CORPORATE PRESENTATION - February 2021 - Investor Relations ...
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CORPORATE PRESENTATION
February 2021
1 © 2021 Progenity, Inc. All rights reserved.
FORWARD-LOOKING STATEMENTS
This presentation contains “forward-looking statements” within the meaning of the federal We cannot assure you that we will realize the results, benefits or developments that we
securities laws, which statements are subject to substantial risks and uncertainties and are expect or anticipate or, even if substantially realized, that they will result in the consequences
based on estimates and assumptions. All statements, other than statements of historical facts or affect us or our business in the way expected. Forward-looking statements are not
included in this presentation, including statements concerning our plans, objectives, goals, historical facts, and reflect our current views with respect to future events. Given the
strategies, future events, future revenues or performance, financing needs, plans or intentions significant uncertainties, you should evaluate all forward-looking statements made in this
relating to product candidates, estimates of market size, estimates of market growth, presentation in the context of these risks and uncertainties and not place undue reliance
business trends, expected testing supply and demand, the anticipated timing, design and on these forward-looking statements as predictions of future events. All forward-looking
conduct of our planned clinical trials, the development of our product candidates, including statements in this presentation apply only as of the date made and are expressly qualified
the timing and likelihood of regulatory filings and approvals for our product candidates, our in their entirety by the cautionary statements included in this presentation. We disclaim any
ability to commercialize our product candidates, if approved, the pricing and reimbursement intent to publicly update or revise any forward-looking statements to reflect subsequent
of our product candidates, if approved, the potential to develop future product candidates, events or circumstances, except as required by law.
the potential benefits of strategic collaborations and our intent to enter into any strategic
arrangements, the timing and likelihood of success, plans and objectives of management for Industry and Market Data: We obtained the industry, market, and competitive position data
future operations and future results of anticipated product development efforts, are forward- used throughout this Presentation from our own internal estimates and research, as well as
looking statements. In some cases, you can identify forward-looking statements by terms from industry and general publications, and research, surveys, and studies conducted by
such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” third parties. Internal estimates are derived from publicly available information released by
“expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of industry analysts and third-party sources, our internal research and our industry experience,
these terms, and similar expressions intended to identify forward-looking statements. These and are based on assumptions made by us based on such data and our knowledge of the
statements involve known and unknown risks, uncertainties and other factors that could industry and market, which we believe to be reasonable. In addition, while we believe the
cause our actual results to differ materially from the forward-looking statements expressed or industry, market, and competitive position data included in this prospectus is reliable and
implied in this presentation, including those described in “Risk Factors” and “Management’s based on reasonable assumptions, we have not independently verified any third-party
Discussion and Analysis of Financial Condition and Results of Operations” in our Quarterly information, and all such data involve risks and uncertainties and are subject to change based
Report on Form 10-Q for the quarter ended September 30, 2020, and elsewhere in such on various factors. These and other factors could cause results to differ materially from those
filings and in other subsequent disclosure documents filed with the U.S. Securities and expressed in the estimates made by the independent parties and by us.
Exchange Commission (SEC).
2 © 2021 Progenity, Inc. All rights reserved.
SUPPORTING WOMEN ON THEIR HEALTH JOURNEY
Helping healthcare providers and patients make informed medical decisions
Preconception Pregnancy Post-reproductive
10 weeks 28 weeks
Screen for
chromosomal disorders
Test for genetic diseases that parents can carry and pass on to their children
Custom, noninvasive prenatal test for single-gene disorders
Steps 1 & 2: Evaluation & verification Step 3: Prenatal test
Preeclampsia
rule-out test
Test for hereditary cancer risk Test for hereditary cancer risk
* In development
3 © 2021 Progenity, Inc. All rights reserved.
2020 CORPORATE HIGHLIGHTS
CONTINUED IN-NETWORK INVESTED IN KEY REACHED PREECLUDIA
TRANSITION INITIATIVES TEST MILESTONE
Added new networks to Customer experience and Completed analytical
reach 146M covered lives revenue cycle management and clinical verification
LAUNCHED ACHIEVED INNATAL 4 ESTABLISHED PHARMA PARTNERSHIP
COVID-19 TESTING DEVELOPMENT MILESTONE FOR PRECISION MEDICINE
Expanded PCR testing to 49 Demonstrated fetal Continued engagement for
states; 24% volume growth in Q4 fraction quantification further potential partnerships
and finalized probe pool
4 © 2021 Progenity, Inc. All rights reserved.
2021: POTENTIAL CATALYSTS FOR CONTINUED GROWTH & INNOVATION
CORE BUSINESS INITIATIVES
REVENUE CYCLE MANAGEMENT
Continue improvements
to maximize revenues
HEALTH PLANS
Continue in-network
transition and expand INNATAL 4
covered lives VALIDATION
AVERAGE-RISK NIPT Targeting
Increase penetration into completion of
NIPT average-risk market PREECLUDIA
clinical validation
as coverage improves Targeting
WOMEN’S completion of
of non-sequencing
HEALTH clinical validation
NIPT to achieve
Core business lower direct COGS
and initiate
anticipated PHARMA PARTNERSHIPS commercial launch
and faster TAT
to return to Seeking to establish additional
strong growth key partnerships for GI Precision
Medicine programs
CLINICAL STUDIES
Launching pre-clinical and clinical studies for GI Precision Medicine
programs; key performance data expected beginning in1H ‘21 INNOVATION INITIATIVES
5 © 2021 Progenity, Inc. All rights reserved.TOTAL ADDRESSABLE MARKETS: A MULTIBILLION DOLLAR OPPORTUNITY
Our platforms, products, and product candidates address markets valued at >$99 billion
with significant growth potential
TOTAL ADDRESSABLE MARKETS (BILLIONS)
U.S. MULTI-GENE CARRIER TESTING $1.0 Current Markets DIAGNOSTICS
Future Markets
U.S. NIPT $1.5+
GLOBAL HEREDITARY CANCER TESTING $4.5
U.S. PREECLAMPSIA $3.0
EPIGENETICS PLATFORM
$13.0+
(E.G. ONCOLOGY, NASH)
U.S. SIBO $36.0
GI TARGETED TOPICAL IBD
$15.0+
THERAPEUTIC DELIVERY Large potential beyond
targeted drugs
ORAL BIOTHERAPEUTICS* $25.0+ THERAPEUTICS
Source: Statistica, Global Data, Myriad Genetics, Natera, Invitae. Market size estimates do not include all applications for individual platforms. NASH market size estimate for 2025; hereditary cancer market size estimate for 2020.
* Monoclonal antibodies only, global biologics market >$250B
6 © 2021 Progenity, Inc. All rights reserved.MOLECULAR TESTING 7 © 2021 Progenity, Inc. All rights reserved.
HIGH PERFORMANCE PRODUCTS AND EXCEPTIONAL CUSTOMER EXPERIENCE
Specifically tailored to the OB/GYN, MFM, and Reproductive Medicine markets
Highest performing NIPT for
tested chromosomes with
>99% sensitivity and specificity1
Pre- and post-test risk
assessment tools
Genetic carrier testing for
both preconception and
prenatal patients with a
variety of test options
Proactive notification
Genetic testing for hereditary
of positive results
cancer risk for 12+ types
of cancer to promote early
detection and prevention
A promising advancement in
development to transform triage Genetic counselors
and diagnosis of preeclampsia on call for providers,
in symptomatic patients payers, and patients
1. Porreco RP, Sekedat M, Bombard A, et al. Evaluation of a novel screening method for fetal aneuploidy using cell-free DNA in maternal plasma. J Med Screen. 2020;27(1):1-8. doi:10.1177/0969141319873682
8 © 2021 Progenity, Inc. Al Rights ReservedEXPECTING STRONG TEST VOLUME GROWTH IN 2021
Projected test volumes expected to climb in core molecular tests & COVID-19 tests
+16% YOY
Test Volume (Thousands)
267 290 – 310 275 – 300
52
2020 2021 Projected 2020 2021 Projected
Core Molecular Tests1 COVID-19 Tests2
1. Volume for Innatal, Preparent, Riscover tests
2. Testing conducted by Avero Diagnostics utilizing third-party tests that have received Emergency Use Authorization from the FDA.
9 © 2021 Progenity, Inc. All rights reserved.EXPANDING IN-NETWORK FOOTPRINT
Progenity tests are now covered for more patients through their health insurance providers
PROGENITY IN-NETWORK LIVES (MILLIONS)
` Added 2.5 million regional
plan covered lives in 2020
37
` Expanding government and
commercial payer coverage
for average-risk NIPT
146
` Continuing contract
negotiations with national 109
and regional health
insurance providers
2019 2020 Additions: Current1
Aetna/Cigna/Others
1. Does not include 60 million participants in Multiplan; some overlap with current in-network lives
10 © 2021 Progenity, Inc. All rights reserved.INNOVATION
PIPELINE
11 © 2021 Progenity, Inc. All rights reserved.PROTEOMICS PLATFORM
Preeclampsia In developmentSIGNIFICANT UNMET NEED IN ASSESSING PATIENTS FOR PREECLAMPSIA
IAGNOSIS OF PREECLAMPSIA RELIES ON METHODS INVENTED IN THE 1800s
` D
#2 CAUSE Assessment tools lack specificity and predictive value
of maternal mortality1
` T
HERE IS NO SINGLE TEST FOR PREECLAMPSIA
Current tests are non-specific and cannot differentiate
preeclampsia from other hypertensive disorders, such
MORE THAN as chronic or gestational hypertension
700,000 PEOPLE
present with symptoms
each year2,3,4 ` HEALTHCARE COST BURDEN OF $9 BILLION+1
Incremental costs associated with managing
a preeclamptic pregnancy support
value-based reimbursement
$3 BILLION U.S.
estimated market
opportunity
1. Henderson JT, et al. Preeclampsia Screening: Evidence Report and Systematic Review for the US Preventive Services Task Force.
JAMA. 2017 Apr 25;317(16):1668-1683.
2. Ananth CV, et al. Pre-eclampsia rates in the United States, 1980-2010: age-period-cohort analysis. BMJ. 2013 Nov 7;347:f6564.
3. https://www.sciencedirect.com/topics/medicine-and-dentistry/gestational-hypertension
4. Center for Disease Control and Prevention. Births: Final Data for 2018 (In press). https://www.cdc.gov/nchs/nvss/births.htm
13 © 2021 Progenity, Inc. Al Rights ReservedINTRODUCING PREECLUDIA – THE FIRST U.S. PREECLAMPSIA RULE-OUT TEST
TM
Helping OB/GYNs rule-out possible preeclampsia with confidence
FIRST-OF-ITS-KIND TEST TO ASSESS THE PATHOPHYSIOLOGY OF PREECLAMPSIA
` A proprietary, multi-analyte protein biomarker
assay with algorithmic interpretation * In development
` Laboratory-developed test (LDT) assesses
markers of both placental and maternal health
RULE-OUT PATIENTS NOT AT RISK FOR DEVELOPING
PREECLAMPSIA FOR UP TO 14 DAYS
` A ctionable results to improve clarity and
confidence in managing patients
` Reassurance for patients
` Testing window of 28-37 weeks’ gestation;
2-3 tests may be performed
POTENTIAL TO REDUCE COSTS AND IMPROVE OUTCOMES
` Return patients to routine care, decreasing health care over-utilization
` Identify at-risk patients early to improve interventions and care management
14 © 2021 Progenity, Inc. All rights reserved.COMPELLING CLINICAL DEVELOPMENT ROADMAP TO SUPPORT A SUCCESSFUL LAUNCH
Test developed with >3,700 patients
CLINICAL VALIDATION: PRO-104
` Pre-validation with ~350 patients in Q1’21
` Up to 1,300 patients in blinded, prospective, multi-center study
` 21 geographically diverse U.S. sites: MFM, OB/GYN
` Establishes rule-out window and final test performance
` Completion expected in mid-2021
FEASIBILITY: PRO-105 VERIFICATION: PRO-129 2021: ROBUST CLINICAL
DEVELOPMENT & LAUNCH PLANS
` Develop algorithm ` Prospective, blinded clinical verification data from 400 patients
training & test sets ` Supports a rule-out window up to 14 days in the target population ` F ocused on generating strong
adoption rates and reimbursement
Sensitivity Specificity NPV within core women’s health channel
` Pursuing trials to establish clinical
88.0% 73.3% 98.2%* utility and expand intended use
(78.2% – 94.4%) (68.1% – 78.0%) (95.5% – 99.3%) population
*NPV calculated at a 10% prevalence representing the expected prevalence
15 © 2021 Progenity, Inc. All rights reserved.SINGLE-MOLECULE
DETECTION PLATFORM
NIPT In development
Oncology FutureINNATAL 4: INNOVATING NEXT-GENERATION NIPT
Novel, single-molecule
counting assay for NIPT
Q3 2020
` A
chieved development milestone
QUALITY RESULTS demonstrating potential to
Maintain premium clinical “quantify” fetal fraction
value and reliability
Q4 2020
` Made critical advancement
FASTER TURNAROUND TIME
by finalizing probe pool
Set a new competitive
design and testing
benchmark in the market
Q4 2021
COST EFFECTIVENESS
` Anticipated
Cost effective chemistry
validation exit
improves COGS
17 © 2021 Progenity, Inc. Al Rights ReservedGI PRECISION
MEDICINE PLATFORM
Therapeutics In development
Diagnostics In developmentPRECISION MEDICINE: DISRUPTIVE PLATFORM AND ROBUST PIPELINE
Focus on diagnosing and treating GI diseases at the site of disease
Unmet medical need Opportunity
Diseases involving the GI tract affect Noninvasive, direct access
hundreds of millions of people worldwide to GI tract could help to:
Current diagnostic modalities are either
Invasive (e.g. endoscopy, surgery, biopsy) or BETTER DIAGNOSE GI DISEASES
Imprecise (e.g. breath and fecal testing)
DISCOVER NOVEL BIOMARKERS
AND DRUG TARGETS
TREATMENT CHALLENGES Replace systemic drug therapy with
` S
ystemic delivery of medication: achieving TARGETED, DIRECT-TO-SITE
therapeutic drug levels can be difficult due to DRUG THERAPIES TO IMPROVE
safety concerns EFFICACY AND SAFETY
` D
elivery of protein-based therapies: injection ORALLY DELIVER INJECTABLE DRUGS
is difficult, expensive, and both patients and to avoid painful needle-based
physicians prefer oral medications over injections SQ/IV injections
19 © 2021 Progenity, Inc. Al Rights ReservedGI PRECISION MEDICINE PROGRAMS
Advancing toward the clinic and progressing with partnerships
THERAPEUTICS DIAGNOSTICS
OBDS oral biopharmaceuticals RSS sampling + preservation technology
Oral delivery of systemic biopharmaceuticals Microbiome, cells, multi-omics, multiple GI diseases
` P rogress continues under current pharma partnership ` Initiating clinical proof of concept study in Q1 2021
` Initiating preclinical study with first fully autonomous
device in Q1 2021 LOCALIZE SAMPLE PRESERVE RECOVER ANALYZE
ADALIMUMAB (PGN-OB1) GMP BATCH PRODUCED
DDS targeted therapeutics PIL Dx ingestible fluorescent technology
Localized drug delivery for GI disorders Lead indication SIBO: >100 million patient visits annually
` Completed in vivo preclinical device function study ` Key assay accuracy data presented at ACG 2020
` Device clinical function study initiation in Q1 2021 ` Full function preclinical study planned for 1H 2021
` Expected to initiate clinical proof of concept study in
2H 2021
GI-TARGETED ADALIMUMAB (PGN-001) GMP BATCH PRODUCED
GI-TARGETED TOFACITINIB (PGN-600) LOCALIZE SAMPLE ANALYZE IN SITU TRANSMIT RESULTS
20 © 2021 Progenity, Inc. All rights reserved.2021 FINANCIAL GUIDANCE 21 © 2021 Progenity, Inc. All rights reserved.
2021 GUIDANCE
Source 2021 Revenue ($ millions)
RETURN TO STRONG GROWTH IN 2021 Core Molecular Testing Revenue2 $115 – $125
Expecting up to 30% revenue growth1
COVID-19 Testing Revenue3 $15 – $20
Expecting up to 16% core volume growth4
Total Revenue $130 – $145
ACTIVELY MANAGING SG&A COSTS Source 2021 Volume (thousands)
Ensure alignment with topline profile
Core Molecular Testing Volume4 290 – 310
COVID-19 Testing Volume 275 – 300
MAINTAINING DISCIPLINED R&D SPEND
Incremental investments stage-gated to
de-risking milestones Source 2021 OpEx (millions)
SG&A $150 – $160
R&D $50 – $55
1. Growth rate of annual 2021 revenue guidance (top of range) over estimated 2020 revenues ex-accruals (a reconciliation of 2020 revenue ex-accruals to its comparable GAAP figure (revenue) is
not available due to the unpredictability of accruals, if any. In addition, the magnitude of any such accruals may be significant, as discussed in our periodic reports previously filed with the SEC)
2. Includes revenues from Avero affiliate
3. Testing conducted by Avero Diagnostics utilizing third-party tests that have received Emergency Use Authorization from the FDA.
4. Volume for Innatal, Preparent, Riscover tests
22 © 2021 Progenity, Inc. All rights reserved.2021: POTENTIAL CATALYSTS FOR CONTINUED GROWTH & INNOVATION
CORE BUSINESS INITIATIVES
REVENUE CYCLE MANAGEMENT
Continue improvements
to maximize revenues
HEALTH PLANS
Continue in-network
transition and expand INNATAL 4
covered lives VALIDATION
AVERAGE-RISK NIPT Targeting
Increase penetration into completion of
NIPT average-risk market PREECLUDIA
clinical validation
as coverage improves Targeting
WOMEN’S completion of
of non-sequencing
HEALTH clinical validation
NIPT to achieve
Core business lower direct COGS
and initiate
anticipated PHARMA PARTNERSHIPS commercial launch
and faster TAT
to return to Seeking to establish additional
strong growth key partnerships for GI Precision
Medicine programs
CLINICAL STUDIES
Launching pre-clinical and clinical studies for GI Precision Medicine
programs; key performance data expected beginning in1H ‘21 INNOVATION INITIATIVES
23 © 2021 Progenity, Inc. All rights reserved.24 © 2021 Progenity, Inc. All rights reserved.
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