First Quarter 2024 Financial Results Conference Call
May 7, 2024
Apellis Participants
C E D R I C F R A N C O I S , M . D . , P h . D .
Co-Founder, President & Chief Executive Officer
A D A M T O W N S E N D
Chief Operating Officer
C A R O L I N E B A U M A L , M . D .
Chief Medical Officer
T I M O T H Y S U L L I VA N
Chief Financial Officer
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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. These statements include, but are not limited to, statements regarding the expected timing of clinical data, the review of the marketing authorization application of SYFOVRE by the EMA. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements
contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the benefit/risk profile of SYFOVRE following the events of retinal vasculitis will impact the Company's commercialization efforts; whether SYFOVRE will receive approval from foreign regulatory agencies for GA when expected or at all, including the impact of the reported events of retinal vasculitis on the likelihood and timing of such approvals; whether the Company's clinical trials will be completed when anticipated; whether results obtained in clinical trials will be indicative of results that will be generated in future clinical trials; whether pegcetacoplan will successfully advance through the clinical trial process on a timely basis, or at all; whether the results of the Company's clinical trials will warrant regulatory submissions and whether systemic pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for C3G and IC-MPGN or any other indication when expected or at all; the period for which the Company believes that its cash resources will be sufficient to fund its operations; and other factors discussed in the "Risk Factors" section of Apellis' Annual Report on Form 10-K with the Securities and Exchange Commission on February 27, 2024 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this presentation speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Strong start to 2024
On track to become multi-billion-dollar U.S. product
- ~$137.5M in 1Q 2024 U.S. net product revenue, a 20% increase QoQ
- ~250,000 injections estimated through March 2024 (including clinical trials)
- Expect CHMP opinion for EU MAA no later than July 2024
Transforming SOC for patients with PNH
- ~$25.6M in 1Q 2024 U.S. net product revenue
- 97% compliance rate
C3G/IC-MPGN topline Phase 3 results expected in mid-2024
Encouraging early research on EMPAVELI's role
in xenotransplant surgeries
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SYFOVRE is #1 chosen GA treatment in the U.S.
✓ ~77k SYFOVRE doses delivered to ECPs in 1Q
20241
✓ ~250k SYFOVRE injections estimated to have
been administered as of March 2024 (incl. clinical trials)2
✓ Double-digit number of new sites each week1
✓ Estimated rate of vasculitis remains rare at | |
approximately 1:10,000, or 0.01%, per injection | SANTI |
Living with GA |
1. ECP vial shipment data on file. 2. Data on file as of March 2024. Injections are calculated based on 1) vials distributed to eyecare professional (ECP) | 5 |
practices and 2) estimates of patient numbers extrapolated from licensed data and inventory levels from key accounts, represe ntative of our market. |
GA market opportunity is large and growing
Up to 1.5M
GA patients estimated in U.S.
GA patients
currently diagnosed
and in ECP office
Treated GA patients
(as of March 2024) | 6 |
Executing the next stage of SYFOVRE commercial strategy
PHYSICIANS
- Increase reach within existing ECP target users
- Expand use among those ECP targets who have not used SYFOVRE yet
- Further educate other referring eyecare providers
PATIENTS
Now Launched!
SYFOVRE Branded Direct-to-Consumer
Patient Campaign
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EMPAVELI continues to elevate the standard of care in PNH
As of March 31, 2024:
- $25.6 million in 1Q 2024 U.S. net product sales
- ~97% patient compliance rate
- Continued strong safety profile, with zero
cases of meningococcal infection and low thrombosis rates
ASHLEY
Living with PNH
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C3G and IC-MPGN: two debilitating kidney diseases
- Rare kidney diseases with no approved therapies
- Progress to kidney failure in ~50% of patients within 5-10 years of diagnosis
- Leads to kidney transplant or lifelong dialysis, neither curative
- ~5,0001 people with C3G/IC-MPGN in U.S.
Chase
Living with C3G
1. Based on moderate & severe patient population. C3G: ClearView Analysis using physician and literature consensus | 9 |
VALIANT Phase 3 study: top-line data expected mid-2024
Primary endpoint
readout
Up to 10 weeks
Screening
Standard of Care (SOC)
(n=124)
26 weeks
Randomized, double-blindplacebo-controlled period
Group 1 (n=62)
Pegcetacoplan + SOC
SC infusion, twice weekly
Group 2 (n=62)
Placebo + SOC
26 weeks
Open-label period
Group 1 + 2 (n=124)
Pegcetacoplan +
SOC
SC infusion, twice weekly
8 weeks
Follow-up*
Wash
Out
VALE extension study
Population: Patients 12 years+ with C3G or primary
IC-MPGN pre- and post- transplant and evidence of active renal disease.
Primary endpoint: Log- transformed ratio of protein- to-creatinineratio (uPCR) at week 26 vs. baseline.
Secondary endpoints:
Change in kidney function measured by eGFR. Reduction in C3 staining. Patient reported fatigue and QOL.
*Subjects entering VALE, the planned long -term extension study, will not complete the follow -up period. | 10 |
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Apellis Pharmaceuticals Inc. published this content on 07 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 May 2024 12:44:04 UTC.