties on ex-U.S. sales and up to **$915.0 million** in milestone payments, recognizing **$1.6 million** in royalty revenue for the nine months ended September 30, 2022[106](index=106&type=chunk)[112](index=112&type=chunk) - The company has non-cancelable purchase obligations of up to **$112.1 million** for pegcetacoplan drug substance and components with its manufacturing partners[122](index=122&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights the successful commercialization of EMPAVELI® for PNH, generating **$45.4 million** in net product revenue, and the advancement of intravitreal pegcetacoplan for Geographic Atrophy (GA) with an NDA under priority review [Overview](index=25&type=section&id=Overview) This overview discusses the commercialization of EMPAVELI®, the progress of intravitreal pegcetacoplan for GA, and future pipeline plans - EMPAVELI® (pegcetacoplan) was approved by the FDA in May 2021 for Paroxysmal Nocturnal Hemoglobinuria (PNH) and generated **$45.4 million** in net product revenue for the nine months ended September 30, 2022[134](index=134&type=chunk) - The company submitted a New Drug Application (NDA) to the FDA for intravitreal pegcetacoplan for Geographic Atrophy (GA) in June 2022, granted priority review, with an amendment expected to extend the PDUFA target action date to February 2023[136](index=136&type=chunk)[138](index=138&type=chunk) - The collaboration with Sobi for systemic pegcetacoplan covers ex-U.S. commercialization and co-development for multiple indications, including C3G, IC-MPGN, ALS, CAD, and HSCT-TMA[135](index=135&type=chunk)[139](index=139&type=chunk)[148](index=148&type=chunk) - The company plans to advance up to three new product candidates into clinical development in 2023, including a siRNA treatment, an oral alternative pathway inhibitor, and a novel compound for both GA and wet AMD[153](index=153&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) This section analyzes the changes in total revenue, operating expenses, and net loss for the three and nine months ended September 30 Comparison of Results for the Three Months Ended September 30 (in thousands) | Line Item | 2022 | 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $22,056 | $5,650 | $16,406 | 290% | | Research and development | $95,207 | $87,733 | $7,474 | 9% | | General and administrative | $78,406 | $45,763 | $32,643 | 71% | | Net loss | $(191,269) | $(195,571) | $4,302 | (2%) | Comparison of Results for the Nine Months Ended September 30 (in thousands) | Line Item | 2022 | 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $52,759 | $6,273 | $46,486 | 741% | | Research and development | $287,813 | $267,688 | $20,125 | 8% | | General and administrative | $192,795 | $135,309 | $57,486 | 42% | | Net loss | $(486,181) | $(598,421) | $112,240 | (19%) | - The **71% increase** in G&A expenses for Q3 2022 versus Q3 2021 was primarily driven by a **$15.7 million** increase in employee-related costs and a **$15.1 million** increase in professional fees and commercial preparation activities[186](index=186&type=chunk) - R&D expenses for Q3 2022 increased by **9%** year-over-year, mainly due to a **$12.3 million** rise in compensation costs, partially offset by an **$8.9 million** decrease in clinical trial costs following the completion of the Phase 3 DERBY and OAKS trials[185](index=185&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) This section details the company's cash position and management's assessment of its ability to fund future operations - As of September 30, 2022, the company had cash, cash equivalents, and marketable securities totaling **$708.6 million**[156](index=156&type=chunk) - Management believes current cash reserves, along with anticipated revenue and committed payments from Sobi, will fund operations at least into the first quarter of 2024[156](index=156&type=chunk)[224](index=224&type=chunk) - Net cash used in operating activities for the nine months ended September 30, 2022, was **$373.0 million**, a decrease from **$450.6 million** in the prior year period[215](index=215&type=chunk)[216](index=216&type=chunk) - Net cash provided by financing activities was **$381.6 million** for the nine months ended September 30, 2022, primarily from a follow-on common stock offering in March 2022 that raised net proceeds of **$380.1 million**[212](index=212&type=chunk)[221](index=221&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to interest rate sensitivity on its **$708.6 million** portfolio of cash, cash equivalents, and marketable securities - The company's market risk is primarily related to interest rate changes affecting its cash, cash equivalents, and marketable securities portfolio of **$708.6 million** as of September 30, 2022[230](index=230&type=chunk) - Due to the short-term and low-risk nature of its investments, the company does not expect changes in market interest rates to have a significant impact on its operating results or cash flows[230](index=230&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation as of September 30, 2022, the company's Chief Executive Officer and Chief Financial Officer concluded that the disclosure controls and procedures were effective at a reasonable assurance level - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of September 30, 2022[233](index=233&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the third quarter of 2022[234](index=234&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section includes additional disclosures such as risk factors, other required information, and a list of exhibits [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) The company directs investors to the risk factors discussed in its Annual Report on Form 10-K for the year ended December 31, 2021 - The report refers to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2021, for a comprehensive understanding of potential risks[236](index=236&type=chunk) [Other Information](index=38&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item for the reporting period - There is no information to report under this item[237](index=237&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, which include forms of exchange agreements, CEO and CFO certifications, and various XBRL data files - Exhibits filed with the report include CEO/CFO certifications (31.1, 31.2, 32.1, 32.2) and Inline XBRL data files[239](index=239&type=chunk)
Apellis(APLS) - 2022 Q2 - Earnings Call Transcript
2022-08-09 02:22
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q2 2022 Earnings Conference Call August 8, 2022 4:30 PM ET Company Participants Meredith Kaya - SVP, IR & Strategic Finance Adam Townsend - Chief Commercial Officer Cedric Francois - Co-Founder, President, CEO & Director Timothy Sullivan - CFO & Treasurer Federico Grossi - Chief Medical Officer Conference Call Participants Madhu Kumar - Goldman Sachs Group Umer Raffat - Evercore Anupam Rama - JPMorgan Tazeen Ahmad - Bank of America Lyla Youssef - Cowen Steven Seed ...