PSNL Personalis Inc.
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Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the fourth quarter and full year ended December 31, 2020.
Fourth Quarter Highlights
- Record quarterly revenue of $20.2 million in the fourth quarter of 2020 compared with $18.2 million in the fourth quarter of 2019, an 11% increase
- Record quarterly revenue of $7.6 million from biopharma and all other customers, excluding VA MVP, in the fourth quarter of 2020 compared with $4.4 million in the fourth quarter of 2019, a 73% increase
- A total of 45 customers have placed orders for NeXT as of December 31, 2020, with 6 of those customers placing their first orders in the fourth quarter of 2020
- Achieved milestone of completing more than 100,000 whole human genomes sequenced under the VA MVP contract
- Launched new neoantigen prediction capabilities (called SHERPA™ and NEOPS™) in the fourth quarter of 2020
"I'm proud to say that we were able to report record revenue once again this quarter and achieved our first $20 million revenue quarter, despite the impact from the COVID-19 pandemic. Biopharma revenue was strong and was a record high as some customers pushed to complete projects before the end of the year," said John West, Chief Executive Officer. "Recently, we announced a partnership with Natera that further validates our NeXT platform as a best-in-class tissue-sequencing front end, capable of detecting mutations in cancer that conventional exomes often miss. It also complements our whole exome liquid biopsy offering that we launched in August 2020 and NeXT Personal, our Minimal Residual Disease (MRD) offering that we expect to launch in 2021, providing Personalis with access to three distinct areas in the rapidly growing cancer monitoring market."
Fourth Quarter 2020 Financial Results
Revenues were $20.2 million in the three months ended December 31, 2020, up 11% from $18.2 million in the same period of the prior year.
Gross margin was 30.1% in the three months ended December 31, 2020, compared with 36.2% in the same period of the prior year.
Operating expenses were $19.4 million in the three months ended December 31, 2020, compared with $13.8 million in the same period of the prior year.
Net loss was $13.3 million in the three months ended December 31, 2020 and net loss per share was $0.34 based on a weighted-average basic and diluted share count of 39.0 million, compared with a net loss of $6.6 million and a net loss per share of $0.21 on a weighted-average basic and diluted share count of 31.2 million in the same period of the prior year.
Cash, cash equivalents, and short-term investments were $203.3 million as of December 31, 2020.
Full Year 2020 Financial Results
Revenues were $78.6 million for the year ended December 31, 2020, up 21% from $65.2 million in 2019.
Gross margin was 25.6% for the year ended December 31, 2020, compared with 33.9% in 2019.
Operating expenses were $62.3 million for the year ended December 31, 2020, compared with $44.5 million in 2019.
Net loss was $41.3 million for the year ended December 31, 2020 and net loss per share was $1.20 based on a weighted-average basic and diluted share count of 34.4 million, compared with a net loss of $25.1 million and a net loss per share of $1.39 on a weighted-average basic and diluted share count of 18.0 million in 2019.
First Quarter 2021 Outlook
Personalis expects the following for the first quarter of 2021:
- Total Company revenues are expected to be approximately $20.3 million
- Revenues from biopharma and all other customers, excluding VA MVP, are expected to be in the range of $5.6 million to $7.0 million
- Net Loss is expected to be in the range of $14.0 million to $15.0 million
Webcast and Conference Call Information
Personalis will host a conference call to discuss the fourth quarter and full year 2020 financial results after market close on Thursday, February 25, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 5065084. The live webinar can be accessed at https://investors.personalis.com.
About Personalis, Inc.
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted, and reported results should not be considered an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "estimate," "expect," "preliminary," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements regarding the company's expectations for revenues and net loss for the first quarter of 2021. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: the timing and pace of new orders from customers, including from the U.S. Department of Veterans Affairs Million Veteran Program, which was the company's largest customer in 2018, 2019, and 2020; the launch of new products and product features, such as NeXT Personal; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter over quarter and year over year; whether orders for the NeXT Platform and revenues from biopharmaceutical customers increase in future periods; the success of Personalis' collaborations and the Natera partnership; the success of the company's international expansion plans; the evolution of cancer therapies and market adoption of the company's services; the company's expectations regarding future performance; and the ongoing COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of our customers and suppliers. In addition, other potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the period ended December 31, 2020 that will be filed after this earnings release, and risk factors included within the registration statement on Form S-3 filed December 30, 2020, and prospectus supplement filed on January 27, 2021. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
PERSONALIS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Three Months Ended December 31,
Year Ended December 31,
2020
2019
2020
2019
(unaudited)
Revenues
$
20,176
$
18,154
$
78,648
$
65,207
Costs and expenses
Costs of revenues
14,106
11,589
58,534
43,127
Research and development
8,520
7,373
28,568
22,418
Selling, general and administrative
10,920
6,388
33,692
22,080
Total costs and expenses
33,546
25,350
120,794
87,625
Loss from operations
(13,370
)
(7,196
)
(42,146
)
(22,418
)
Interest income
76
580
949
1,620
Interest expense
—
—
(2
)
(1,133
)
Loss on debt extinguishment
—
—
—
(1,704
)
Other (expense) income, net
(29
)
(25
)
(24
)
(1,440
)
Loss before income taxes
(13,323
)
(6,641
)
(41,223
)
(25,075
)
Provision for income taxes
(18
)
(4
)
(57
)
(9
)
Net loss
$
(13,341
)
$
(6,645
)
$
(41,280
)
$
(25,084
)
Net loss per share, basic and diluted
$
(0.34
)
$
(0.21
)
$
(1.20
)
$
(1.39
)
Weighted-average shares outstanding, basic and diluted
38,962,860
31,205,546
34,374,903
18,011,470
PERSONALIS, INC.
SUPPLEMENTAL REVENUE INFORMATION
(in thousands)
Three Months Ended December 31,
Year Ended December 31,
2020
2019
2020
2019
(unaudited)
VA MVP
$
12,556
$
13,754
$
56,154
$
43,545
All other customers
7,620
4,400
22,494
21,662
Total
$
20,176
$
18,154
$
78,648
$
65,207
PERSONALIS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
December 31,
December 31,
2020
2019
Assets
Current assets
Cash and cash equivalents
$
68,525
$
55,046
Short-term investments
134,765
73,243
Accounts receivable, net
6,349
3,300
Inventory and other deferred costs
5,639
4,606
Prepaid expenses and other current assets
5,441
3,383
Total current assets
220,719
139,578
Property and equipment, net
11,834
14,106
Operating lease right-of-use assets
10,271
1,845
Other long-term assets
2,018
1,762
Total assets
$
244,842
$
157,291
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable
$
8,301
$
7,337
Accrued and other current liabilities
11,301
6,648
Contract liabilities
21,034
35,977
Total current liabilities
40,636
49,962
Long-term operating lease liabilities
8,541
639
Other long-term liabilities
720
—
Total liabilities
49,897
50,601
Commitments and Contingencies
Stockholders' equity
Preferred stock, $0.0001 par value — 10,000,000 shares authorized; none issued
—
—
Common stock, $0.0001 par value — 200,000,000 shares authorized; 39,105,548 and 31,243,029 shares issued and outstanding at December 31, 2020 and 2019, respectively
4
3
Additional paid-in capital
376,788
247,282
Accumulated other comprehensive income (loss)
22
(6
)
Accumulated deficit
(181,869
)
(140,589
)
Total stockholders' equity
194,945
106,690
Total liabilities and stockholders' equity
$
244,842
$
157,291
View source version on businesswire.com: https://www.businesswire.com/news/home/20210225005988/en/
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Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, and Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA testing, today announced that the two companies have entered into a partnership in the field of personalized oncology. The partnership will pair Personalis' NeXT tumor profiling and diagnostic products with Natera's personalized ctDNA platform Signatera™ for treatment monitoring and molecular residual disease (MRD) assessment.
Under this non-exclusive agreement, Natera will validate the design of Signatera personalized ctDNA assays using matched tumor and normal exome sequence data from Personalis, and Natera will be responsible for commercialization. The agreement covers MRD testing for both clinical use and research use.
"This represents another step forward in Natera's vision for Signatera, as a personalized monitoring and MRD platform that can be scaled and integrated robustly with high-quality exome-scale tissue sequencing assays worldwide, of which Personalis' NeXT is a leading example," commented Solomon Moshkevich, Natera's General Manager of Oncology. "We are pleased to partner with them and to expand access of Signatera to a new set of potential customers."
"The NeXT Platform™ complements Signatera by offering advanced tumor analysis with augmented coverage across all 20,000 genes," said Richard Chen, Chief Scientific Officer of Personalis. "We are excited to partner with Natera on this sensitive tumor-informed approach to accelerate molecular residual disease detection in cancer."
About Natera
Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. 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 ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. 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. For more information, visit natera.com. Follow Natera on LinkedIn.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers, or our ability to successfully execute the partnership. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Natera Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., [email protected]About Personalis
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).
Forward-Looking Statements
All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform (including with respect to its pairing with the Signatera platform), expected benefits from the partnership between Personalis and Natera, Personalis' business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210217005333/en/
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SAN CARLOS, Calif. and MENLO PARK, Calif., Feb. 17, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA testing, and Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the two companies have entered into a partnership in the field of personalized oncology. The partnership will pair Personalis' NeXT tumor profiling and diagnostic products with Natera's personalized ctDNA platform Signatera™ for treatment monitoring and molecular residual disease (MRD) assessment.
Under this non-exclusive agreement, Natera will validate the design of Signatera personalized ctDNA assays using matched tumor and normal exome sequence data from Personalis, and Natera will be responsible for commercialization. The agreement covers MRD testing for both clinical use and research use.
"This represents another step forward in Natera's vision for Signatera, as a personalized monitoring and MRD platform that can be scaled and integrated robustly with high-quality exome-scale tissue sequencing assays worldwide, of which Personalis' NeXT is a leading example," commented Solomon Moshkevich, Natera's General Manager of Oncology. "We are pleased to partner with them and to expand access of Signatera to a new set of potential customers."
"The NeXT Platform™ complements Signatera by offering advanced tumor analysis with augmented coverage across all 20,000 genes," said Richard Chen, Chief Scientific Officer of Personalis. "We are excited to partner with Natera on this sensitive tumor-informed approach to accelerate molecular residual disease detection in cancer."
About Natera
Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. 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 ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. 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. For more information, visit natera.com. Follow Natera on LinkedIn.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers, or our ability to successfully execute the partnership. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Natera Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., [email protected]About Personalis
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP-aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).
Forward-Looking Statements
All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform (including with respect to its pairing with the Signatera platform), expected benefits from the partnership between Personalis and Natera, Personalis' business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.
Contacts for Personalis, Inc.
Investor Relations Contact for Personalis:
Caroline Corner
[email protected]
415-202-5678Media Contact for Personalis:
Jennifer Havlek
[email protected]
www.personalis.com
650-752-1300
View original content to download multimedia:http://www.prnewswire.com/news-releases/natera-and-personalis-partner-for-personalized-monitoring-in-oncology-301229656.htmlSOURCE Natera, Inc.
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Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the following upcoming investor conferences:
-
Cowen 41st Annual Healthcare Conference
Presenting on Tuesday, March 2, 2021 at 1:30 p.m. Eastern Time
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Barclays Global Healthcare Conference
Presenting on Wednesday, March 10, 2021 at 11:30 a.m. Eastern Time
About Personalis, Inc.
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210216005089/en/
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Cowen 41st Annual Healthcare Conference
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Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its fourth quarter 2020 financial results after the market closes on Thursday, February 25, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.
Interested parties may access the live call via telephone by dialing (866) 990-1997 for domestic callers or (470) 495-9127 for international callers, using conference ID: 5065084. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website.
About Personalis, Inc.
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210211005015/en/