psnl-8k_20210505.htm
false 0001527753 0001527753 2021-05-05 2021-05-05

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 5, 2021

 

Personalis, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38943

27-5411038

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

 

 

 

1330 O’Brien Drive

Menlo Park, California 94025

 

94025

(Address of Principal Executive Offices)

 

 

(Zip Code)

(650) 752-1300

Registrant’s Telephone Number, Including Area Code

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

PSNL

 

The Nasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

 

 


 

 

Item 2.02 Results of Operations and Financial Condition.

On May 5, 2021, Personalis, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2021. The full text of the press release is furnished as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference.

The information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

Number

 

Description

99.1

 

Press release of Personalis, Inc., dated May 5, 2021

104

 

Cover Page Interactive Data File (embedded within the inline XBRL document)

 

 


 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: May 5, 2021

 

Personalis, Inc.

 

 

 

 

 

 

By:

/s/ Aaron Tachibana

 

 

 

Aaron Tachibana

 

 

 

Chief Financial Officer

 

 

psnl-ex991_6.htm

Exhibit 99.1

 

Personalis Reports First Quarter 2021 Financial Results

MENLO PARK, Calif. – May 5, 2021 – Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the first quarter ended March 31, 2021.

 

First Quarter Highlights

 

 

Record quarterly revenue of $20.9 million in the first quarter of 2021 compared with $19.2 million in the first quarter of 2020, a 9% increase

 

 

Revenue of $7.7 million from biopharma and all other customers, excluding VA MVP, in the first quarter of 2021 compared with $4.4 million in the first quarter of 2020, a 74% increase

 

 

Announced a collaboration with Natera in the field of personalized oncology; Personalis to provide the exome sequence data for Natera to pair with their personalized ctDNA platform, SignateraTM

 

 

Announced a collaboration with MapKure, LLC, a company jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., LLC for use of the NeXT PlatformTM for clinical trials and companion diagnostic development

 

 

Added approximately $162 million of cash to balance sheet from public offering of common stock financing in the first quarter of 2021; ended the quarter with cash, cash equivalents, and short-term investments of $353.4 million as of March 31, 2021

 

“I’m proud to say that we were able to report record revenue once again this quarter and achieved our nineteenth consecutive quarter of growth, as we converted an increasing number of orders into revenue.  Biopharma and all other customer revenue grew 74% year-over-year, and orders from customers exceeded revenues reported once again this quarter,” said John West, Chief Executive Officer. “Recently, we announced a partnership with Natera in the field of personalized oncology, and a companion diagnostics collaboration with MapKure.  Both collaborations further validate our NeXT platform as a leading front end tissue-sequencing platform, capable of detecting cancer cell mutations that conventional exome tests often miss.  Our tissue offering complements our whole exome liquid biopsy product 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 revenue opportunities in the rapidly growing cancer monitoring market.”  

  

 

First Quarter 2021 Financial Results

 

Revenues were $20.9 million in the three months ended March 31, 2021, up 9% from $19.2 million in the same period of the prior year.

 

Gross margin was 35.6% in the three months ended March 31, 2021, compared with 21.1% in the same period of the prior year.

 

1

 


 

Operating expenses were $19.9 million in the three months ended March 31, 2021, compared with $13.7 million in the same period of the prior year.

 

Net loss was $12.4 million in the three months ended March 31, 2021 and net loss per share was $0.29 based on a weighted-average basic and diluted share count of 42.3 million, compared with a net loss of $9.1 million and a net loss per share of $0.29 on a weighted-average basic and diluted share count of 31.3 million in the same period of the prior year.

 

Business Outlook

 

Personalis expects the following for the second quarter of 2021:

 

 

Total Company revenues to be approximately $21.3 million

 

 

Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $7.3 million to $7.7 million

 

 

Net Loss to be in the range of $16 million to $17 million; estimated outstanding shares of 43 million

 

Personalis expects the following for the full year of 2021:

 

 

Total Company revenues to be approximately $85 million

 

 

Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $30 million to $32 million

 

 

Net Loss to be in the range of $70 million to $75 million; estimated outstanding shares of 44 million

 

Webcast and Conference Call Information


Personalis will host a conference call to discuss the first quarter 2021 financial results after market close on Wednesday, May 5, 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: 6587766. 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).

 

 


2

 


 

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,” “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 second quarter and full year 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 new product features, such as NeXT Personal; the market adoption of offerings launched in 2020, such as Personalis’ whole exome liquid biopsy product; 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 including those with Natera and the MapKure; 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 Quarterly Report on Form 10-Q for the period ended March 31, 2021 that will be filed after this earnings release, and risk factors included within the  Annual Report on Form 10-K filed on February 25, 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.

 

 

 

Contacts:

 

Investor Relations Contact:

Caroline Corner

investors@personalis.com

415-202-5678

 

Media Contact:

Jennifer Havlek

pr@personalis.com

www.personalis.com

650-752-1300

 

 

 

 

 

3

 


 

PERSONALIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

(in thousands, except share and per share data)

 

 

 

 

 

 

Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

Revenues

 

$

20,881

 

 

$

19,161

 

Costs and expenses

 

 

 

 

 

 

 

 

Costs of revenues

 

 

13,454

 

 

 

15,122

 

Research and development

 

 

9,496

 

 

 

6,390

 

Selling, general and administrative

 

 

10,421

 

 

 

7,274

 

Total costs and expenses

 

 

33,371

 

 

 

28,786

 

Loss from operations

 

 

(12,490

)

 

 

(9,625

)

Interest income

 

 

95

 

 

 

510

 

Interest expense

 

 

 

 

 

(2

)

Other income (expense), net

 

 

(12

)

 

 

8

 

Loss before income taxes

 

 

(12,407

)

 

 

(9,109

)

Provision for (benefit from) income taxes

 

 

(3

)

 

 

30

 

Net loss

 

$

(12,404

)

 

$

(9,139

)

Net loss per share, basic and diluted

 

$

(0.29

)

 

$

(0.29

)

Weighted-average shares outstanding, basic and diluted

 

 

42,265,596

 

 

 

31,345,029

 

 

4

 


 

PERSONALIS, INC.

SUPPLEMENTAL REVENUE INFORMATION (unaudited)

(in thousands)

 

 

 

Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

VA MVP

 

$

13,210

 

 

$

14,756

 

All other customers

 

 

7,671

 

 

 

4,405

 

Total

 

$

20,881

 

 

$

19,161

 

 

 

 


5

 


 

PERSONALIS, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

 

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

137,089

 

 

$

68,525

 

Short-term investments

 

 

216,340

 

 

 

134,765

 

Accounts receivable, net

 

 

8,053

 

 

 

6,349

 

Inventory and other deferred costs

 

 

5,579

 

 

 

5,639

 

Prepaid expenses and other current assets

 

 

5,607

 

 

 

5,441

 

Total current assets

 

 

372,668

 

 

 

220,719

 

Property and equipment, net

 

 

11,152

 

 

 

11,834

 

Operating lease right-of-use assets

 

 

9,899

 

 

 

10,271

 

Other long-term assets

 

 

1,787

 

 

 

2,018

 

Total assets

 

$

395,506

 

 

$

244,842

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

6,522

 

 

$

8,301

 

Accrued and other current liabilities

 

 

13,805

 

 

 

11,301

 

Contract liabilities

 

 

18,237

 

 

 

21,034

 

Total current liabilities

 

 

38,564

 

 

 

40,636

 

Long-term operating lease liabilities

 

 

8,162

 

 

 

8,541

 

Other long-term liabilities

 

 

360

 

 

 

720

 

Total liabilities

 

 

47,086

 

 

 

49,897

 

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; 43,798,661 and 39,105,548 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

542,694

 

 

 

376,788

 

Accumulated other comprehensive income (loss)

 

 

(5

)

 

 

22

 

Accumulated deficit

 

 

(194,273

)

 

 

(181,869

)

Total stockholders’ equity

 

 

348,420

 

 

 

194,945

 

Total liabilities and stockholders’ equity

 

$

395,506

 

 

$

244,842

 

 

 

 

 

6