INVIVYD Q1 2024 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS
May 9, 2024
© 2024 Invivyd, Inc. Invivyd , Pemgarda , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS | |
This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not | |
statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "seek," "could," "intend," "target," "aim," "project," | |
"designed to," "estimate," "believe," "predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, | |
though not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning, among other things, PEMGARDA as a | |
monoclonal antibody (mAb) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise; our plans, strategy and | |
expectations related to the launch and commercialization of PEMGARDA; our intention to pursue a rapid immunobridging pathway to potential Emergency Use Authorization (EUA) for | |
COVID-19 treatment in certain immunocompromised people; our anticipated submission of a COVID-19 treatment EUA request to the U.S. Food and Drug Administration (FDA) for | |
pemivibart, and the timing thereof; our belief that pemivibart has the potential to offer Invivyd's first, one-time, outpatient, long-actingCOVID-19 treatment, if authorized; the potential of | |
VYD222 for clinical protection from symptomatic COVID-19 based on interim exploratory data from the CANOPY Phase 3 clinical trial; the future of the COVID-19 landscape; our | |
expectations about the size of target patient populations and the potential market opportunity for our product candidates, as well as our market position; our research and clinical | |
development efforts, including statements regarding initiation or completion of studies or trials, the time-frame during which results may become available, and the potential utility of | |
generated data; potential alignment of our strategy and the evolving U.S. regulatory landscape; our expectation regarding a repeatable, low-cost pathway for novel molecules with | |
anticipated improved profiles over pemivibart; the potential of our SARS-CoV-2 variant tracking and analysis capabilities; our expectations regarding advancement of our pipeline and | |
anticipated improved pharmaceutical profiles; the company's anticipated 2024 net product revenue and projected 2024 year-end cash position; our business strategies and objectives, | |
and ability to execute on them; our future prospects; and other statements that are not historical fact. We may not actually achieve the plans, intentions or expectations disclosed in our | |
forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could | |
cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: how long the EUA granted by the | |
FDA for PEMGARDA for COVID-19 PrEP in certain adults and adolescents with moderate-to-severe immune compromise will remain in effect and whether such EUA is revoked or revised | |
by the FDA; our ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; our | |
ability to effectively utilize an immunobridging pathway to potential EUA for pemivibart for COVID-19 treatment in certain immunocompromised people; whether we are able to | |
successfully submit a COVID-19 treatment EUA request to the FDA, and the timing, scope and outcome of any such EUA request; uncertainties related to the regulatory authorization or | |
approval process; changes in the regulatory environment; the timing, progress and results of our discovery, preclinical and clinical development activities; unexpected safety or efficacy | |
data observed during preclinical studies or clinical trials; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of PEMGARDA or any other product | |
candidate following regulatory authorization or approval; the predictability of clinical success of our product candidates based on neutralizing activity in preclinical studies; the risk that | |
results of preclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; our reliance on third parties with respect to virus assay | |
creation and product candidate testing and with respect to our clinical trials; variability of results in models used to predict activity against SARS-CoV-2 variants; whether PEMGARDA or | |
any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the complexities of | |
manufacturing mAb therapies; our dependence on third parties to manufacture, label, package, store and distribute clinical and commercial supplies of our product candidates; whether | |
we are able to provide sufficient commercial supply of PEMGARDA to meet market demand; whether we can obtain and maintain third-party coverage and adequate reimbursement for | |
PEMGARDA or any other product candidate; the ability of our SARS-CoV-2 variant tracking and analysis capabilities to effectively enable epitope surveillance and intelligent mAb | |
selection in addition to surveillance of emergent SARS-CoV-2 lineages; whether we are able to achieve high potency and/or variation resistance with our future product pipeline; any | |
litigation and other proceedings or government investigations relating to the company; our ability to continue as a going concern; our ability to optimize operating expenses; and | |
whether we have adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause our actual results to differ materially from | |
those expressed or implied in the forward-looking statements in this presentation are described under the heading "Risk Factors" in our most recent Annual Report on Form 10-K for the | |
year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC), and in our other filings with the SEC, and in our future reports to be filed with the SEC and | |
available at www.sec.gov. Forward-looking statements contained in this presentation are made as of this date, and we undertake no duty to update such information whether as a result | |
of new information, future events or otherwise, except as required under applicable law. | 2 |
AGENDA
- Introduction/Overview
- Financials
• PEMGARDA EUA & Commercial Launch
- CANOPY Clinical Data
- Pathway to Potential Treatment EUA
- Variant Monitoring & Predictive Modeling
- Product Pipeline
- Q&A
3
INVIVYD HAS ENTERED A TRANSFORMATIONAL PERIOD OF GROWTH
- Invivyd has been built to address the unique challenges presented by SARS-CoV-2, and potentially other viruses in the future
- We are pioneering a still brand-newapproach to antibody therapeutics and prophylactics, starting with SARS-CoV-2
- Our strategy is to combine the potential for high efficacy and attractive safety of monoclonal antibodies (mAbs) targeting the SARS-CoV-2 spike protein with the opportunity for product evolution commonly seen in the vaccine space
- The U.S. FDA's recent emergency use authorization (EUA) of PEMGARDA for pre- exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and our opportunity to pursue a rapid immunobridging pathway to a potential EUA for treatment of mild-to-moderateCOVID-19 in certain immunocompromised people, represent growing alignment between our strategy and the evolving U.S. regulatory landscape
4
FINANCIALS
Cash and cash equivalents were $189.4 million as of March 31, 2024
Invivyd is maintaining its existing guidance of $150-$200 million in anticipated 2024 PEMGARDA net product revenue and year-end cash guidance of at least $75 million in cash and cash equivalents
- Previously issued guidance was based on PEMGARDA being authorized for PrEP of COVID-19 in certain immunocompromised people and did not contemplate any potential sales for COVID-19 treatment, if authorized, or inventory build that may be required to deliver medicine timely to patients in need
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PEMGARDA EUA MAKES AN IMPORTANT THERAPY AVAILABLE TO CERTAIN PATIENTS & PROVIDES PROOF-OF-CONCEPT FOR PLATFORM
PEMGARDA has not been approved, but has been authorized for emergency use by FDA under an emergency use authorization (EUA), for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.
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INVIVYD IS RAPIDLY EXECUTING ON ITS COMMERCIAL STRATEGY
Product
Availability
- Publish WAC in pricing compendia
- Make product available for order through major distributors
- Receive and ship first order
√
√
IP
IP
Securing
Reimbursement
& Access
Deploy national account managers focused on payor engagement
Obtain HCPCS code from CMS and associated coverage
Secure inclusion in institutional formularies, as needed
Obtain coverage from major commercial payors
√
√
√
Full Commercial
Implementation
Fully deploy contracted Key Account Managers (KAMs)
Activate targeted awareness campaigns
Account reordering
Expand utilization within authorized population
WAC: Wholesale acquisition cost; HCPCS: Healthcare Common Procedure Coding System; CMS: U.S. Centers for Medicare & Medicaid Services; IP: In process
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THE PEMGARDA EUA FOR PRE-EXPOSURE PROPHYLAXIS IS BASED ON AN IMMUNOBRIDGING CLINICAL TRIAL (CANOPY)
CANOPY CLINICAL TRIAL OVERVIEW
VYD222 4500 mg IV (n≈300)
COHORT A
Moderate-to-severe immuneOpen Label compromise (N≈300)
Primary endpoints:
- Safety/tolerability
-
Day 28 serum virus neutralizing antibody (sVNA) titers (calculated from the pharmacokinetic
concentrations of VYD222 and the EC50 value for VYD222 against relevant SARS-CoV-2 variants)
Day 1
(Dosing)
// | |||
Month 3 | Month 12 | ||
(Redosing) | (Last visit) |
VYD222 4500 mg IV (n≈300) | ||||||
COHORT B | ||||||
At risk of SARS-CoV-2 exposure | 2:1 Randomization | |||||
// | ||||||
due to regular unmasked indoor | ||||||
Day 1 | Month 3 | Month 12 | ||||
interactions (N≈450) | ||||||
(Dosing) | (Redosing) | (Last visit) | ||||
Primary endpoint: | Placebo IV (n≈150) | |||||
• Safety/tolerability |
Source: F: NCT06039449; IV, intravenous; SAEs, serious adverse events; AEs, adverse events
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SVNA TITERS & EXPLORATORY EFFICACY DATA FROM IMMUNOCOMPROMISED COHORT IN CANOPY CLINICAL TRIAL
Cohort A - Calculated VYD222 sVNA titers against JN.1 based on observed PK concentration by timepoints
Additional exploratory COVID-19 clinical | |
Proportion of participants with | event data anticipated mid-year 2024 |
confirmed symptomatic COVID-19 | While the PEMGARDA EUA was based on |
through Day 90 (exploratory data): | |
immunobridging data from Cohort A, the | |
1% (3/298) | exploratory event data are expected to be |
hypothesis generating for future studies in | |
terms of dose and titers |
Notes: The interim exploratory COVID-19 clinical event data shown were not used for the basis of the EUA nor referenced in the PEMGARDA Fact Sheet. Beyond this interim update, additional cases of confirmed symptomatic COVID-19 have occurred in Cohort A post Day 90.
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INTERIM EXPLORATORY DATA FROM CANOPY CLINICAL TRIAL
While not part of the primary immunobridging endpoint of the CANOPY clinical trial, interim exploratory data may be hypothesis generating for future Invivyd discovery and development work
Cohort B (Randomized, placebo-controlled cohort without moderate-to-severe immune compromise at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions) - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19:
As of Dec 1, 2023 | Through Day 90 | |
(median 67 days follow-up) | ||
Pemivibart | 0% (0/322) | 0.3% (1/314) |
Placebo | 3% (5/162) | 5% (8/159) |
Relative Risk Reduction | 100% | 94% |
Cohort A (Open-label cohort with moderate-to-severe immune compromise) - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19:
As of Dec 1, 2023 | Through Day 90 | |||||
(median 35 days follow-up) | ||||||
Pemivibart | 0% (0/306) | 1% (3/298) | ||||
Notes: These are exploratory endpoints; these data were not used for the basis of the EUA nor referenced in the PEMGARDA Fact Sheet. Beyond this interim update, | ||||||
additional cases of confirmed symptomatic COVID-19 have occurred in Cohort A and Cohort B post Day 90. These data will be analyzed and presented at a later timepoint. | 10 |
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Invivyd Inc. published this content on 10 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 May 2024 04:50:08 UTC.