EX-99.2 3 tm2314862d1_ex99-2.htm EXHIBIT 99.2

 

Exhibit 99.2

 

Natera, Inc. Investor presentation First Quarter 2023 Earnings Call May 9, 2023

 

 

Not for reproduction or further distribution. This presentation contains forward - looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including statements regarding our market opportunities, our proposed products and launch schedules, our reimbu rse ment coverage and our product costs, our commercial partners and potential acquisitions, our user experience, our clinical trials and studies and related publications, including timelines, our financi al performance, our strategies, our anticipated revenue and financial outlook, our goals and general business and market conditions, are forward - looking statements. These forward - looking statements are subject to known and unknown risks and uncertainties that may cause actual results to diffe r materially, including: we face numerous uncertainties and challenges in achieving our financial projections and goals; we may be unable to further increase the use and adoption of our products t hro ugh our direct sales efforts or through our laboratory partners; we have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future; our quarterly res ults may fluctuate from period to period; our estimates of market opportunity and forecasts of market growth may prove to be inaccurate; we may be unable to compete successfully with existing or future produ cts or services offered by our competitors; we may engage in acquisitions, dispositions or other strategic transactions that may not achieve our anticipated benefits and could otherwise disrupt our bu sin ess, cause dilution to our stockholders or reduce our financial resources; we may not be successful in commercializing our cloud - based distribution model; our products may not perform as expected; the results of ou r clinical studies, including our SNP - based Microdeletion and Aneuploidy Registry, or SMART, Study, may not be compelling to professional societies or payors as supporting the use of our tests, particularly f or microdeletions screening, or may not be able to be replicated in later studies required for regulatory approvals or clearances; if either of our primary CLIA - certified laboratories becomes inoperable, we will be unab le to perform our tests and our business will be harmed; we rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to fi nd replacements or immediately transition to alternative suppliers; if we are unable to successfully scale our operations, our business could suffer; the marketing, sale, and use of Panorama and our other products co uld result in substantial damages arising from product liability or professional liability claims that exceed our resources; we may be unable to expand, obtain or maintain third - party payer coverage and reimbu rsement for Panorama, Horizon and our other tests, and we may be required to refund reimbursements already received; third - party payers may withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors; if the FDA were to begin actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket c lea rance or approval and incur costs associated with complying with post - market controls; litigation or other proceedings, resulting from either third party claims of intellectual property infringement or thi rd party infringement of our technology, is costly, time - consuming and could limit our ability to commercialize our products or services; any inability to effectively protect our proprietary technology could harm ou r competitive position or our brand; and we cannot guarantee that we will be able to service and comply with our outstanding debt obligations or achieve our expectations regarding the conversion of our outstand ing convertible notes. We discuss these and other risks and uncertainties in greater detail in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results o f O perations” in our periodic reports on Forms 10 - K and 10 - Q and in other filings we make with the SEC from time to time. Moreover, we operate in a very competitive and rapidly changing environment. New risks e mer ge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may ca use actual results to differ materially from those contained in any forward - looking statement. In light of these risks, uncertainties and assumptions, the forward - looking events and circumstances discussed in thi s presentation may not occur and our actual results could differ materially and adversely from those anticipated or implied. As a result, you should not place undue reliance on our forward - looking statements. Except as required by law, we undertake no obligation to update publicly any forward - looking statements for any reason after the date of this presentation to conform these statements to actual results or t o changes in our expectations. We file reports, proxy statements, and other information with the SEC. Such reports, proxy statements, and other information concerning us is available at http:// www.sec.gov . Requests for copies of such documents should be directed to our Investor Relations department at Natera , Inc., 13011 McCallen Pass, Building A Suite 100, Austin, TX 78753. Our telephone number is (650) 980 - 9190. 2 Safe harbor statement

 

 

Not for reproduction or further distribution. Recent highlights Strong Q1’23 Financial Results / 2023 Guidance Continued Data Leadership Reimbursement & Medical Society Endorsements • Reinforced Panorama NIPT differentiation and data leadership with three papers (2 published, 1 accepted), including new evidence from the SMART study • New study published in Cancer highlights Signatera’s performance in stages III - IV melanoma • Expanded I - SPY2 study published in Cancer Cell demonstrates prognostic/predictive value of Signatera for breast cancer patients in neoadjuvant setting • ~25% growth in revenues YoY (total revenues of $242M) • ~28% growth in processed tests YoY (626K tests processed) • ~102% growth in oncology volumes YoY ( 71 K tests performed) • Raising 2023 revenue guidance to $995M – $1.015B • O n track to reduce cash burn ~$150M YoY • Secured pan - cancer coverage policy from Blue Shield of California; first major commercial coverage decision for Signatera • Received Medicare coverage for Prospera Heart • Recent medical society endorsements of dd - cfDNA testing for transplant patients from the American Society of Transplant Surgeons and the American Society of Transplantation 3

 

 

Not for reproduction or further distribution. Record Q1 23 volume of 626,000 units Core Volume Drivers • Serving large, underpenetrated markets • Differentiated technology backed by strong evidence Strategic Volume Initiatives • NIPT growth in CA • Market share gains due to competitor carrier screening exits • Growth in Signatera clinical as margin profile matures 200 K 195 K 200 K 209 K 235 K 234 K 262 K 295 K 348 K 376 K 407 K 439 K 489 K 500 K 518 K 560K 626K Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 4

 

 

Not for reproduction or further distribution. 173M 194M 198M 211M 217M 242M Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Strong sequential revenue growth in Q1 • ~25% revenue growth over Q1’22 • ~12% revenue growth over Q4’22 • Strong volume growth • Significant growth in Signatera ASP Total revenues: year on year trend ($ in millions) 2 % 6 % 3 % 12 % 12 % 5

 

 

Not for reproduction or further distribution. Three new publications reinforce Panorama data leadership 1. Goldring G, Trotter C, Meltzer JT, et al. Maternal Malignancy After Atypical Findings on Single - Nucleotide Polymorphism - Based Prenatal Cell - Free DNA Screening . Obstetrics and Gynecology 2023 Mar 09. 2. Norton ME, MacPherson C, Demko Z et al. Obstetrical, perinatal and genetic outcomes associated with non - reportable prenatal cell free DNA screening results . American Journal of Obstetrics and Gynecology 2023 Mar 23, Supplementary Table 1. 3. Martin K, Norton M, MacPherson C, et al. Performance Analysis of cfDNA in Predicting Sex Chromosome Count in an Unselected Po pul ation. 32nd World Congress on Ultrasound in Obstetrics and Gynecology. Hybrid Meeting, London, UK. Poster Presentation. 2022 Sep 16 - 18. New SMART study publication on Panorama’s ability to identify certain patients at risk of adverse outcomes Identified a sub - category of ~1 in 200 pregnancies with a significant increased risk for adverse outcomes: • > 4x risk for preeclampsia • >4x risk for preterm birth <37 weeks • >10x risk for preterm birth <28 weeks Review of Panorama “suspected maternal malignancy” result type: • Review of >2M Panorama tests • 1:53,000 suspicious for maternal malignancy While rare, these Panorama results have high PPV and provide critical health information: • Cancer diagnosis confirmed in 66.7% (20/30) of these patients with clinical follow up • Authors recommend investigation for malignancy for all pregnant patients with this result type Largest, prospective clinical validation study of sex chromosome aneuploidies : • >17,000 pregnancies with confirmed outcomes Strong results with SNP - based NIPT: • Real world SCA screening results consistent with previous studies • 100% accuracy in calling fetal sex in 14,476 pregnancies Pregnancy Complications 2 Maternal Findings 1 Sex Chromosomes 3 6

 

 

Not for reproduction or further distribution. Medicare coverage for Prospera Heart Estimated test TAM of >$500M per year MolDX Local Coverage Determination (LCD) • Confirmed coverage from CMS MolDX for Prospera Heart under local coverage determination #L38568 for solid organ transplant rejection • Prospera test now has Medicare coverage for both heart and kidney transplant patients • Prospera Heart CMS price: $2,753 7

 

 

Not for reproduction or further distribution. Endorsements of dd - cfDNA testing in transplantation 1. American Society of Transplant Surgeons. ASTS Statement on donor - derived cell - free DNA (dd cf - DNA) . asts.org 2023 Mar 06. 2. Kobashigawa J, Hall S, Shah P, et al. The evolving use of biomarkers in heart transplantation: consensus of an expert panel . American Journal of Transplantation 2023 Mar 02. 3. Velleca A, Shullo MA, Dhital K, et al. The International Society for Heart and Lung Transplantation (ISHLT) Guidelines for the Care of Heart Transplant Recipients . The Journal of Heart and Lung Transplantation 2022 Dec 20. 4. The European Society for Organ Transplantation. ESOT TLJ Consensus Conference Highlights Report . esot.org 2023 Mar 17. American Society of Transplant Surgeons 1 European Society of Transplantation 4 Kidney Transplants : • Recommend use of dd - cfDNA for - cause use to rule out ABMR • Suggest surveillance use of dd - cfDNA to rule out sub - clinical rejection Heart Transplants : • Recommend dd - cfDNA surveillance and for - cause use in heart transplant patients Kidney Transplants : • Consensus in favor of surveillance and for - cause dd - cfDNA use to rule out rejection Heart Transplants : • Consensus in favor of dd - cfDNA to rule out sub - clinical rejection (both AMR and ACR) American Society of Transplantation 2 • “Currently, DSA and dd - cfDNA used in combination may be the optimal biomarker to assess clinical outcomes” in heart transplant recipients International Society for Heart & Lung Transplantation 3 • dd - cfDNA included in Class I, Level B guideline recommendation on tools for ongoing heart rejection monitoring 8

 

 

Not for reproduction or further distribution. Renasight – key study on track for H2 23 publication 1. Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2021 . US Department of Health and Human Services, Centers for Disease Control and Prevention 2021. 2. Internal company estimates based on publicly available data. RenaCARE Study for Renasight • Real - world, prospective, multi - center study to assess clinical utility of the Renasight genetic testing panel for patients with chronic kidney disease (CKD) • Completed enrollment in August 2022 with more than 1,600 patients across 30+ sites • Publication expected in H2 23 Key metrics for the RenaCARE study include: • Diagnostic yield – the number of CKD cases with positive genetic findings • Clinical utility – the number of patients that had changes in clinical management and treatment CKD is a large and growing area of healthcare that can be improved with genetic testing ~37M ~1M >10% patients living with CKD in the U.S. newly diagnosed CKD patients per year of the U.S. population has CKD and is eligible for testing 1 2 2 9

 

 

Not for reproduction or further distribution. Oncology continues to generate strong volume growth Signatera and Altera quarterly unit volumes • >30% of US oncologists have ordered Signatera in the quarter with continued increases in new accounts • Growth driven by both new patients and recurrence monitoring • Strong clinical volume growth in Q1 • Increase in utilization across indications 1 K 10 K 35K 71K Q1'20 Q1'21 Q1'22 Q1'23 10

 

 

Not for reproduction or further distribution. Major commercial carriers now covering Signatera • Blue Shield of California implemented new pan - cancer policy for Signatera • Effective 3/1/23, the policy covers adjuvant, recurrence monitoring, and treatment monitoring • Includes all solid tumors for stages I - IV cancer • BSCA serves 4.7M members • Coverage driven by payer - conducted clinical utility analysis demonstrating improved outcomes, reduced costs 11

 

 

Not for reproduction or further distribution. Prospective/randomized CRC study pipeline in progress CRC commercial experience study (NR) Est. submission for publication (H2 23) Clinical experience of ~13,500 patients Est. publication of data (Q4 23) Predictive randomized CRC data Est. presentation of GALAXY data (Q4 23) 24 - month outcomes data on >2K CRC patients; expansion of the Nature Medicine paper published in Jan. ’23 Est. planned submission (2024) Enrollment complete, ~400 patients now have ~2 years of follow up Est. readout (mid - 2024) , publication thereafter Escalation/treatment on molecular recurrence study Est. readout (2026) De - escalation to observation Est. readout on first ~800 patients (2026) Escalation cohort Blinded RCT Biobank (not yet announced) (RCT) BESPOKE CRC study (NR) CIRCULATE - Japan (ALTAIR study) (RCT) CIRCULATE - Japan (VEGA study) (RCT) CIRCULATE - US (NRG 008 study) (RCT) GALAXY 24 - month follow up (NR) 2024 2025 2026 2023 NOTE: RCT refers to randomized controlled trial (prospective or retrospective). NR refers to non - randomized. All publication/pre sentation timeframes are estimates. 12

 

 

Not for reproduction or further distribution. New clinical evidence across multiple indications 1. Huffman BM, Aushev VN, Budde GL, et al. Analysis of circulating tumor DNA to predict risk of recurrence in patients with esophageal and gastric cancers . JCO Precision Oncology 2022 Dec 08. 2. Azzi G, Tavallai M, Aushev VA, et al. Using Tumor - Informed Circulating Tumor DNA (ctDNA) - Based Testing for Patients with Anal Squamous Cell Carcinoma . The Oncologist 2022 Dec 23. 3. Eroglu Z, Krinshpun S, Kalashnikova E, et al. Circulating tumor DNA - based molecular residual disease detection for treatment monitoring in advanced melanoma patients . Cancer 2023 Mar 04. 4. Magbanua MJM, Swigart LB, Ahmed Z, et al. Clinical significance and biology of circulating tumor DNA in high - risk early - stage HER2 - negative breast cancer receiving neoadj uvant chemotherapy . Cancer Cell 2023 May 04. Source: internal company data Journal Indication Description Patients, plasma time points Publication Status JCO Precision Oncology Gastroesophageal 1 Multi - center - RWE 295 patients 943 plasma time points Dec 2022 The Oncologist Anal squamous cell carcinoma 2 Multi - center - RWE 251 patients 817 plasma time points Dec 2022 Cancer Melanoma 3 Single center - RWE 69 patients 555 plasma time points Mar 2023 Cancer Cell Breast Cancer 4 I - SPY 2.0 neoadjuvant setting 283 patients 1024 plasma time points May 2023 Submitted for publication Breast Cancer EBLIS expanded cohort Long - term surveillance >175 patients >1200 plasma time points Expected 2H 2023 Planned submission in Q2 Pancreatic Multi - center - RWE >300 patients >1900 plasma time points Expected 2H 2023 To date, Signatera has been validated in >40 published peer - reviewed studies across >25 tumor types 13

 

 

Not for reproduction or further distribution. I - SPY 2 Results ( Cancer Cell, 2023 ) 2 I - SPY2: Signatera both prognostic and predictive in neoadjuvant setting • Approximately 50% get NAC (regardless of tumor subtype) • Guidelines recommend response assessment during NAC, but also state this can be difficult with current methods 1 • Individualization of NAC difficult, leads to possible over and undertreatment Neoadjuvant Therapy (NAC) Trends 1. National Comprehensive Cancer Network®. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Breast Cancer, vers ion 4.2023. 2023 Mar 23. 2. Magbanua MJM, Swigart LB, Ahmed Z, et al. Clinical significance and biology of circulating tumor DNA in high - risk early - stage HER2 - negative breast cancer receiving neoadj uvant chemotherapy . Cancer Cell 2023 May 04. Prognostic • ctDNA - positivity before, during, and after NAC was significantly associated with inferior distant recurrence - free survival (DRFS) (p=0.02 to p<0.0001) 14 Predictive • Early ctDNA clearance at 3 weeks of NAC was a significant predictor of response (p=0.0002) • ctDNA - negativity after NAC was significantly associated with improved DRFS, even in patients with extensive residual cancer burden at surgery (p<0.0001)

 

 

Not for reproduction or further distribution. Extending Signatera data leadership at ASCO 2 Oral & 12 poster presentations American Society of Clinical Oncology (ASCO) annual meeting in June 2023 • Indications: Colorectal cancer, pancreatic, esophageal, cholangiocarcinoma, non - small cell lung cancer (NSCLC), muscle - invasive bladder cancer, melanoma and sarcoma • Poster Discussion: INTERCEPT Program MD Anderson (CRC) Patients: >1200 | Setting: Surveillance Title: Positive ctDNA - based MRD assays during surveillance is associated with high rates of concomitant radiographic recurrences in CRC • Poster Discussion: EMPOWER Lung - 1 (Advanced NSCLC) Patients: >150 | Setting: On - treatment ctDNA response Title: ctDNA dynamics and survival outcomes in patients with advanced NSCLC and high PD - L1 expression, randomized to cemiplimab and chemotherapy • Poster Discussion: Galaxy CIRCULATE - Japan (CRC) Patients: >2000 | Prospective, Observational Study Title: Circulating tumor DNA dynamics as an early predictor of recurrence in patients with radically resected colorectal cancer: Updated results from GALAXY study in the CIRCULATE - Japan 15

 

 

Q1 23 Financial Overview ($ in millions, except for per share data) Balance sheet March 31, 2023 Dec 31, 2022 Change Q/Q Cash & investments 1 $812.0 $898.4 ($86.4) UBS line of credit $80.4 $80.4 $ — Convertible senior notes 2 $282.0 $281.7 $0.3 P&L Q1’23 Q1’22 Change Y/Y Product revenues $237.8 $190.0 $47.8 Licensing and other revenues $4.0 $4.1 ($0.1) Total revenues $241.8 $194.1 $47.7 Gross margin% 38.7% 46.8% (810) bps R&D $82.3 $80.4 $1.9 SG&A $149.6 $147.6 $2.0 Net loss per diluted share ($1.23) ($1.45) $0.22 1. Cash and investments also include cash equivalents and restricted cash. 2. This balance reflects net carrying value for the Convertible Senior Notes under ASC 470 - 20 while the gross principal amounts out standing is $287.5 million as of March 31, 2023. 16 Not for reproduction or further distribution.

 

 

Not for reproduction or further distribution. Cash burn reduction target on track • Expect cash burn reduction of ~$150M on continued revenue growth and reduction in operating expenses • Cash burn reductions will fluctuate quarter to quarter based on working capital dynamics • Improved trends on DSOs and Signatera ASPs driven by broader coverage, reimbursement execution • Strong sequential growth in Q1 on stable commercial footprint $162M $86M Q1'22 Q1'23 Quarterly cash burn 1 : year on year trend ($ in millions) 1. Cash burn for the period ended March 31, 2022, is derived from the GAAP Statement of Cash Flows and Stockholders’ Equity as f oll ows: net cash used in operating activities of $137.3 million, cash used in investing activities for purchases of property and equipment of $15.9 million, and $13.4 million in unrealized loss and amortization or accretion on investments, o ffs et by cash provided in financing activities of $4.2 million. Cash burn for the period ended March 31, 2023, is derived from the GAAP Statement of Cash Flows and Stockholders’ Equity as follows: net cash used in operating activities of $80.9 mi lli on, cash used in investing activities for purchases of property and equipment of $11.6 million, offset by cash provided in financing activities of $2.3 million, and $3.8 million unrealized gain and amortization or accretion on investments. 17

 

 

Not for reproduction or further distribution. Guide ($ millions) Original Current Key drivers Revenue $ 980 – $ 1,000 $ 995 – $ 1,015 Continued volume growth, conservative ASPs, strong oncology contribution Gross margin % revenue 4 1 % – 4 4 % 4 1 % – 4 4 % Conservative ASP assumptions, strong oncology growth, completing key COGS improvement projects in 2023 for future leverage SG&A $5 10 – $5 40 $5 10 – $5 40 Modest reduction in spend vs. 2022 on mature commercial platforms R&D $3 25 – $3 45 $3 25 – $3 45 Focused investments in COGS reduction projects, clinical trials intended to drive guideline adoption Cash burn $3 00 – $ 325 $3 00 – $ 325 ~$150M reduction vs. 2022 cash burn Raising 2023 annual revenue guidance 18

 

 

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