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Item 2.02. Results of Operations and Financial Condition.
On November 5, 2020, Natera, Inc. issued a press release announcing its results for its third quarter ended September 30, 2020 and provided a related investor presentation. A copy of the press release and a copy of the investor presentation are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
The information in this Current Report on Form 8-K and the accompanying Exhibit 99.1 and Exhibit 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by reference in such filing.
Item 9.01. Financial Statements and Exhibits.
|99.1||Press Release dated November 5, 2020.|
|104||Cover Page Interactive Data File (formatted as inline XBRL)|
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|By:||/s/ Michael Brophy|
|Chief Financial Officer (Principal Financial and Accounting Officer)|
|Dated: November 5, 2020|
Natera Reports Third Quarter 2020 Financial Results
SAN CARLOS, Calif., November 5, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today reported financial results for the third quarter ended September 30, 2020 and provided an update on recent business progress.
Recent Accomplishments & Highlights
|●||Processed approximately 262,000 tests in the third quarter of 2020 compared to approximately 200,200 tests processed in the third quarter of 2019, an increase of 31%.|
|●||Generated total revenues of $98.1 million in the third quarter of 2020 compared to $77.9 million in the third quarter of 2019, an increase of 26%. Generated product revenues of $93.3 million in the third quarter of 2020 compared to $66.9 million in the third quarter of 2019, an increase of 39.5%.|
|●||Practice Bulletin published by American College of Obstetrics and Gynecology (ACOG) and Society of Maternal Fetal Medicine (SMFM) supporting use of Non-Invasive Prenatal Testing (NIPT) for all pregnancies.|
|●||Received positive final coverage decision from Medicare for Signatera™ in colorectal cancer and commenced full commercial launch.|
|●||Received draft local coverage determination from Medicare for Signatera in immunotherapy monitoring.|
|●||Presented new Signatera data at the 2020 European Society for Medical Oncology.|
|●||Announced two prospective phase 2 trials to evaluate early stage breast cancer patients with leading pharmaceutical companies.|
|●||Successfully completed $287.5 million follow-on equity offering.|
“Q3 was an exceptional quarter,” said Steve Chapman, Natera's Chief Executive Officer. “We delivered a significant increase in volumes over an already strong second quarter. We are pleased with the initial positive reaction to the ACOG/SMFM Practice Bulletin, and continue to execute nicely on our oncology and organ health commercialization plans. After years of hard work, we're now seeing the new businesses contribute to our strong revenue growth. We are very excited about our current trajectory and are significantly raising our 2020 revenue guidance.”
Third Quarter Ended September 30, 2020 Financial Results
Total revenues were $98.1 million in the third quarter of 2020 compared to $77.9 million for the third quarter of 2019. The increase in total revenues was driven primarily by a 39.5% increase in product revenues compared to the third quarter of 2019. Natera processed 262,000 tests in the third quarter of 2020, including approximately 249,300 tests accessioned in its laboratory, compared to 200,200 tests processed in the third quarter of 2019 including approximately 187,200 tests accessioned in its laboratory.
In the three months ended September 30, 2020, Natera recognized revenue on approximately 238,600 tests for which results were reported to customers in the period (tests reported), including approximately 226,700 tests accessioned in its laboratory, compared to approximately 189,600 tests reported, including approximately 178,000 tests accessioned in its laboratory, in the third quarter of 2019.
Gross profit* for the three months ended September 30, 2020 and 2019 was $46.3 million and $34.0 million, respectively, representing approximately 47% and 44% gross margin*, respectively. The company was able to achieve higher margins in the third quarter of 2020 primarily due to improved cost of goods sold per test and increased revenues.
Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the third quarter of 2020 were $102.1 million, compared to $69.5 million in the same period of the prior year. The increases were primarily driven by headcount growth to support new product offerings.
Loss from operations for the third quarter of 2020 was $55.8 million compared to $21.1 million for the same period of the prior year, which included a gain from the sale of the Evercord cord blood banking business of approximately $14.4 million.
Net loss for the third quarter of 2020 was $58.3 million, or ($0.72) per diluted share, compared to net loss of $23.1 million, or ($0.33) per diluted share, for the same period in 2019. Weighted average shares outstanding were approximately 80.9 million in the third quarter of 2020.
At September 30, 2020, Natera held $809.7 million in cash, cash equivalents, short-term investments and restricted cash, compared to $441.0 million as of December 31, 2019. As of September 30, 2020, Natera had a total outstanding debt balance of $250.0 million, comprised of $50.1 million with accrued interest under its $50.0 million line of credit with UBS at a variable interest rate of 30-day LIBOR plus 110 bps and a net carrying amount of $200.0 million under its seven-year convertible senior notes. The convertible senior notes were issued in April 2020 for net proceeds of $278.9 million, of which a portion was used to repay the $79.2 million obligations under the company’s 2017 term loan with OrbiMed Advisors. The gross principal balance outstanding for the convertible senior notes was $287.5 million as of September 30, 2020.
Natera anticipates 2020 total revenue of $380 million to $390 million; 2020 cost of revenues to be approximately 51% to 54% of revenues; selling, general and administrative costs to be approximately $270 million to $280 million; research and development costs to be $90 million to $95 million, and net cash burn to be $140 million to $150 million**.
* Gross profit is calculated as GAAP total revenues less GAAP cost of revenues. Gross margin is calculated as gross profit divided by GAAP total revenues.
** Cash burn is calculated as the sum of GAAP net cash used by operating activities (estimated for 2020 to be between $132 million and $142 million) and GAAP net purchases of property and equipment (estimated for 2020 to be approximately $8 million).
Test Volume Summary
|Unit||Q3 2020||Q3 2019||Definition|
|Tests processed||262,000||200,200||Tests accessioned in our laboratory plus units processed outside of our laboratory|
|Tests accessioned||249,300||187,200||Test accessioned in our laboratory|
|Tests reported in our laboratory||226,700||178,000||Total tests reported in our laboratory less units reported outside of our laboratory including Evercord units in prior periods|
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform.
Conference Call Information
|Event:||Natera's Third Quarter 2020 Financial Results Conference Call|
|Date:||Thursday, November 5, 2020|
|Time:||1:30 p.m. PT (4:30 p.m. ET)|
|Live Dial-In:||(877) 823-0171, Domestic|
|(617) 500-6932, International|
This release contains forward-looking statements, including regarding the company's business operations in light of the COVID-19 pandemic. Any forward-looking statements contained in this release are based upon Natera's current plans, estimates, and expectations, as of the date of this release, and are not a representation that such plans, estimates, or expectations will be achieved. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements in the future.
These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including: we face numerous uncertainties and challenges in achieving our financial projections and goals; we may be unable to maintain our business and operations as planned in light of the COVID-19 pandemic; we may be unable to further increase the use and adoption of Panorama and Horizon, through our direct sales efforts or through our laboratory partners, or to develop and successfully commercialize new products, including Signatera and Prospera; we have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future; our quarterly results 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 products or services offered by our competitors; we may not be successful in commercializing our cloud-based distribution model; our products may not perform as expected; the results of our 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 in the average-risk pregnancy population or for microdeletions screening, or may not be able to be replicated in later studies required for regulatory approvals or clearances; if our primary CLIA-certified laboratory facility becomes inoperable, we will be unable 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 find 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 could result in substantial damages arising from product liability or professional liability claims that exceed our resources; we may be unable to expand third-party payer coverage and reimbursement 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, such as the increased focus by third-party payers on requiring that prior authorization be obtained prior to conducting a test; if the FDA were to begin actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance 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 third 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 our 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 outstanding convertible notes.
Additional risks and uncertainties that could affect our financial results are included under the captions, "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our most recent filings on Forms 10-K and 10-Q and in other filings that we make with the SEC from time to time. These documents are available on our website at www.natera.com under the Investor Relations section and on the SEC's website at www.sec.gov.
Natera assumes no obligation to, and does not currently intend to, update any such forward-looking statements after the date of this release.
Mike Brophy, CFO, Natera, Inc., 650-249-9090
Paul Greenland, VP of Corporate Marketing, Natera, Inc., email@example.com
Condensed Consolidated Balance Sheets
|September 30,||December 31,|
|Cash and cash equivalents||$||209,351||$||61,926|
|Accounts receivable, net of allowance of $3,080 in 2020 and $2,919 in 2019||70,674||53,351|
|Prepaid expenses and other current assets, net||15,227||16,376|
|Total current assets||916,012||523,167|
|Property and equipment, net||28,249||23,283|
|Operating lease right-of-use assets||20,296||23,730|
|Liabilities and Stockholders’ Equity|
|Other accrued liabilities||62,893||49,043|
|Deferred revenue, current portion||51,227||56,016|
|Short-term debt financing||50,052||50,123|
|Total current liabilities||195,872||179,874|
|Long-term debt financing||199,959||73,656|
|Deferred revenue, long-term portion||23,128||23,808|
|Operating lease liabilities, long-term portion||21,444||26,297|
|Other long-term liabilities||310||310|
|Commitments and contingencies|
|Common stock (2)||9||8|
|Additional paid in capital||1,383,727||976,955|
|Accumulated other comprehensive income||5,170||919|
|Total stockholders’ equity||536,000||278,711|
|Total liabilities and stockholders’ equity||$||976,713||$||582,656|
(1) The condensed, consolidated balance sheet at December 31, 2019 has been derived from the audited consolidated financial statements at that date included in the company’s Annual Report on Form 10-K for the year ended December 31, 2019.
(2) As of September 30, 2020, there were approximately 85,281,000 shares of common stock issued and outstanding.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
|Three months ended||Nine months ended|
|September 30,||September 30,|
|Licensing and other revenues||4,857||10,973||17,881||23,689|
|Cost and expenses|
|Cost of product revenues||46,873||40,138||131,124||123,125|
|Cost of licensing and other revenues||4,948||3,742||12,614||7,883|
|Research and development||26,421||12,796||67,651||36,355|
|Selling, general and administrative||75,678||56,715||209,547||147,589|
|Gain from disposal of business||—||(14,388||)||—||(14,388||)|
|Total cost and expenses||153,920||99,003||420,936||300,564|
|Loss from operations||(55,777||)||(21,094||)||(142,309||)||(81,476||)|
|Interest and other income, net||1,749||673||5,661||1,962|
|Loss on debt extinguishment||—||—||(5,848||)||—|
|Loss before income taxes||(58,298||)||(23,093||)||(153,268||)||(87,631||)|
|Income tax expense||(25||)||(44||)||(63||)||(2,013||)|
|Unrealized gain (loss) on available-for-sale securities, net of tax||(600||)||63||4,251||1,410|
|Net loss per share:|
|Basic and diluted||$||(0.72||)||$||(0.33||)||$||(1.93||)||$||(1.33||)|
|Weighted-average number of shares used in computing basic and diluted net loss per share:|
|Basic and diluted||80,908||70,456||79,430||67,198|
1 Not for reproduction or further distribution. Natera, Inc. Third Quarter 2020 Earnings Presentation November 5, 2020
2 Not for reproduction or further distribution. Safe harbor statement 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 the market opportunity, products and launch s che dules, reimbursement coverage and product costs, commercial partners, user experience, clinical trials, financial performance, strategies, anticipated revenue and financial o utl ook and goals and general business conditions of Natera, Inc. (“Natera”, the “Company”, “we” or “us”), are forward - looking statements. These forward - looking statements are subje ct to known and unknown risks and uncertainties that may cause actual results to differ materially, including: we face numerous uncertainties and challenges in achieving our fi nancial projections and goals; we may be unable to maintain our business and operations as planned due to disruptions and economic uncertainty caused by the COVID - 19 pandemic; we may be unable to further increase the use and adoption of Panorama and Horizon, through our direct sales efforts or through our laboratory partners, or to develop and suc cessfully commercialize new products, including Signatera and Prospera; we have incurred losses since our inception and we anticipate that we will continue to incur losses f or the foreseeable future; our quarterly results may fluctuate from period to period; our estimates of market opportunity and forecasts of market growth may prove to be inaccurat e; we may be unable to compete successfully with existing or future products or services offered by our competitors; we may not be successful in commercializing our cloud - based distribution model; our products may not perform as expected; the results of our 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 in the average - risk pregnancy population or for microdeleti ons screening, or may not be able to be replicated in later studies required for regulatory approvals or clearances; if our primary CLIA - certified laboratory facility becomes inopera ble, we will be unable 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 labora tor y instruments and materials and may not be able to find 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 could result in substantial damages arising from product liability or professional liabili ty claims that exceed our resources; we may be unable to expand, obtain or maintain third - party payer coverage and reimbursement 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, bi lling complexities or other factors, such as the increased focus by third - party payers on requiring that prior authorization be obtained prior to conducting a test; if the FDA w ere to begin actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance or approval and incur costs associate d w ith complying with post - market controls; litigation or other proceedings, resulting from either third party claims of intellectual property infringement or third party infringem ent 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 cou ld harm our competitive position or our brand; and with respect to our ability to service and comply with our outstanding debt obligations and our expectations regarding the convers ion of our outstanding convertible notes.” We discuss these and other risks and uncertainties in greater detail in the sections entitled “Risk Factors” and "Management's Discussio n a nd Analysis of Financial Condition and Results of Operations" in our periodic reports on Forms 10 - K and 10 - Q and in other filings we make with the SEC from time to time. Given th ese uncertainties, you should not place undue reliance on the forward - looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New ris ks emerge 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 its business or the extent to which a ny factor, or combination of factors, may cause actual results to differ materially from those contained in any forward - looking statement. In light of these risks, uncertainties and a ssumptions, the forward - looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from thos e a nticipated or implied. Except as required by law, we undertake no obligation to update publicly any forward - looking statements for any reason after the date of this presenta tion to conform these statements to actual results or to changes in our expectations. We file reports, proxy statements, and other information with the SEC. Such reports, proxy st atements, 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., 201 Industrial Road, Suite 410, San Carlos, California 94070. Our telephone number is (650) 249 - 9090.
3 Not for reproduction or further distribution. • Processed a record 262,000 tests; up ~12% sequentially and 31 % versus Q3 2019 • Total revenues of ~$ 98.1 M; up 26 % vs Q3 2019. Product revenues up 39.5 % vs Q3 2019 • Strong momentum from ACOG and SMFM practice bulletin supporting NIPT in all pregnant women • Unblinded positive SMART trial data, the largest ever prospective NIPT and microdeletions study • Published Prospera™ clinical utility study, announced Cancer in Transplant Program • Received positive final coverage decision from CMS for Signatera ™ in colorectal cancer and commenced full commercial launch • Received CMS draft local coverage determination for Signatera in immunotherapy (IO) monitoring • Announced two separate prospective phase 2 trials using Signatera with Pfizer and Novartis • Significantly raising 2020 annual guidance Recent highlights
4 Not for reproduction or further distribution. Total processed units (in thousands) • Strong market share gains in reproductive health • Commercial launch on track in transplant and oncology 164 163 167 174 200 194 200 209 236 234 262 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2020 Step function change in volumes
5 Not for reproduction or further distribution. • Volume outperformance combined with improving ASPs • New products beginning to gain momentum $55.9 $65.3 $77.9 $98.1 Q3 2017 Q3 2018 Q3 2019 Q3 2020 17% 19% Accelerating revenue growth 1. Excludes licensing and other revenues $66.9 $93.3 Q3 2019 Q3 2020 Total Revenues ($ in millions) Product Revenues 1 ($ in millions) 26% 39.5 %
6 Not for reproduction or further distribution. Average selling prices and COGS momentum ASP: Total revenues/tests reported 1 Blended COGS trajectory 2 1. ASP is calculated as total revenues / tests reported in Natera’s laboratory. Total revenues excludes revenue recognition f rom Qiagen, FMI, and BGI partnerships, and certain non - recurring items 2. Blended COGS trajectory is computed by total COGS divided by tests accessioned $388 $270 $234 $207 $200 $0 $50 $100 $150 $200 $250 $300 $350 $400 $450 Q1 2015 Q3 2018 Q3 2019 Q3 2020 Target $384 $393 $395 $404 $416 $407 $422 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2020
7 Not for reproduction or further distribution. ACOG/SMFM practice bulletin supports NIPT • Level A recommendation: “ cfDNA is the most sensitive and specific screening test for the common fetal aneuploidies” • SNP - based method highlighted as having advantages for detection of triploidy and twin screening
8 Not for reproduction or further distribution. Step change in average risk NIPT coverage ~134M ~201M 2016-19 2020 (YTD) 50% Medicaid states covered 8 14 2016-19 2020 (YTD) 75 % Total lives covered 1 (in millions) 1. Source : Policy Reporter/Natera estimates
9 Not for reproduction or further distribution. Expanding data set in Organ Health • 3 studies using Signatera and Prospera tests • Improve understanding of cancer recurrence and organ rejection risk for transplant patients with cancer Cancer in Transplant • 154 physicians used Prospera to evaluate rejection in post - transplant patients • 300% increase in probability of confirming rejection via biopsy • Published in International Urology and Nephrology Clinical Utility Study 1 1. Peabody J, et al. Randomized clinical trial of a novel donor - derived cfDNA test to detect rejection in CPV - simulated renal transplant patients. Int Urol Nephrol. 2020;52(8):1593 - 1601.
10 Not for reproduction or further distribution. Signatera CRC reimbursement pathway 2019 2020 x Successful pre - submission meeting x Obtained Z - code x Completed clinical validation x CLIA soft launch x Formal LCD submission x Draft LCD release x Launch registry trial x Final LCD published • Final pricing
11 Not for reproduction or further distribution. New application for Signatera: IO response monitoring ● 200,000 patients treated with immunotherapy (IO) annually, most do not respond 1 ● Pseudo - progression causes uncertainty and delays in assessing efficacy ● Continued response monitoring for secondary resistance and exceptional response 1. IQVIA™ Institute for Human Data Science Releases Global Oncology Trends 2019 Study: Record Number of Cancer Drugs Launched in 2018 across 17 Indications. IQVIA. DECISION POINT 2 CT #1 CT #2 CT #3 Signatera TM Regimen B Regimen A Modify or discontinue treatments? True progression? TIME DECISION POINT 3 Discontinue IO in exceptional responders? DECISION POINT 1 BASELINE Si gnatera
12 Not for reproduction or further distribution. Signatera IO: Broad draft local coverage decision • Received in response to IO monitoring dossier • Draft LCD creates accelerated pathway to reimbursement in a broad range of solid cancers
13 Not for reproduction or further distribution. Signatera IO: Medicare reimbursement ahead of schedule 2020 2021 x Successful pre - submission meeting x Obtained Z - code x Completed clinical validation x Formal LCD submission x Draft LCD release • CLIA soft launch • Final LCD published • Final pricing
14 Not for reproduction or further distribution. Continued momentum in Signatera Pharma Channel • DARE study: multi - center, randomized phase 2 trial of Palbociclib • Signatera to be used for patient enrollment eligibility and continued therapy effectiveness monitoring • Multiple Signatera trials in breast cancer underway
15 Not for reproduction or further distribution. F inancial overview ($ in millions, except for per share data) Balance Sheet Q3’20 Q2’20 Change QoQ Cash & Investments 2 $809.7 $571.2 $238.5 UBS Line of Credit $50.1 $50.1 $ — Convertible Senior Notes 3 $200.0 $197.5 $2.5 P&L Q3’20 Q3’19 Change Product Revenues $93.3 $66.9 $26.4 Licensing and Other Revenues $4.9 $11.0 ($6.1) Total Revenues $98.1 $77.9 $20.2 Gross Margin% 1 47% 44% 352 bps R&D $26.4 $12.8 $13.6 SG&A $75.7 $56.7 $19.0 Net Loss Per Share (Basic and Diluted) ($0.72) ($0.33) ($0.39) 1. Gross margin is calculated as gross profit divided by GAAP total revenues. Gross profit is calculated as GAAP total revenues les s GAAP cost of revenues. 2. Cash and investments also include cash equivalents and restricted cash. 3. 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 September 30, 2020
16 Not for reproduction or further distribution. $ (millions) Original Q2 Raise Current Revenue $335 – $350 $345 – $365 $380 – $390 Gross margin % revenue 43% – 49% 45% - 49% 46% - 49% SG&A $240 – $260 $260 - $280 $270 - $280 R&D $80 – $90 $85 - $95 $90 - $95 Cash burn $125 – $150 $125 – $155 $140 – $150 Re - raising 2020 annual guidance