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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2022
OR
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☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the transition period from __________ to
__________
Commission file number 001-39482
Sema4 Holdings Corp.
(Exact name of registrant as specified in its charter)
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Delaware |
85-1966622
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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333 Ludlow Street, North Tower, 8th Floor
Stamford, Connecticut
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06902
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(Address of Principal Executive Offices) |
(Zip Code) |
(800) 298-6470
Registrant's telephone number, including area code
(Former
name, former address and former fiscal year, if changed since last
report)
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Class A common stock, par value $0.0001 per share |
SMFR |
The Nasdaq Global Select Market |
Warrants to purchase one share of Class A common stock, each at an
exercise price of $11.50 per share |
SMFRW |
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports) and (2) has been subject to such filing requirements
for the past 90 days. Yes
x
No
o
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such files). Yes
x
No
o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act. (Check one):
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Large accelerated filer |
o |
Accelerated filer |
o |
Non-accelerated filer |
x |
Smaller reporting company |
x |
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Emerging growth company |
x |
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.
o
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Act). Yes
o
No
x
The registrant had outstanding 377,249,186 shares of Class A common
stock as of April 29, 2022.
Table of Contents
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Page |
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Cautionary Note Regarding Forward Looking Statements
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EXPLANATORY NOTE
Unless otherwise stated in this report or the context otherwise
requires, references to the “Company,” “Sema4” and “we,” “us” and
“our” refer to (i) Mount Sinai Genomics, Inc. d/b/a as Sema4, or
Legacy Sema4, prior to the consummation of our business combination
with CM Life Sciences, Inc., or CMLS, on July 22, 2021 and (ii)
Sema4 Holdings Corp. and its consolidated subsidiaries following
the consummation of our business combination.
In addition, on April 29, 2022, we consummated the transactions
contemplated by that certain Agreement and Plan of Merger, dated as
of January 14, 2022 (as amended, the “Merger Agreement”), by and
among us and our wholly-owned subsidiaries, Orion Merger Sub I,
Inc. (“Merger Sub I”) and Orion Merger Sub II, LLC (“Merger Sub II”
and, together with Merger Sub I, “Merger Subs”), and GeneDx, Inc.
(“GeneDx”), a New Jersey corporation and wholly-owned subsidiary of
OPKO Health, Inc. (“OPKO”), GeneDx Holding 2, Inc., which held 100%
of GeneDx (“Holdco2”), and OPKO, which provided for, among other
things, the acquisition of GeneDx from OPKO. Pursuant to the terms
of the Merger Agreement, we acquired GeneDx through the merger of
Merger Sub I with and into Holdco2 (the “First Merger”), with
Holdco2 as the surviving corporation in the First Merger.
Immediately after the consummation of the First Merger, as part of
the same overall transaction, Holdco2, as the surviving corporation
in the First Merger, merged with and into Merger Sub II (the
“Second Merger” and, together with the First Merger, the
“Mergers”), with Merger Sub II as the surviving company. After
giving effect to the Mergers and the other transactions
contemplated by the Merger Agreement, GeneDx was converted into a
Delaware limited liability company and became our wholly-owned
indirect subsidiary. At the closing of the Acquisition (as defined
below), we paid OPKO gross cash consideration of $150 million and
issued to OPKO 80 million shares of our Class A common stock. We
refer to these transactions herein as the “Acquisition.” In
addition, up to $150 million is payable following the closing of
the Acquisition, if certain revenue-based milestones are achieved
for each of the fiscal years ending December 31, 2022 and December
31, 2023. Concurrently with the closing of the Acquisition, we also
issued and sold in private placement 50,000,000 shares of our Class
A common stock to certain institutional investors for aggregate
gross proceeds of $200 million (the “Acquisition PIPE Investment”).
Unless stated otherwise in this report, all forward-looking
information contained in this report does not take into account or
give any effect to the impact of the Acquisition or the Acquisition
PIPE Investment.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain matters discussed in this report, including matters
discussed under the caption “Management’s Discussion and Analysis
of Financial Condition and Results of Operations,” may constitute
forward-looking statements for purposes of the Securities Act of
1933, as amended, or the Securities Act, and the Securities
Exchange Act of 1934, as amended, or the Exchange Act, and involve
known and unknown risks, uncertainties and other factors that may
cause our actual results, performance or achievements to be
materially different from the future results, performance or
achievements expressed or implied by such forward-looking
statements. The words “anticipate,” “believe,” “estimate,” “may,”
“expect” and similar expressions are generally intended to identify
forward-looking statements. Our actual results may differ
materially from the results anticipated in these forward-looking
statements due to a variety of factors, including, without
limitation, those discussed under the captions “Risk Factors,”
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” and elsewhere in this report, as well as
other factors which may be identified from time to time in our
other filings with the Securities and Exchange Commission, or the
SEC, or in the documents where such forward-looking statements
appear. All written or oral forward-looking statements attributable
to us are expressly qualified in their entirety by these cautionary
statements. Such forward-looking statements include, but are not
limited to, statements about:
•our
estimates of the sufficiency of our existing capital resources
combined with future anticipated cash flows to finance our
operating requirements
•our
expected losses;
•our
expectations for incurring capital expenditures to expand our
research and development and manufacturing
capabilities;
•unforeseen
circumstances or other disruptions to normal business operations,
including supply chain interruptions and manufacturing constraints,
arising from or related to the ongoing COVID-19
pandemic;
•our
ability to realize the benefits expected from the
Acquisition;
•our
expectations for generating revenue or becoming profitable on a
sustained basis;
•our
expectations or ability to enter into service, collaboration and
other partnership agreements;
•our
expectations or ability to build our own commercial infrastructure
to scale market and sell our products;
•actions
or authorizations by the U.S. Food and Drug Administration, or the
FDA, or other regulatory authorities;
•risks
related to governmental regulation and other legal obligations,
including privacy, data protection, information security, consumer
protection, and anti-corruption and anti-bribery;
•our
ability to obtain and maintain intellectual property protection for
our product candidates;
•our
ability to compete against existing and emerging
technologies;
•our
stock price and its volatility;
•our
ability to attract and retain key personnel;
•third-party
payor reimbursement and coverage decisions;
•our
reliance on third-party laboratories and service providers for our
test volume in connection with our diagnostic solutions and data
programs;
•our
expectations for future capital requirements; and
•our
ability to successfully implement our business
strategy.
The forward-looking statements contained in this report reflect our
views and assumptions only as of the date that this report is
signed. Except as required by law, we assume no responsibility for
updating any forward-looking statements.
We qualify all of our forward-looking statements by these
cautionary statements. In addition, with respect to all of our
forward-looking statements, we claim the protection of the safe
harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995.
Sema4 Holdings Corp.
Condensed Consolidated Balance Sheets
(in thousands, except share amounts)
Part I - Financial Information
Item 1. Unaudited Condensed Consolidated Financial
Statements
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 (unaudited) |
|
December 31, 2021 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
315,002 |
|
|
$ |
400,569 |
|
Accounts receivable, net |
37,642 |
|
|
26,509 |
|
Due from related parties |
125 |
|
|
54 |
|
Inventory, net |
36,318 |
|
|
33,456 |
|
Prepaid expenses |
17,241 |
|
|
19,154 |
|
Other current assets |
4,096 |
|
|
3,802 |
|
Total current assets |
$ |
410,424 |
|
|
$ |
483,544 |
|
Operating lease right-of-use assets |
38,417 |
|
|
— |
|
Property and equipment, net |
60,976 |
|
|
62,719 |
|
Restricted cash |
900 |
|
|
900 |
|
Other assets |
6,953 |
|
|
6,930 |
|
Total assets |
$ |
517,670 |
|
|
$ |
554,093 |
|
Liabilities and Stockholders’ Equity |
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
68,880 |
|
|
$ |
64,801 |
|
Due to related parties |
3,237 |
|
|
2,623 |
|
Contract liabilities |
66 |
|
|
473 |
|
Short-term lease liabilities |
5,072 |
|
|
— |
|
Other current liabilities |
23,384 |
|
|
33,387 |
|
Total current liabilities |
$ |
100,639 |
|
|
$ |
101,284 |
|
Long-term debt, net of current portion |
11,000 |
|
|
11,000 |
|
Long-term lease liabilities |
57,478 |
|
|
— |
|
Other liabilities |
500 |
|
|
21,907 |
|
Warrant liability |
15,177 |
|
|
21,555 |
|
Earn-out contingent liability |
3,432 |
|
|
10,244 |
|
Total liabilities |
$ |
188,226 |
|
|
$ |
165,990 |
|
Commitments and contingencies (Note 10) |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred Stock, $0.0001 par value: 1,000,000 and 0 shares
authorized at March 31, 2022 and December 31, 2021,
respectively; 0 shares issued and outstanding at March 31,
2022 and December 31, 2021, respectively
|
— |
|
|
— |
|
Class A common stock, $0.0001 par value, 380,000,000 shares
authorized, 245,154,475 shares issued and outstanding at
March 31, 2022 and $0.0001 par value: 380,000,000 shares
authorized, 242,647,604 shares issued and outstanding at
December 31, 2021
|
24 |
|
|
24 |
|
Additional paid-in capital
|
981,757 |
|
|
$ |
963,520 |
|
Accumulated deficit
|
(652,337) |
|
|
(575,441) |
|
Total stockholders’ equity
|
329,444 |
|
|
388,103 |
|
Total liabilities and stockholders’ equity
|
$ |
517,670 |
|
|
$ |
554,093 |
|
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
Sema4 Holdings Corp.
Condensed Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share and per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 (1) |
Revenue: |
|
|
|
Diagnostic test revenue (including related party revenue of $170
and $33 for the three months ended March 31, 2022 and 2021,
respectively)
|
$ |
52,495 |
|
|
$ |
62,760 |
|
Other revenue (including related party revenue of $74 and $27 for
the three months ended March 31, 2022 and 2021,
respectively)
|
1,446 |
|
|
1,441 |
|
Total revenue
|
53,941 |
|
|
64,201 |
|
Cost of services (including related party expenses of $1,056 and
$278 for the three months ended March 31, 2022 and 2021,
respectively)
|
48,316 |
|
|
68,524 |
|
Gross profit (loss)
|
5,625 |
|
|
(4,323) |
|
Research and development
|
21,315 |
|
|
53,133 |
|
Selling and marketing
|
29,547 |
|
|
35,366 |
|
General and administrative
|
42,784 |
|
|
102,038 |
|
Related party expenses
|
1,284 |
|
|
1,797 |
|
Loss from operations
|
(89,305) |
|
|
(196,657) |
|
|
|
|
|
Other income (expense), net:
|
|
|
|
Change in fair market value of warrant and earn-out contingent
liabilities |
13,190 |
|
|
— |
|
Interest income
|
27 |
|
|
21 |
|
Interest expense
|
(808) |
|
|
(723) |
|
Other income
|
— |
|
|
5,584 |
|
Total other income (expense), net
|
12,409 |
|
|
4,882 |
|
Loss before income taxes
|
$ |
(76,896) |
|
|
$ |
(191,775) |
|
Income tax provision
|
— |
|
|
— |
|
Net loss and comprehensive loss
|
$ |
(76,896) |
|
|
$ |
(191,775) |
|
Weighted average shares outstanding of Class A common
stock
|
244,368,743 |
|
|
549,778 |
|
Basic and diluted net loss per share, Class A common
stock
|
$ |
(0.31) |
|
|
$ |
(348.82) |
|
(1) As previously disclosed in Note 2, “Summary of Significant
Accounting Policies” to our consolidated financial statements
included in our Annual Report on Form 10-K for the year ended
December 31, 2021, certain adjustments were made to reclassify
certain expenses between cost of services and operating expenses.
The adjustments are reflected as disclosed.
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
Sema4 Holdings Corp.
Condensed Consolidated Statement of Redeemable Convertible
Preferred Stock and Stockholders' Equity (Deficit)
(in thousands, except share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, 2022 |
|
Preferred Stock |
|
|
Class A Common Stock |
|
Additional paid-in capital |
|
Accumulated deficit |
|
Total stockholders’ equity |
|
Shares |
|
Par value |
|
|
Shares |
|
Par value |
|
|
|
Balances at December 31, 2021 |
|
|
|
|
|
242,647,604 |
|
$ |
24 |
|
|
$ |
963,520 |
|
|
$ |
(575,441) |
|
|
$ |
388,103 |
|
Net loss |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
(76,896) |
|
|
(76,896) |
|
Stock option exercises |
— |
|
|
— |
|
|
|
2,108,502 |
|
|
— |
|
|
678 |
|
|
— |
|
|
678 |
|
Stock based compensation expense |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
17,559 |
|
|
— |
|
|
17,559 |
|
Vested restricted stock units converted to common stock |
— |
|
|
— |
|
|
|
398,369 |
|
|
|
|
|
|
|
|
|
Balances at March 31, 2022
|
— |
|
$ |
— |
|
|
|
245,154,475 |
|
$ |
24 |
|
|
$ |
981,757 |
|
|
$ |
(652,337) |
|
|
$ |
329,444 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
months ended March 31, 2021 (1) |
|
Redeemable Convertible Preferred Stock |
|
|
Class A Common Stock |
|
Class B Common Stock |
|
Additional paid-in capital |
|
Accumulated deficit (1) |
|
Total stockholders’ (deficit) |
|
Shares |
|
Amount |
|
|
Shares |
|
Par value |
|
Shares |
|
Par value |
|
|
|
Balances at December 31, 2020 |
171,535,213 |
|
$ |
334,439 |
|
|
|
124 |
|
$ |
— |
|
|
130,557 |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(330,051) |
|
|
$ |
(330,051) |
|
Net loss |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(191,775) |
|
|
(191,775) |
|
Common stock class B issued pursuant to stock options |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
618,204 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Balances at March 31, 2021
|
171,535,213 |
|
$ |
334,439 |
|
|
|
124 |
|
$ |
— |
|
|
748,761 |
|
$ |
— |
|
|
$ |
— |
|
|
(521,826) |
|
|
(521,826) |
|
(1)
As previously disclosed in Note 2, “Summary of Significant
Accounting Policies” to our consolidated financial statements
included in our Annual Report on Form 10-K for the year ended
December 31, 2021, certain adjustments were made which impacted
previously reported net loss for the first quarter of 2021 and the
adjusted net loss is reflected as disclosed.
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
Sema4 Holdings Corp.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 (1) |
Operating activities |
|
|
|
Net loss
|
$ |
(76,896) |
|
|
$ |
(191,775) |
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in
operating activities:
|
|
|
|
Depreciation and amortization expense
|
5,803 |
|
|
4,902 |
|
Stock-based compensation expense
|
17,559 |
|
|
164,962 |
|
Change in fair value of warrant and earn-out contingent
liabilities
|
(13,190) |
|
|
— |
|
Provision for excess and obsolete inventory
|
43 |
|
|
1,821 |
|
Non-cash lease expense
|
167 |
|
|
191 |
|
Amortization of deferred debt issuance costs |
128 |
|
|
— |
|
Change in operating assets and liabilities:
|
|
|
|
Accounts receivable
|
(11,132) |
|
|
(1,296) |
|
Inventory
|
(2,904) |
|
|
(9,828) |
|
Prepaid expenses and other current assets
|
1,596 |
|
|
(6,327) |
|
Due to/from related parties
|
543 |
|
|
(688) |
|
Other assets
|
(151) |
|
|
— |
|
Accounts payable and accrued expenses
|
3,932 |
|
|
3,951 |
|
Contract liabilities
|
(408) |
|
|
1,027 |
|
Other current liabilities
|
(6,584) |
|
|
(9,148) |
|
Net cash used in operating activities
|
(81,494) |
|
|
(42,208) |
|
|
|
|
|
Investing activities
|
|
|
|
Purchases of property and equipment
|
(1,378) |
|
|
(2,075) |
|
Development of internal-use software assets
|
(2,535) |
|
|
(2,919) |
|
Net cash used in investing activities
|
(3,913) |
|
|
(4,994) |
|
|
|
|
|
Financing activities
|
|
|
|
Payment of deferred transaction
costs |
— |
|
|
(1,254) |
|
Finance lease principal payments |
(862) |
|
|
(1,052) |
|
Long-term debt principal payments |
— |
|
|
(394) |
|
Exercise of stock options |
702 |
|
|
422 |
|
Net cash used in financing activities
|
(160) |
|
|
(2,278) |
|
|
|
|
|
Net decrease in cash, cash equivalents and restricted
cash
|
(85,567) |
|
|
(49,480) |
|
Cash, cash equivalents and restricted cash, at beginning of
period
|
401,469 |
|
|
118,960 |
|
Cash, cash equivalents and restricted cash, at end of
period
|
$ |
315,902 |
|
|
$ |
69,480 |
|
|
|
|
|
Supplemental disclosures of cash flow information
|
|
|
|
Cash paid for interest
|
$ |
607 |
|
|
$ |
723 |
|
Cash paid for taxes
|
$ |
168 |
|
|
$ |
— |
|
Purchases of property and equipment in accounts payable and accrued
expenses
|
$ |
1,325 |
|
|
$ |
1,164 |
|
Software development costs in accounts payable and accrued
expenses
|
$ |
717 |
|
|
$ |
1,570 |
|
Unpaid deferred transaction costs included in accounts payable and
accrued expenses |
$ |
227 |
|
|
$ |
4,228 |
|
(1)
As previously disclosed in Note 2, “Summary of Significant
Accounting Policies” to our consolidated financial statements
included in our Annual Report on Form 10-K for the year ended
December 31, 2021, certain adjustments were made to certain current
asset and liability accounts previously reported in the condensed
balance sheets as of March 31, 2021. The adjustments are reflected
accordingly as disclosed.
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
1. Organization and Description of Business
Sema4 Holdings Corp. (“Sema4 Holdings”) through its subsidiary
Sema4 OpCo, Inc.,, formerly Mount Sinai Genomics Inc., a Delaware
corporation (“Legacy Sema4”), as discussed further below, provides
genomics-related diagnostic and information services and pursues
genomics medical research. Legacy Sema4 utilizes an integrated
portfolio of laboratory processes, software tools and informatics
capabilities to process DNA-containing samples, analyze information
about patient-specific genetic variation and generate test reports
for clinicians and their patients. Legacy Sema4 provides a variety
of genetic diagnostic tests and information with a focus on
reproductive health, including pediatric, oncology and other
conditions. Legacy Sema4 primarily serves healthcare professionals
who work with their patients and bills third-party payors across
the United States, with a substantial portion of its diagnostic
testing volume occurring in New York, California, Florida,
Connecticut and New Jersey.
On July 22, 2021 (the “Closing Date”), CM Life Sciences, Inc.
(“CMLS”) completed the acquisition of Legacy Sema4, pursuant to
that certain Agreement and Plan of Merger (as amended, the “Prior
Merger Agreement”), dated February 9, 2021. On the Closing
Date, S-IV Sub, Inc. (“Prior Merger Sub”) merged with and into the
Legacy Sema4, with Legacy Sema4 surviving the merger as a
wholly-owned subsidiary of CMLS (the “Prior Merger” and, together
with the other transactions contemplated by the Prior Merger
Agreement, the “Business Combination”). In connection with the
consummation of the Business Combination, CMLS changed its name to
“Sema4 Holdings Corp.” and Legacy Sema4 changed its name to “Sema4
OpCo, Inc.” All equity securities of Legacy Sema4 were converted
into the right to receive the applicable portion of the merger
consideration.
The Prior Merger was accounted for as a reverse recapitalization
with Legacy Sema4 as the accounting acquirer and CMLS as the
acquired company for accounting purposes. The shares and net loss
per common share, prior to the Prior Merger, have been
retroactively restated as shares reflecting the exchange ratio
established in the Prior Merger (1 share of Legacy Sema4 Class A
common stock for 123.8339 shares of Sema4 Holdings Class A common
stock (the “Class A common stock”)) (the “Conversion
Ratio”).
Prior to the Prior Merger, shares of CMLS Class A common stock,
CMLS’s public warrants, and CMLS’s public units were traded on the
Nasdaq Capital Market under the ticker symbols “CMLF”, “CMFLW”, and
“CMLFU” respectively. On July 23, 2021, shares of Sema4 Holdings
Class A common stock and Sema4 Holdings’ public warrants began
trading on the Nasdaq Global Select Market (the “Nasdaq”) under the
ticker symbols “SMFR” and “SMFRW,” respectively. See Note 3,
“Business Combination,” for additional details.
Unless otherwise stated herein or unless the context otherwise
requires, references in these notes to the “Company,” or “Sema4”
refer to (i) Legacy Sema4 prior to the consummation of the Business
Combination; and (ii) Sema4 Holdings and its subsidiaries following
the consummation of the Business Combination.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial
statements have been prepared in conformity with accounting
principles generally accepted in the United States of America
(“U.S. GAAP”) for interim financial information and pursuant to the
accounting disclosure rules and regulations of the Securities and
Exchange Commission (the “SEC”) regarding interim financial
reporting. Accordingly, they do not include all of the information
and footnotes required by U.S. GAAP for complete financial
statements. As such, the accompanying unaudited condensed
consolidated financial statements should be read in conjunction
with the Company’s audited financial statements and notes thereto
as of and for the years ended December 31, 2021, 2020 and 2019
included in the Company’s Annual Report on Form 10-K for the year
ended December 21, 2021 filed on March 14, 2022 (the “Annual
Report”).
The accompanying unaudited condensed consolidated financial
statements reflect all normal recurring adjustments that are
necessary to state fairly the results for the interim periods
presented. Interim results are not necessarily indicative of the
results of operations or cash flows for a full year or any
subsequent interim period.
The Company’s historical financial information includes costs of
certain services historically provided by Icahn School of Medicine
at Mount Sinai (“ISMMS”) pursuant to the Transition Services
Agreement ("TSA") and service agreements.
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
As discussed in the Company’s Annual Report, the Company identified
the misclassification of certain expenses and out of period
adjustments generally related to the recognition of cost of
services. The impact of these adjustments were disclosed in the
Company’s Annual Report and are reflected in the condensed
consolidated statements of operations and comprehensive loss,
condensed consolidated statement of redeemable convertible
preferred stock and stockholders’ equity (deficit) and condensed
consolidated statements of cash flows for the period ended March
31, 2021.
Although the Company has incurred recurring losses in each year
since inception, the Company expects its cash and cash equivalents
will be sufficient to fund operations for at least the next twelve
months from the date of filing of this Form 10-Q.
Segment Information
The Company operates and manages its business as one reportable
operating segment based on how the Chief Executive Officer, who is
the Company’s chief operating decision maker (“CODM”), assesses
performance and allocates resources across the
business.
Use of Estimates
The preparation of unaudited condensed consolidated financial
statements in conformity with U.S. GAAP requires management to make
certain estimates, judgments and assumptions that affect the
reported amounts of assets and liabilities and the related
disclosures at the date of the unaudited condensed consolidated
financial statements as well as the reported amounts of revenues
and expenses during the periods presented. The Company bases these
estimates on current facts, historical and anticipated results,
trends and various other assumptions that it believes are
reasonable in the circumstances, including assumptions as to future
events. These estimates include, but are not limited to, the
transaction price for certain contracts with customers, the
capitalization of software costs and the valuation of stock-based
awards, inventory, earn-out contingent liability and earn-out
Restricted Stock Units (“RSUs”). Actual results could differ
materially from those estimates, judgments and
assumptions.
Concentration of Credit Risk and Other Risks and
Uncertainties
Financial instruments that potentially subject the Company to
concentrations of credit risk consist primarily of cash and cash
equivalents and accounts receivable.
The Company’s cash and cash equivalents are deposited with
high-quality financial institutions. The Company has balances in
financial institutions that exceed federal depository insurance
limits. Management believes these financial institutions are
financially sound and, accordingly, that minimal credit risk
exists. The Company has not experienced any losses on its deposits
of cash and cash equivalents.
The Company assesses both the self-pay patient and, if applicable,
the third-party payor that reimburses the Company on the patient’s
behalf when evaluating the concentration of credit risk.
Significant customers and payors are those that represent more than
10% of the Company’s total revenues for the period or accounts
receivable balance at each respective balance sheet date. The
significant concentrations of accounts receivable as of
March 31, 2022 and December 31, 2021 were primarily from
large managed care insurance companies and a reference laboratory.
There was no individual patient that accounted for 10% or more of
the Company’s revenue or accounts receivable for any of the periods
presented. The Company does not require collateral as a means to
mitigate customer credit risk.
For each significant payor, revenue as a percentage of total
revenues and accounts receivable as a percentage of total accounts
receivable are as follows:
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
Accounts Receivable |
|
Three months ended March 31, |
|
As of
March 31,
|
|
As of
December 31,
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Payor A |
24% |
|
14% |
|
26% |
|
15% |
Payor B
|
* |
|
* |
|
19% |
|
15% |
Payor C
|
* |
|
12% |
|
* |
|
* |
Payor D
|
10% |
|
12% |
|
11% |
|
* |
*less than 10%
|
|
|
|
|
|
|
|
The Company is subject to a concentration of risk from a limited
number of suppliers for certain reagents and laboratory supplies.
One supplier accounted for approximately 13% and 11% for the three
months ended March 31, 2022 and 2021, respectively. This risk
is managed by maintaining a target quantity of surplus
stock.
Impact of COVID-19
Beginning in April 2020, the Company’s diagnostic test volumes
decreased significantly as compared to the prior year as a result
of the initial outbreak of the COVID-19 pandemic and the related
limitations and priorities across the healthcare system. In
response, beginning in May 2020, the Company entered into several
service agreements with state governments and healthcare
institutions to provide testing for the presence of COVID-19
variants. While test volumes have since improved, the Company
continues to experience changes in the mix of tests due to the
impact of the COVID-19 pandemic. COVID-19 could continue to have a
material impact on the Company’s results of operations, cash flows
and financial condition for the foreseeable future.
In March 2020, the Coronavirus Aid, Relief and Economic Security
Act (“CARES Act”) was signed into law which was a stimulus bill
that, among other things, provided assistance to qualifying
businesses and individuals and included funding for the healthcare
system. During 2020, as part of the stimulus provided by the CARES
Act, the Company received $5.4 million, comprised of $2.6
million received under the Provider Relief Fund (“PRF”)
distribution and $2.8 million received under the Employee Retention
Credit (“ERC”) distribution which was recorded in other current
liabilities and reflected in this balance as of March 31, 2022 and
December 31, 2021.
During the three months ended March 31, 2021, the Company received
an additional $5.6 million under the PRF distribution, which was
recognized in other income in the condensed consolidated statements
of operations and comprehensive loss.
Additionally, under the CARES Act, the Company deferred payment of
U.S. social security taxes in 2020. As a result, $3.8 million
of employer payroll tax payments were initially deferred as of
December 31, 2020 with $1.9 million paid in December 2021 and
the remaining $1.9 million payment will be made in December
2022. As of March 31, 2022, the remaining payable is recorded in
other current liabilities.
Following the Company’s announcement that it would discontinue
COVID-19 testing services by March 31, 2022, the Company no longer
provides COVID-19 testing services. During the three months ended
March 31, 2022, the Company wrote off an accounts receivable
balance of $0.5 million related to COVID-19 testing
services.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with original
maturities of three months or less from the date of purchase to be
cash equivalents. Cash equivalents consist of amounts invested in
money market funds. Carrying values of cash equivalents approximate
fair value due to the short-term nature of these
instruments.
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
The following table provides a reconciliation of cash, cash
equivalents and restricted cash reported on the condensed
consolidated balance sheets that sum to the total of the same
amounts shown on the condensed consolidated statements of cash
flows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
March 31, 2022
|
|
As of
December 31, 2021
|
Cash and cash equivalents |
$ |
315,002 |
|
|
$ |
400,569 |
|
Restricted cash |
900 |
|
|
900 |
|
Total |
$ |
315,902 |
|
|
$ |
401,469 |
|
Restricted cash as of March 31, 2022 consists of money market
deposit accounts that secure an irrevocable standby letter of
credit that serves as collateral for security deposit operating
leases (see Note 9,
“Leases”).
Warrant Liability
As of the consummation of the Prior Merger in July 2021, there were
21,995,000 warrants to purchase shares of Class A common stock
outstanding, including 14,758,333 public warrants and 7,236,667
private placement warrants. As of December 31, 2021, there were
21,994,972 warrants to purchase shares of Class A common stock
outstanding, including 14,758,305 public warrants and 7,236,667
private placement warrants outstanding. Each warrant expires five
years after the Business Combination or earlier upon redemption or
liquidation, and entitles the holder to purchase one share of Class
A common stock at an exercise price of $11.50 per share, subject to
adjustment, at any time commencing on September 4,
2021.
The Company may redeem the outstanding public warrants if the price
per share of the Class A common stock equals or exceeds $18.00 as
described below:
•in
whole and not in part;
•at
a price of $0.01 per public warrant;
•upon
not less than 30 days’ prior written notice of redemption to each
warrant holder; and
•if,
and only if, the closing price of the Class A common stock equals
or exceeds $18.00 per share (as adjusted) for any 20 trading days
within a 30-trading day period ending three trading days before
sending the notice of redemption to warrant holders.
The Company may redeem the outstanding public warrants if the price
per share of the common stock equals or exceeds $10.00 as described
below:
•in
whole and not in part;
•at
$0.10 per warrant upon a minimum of 30 days’ prior written notice
of redemption provided that holders will be able to exercise their
warrants on a cashless basis prior to redemption and receive that
number of shares based on the redemption date and the fair market
value of the common stock;
•if,
and only if, the closing price of the Class A common stock equals
or exceeds $10.00 per share (as adjusted) for any 20 trading days
within the 30-trading day period ending three trading days before
the Company sends the notice of redemption to the warrant holders;
and
•if
the closing price of the common stock for any 20 trading days
within a 30-trading day period ending three trading days before the
Company sends notice of redemption to the warrant holders is less
than $18.00 per share (as adjusted), the private placement warrants
must also be concurrently called for redemption on the same terms
as the outstanding public warrants, as described
above.
The private placement warrants were issued to CMLS Holdings, LLC,
Mr. Munib Islam, Dr. Emily Leproust and Mr. Nat Turner, and are
identical to the public warrants underlying the units sold in the
initial public offering, except that (1) the private placement
warrants and the common stock issuable upon the exercise of the
private placement warrants would
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
not be transferable, assignable or salable until 30 days after the
completion of a Business Combination, subject to certain limited
exceptions, (2) the private placement warrants are exercisable on a
cashless basis, (3) the private placement warrants are
non-redeemable (except as described above, upon a redemption of
warrants when the price per share of Class A common stock equals or
exceeds $10.00) so long as they are held by the initial purchasers
or their permitted transferees, and (4) the holders of the private
placement warrants and the common stock issuable upon the exercise
of the private placement warrants have certain registration rights.
If the private placement warrants are held by someone other than
the initial purchasers or their permitted transferees, the private
placement warrants will be redeemable by the Company and
exercisable by such holders on the same basis as the public
warrants.
The Company accounts for warrants as liability-classified
instruments based on an assessment of the warrant terms and
applicable authoritative guidance in accordance with ASC
480-Distinguishing Liabilities from Equity (“ASC 480”) and ASC
815-Derivatives and Hedging (“ASC 815”). The assessment considers
whether the warrants are freestanding financial instruments
pursuant to ASC 480, whether the warrants meet the definition of a
liability pursuant to ASC 480, and whether the warrants meet all of
the requirements for equity classification under ASC 815. This
assessment is conducted at the time of warrant issuance and as of
each subsequent quarterly period end date while the warrants are
outstanding.
Earn-out contingent liability
In connection with the Prior Merger, all Legacy Sema4 stockholders
and option holders at that time became entitled to a pro rata share
of 19,021,576 earn-out shares and earn-out RSUs. Based on an
assessment of the earn-out shares for the Legacy Sema4
stockholders, the Company considered ASC 480 and ASC 815 and
accounted for the earn-out shares as a liability. The Company
subsequently measures the fair value of the liability at each
reporting period and reports the changes in fair value recorded as
a component of other income (expense), net in the condensed
consolidated statements of operations and comprehensive
loss.
The Company determined the fair value of the earn-out shares issued
to the Legacy Sema4 stockholders as of March 31, 2022 was $3.4
million.
As for the earn-out RSUs for the Legacy Sema4 option holders, a
total of 2.7 million RSUs were granted on December 9, 2021.
The vesting of such arrangement is conditioned on the satisfaction
of both a service requirement and on the satisfaction of a
market-based requirement. The market-based requirement would be
achieved if the Company’s stock price is greater than or equal to
$13 (Triggering Event I), $15 (Triggering Event II) and $18
(Triggering Event III) during the applicable performance period,
based on the volume-weighted average price for a period of at least
20 days out of 30 consecutive trading days. Therefore, the Company
accounts for this arrangement in accordance with ASC 718-
Compensation — Stock Compensation (“ASC 718”) and stock-based
compensation expense is recognized over the longer of the expected
achievement period for the market-based requirement and the service
requirement. The Company recorded $0.5 million of stock-based
compensation expense in relation to the earn-out RSUs for the
quarter ended March 31, 2022. In the event that any earn-out RSUs
that are forfeited as a result of a failure to achieve the service
requirement, the underlying shares will be reallocated on an annual
basis to the Legacy Sema4 stockholders and to the Legacy Sema4
option holders who remain employed as of the date of such
reallocation. The Company accounts for the re-allocations to Legacy
Sema4 option holders as new grants.
The estimated fair value of the earn-out is determined using a
Monte Carlo valuation analysis.
Capitalized Internal-Use Software Costs
The Company capitalizes certain costs incurred related to the
development of its software applications for internal use during
the application development state. If a project constitutes an
enhancement to existing software, the Company assesses whether the
enhancement creates additional functionality to the software, thus
qualifying the work incurred for capitalization. Costs incurred
prior to meeting these criteria together with costs incurred for
training and maintenance are expensed as incurred. Once the project
is available for general release, capitalization ceases and the
Company estimates the useful life of the asset and begins
amortization.
Restructuring Costs
During the three months ended March 31, 2022, the Company’s
Compensation Committee of the Board of Directors approved by
written consent dated February 17, 2022 a restructuring plan which
was executed by management and
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
$2.7 million of restructuring charges were incurred and
recorded in connection therewith. These costs include severance
packages offered to the employees impacted by the plan and third
party consulting costs. Additionally, as discussed in the “Note
14—Subsequent Events”, the Board of Directors approved additional
headcount reductions in an effort to streamline operations and the
Company expects to recognize expenses of $5.4 million during
the second quarter of 2022.
Emerging Growth Company
The Company is an “emerging growth company” as defined in the
Jumpstart Our Business Startups Act of 2012. As such, the Company
is eligible for exemptions from various reporting requirements
applicable to other public companies that are not emerging growth
companies, including reduced reporting and extended transition
periods to comply with new or revised accounting standards for
public business entities. The Company has elected to avail itself
of this exemption and, therefore, will not be subject to the same
new or revised accounting standards as other public companies that
are not emerging growth companies.
Recently Adopted Accounting Pronouncements in the First Quarter of
2022
In February 2016, the FASB issued ASU 2016-02, Leases (“Topic
842”), which requires lessees to recognize right-of-use assets and
lease liabilities for most leases on their balance sheets. Expense
recognition for lessees under ASC 842 is similar to current lease
accounting. ASC 842 requires enhanced disclosures to help the
financial statement users better understand the amount, timing, and
uncertainty of cash flows arising from leases. The Company adopted
ASC 842 as of January 1, 2022, utilizing the modified retrospective
adoption approach. In transition to the ASC 842, the Company
elected to use the package of practical expedients permitted under
the transition guidance that allowed us to not reassess: (i)
whether any expired or existing contracts are or contain leases,
(ii) the lease classification for any expired or existing leases,
or (iii) initial direct costs for any existing leases.
Additionally, the Company did not elect the hindsight practical
expedient which would have permitted the use of hindsight in
determining the lease term and assessing impairment. The Company
elected to combine lease and non-lease components that are fixed
and also elected not to recognize right-of-use assets and lease
liabilities for leases with terms of 12 months or less (“short-term
leases”). The adoption of the ASC 842 as of January 1, 2022,
resulted in the recognition of operating lease right-of-use assets
and operating lease liabilities of $39.2 million and
$42.2 million, respectively. The adoption did not have
material impact on finance leases. The adoption did not have
material impact on the condensed consolidated statements of
operations and comprehensive loss. Refer to
“Note 9 Leases”
for a discussion of the Company’s lease accounting following the
adoption of ASC 842.
In November 2021, the FASB issued ASU 2021-10, Government
Assistance (Topic 832), Disclosures by Business Entities About
Government Assistance, which requires entities to provide
disclosures on material government assistance transactions for
annual reporting periods. The disclosures include information
around the nature of the assistance, the related accounting
policies used to account for government assistance, the effect of
government assistance on the entity’s financial statements, and any
significant terms and conditions of the agreements, including
commitments and contingencies. The Company adopted ASU 2021-10
effective January 1, 2022. The Company did not receive any such
grants during the three months ended March 31, 2022.
Recently Issued Accounting Pronouncements Not Yet
Adopted
In June 2016, the FASB issued ASU 2016-13,
Financial Instruments – Credit Losses (Topic 326): Measurement of
Credit Losses on Financial Instruments
(“ASU 2016-13”). The new credit losses standard changes the
impairment model for most financial assets and certain other
instruments. For trade and other receivables, contract assets
recognized as a result of applying ASC 606, loans and certain other
instruments, entities will be required to use a new forward looking
“expected loss” model that generally will result in earlier
recognition of credit losses than under today’s incurred loss
model. As an emerging growth company, ASU 2016-13 is effective for
annual periods beginning after December 15, 2022, with early
adoption permitted. Application of the amendments is through a
cumulative-effect adjustment to the opening retained earnings as of
the beginning of the first reporting period in which the guidance
is effective. The Company is currently evaluating the impact of the
new guidance on its consolidated financial statements and related
disclosures.
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
3. Business Combination
As discussed in Note 1, on July 22, 2021, the Company
consummated the Business Combination and received net cash proceeds
of $510.0 million.
Pursuant to the Business Combination, the following
occurred:
•Holders
of 10,188 shares of CMLS’s Class A common stock sold in its initial
public offering (the “public shares”) exercised their right to have
such shares redeemed for a full pro rata portion of the trust
account holding the proceeds from CMLS’s initial public offering
(the “IPO”), which was approximately $10.00 per share, or $101,880
in aggregate.
•Each
share of CMLS’s Class B common stock was automatically converted
into common stock of the Company.
•Each
share of the Legacy Sema4 Class B common stock was converted into
1/100th of a share of Legacy Sema4 Class A common stock and each
share of Legacy Sema4 common stock and preferred stock was canceled
and received a portion of the merger consideration, resulting in
certain Legacy Sema4 stockholders receiving $230,665,220 of cash
and the Legacy Sema4 stockholders receiving an aggregate of
178,336,298 shares of common stock of the Company.
•Pursuant
to subscription agreements entered into on February 9, 2021,
certain investors agreed to subscribe for an aggregate of
35,000,000 newly-issued shares of common stock at a purchase price
of $10.00 per share for an aggregate purchase price of $350,000,000
(the “PIPE Investment”). Concurrently with the closing of the
Business Combination, the Company consummated the PIPE
Investment.
•After
giving effect to the Prior Merger, the redemption of public shares
and the conversion of the CMLS Class B common stock as described
above, and the consummation of the PIPE Investment, there were
240,190,402 shares of the Company’s common stock issued and
outstanding.
In 2021, the Company recorded $51.8 million of transaction
costs which consisted of direct, incremental legal, professional,
accounting, and other third-party fees that were directly related
to the execution of the Prior Merger in additional paid-in capital.
Upon consummation of the Prior Merger, $9.0 million of the
transaction costs relates to costs incurred by Legacy Sema4 and
reclassed to offset against equity from prepaid expense and other
current assets.
4. Revenue Recognition
Diagnostic Revenue
The Company’s diagnostic test revenue contracts typically consist
of a single performance obligation to deliver diagnostic testing
services to the ordering facility or patient and therefore
allocation of the contract transaction price is generally not
applicable. Revenue from diagnostic testing services is recorded at
the estimated transaction price, subject to the constraint for
variable consideration, upon transfer of control of the service.
Control over diagnostic testing services is generally transferred
at a point in time when the customer obtains control of the
promised service which is upon delivery of the test.
Other Revenue
The Company enters into both short-term and long-term project-based
collaboration and service agreements with third parties, whereby
the Company provides diagnostic testing, research and related data
aggregation reporting services. The consideration to which the
Company is entitled pursuant to its collaboration and service
agreements includes non-refundable upfront payments, fixed and
variable payments based upon the achievement of certain milestones
during the contract term. Non-refundable upfront payments are
generally received in advance of performing the services and,
therefore, are recorded as a contract liability upon receipt. Fixed
and variable milestone payments are included in the transaction
price only when it is probable that doing so will not result in a
significant reversal of cumulative revenue recognized when the
uncertainty associated with the milestone is subsequently resolved.
Revenue for such collaboration and service agreements is recognized
over time using an input measure based on costs incurred to satisfy
the performance obligation.
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
Disaggregated revenue
The following table summarizes the Company’s disaggregated revenue
by payor category (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 |
Diagnostic test revenue |
|
|
|
Patients with third-party insurance
|
$ |
47,462 |
|
|
$ |
46,197 |
|
Institutional customers
|
4,031 |
|
|
15,664 |
|
Self-pay patients
|
1,002 |
|
|
899 |
|
Total diagnostic test revenue
|
52,495 |
|
|
62,760 |
|
Other revenue
|
1,446 |
|
|
1,441 |
|
Total
|
$ |
53,941 |
|
|
$ |
64,201 |
|
Reassessment of variable consideration
Subsequent changes to the estimate of the transaction price,
determined on a portfolio basis when applicable, are generally
recorded as adjustments to revenue in the period of the change. The
Company updates estimated variable consideration
quarterly.
For the three months ended March 31, 2022, the quarterly
change in estimate resulted in a net $3.6 million increase to
revenue for tests in which the performance obligation of delivering
the test results was met in prior periods. The change in estimate
is a result of changes in the estimated transaction price due to
contractual adjustments, obtaining updated information from payors
and patients that was unknown at the time the performance
obligation was met and settlements with third party payors. The
quarterly change in estimate did not result in material adjustments
to the Company’s previously reported revenue or accounts receivable
amounts.
Remaining performance obligations
For certain long-term collaboration service agreements with
original expected durations of more than one year, the Company’s
obligations pursuant to such agreement represents partially
unsatisfied performance obligations as of March 31, 2022. The
revenues under the agreements are estimated to be approximately
$10.3 million. The Company expects to recognize the majority of
this revenue over the next 3 years.
Contract assets and liabilities
Contract assets consist of the Company’s right to consideration
that is conditional upon its future performance. Contract assets
arise in collaboration and service agreements for which revenue is
recognized over time but the Company’s right to bill the customer
is contingent upon the achievement of contractually-defined
milestones.
Contract liabilities consist of customer payments in excess of
revenues recognized. For collaboration and service agreements, the
Company assesses the performance obligations and recognizes
contract liabilities as current or non-current based upon
forecasted performance.
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
A reconciliation of the beginning and ending balances of contract
assets and contract liabilities is shown in the table below (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
Assets
|
|
Contract
Liabilities |
December 31, 2021
|
$ |
3,296 |
|
|
$ |
3,769 |
|
Contract asset additions
|
453 |
|
|
— |
|
Customer prepayments
|
— |
|
|
350 |
|
Revenue recognized
|
— |
|
|
(304) |
|
March 31, 2022
|
$ |
3,749 |
|
|
$ |
3,815 |
|
The Company presents contract assets and contract liabilities with
respect to customer contracts on a net basis on its condensed
consolidated balance sheets. As of March 31, 2022 and
December 31, 2021, $0.1 million and $0.5 million is recorded
as current contract liabilities, respectively.
Revenues recognized for the three months ended March 31, 2022 and
March 31, 2021 that were included in the contract liability balance
at the beginning of each period were $0.5 million and $0.5 million,
respectively.
Costs to fulfill contracts
Costs associated with fulfilling the Company’s performance
obligations pursuant to its collaboration service agreements
include costs for services that are subcontracted to ISMMS. Amounts
prepaid are expensed in line with the pattern of revenue
recognition. Prepayment of amounts prior to the costs being
incurred are recognized on the condensed consolidated balance
sheets as current or non-current based upon forecasted
performance.
As of March 31, 2022 and December 31, 2021, the Company
had outstanding deferred costs to fulfill contracts of $1.5 million
and $1.8 million, respectively. As of March 31, 2022 and
December 31, 2021, all outstanding deferred costs were
recorded as other current assets.
Amortization of deferred costs was $0.3 million and $0.3 million
for the three months ended March 31, 2022 and 2021,
respectively. The amortization of these costs is recorded in the
cost of services on the condensed consolidated statements of
operations and comprehensive loss.
5. Fair Value Measurements
Financial assets and liabilities are recorded at fair value. Fair
value is defined as the price that would be received to sell an
asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date.
The Company utilizes valuation techniques that maximize the use of
observable inputs and minimize the use of unobservable inputs to
the extent possible. The Company determines the fair value of its
financial instruments based on assumptions that market participants
would use in pricing an asset or liability in the principal or most
advantageous market. The following hierarchy lists three levels of
fair value based on the extent to which inputs used in measuring
fair value are observable in the market:
Level 1:
Observable inputs such as quoted prices (unadjusted) in active
markets that are accessible at the measurement date for identical
assets or liabilities.
Level 2:
Observable inputs such as quoted prices for similar instruments in
active markets, quoted prices for identical or similar instruments
in markets that are not active or model-derived valuations whose
significant inputs are observable.
Level 3:
Unobservable inputs that are significant to the measurement of fair
value but are supported by little to no market data.
The Company’s financial assets and liabilities consist of cash and
cash equivalents, restricted cash, accounts receivable, accounts
payable, accrued liabilities, finance leases, warrant liability,
earn-out contingent liability and long-
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
term debt. The Company’s cash and cash equivalents, restricted
cash, accounts receivable, accounts payable and accrued liabilities
approximate their fair value due to the relatively short-term
nature of these accounts.
The Company’s finance leases are classified within Level 1 of the
fair value hierarchy because such finance lease agreements bear
interest at rates for instruments with similar characteristics;
accordingly, the carrying value of these liabilities approximate
their fair values.
The Company’s loan from the Connecticut Department of Economic and
Community Development is classified within Level 2 of the fair
value hierarchy. As of March 31, 2022, the long-term debt was
recorded at its carrying value of $11.0 million in the
condensed consolidated balance sheet. The fair value was
$9.5 million, which is estimated based on discounted cash
flows using the yields of similar debt instruments of other
companies with similar credit profiles.
The following tables set forth the fair value of financial
instruments that were measured at fair value on a recurring basis
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2022
|
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
Financial Assets: |
|
|
|
|
|
|
|
Money market funds
|
$ |
62,282 |
|
|
$ |
62,282 |
|
|
$ |
— |
|
|
$ |
— |
|
Total financial assets
|
$ |
62,282 |
|
|
$ |
62,282 |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
Financial Liabilities: |
|
|
|
|
|
|
|
Public warrant liability
|
$ |
10,183 |
|
|
$ |
10,183 |
|
|
$ |
— |
|
|
$ |
— |
|
Private warrant liability
|
4,993 |
|
|
— |
|
|
4,993 |
|
|
— |
|
Earn-out contingent liability |
3,432 |
|
|
— |
|
|
— |
|
|
3,432 |
|
Total financial liabilities
|
$ |
18,608 |
|
|
$ |
10,183 |
|
|
$ |
4,993 |
|
|
$ |
3,432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2021
|
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
Financial Assets: |
|
|
|
|
|
|
|
Money market funds
|
$ |
385,370 |
|
|
$ |
385,370 |
|
|
$ |
— |
|
|
$ |
— |
|
Total financial assets
|
$ |
385,370 |
|
|
$ |
385,370 |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
Financial Liabilities: |
|
|
|
|
|
|
|
Public warrant liability
|
$ |
14,463 |
|
|
$ |
14,463 |
|
|
$ |
— |
|
|
$ |
— |
|
Private warrant liability
|
7,092 |
|
|
— |
|
|
7,092 |
|
|
— |
|
Earn-out contingent liability |
10,244 |
|
|
— |
|
|
— |
|
|
10,244 |
|
Total financial liabilities
|
$ |
31,799 |
|
|
$ |
14,463 |
|
|
$ |
7,092 |
|
|
$ |
10,244 |
|
Of the $315.0 million cash and cash equivalents presented on
the condensed consolidated balance sheets as of March 31, 2022,
$62.3 million was in money market funds and was classified
within Level 1 of the fair value hierarchy as the fair value was
based on quoted prices in active markets.
The Company’s outstanding warrants include publicly-traded warrants
(the “Public Warrants”) which were originally issued in the IPO and
warrants sold in a private placement to CMLS Holdings LLC (the
“Private Warrants”). The Company evaluated its warrants under ASC
815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity,
and concluded that they do not meet the criteria to be classified
in stockholders’ equity. Since the Public Warrants and Private
Warrants meet the definition of a derivative under ASC 815, the
Company recorded these warrants as non-current liabilities on the
balance sheet at fair value upon the closing of the Business
Combination, with subsequent changes in their respective fair
values recognized in other income (expense), net on the condensed
consolidated statements of operations and comprehensive loss at
each reporting date. As of March 31, 2022, the Public Warrants are
classified within Level 1 of the fair value hierarchy as they are
traded in active markets. The Private Warrants are classified
within Level 2 of the fair
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
value hierarchy as management determined the fair value of each
Private Warrant is the same as that of a Public Warrant because the
terms are substantially the same.
The contingent obligation to issue earn-out shares for Legacy Sema4
stockholders was accounted for as a liability and required
remeasurement at each reporting date. The estimated fair value of
the total earn-out shares as of March 31, 2022 is determined
based on a Monte Carlo simulation valuation model. The fair value
of the earn-out contingent liability is sensitive to expected
volatility estimated based on selected guideline public companies’
stock prices, the Company’s implied volatility and Company’s common
stock price which is sensitive to changes in the forecasts of
earnings and/or the relevant operating metrics. The key assumptions
utilized in determining the valuation as of March 31, 2022 and
December 31, 2021 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
Stock price |
$3.07 |
|
$4.46 |
Expected volatility |
72.5% |
|
62.5% |
Expected term (in years) |
1.3 |
|
1.6 |
Risk-free interest rate |
1.83% |
|
0.58% |
The earn-out contingent liability is categorized as Level 3 of the
fair value hierarchy as the Company utilizes unobservable inputs in
estimating volatility rate. The fair value determined and recorded
as of December 31, 2021 was $10.2 million and during the three
months ended March 31, 2022 a gain of $6.8 million was
recorded in the change in fair market value of warrant and earn-out
contingent liability in the condensed consolidated statements of
operations and comprehensive loss based on re-measurement performed
as of the period end date.
There were no transfers between Level 1, Level 2 and Level 3 during
the periods presented.
6. Property and Equipment
Property and equipment, net consisted of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
March 31,
2022
|
|
As of
December 31,
2021
|
Laboratory equipment |
$ |
27,838 |
|
|
$ |
28,552 |
|
Equipment under finance leases
|
21,384 |
|
|
21,384 |
|
Leasehold improvements
|
21,915 |
|
|
21,905 |
|
Capitalized software
|
27,797 |
|
|
25,693 |
|
Building under finance lease
|
6,276 |
|
|
6,276 |
|
Construction in-progress
|
2,709 |
|
|
940 |
|
Computer equipment
|
7,536 |
|
|
6,634 |
|
Furniture, fixtures and other equipment
|
3,230 |
|
|
3,241 |
|
Total property and equipment
|
118,685 |
|
|
114,625 |
|
Less: accumulated depreciation and amortization
|
(57,709) |
|
|
(51,906) |
|
Property and equipment, net
|
$ |
60,976 |
|
|
$ |
62,719 |
|
For the three months ended March 31, 2022 and 2021,
depreciation and amortization expense was $5.8 million and $4.9
million. This included software amortization expense of $1.6
million and $1.2 million for the three months ended
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
March 31, 2022 and 2021. Depreciation and amortization expense
is included within the condensed consolidated statements of
operations and comprehensive loss as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 |
Cost of services |
$ |
2,816 |
|
|
$ |
3,058 |
|
Research and development
|
1,849 |
|
|
1,251 |
|
Selling and marketing
|
1 |
|
|
— |
|
General and administrative
|
1,137 |
|
|
593 |
|
Total depreciation and amortization expenses
|
$ |
5,803 |
|
|
$ |
4,902 |
|
7. Related Party Transactions
For three months ended March 31, 2022 and 2021, the Company
incurred certain related party costs. There were no expenses
recognized under the TSA for the three months ended March 31, 2022
and $1.4 million for the three months ended March 31, 2021 which is
presented within related party expenses in the condensed
consolidated statements of operations and comprehensive loss. The
Company had no TSA payables due to ISMMS as of March 31, 2022
and December 31, 2021.
Expenses recognized pursuant to other service arrangements with
ISMMS, including certain sub-lease arrangements the Company has
through ISMMS, totaled $1.9 million and $0.7 million for the three
months ended March 31, 2022 and 2021, respectively. These
amounts include certain lease expenses the Company incurs and pay
to ISMMS for certain sub-lease arrangements. They are included in
either cost of services or related party expenses on the condensed
consolidated statements of operations and comprehensive loss
depending on the particular activity to which the costs relate.
Payables due to ISMMS for the other service arrangements were $2.5
million $2.6 million as of March 31, 2022 and
December 31, 2021, respectively. These amounts include unpaid
lease payments the Company accrued for the payments to be made to
ISMMS and are included within due to related parties on the
Company’s condensed consolidated balance sheets.
Additionally, since the closing of the Prior Merger in July 2021
the Company has purchased $0.7 million of diagnostic testing
kits and materials of which $0.4 million was recorded in cost
of services for the three months ended March 31, 2022 from an
affiliate of a member of the Board of Directors who has served in
the role since July 2021. The prices paid represent market rates.
Payables due were $0.7 million and $0.1 million as of
March 31, 2022 and December 31, 2021, respectively.
Total related party costs are included within cost of services and
related party expenses in the condensed consolidated statements of
operations and comprehensive loss as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 |
Cost of services |
$ |
1,056 |
|
|
$ |
278 |
|
Related party expenses
|
1,284 |
|
|
1,797 |
|
Total related party costs
|
$ |
2,340 |
|
|
$ |
2,075 |
|
8. Long-Term Debt
Loan and Security Agreement (the “SVB Agreement”)
On November 15, 2021, the Company and Sema4 OpCo, Inc. (together,
the “Borrower”) entered into a Loan and Security Agreement (the
“SVB Agreement”) with Silicon Valley Bank (“SVB”). The SVB
Agreement provides for a revolving credit facility (the “Revolver”)
up to an aggregate principal amount of $125.0 million,
including a sublimit of $20.0 million for Letters of Credit
(as such terms are defined in the SVB Agreement). The outstanding
principal amount of any Advance (as such term is defined in the SVB
Agreement) will bear interest at a floating rate per annum equal to
the greater of (1) 4.00% and (2) the Prime Rate plus the Prime Rate
Margin. The Revolver will mature on November 15, 2024. In
connection with entering into the SVB agreement, the Company paid
$0.5 million in debt issuance costs during 2021.
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
The Company will pay an additional $0.5 million in fees to SVB
at each anniversary of the SVB Agreement date for a total of
$1.0 million and these fees are recorded in other current
liabilities and other liabilities in the condensed consolidated
balance sheets as of March 31, 2022. These costs are capitalized
and amortized on a straight-line basis over the contractual term.
Any unused fees charged on the Revolver is expensed as
incurred.
The obligations under the SVB Agreement are secured by a first
priority perfected security interest in substantially all of the
Borrower’s assets except for (i) Governmental Collection Accounts
(as defined in the SVB Agreement), (ii) more than 65% of the
presently existing and thereafter arising issued and outstanding
shares of capital stock owned by Borrowers in a Foreign Subsidiary
(as such term is defined in the SVB Agreement) and (iii)
intellectual property pursuant to the terms of the SVB
Agreement.
The SVB Agreement contains affirmative and negative covenants,
including, among other things, restrictions on indebtedness, liens,
investments, mergers, dispositions, and dividends and other
distributions.
The SVB Agreement requires the Borrower to comply with certain
financial covenants if Liquidity (as such term is defined in the
SVB Agreement) falls below $135.0 million. These financial
covenants include (i) a minimum Adjusted Quick Ratio (as such term
is defined in the SVB Agreement) and (ii) the achievement of
certain minimum revenue targets. On a monthly basis, the Borrowers
would be required to maintain a minimum Adjusted Quick Ratio of
greater than or equal to 1.25 to 1.0. The Borrower must also
maintain certain trailing six-month minimum revenue targets through
maturity if outstanding borrowings under the Revolver exceed
$50.0 million.
The SVB Agreement also includes customary events of default,
including failure to pay principal, interest or certain other
amounts when due, material inaccuracy of representations and
warranties, violation of covenants, certain bankruptcy and
insolvency events, certain undischarged judgments, material
invalidity of guarantees or grant of security interest, material
adverse change, and involuntary delisting from the Nasdaq Stock
Market, in certain cases subject to certain thresholds and grace
periods. If one or more events of default occurs and continues
beyond any applicable cure period, SVB may, without notice or
demand to the Borrower, terminate its commitment to make further
loans and declare all of the obligations of the Borrowers under the
SVB Agreement to be immediately due and payable. The Company was in
compliance with all covenants as of March 31, 2022.
No amounts have been drawn under the SVB Agreement as of March 31,
2022.
2016 Funding Commitment
In June 2017, ISMMS assigned a loan funding commitment from the
Connecticut Department of Economic and Community Development
(“DECD”) to the Company (as amended, the “DECD Loan Agreement”).
The DECD Loan Agreement, provides for a total loan commitment of
$15.5 million at a fixed annual interest rate of 2.0% for a term of
10 years. The Company is required to make interest-only payments
through July 2023 and principal and interest payments commencing in
August 2023. The final payment of principal and interest is due in
July 2028. However, under the terms of the DECD Loan Agreement, the
DECD may grant partial principal loan forgiveness of up to
$12.3 million in the aggregate. Such forgiveness is contingent
upon the Company achieving job creation and retention milestones
and $7.3 million has been forgiven as of March 31, 2022. This
commitment is collateralized by providing a security interest in
certain machinery and equipment the Company acquired from ISMMS, as
defined in a separate security agreement.
The outstanding loan balance from the DECD Loan Agreement was $11.0
million as of March 31, 2022 and December 31,
2021.
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
Maturities of Long-Term Debt
As of March 31, 2022, long-term debt matures as follows (in
thousands):
|
|
|
|
|
|
|
|
2022 (remainder of year)
|
$ |
— |
|
2023 |
875 |
|
2024 |
2,131 |
|
2025 |
2,174 |
|
2026 |
2,218 |
|
Thereafter |
3,602 |
|
Total maturities of long-term debt
|
11,000 |
|
Less: current portion of long-term debt
|
— |
|
Total long-term debt, net of current maturities
|
$ |
11,000 |
|
2020 Master Loan Agreement
In August 2020, the Company entered into a loan and security
agreement with a bank (the “Master Loan Agreement”), in which the
Company received a loan of $6.3 million and deposited the proceeds
into a deposit account held by the bank. The Company was required
to make sixty consecutive monthly payments of principal and
interest at a fixed monthly amount of $0.1 million beginning in
November 2020. Interest payments were fixed at an annual interest
rate of 4.75%.
In July 2021, the Company terminated the Master Loan Agreement by
paying off the full amount, including $5.4 million principal
and interest and $0.1 million in early payment penalties
assessed pursuant to the terms of the agreement.
2020 Master Lease Agreement
In December 2020, the Company entered into a lease agreement with a
lender whereby the Company agreed to sell certain equipment and
immediately lease back the equipment, resulting in proceeds of $3.6
million. Per the terms of the agreement, a financial institution
issued an irrevocable standby letter of credit to the lender for
$3.6 million. The Company was required to make sixty consecutive
monthly payments of principal and interest at a fixed monthly
amount of $0.1 million beginning in February 2021. Interest
payments were fixed at an annual interest rate of
3.54%.
The Company was required to maintain an aggregate amount on deposit
equal to at least 105% of the value of any outstanding letters of
credit issued by the financial institution on the Company’s behalf.
The letter of credit was required to be in place until all
obligations had been paid in full. Further, the Company was
required to furnish annual audited financial statements and other
financial information to the lender on a regular
basis.
In July 2021, the Company terminated the Master Lease Agreement by
paying off the full amount, including $3.3 million principal
and interest and early payment penalties of $0.2 million
assessed pursuant to the terms of the agreement.
9. Leases
Lease Accounting
The Company enters into contracts in the normal course of business
and assesses whether any such contracts contain a lease. The
Company determines if an arrangement is a lease at inception if it
conveys the right to control the identified asset for a period of
time in exchange for consideration. The Company classifies leases
as operating or financing in nature. All lease liabilities are
measured at the present value of the associated payments,
discounted using the Company’s incremental borrowing rate
determined based on the rate of interest that the Company would pay
to borrow on a
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
collateralized basis an amount equal to the lease payments for
similar term and in a similar economic environment on a
collateralized basis, unless there is a rate implicit in the lease
that is readily determinable.
Operating Leases
The Company's operating lease arrangements are principally for
office space and laboratory facilities. The Company’s headquarter
lease was initially entered into via sub-lease agreements with
ISMMS and a third party and they will expire in 2034. The
agreements include escalating rent and rent-free period provisions.
Pursuant to the terms of the lease agreement, the Company was
required to have issued an irrevocable standby letter of credit to
the lessor for $0.9 million, which was included in restricted cash
on the condensed consolidated balance sheets as of March 31,
2022 and consolidated balance sheets as of December 31,
2021.
In April 2019, the Company entered into a sublease agreement to
rent a building to be used for office and laboratory facility (the
“Stamford Lease”) for a base term of 325 months, expiring in
October 2046. The Company has the option to renew the lease at the
end of the initial base term for either one period of 10 years, or
two periods of 5 years. There is also an early termination option
in which the Company may cancel the lease after the 196th month
with cancellation fees. At inception of the Stamford Lease, the
value of the land was determined to be more than 25% of the total
value and therefore the building is accounted for as a finance
lease and the land as an operating lease.
In January 2020, the Company entered into a lease agreement which
expanded the Company’s existing laboratory facility in Branford,
Connecticut. The lease commenced in February 2020 with a 10 year
term. The lease includes escalating rent fees over the lease
term.
Finance Leases
The Company enters into various finance lease agreements to obtain
laboratory equipment that contain bargain purchase commitments at
the end of the lease term. The leases are secured by the underlying
equipment. As discussed above, the Company also leases a building
used for office and laboratory space in which the building is
accounted for as a finance lease and the land is as an operating
lease. The interest rate used for the Stamford Lease is 13.1%,
which is used to measure the operating and finance lease
liability.
The tables below present financial information associated with the
Company’s leases. This information is only presented as of, and for
the three months ended, March 31, 2022 because, the Company adopted
the ASC 842 using a transition method that does not require
application to periods prior to adoption (in
thousands).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Classification |
|
March 31, 2022 |
Assets |
|
|
|
|
Operating lease assets |
|
Operating lease right-of-use assets |
|
$ |
38,417 |
|
Finance lease assets |
|
Property and Equipment, net |
|
13,190 |
|
Total lease assets |
|
|
|
$ |
51,607 |
|
|
|
|
|
|
Liabilities |
|
|
|
|
Current |
|
|
|
|
Operating |
|
Due to related parties |
|
$ |
566 |
|
|
|
Short-term lease liabilities |
|
1,892 |
|
Finance |
|
Due to related parties |
|
304 |
|
|
|
Short-term lease liabilities |
|
3,180 |
|
Non-current |
|
|
|
|
Operating |
|
Long-term lease liabilities |
|
39,649 |
|
Finance |
|
Long-term lease liabilities |
|
17,829 |
|
Total lease liabilities |
|
|
|
$ |
63,420 |
|
|
|
|
|
|
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
|
|
|
|
|
|
|
|
|
Lease cost |
|
Three months ended March 31, 2022 |
Operating lease cost |
|
|
Operating lease cost |
|
$ |
1,380 |
|
Short-term lease cost |
|
169 |
|
Variable lease cost |
|
127 |
|
Total operating lease cost |
|
$ |
1,676 |
|
|
|
|
Finance lease cost |
|
|
Depreciation and amortization of leased assets |
|
$ |
912 |
|
Interest on lease liabilities |
|
552 |
|
Total finance lease cost |
|
$ |
1,464 |
|
Total lease cost |
|
$ |
3,140 |
|
Future minimum lease payments under non-cancellable leases as of
March 31, 2022 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturity of lease liabilities |
|
Operating leases |
|
Finance leases |
|
Total |
2022 (remainder of the year) |
|
$ |
3,862 |
|
|
$ |
3,808 |
|
|
$ |
7,670 |
|
2023 |
|
4,338 |
|
|
3,584 |
|
|
7,922 |
|
2024 |
|
4,440 |
|
|
2,763 |
|
|
7,203 |
|
2025 |
|
4,835 |
|
|
2,451 |
|
|
7,286 |
|
2026 |
|
4,949 |
|
|
2,003 |
|
|
6,952 |
|
Thereafter |
|
51,920 |
|
|
49,884 |
|
|
101,804 |
|
Total |
|
$ |
74,344 |
|
|
$ |
64,493 |
|
|
$ |
138,837 |
|
Less: imputed interest |
|
$ |
(32,237) |
|
|
$ |
(43,180) |
|
|
$ |
(75,417) |
|
Present value of lease liabilities |
|
$ |
42,107 |
|
|
$ |
21,313 |
|
|
$ |
63,420 |
|
Other information related to leases as of and the three months
ended March 31, 2022 are as follows:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
Weighted-average remaining lease term (years) |
|
|
Operating leases |
|
13.5 |
Finance leases |
|
17.8 |
|
|
|
Weighted-average discount rate |
|
|
Operating leases |
|
6.8% |
Finance leases |
|
10.5% |
|
|
|
Cash paid for amounts included in the measurement of lease
liabilities |
|
|
Operating cash flows from operating leases |
|
$1,236 |
Operating cash flows from finance leases |
|
$552 |
Financing cash flows from finance lease |
|
$862 |
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
10. Commitments and Contingencies
Purchase Obligations
In the normal course of business, the Company enters into various
purchase commitments primarily related to material and service
agreements, laboratory supplies and software. At March 31, 2022,
the Company’s total future payments under noncancelable
unconditional purchase commitments having a remaining term of over
one year were $19.4 million.
Contingencies
The Company is a party to various actions and claims arising in the
normal course of business. The Company does not believe that the
outcome of these matters will have a material effect on the
Company’s condensed consolidated financial position, results of
operations or cash flows. However, no assurance can be given that
the final outcome of such proceedings will not materially impact
the Company’s condensed consolidated financial condition or results
of operations.
The Company was not a party to any material legal proceedings as of
March 31, 2022, nor is it a party to any material legal
proceedings as of the date of issuance of these unaudited condensed
consolidated financial statements.
11. Stock-Based Compensation
Stock Incentive Plans
The Company’s 2017 Equity Incentive Plan (the “2017 Plan”), as
amended in February 2018, allowed the grant of options, restricted
stock awards, stock appreciation rights and restricted stock units.
No options granted under the 2017 Plan are exercisable after 10
years from the date of grant, and option awards generally vest over
a four-year period.
The 2017 Plan was terminated in connection with the adoption of the
Company's 2021 Equity Incentive Plan (the "2021 Plan"). Any awards
granted under the 2017 Plan that remained outstanding as of the
Closing Date and were converted into awards with respect to the
Company’s Class A common stock in connection with the consummation
of the Business Combination continue to be subject to the terms of
the 2017 Plan and applicable award agreements, except for a
modification of the repurchase provision, which is discussed
further below.
On July 22, 2021, in connection with the Business Combination,
the 2021 Plan became effective and 32,734,983 authorized shares of
Class A common stock were reserved for issuance thereunder. This
Plan will be administered by the Compensation Committee of the
Company’s Board of Directors, including determination of the
vesting, exercisability and payment of the awards to be granted
under this Plan. No awards granted under the 2021 Plan are
exercisable after 10 years from the date of grant, and the awards
granted under the 2021 Plan generally vest over a four-year period
on a graded vesting basis.
Employee Stock Purchase Plan
The 2021 Employee Stock Purchase Plan (the “2021 ESPP”) became
effective in connection with the Business Combination. The 2021
ESPP authorizes the issuance of shares of Class A common stock
pursuant to purchase rights granted to employees. On each January 1
of each of 2022 through 2031, the aggregate number of shares of
Class A common stock reserved for issuance under the 2021 Plan may
be increased automatically by the number of shares equal to one
percent (1%) of the total number of shares of all classes of common
stock issued and outstanding immediately preceding December 31. The
Company did not make any grants of purchase rights under the 2021
ESPP during the quarter ended March 31, 2022. A total of 7,229,799
shares of Class A common stock have been reserved for future
issuance under the 2021 ESPP.
Stock Option Activity
Under the 2017 Plan, the Company had a call option to repurchase
awards for cash from the plan participants upon termination of the
participant’s employment or consulting agreement (the “2017 Plan
Call Option”). The options granted under the 2017 plan were
accounted for as liability awards due to the 2017 Plan Call Option.
The Company had a history of repurchase practice and the intention
to repurchase the vested options. Therefore, the fair value of the
liability awards was remeasured at each reporting period until the
stockholder bears the risks and rewards of equity ownership for a
reasonable period of time, which the Company concludes is at least
six months.
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
Upon consummation of the Business Combination, the Company’s Board
of Directors waived the Company’s right under the 2017 Plan Call
Option to repurchase awards for cash from the plan participants
upon termination of the participant’s employment or consulting
agreement. As such, the Company modified the liability awards to
equity awards and reclassified the modification date fair value of
the awards to stockholders’ equity in the condensed consolidated
financial statements as of July 22, 2021.
All stock options granted under the 2021 Plan are accounted for as
equity awards.
The following summarizes the stock option activity, which reflects
the conversion of the options granted under the 2017 Plan into
awards with respect to the Company Class A common stock in
connection with the consummation of the Business Combination (in
thousands, except share and per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options Outstanding
|
|
Weighted Average Exercise Price
|
Balance at December 31, 2021 |
|
30,905,543 |
|
$ |
1.24 |
|
Options granted |
|
851,884 |
|
$ |
3.37 |
|
Options exercised |
|
(2,108,502) |
|
$ |
0.32 |
|
Options forfeited or canceled |
|
(759,629) |
|
$ |
2.98 |
|
|
|
|
|
|
Balance at March 31, 2022 |
|
28,889,296 |
|
$ |
1.33 |
|
Options exercisable at March 31, 2022
|
|
21,620,867 |
|
$ |
0.54 |
|
As of March
31, 2022, unrecognized stock-based compensation cost related to the
unvested portion of the Company’s stock options was
$22.1 million, which is expected to be recognized on a
graded-vesting basis over a weighted-average period of 1.5
years.
The fair value of the stock option awards for the period ended
March 31, 2022, and March 31, 2021 were estimated using the
Black-Scholes option pricing model with the following
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended March 31, |
|
2022 |
|
2021 |
Expected volatility |
65.20% - 67.60%
|
|
68.50%- 75.60%
|
Expected term (in years) |
5.48-6.06
|
|
0.50- 1.75
|
Risk-free interest rate |
1.65%-1.70%
|
|
0.05%- 0.16%
|
Dividend yield |
— |
|
— |
Fair value of Class A common stock |
$3.29-$3.45
|
|
$4.57- $12.51
|
The Company estimated a volatility factor for the Company’s options
based on analysis of historical share prices of a peer group of
public companies. The Company did not rely on the volatility of the
Company’s Class A common stock because its limited trading history.
The Company estimated the expected term of options granted using
the “simplified method,” which is the mid-point between the vesting
date and the ending date of the contractual term. The Company did
not rely on the historical holding periods of the Company’s options
due to the limited availability of exercise data. The Company used
a risk-free interest rate based on the U.S. Treasury yield curve in
effect for bonds with maturities consistent with the expected term
of the option.
Restricted Stock Units (RSUs)
The Company issued time-based RSUs to employees under the 2021
Plan. The RSUs automatically convert to shares of Class A common
stock on a one-for-one basis as the awards vest. The Company
measures the value of RSUs at fair value based on the closing price
of the underlying Class A common stock on the grant date. The RSUs
granted generally vest over a four year vesting period from the
grant date, however, the Company also granted certain RSUs during
the three
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
months ended December 31, 2021, which were vesting beginning 12
months from the grant date and vesting immediately on the grant
date. The following table summarizes the activity related to the
Company's time-based RSUs:
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted Stock Units Outstanding |
|
Weighted Average Grant Date Fair Value Per Unit
|
Balance at December 31, 2021 |
12,589,558 |
|
$7.64 |
Restricted Stock Units granted |
762,190 |
|
$3.48 |
Restricted Stock Units vested |
(398,369) |
|
$7.63 |
Restricted Stock Units forfeited |
(830,620) |
|
$7.62 |
|
|
|
|
Balance at March 31, 2022 |
12,122,759 |
|
$7.38 |
As of March 31, 2022, unrecognized stock-based compensation cost
related to the unvested portion of the Company’s RSUs was
$60.2 million, which is expected to be recognized on a
graded-vesting basis over a weighted-average period of 1.6
years.
Earn-out RSUs
The grant date fair value determined for Triggering Event I, II and
III was $1.82, $1.39 and $0.94 per unit, respectively. Any
re-allocated RSUs due to the Sema4 Legacy option holders’
forfeiture activities during the three months ended March 31, 2022
were accounted for as new grants and the fair value determined for
Triggering Event I, II and III was $0.29, $0.21 and $0.12 per unit,
respectively. Based on the grant date fair value, the Company
expects to record total expense related to the earn-out RSU awards
of $2.7 million without considering the impact of the Sema4
Legacy option holders’ forfeiture activities. The Company expects
to recognize the stock-compensation cost over the longer of the
derived service period or service period.
Stock Appreciation Rights (SAR) Activity
The Company historically granted SAR to one employee and one
consultant with exercise condition of a liquidation event. As a
result of the Business Combination, settlement of the outstanding
vested SARs in exchange for a cash payment and to cancel the
outstanding unvested SARs was agreed upon and an expense of
$3.8 million related to the vested SAR was recognized by the
Company. There were no outstanding SARs as of March 31,
2022.
During the three months ended March 31, 2022, the Company recorded
a reversal of stock-based compensation of $5.2 million due to
forfeiture activities upon employee terminations. Stock-based
compensation expense for all awards granted and outstanding is
included within the condensed consolidated statements of operations
and comprehensive loss as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 |
Cost of services |
$ |
1,381 |
|
|
$ |
18,475 |
|
Research and development
|
4,341 |
|
|
38,187 |
|
Selling and marketing
|
2,825 |
|
|
18,688 |
|
General and administrative
|
9,012 |
|
|
89,612 |
|
Total stock-based compensation expense
|
$ |
17,559 |
|
|
$ |
164,962 |
|
12. Income Taxes
Income taxes for the three months ended March 31, 2022 are recorded
at the Company’s estimated annual effective income tax rate,
subject to adjustments for discrete events, should they occur. The
Company’s estimated annual effective tax rate was 0.0% for the
three months ended March 31, 2022. The primary reconciling item
between the federal statutory
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
rate of 21.0% for these periods and the Company’s overall effective
tax rate of 0.0% was related to the effects of the valuation
allowance recorded against the full amount of its net deferred tax
assets.
A valuation allowance is required when it is more likely than not
that some portion or all of the Company’s deferred tax assets will
not be realized. The realization of deferred tax assets depends on
the generation of sufficient future taxable income during the
period in which the Company’s related temporary differences become
deductible. The Company has recorded a full valuation allowance
against its net deferred tax assets as of March 31, 2022 since
management believes that based on the earnings history of the
Company, it is more likely than not that the benefits of these
assets will not be realized.
13. Net Loss per Share
Basic and diluted loss per share attributable to common
stockholders was calculated as follows (amounts in thousands,
except for share and per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 |
Numerator: |
|
|
|
Net loss attributable to common stockholders
|
$ |
(76,896) |
|
|
$ |
(191,775) |
|
Denominator:
|
|
|
|
Denominator for basic and diluted earnings per
share-weighted-average common shares
|
244,368,743 |
|
|
549,778 |
|
Basic and diluted loss per share |
$ |
(0.31) |
|
|
$ |
(348.82) |
|
As a result of the Prior Merger, the Company has retroactively
adjusted the weighted-average number of shares of common stock
outstanding prior to the Prior Merger by multiplying them by the
conversion ratio of 123.8339 used to determine the number of shares
of common stock into which they converted. The common stock issued
as a result of the redeemable convertible preferred stock
conversion upon closing of the Prior Merger was included in the
basic and diluted earnings/(loss) per share calculation on a
prospective basis.
Prior to the consummation of the Prior Merger, the Company applied
the two-class method to calculate its basic and diluted net loss
per share of common stock, as there were outstanding Class B common
stock and redeemable convertible preferred stock that were
participating securities. The two-class method is an earnings
allocation formula that treats a participating security as having
rights to earnings that otherwise would have been available to
common stockholders. As the securities were all converted into
Sema4 Holdings Class A common stock upon consummation of the Prior
Merger, all outstanding Legacy Sema4 Class B common stock has been
retroactively converted to the Sema4 Holdings Class A common
stock.
The following tables summarize the outstanding shares of
potentially dilutive securities that were excluded from the
computation of diluted net loss per share attributable to common
stockholders for the period presented because including them would
have been anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 |
Outstanding options and RSUs to purchase Class A common
stock |
41,012,055 |
|
|
29,608,717 |
|
Outstanding warrants
|
21,994,972 |
|
— |
|
Outstanding earn-out shares
|
16,611,117 |
|
|
— |
|
Outstanding earn-out RSUs |
2,410,459 |
|
|
— |
|
Redeemable convertible preferred stock (on an if-converted
basis) |
— |
|
|
171,535,214 |
|
Total
|
82,028,603 |
|
|
201,143,931 |
|
Sema4 Holdings Corp.
Notes to Unaudited Condensed Consolidated Financial
Statements
14. Subsequent Events
GeneDx Acquisition
On April 29, 2022, the Company completed the acquisition (the
“Acquisition”) of GeneDx LLC (“GeneDx”), from OPKO Health Inc.
(“OPKO”). Sema4 acquired GeneDx for an upfront payment of
$150 million in cash, subject to adjustment, plus
80 million shares of Sema4’s Class A common stock, with up to
an additional $150 million payable if certain revenue-based
milestones are achieved over the next two years (which will be
payable in cash or shares of Sema4’s Class A common stock at
Sema4’s discretion). Based on the closing stock price of Sema4’s
Class A common stock as of April 29, 2022, the trading day on the
closing of the transaction, the total upfront consideration
represents approximately $322 million, subject to adjustment,
and the total aggregate consideration including potential
milestones is approximately $472 million. The transaction was
announced on January 18, 2022 and the issuance of the shares of
Sema4’s Class A common stock in connection with the acquisition,
among other proposals, received approval from Sema4 stockholders on
April 27, 2022.
Subscription Agreements and Acquisition PIPE Investment (Private
Placement)
In connection with the Acquisition of GeneDx, the Company also
closed a private placement financing (the “Acquisition PIPE
Investment”) in which it issued 50 million shares of Sema4’s
Class A common stock at a price of $4.00 per share with a syndicate
of institutional investors, receiving gross proceeds of
$200 million.
Restructuring
On May 2, 2022, the Company’s Compensation Committee of the Board
of Directors approved by written consent for the Company to
implement an employee restructuring plan, which is intended to
reduce costs and optimize its organizational and operational
efficiency. The Company’s management executed the plan and expects
to recognize expenses of $5.4 million during the second
quarter of 2022. The costs primarily consist of the cost of
benefits provided pursuant to the severance programs for the
employees impacted by the plan and third party consulting costs
expected to be incurred.
Item 2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations
You should read the following discussion and analysis of our
financial condition and results of operations together with our
unaudited condensed consolidated financial statements and related
notes appearing elsewhere in this Quarterly Report and our audited
financial statements for the year ended December 31, 2021 and the
related notes in our Annual Report on Form 10-K for the year ended
December 31, 2021. This discussion contains forward-looking
statements and involves numerous risks and uncertainties. Actual
results may differ materially from the results described in or
implied by the forward-looking statements. You should carefully
read the section entitled “Risk Factors” to gain an understanding
of the important factors that could cause actual results to differ
materially from these forward-looking statements.
Overview
We are a patient-centered, health intelligence company with a
mission to use artificial intelligence, or AI, and machine learning
to enable personalized medicine for all. By leveraging leading data
scientists and technology, our platform powers remarkable and
unique insights that transform the practice of medicine including
how disease is diagnosed, treated, and prevented.
On June 1, 2017, we signed a contribution and funding agreement and
other agreements with Icahn School of Medicine at Mount Sinai, or
ISMMS, whereby ISMMS contributed certain assets and liabilities
related to our operations, provided certain services to us, and
also committed to funding us up to $55.0 million in future
capital contributions in exchange for equity in Legacy Sema4, of
which $55.0 million was drawn as of December 31, 2019.
Following the transaction, we commenced operations as a commercial
entity that could effectively engage diverse patient populations
and health care institutions at scale.
We have since established and deployed our comprehensive and
integrated genomic and clinical data platform and established a
mature diagnostic testing business. We now maintain a database that
includes more than 12 million de-identified individual clinical
records, many with genomic profiles. We also manage a data asset
over 49 petabytes in size, that has been expanding at more than 1
petabyte per month with an accelerating growth rate.
Currently, we derive the majority of our revenue from our
diagnostic test solutions. Our diagnostic business generates
revenue and engages with healthcare professionals working with
patients primarily through our Women’s Health and Oncology
solutions.
Our Women’s Health solutions sequence and analyze an
industry-leading number of genes and use interpretive information
tools to translate raw sequencing and clinical data efficiently and
accurately into digestible clinical reports that guide
decision-making by patients and physicians. Our Oncology diagnostic
solutions feature both somatic tumor profiling and hereditary
cancer screenings, along with a foundational whole exome and whole
transcriptome sequencing approach. Our Sema4 Signal Hereditary
Cancer solution determines if a patient carries an inherited
genetic change that increases the risk of cancer or informs on
cancer treatment. We believe our Signal Whole Exome and
Transcriptome solution is one of the most comprehensive molecular
profiling solutions from a commercial entity to receive New York
State approval. Beginning in May of 2020 through March 31, 2022, we
also provided diagnostic testing services to identify the presence
of COVID-19.
We have also expanded beyond diagnostic testing to enter into
service agreements with third parties to provide diagnostic
testing, research, and related data aggregation reporting services.
We have established and continue to seek strategic relationships
with pharmaceutical and biotech, or Biopharma, companies to enable
innovation across the entire drug lifecycle, from next-generation
drug discovery and development, to post-market efficacy
surveillance, to informing on bioavailability, toxicity,
tolerability, and other features critical to drug
development.
Factors Affecting Our Performance
We believe several important factors have impacted, and will
continue to impact, our performance and results of operations.
While each of these areas presents significant opportunities for
us, they also pose significant risks and challenges that we must
address. See the section titled
“Item 1A. Risk Factors”
for more information.
Number of resulted tests
A test is resulted once the appropriate workflow is completed and
details are provided to the ordered patients or healthcare
professional for reviews, which corresponds to the timing of our
revenue recognition. We believe the number of
resulted tests in any period is important and useful to our
investors because it directly correlates with long-term patient
relationships and the size of our genomic database.
Success obtaining and maintaining reimbursement
Our ability to increase the number of billable tests and our
revenue therefrom will depend on our success in achieving
reimbursement for our tests from third-party payors. Reimbursement
by a payor may depend on several factors, including a payor’s
determination that a test is appropriate, medically necessary,
cost-effective, and has received prior authorization. Since each
payor makes its own decision as to whether to establish a policy or
enter into a contract to provide coverage for our tests, as well as
the amount it will reimburse us for a test, seeking these approvals
is a time-consuming and costly process.
In cases where we or our partners have established reimbursement
rates with third-party payors, we face additional challenges in
complying with their procedural requirements for reimbursement.
These requirements often vary from payor to payor and are
reassessed by third-party payors regularly. As a result, in the
past we have needed additional time and resources to comply with
the requirements.
We expect to continue to focus our resources on increasing the
adoption of, and expanding coverage and reimbursement for, our
current and any future tests we may develop or acquire. If we fail
to expand and maintain broad adoption of, and coverage and
reimbursement for, our tests, our ability to generate revenue and
our future business prospects may be adversely
affected.
Ability to lower the costs associated with performing our
tests
Reducing the costs associated with performing our diagnostic tests
is both our focus and a strategic objective. We source, and will
continue to source, components of our diagnostic testing workflows
from third parties. We also rely upon third-party service providers
for data storage and workflow management.
Increasing adoption of our services by existing and new
customers
Our performance depends on our ability to retain and broaden the
adoption of our services with existing customers as well as our
ability to attract new customers. Our success in retaining and
gaining new customers is dependent on the market’s confidence in
our services and the willingness of customers to continue to seek
more comprehensive and integrated genomic and clinical data
insights.
Investment in platform innovation to support commercial
growth
We are seeking to leverage and deploy our Centrellis and Traversa
platforms to develop a pipeline of future disease-specific research
and diagnostic and therapeutic products and services. We have
limited experience in the development or commercialization of
clinical or research products in connection with our database and
our Centrellis platform.
We operate in a rapidly evolving and highly competitive industry.
Our business faces changing technologies, shifting provider and
patient needs, and frequent introductions of rival products and
services. To compete successfully, we must accurately anticipate
technology developments and deliver innovative, relevant, and
useful products, services, and technologies on time. As our
business evolves, the competitive pressure to innovate will
encompass a wider range of products and services. We must continue
to invest significant resources in research and development,
including investments through acquisitions and partnerships. These
investments are critical to the enhancement of our current
diagnostics and health information and data science technologies
from which existing and new service offerings are
derived.
We expect to incur significant expenses to advance these
development efforts, but they may not be successful. New potential
services may fail at any stage of development and, if we determine
that any of our current or future services are unlikely to succeed,
we may abandon them without any return on our investment. If we are
unsuccessful in developing additional services, our growth
potential may be impaired.
Key Performance Indicators
We use the following key financial and operating metrics to
evaluate our business and operations, measure our performance,
identify trends affecting our business, project our future
performance, and make strategic decisions. These key financial and
operating metrics should be read in conjunction with the following
discussion of our results of operations
and financial condition together with our condensed consolidated
financial statements and the related notes and other financial
information included elsewhere in this report.
The principal focus of our commercial operations is to offer our
diagnostic tests through both our direct sales force and laboratory
distribution partners. Test volume correlates with genomic database
size and long-term patient relationships. Thus, test volumes drive
database diversity and enable potential identification of variants
of unknown significance and population-specific insights. The
number of tests resulted is a key indicator that we use to assess
the operational efficiency of our business. Once the appropriate
workflow is completed, the test is resulted and details are
provided to ordered patients or healthcare professionals for
reviews.
During the three months ended March 31, 2022, we resulted
151,264 tests in our laboratories, 66,339 tests of which were for
COVID-19, compared to the three months ended March 31, 2021, in
which we resulted 237,729 tests in our laboratories, 170,784 of
which were for COVID-19. This 27% increase in resulted volumes,
excluding COVID-19 tests volumes, largely resulted from an increase
in our oncology testing.
COVID-19 Impact
COVID-19 has had, and continues to have, an extensive impact on the
global health and economic environments since the initial outbreak
in March 2020.
While test volumes have since improved, we continue to experience
changes in the mix of tests due to the impact of COVID-19. The full
extent to which the COVID-19 pandemic will directly or indirectly
impact our business, results of operations, and financial condition
will depend on future developments that are highly uncertain and
cannot be accurately predicted, including new information that may
emerge concerning COVID-19, the actions taken to contain it or
treat it and the economic impact on local, regional, national and
international markets and supply chains. Therefore, COVID-19 could
continue to have a material impact on our results of operations,
cash flows, and financial condition for the foreseeable
future.
In March 2020, the Coronavirus Aid, Relief and Economic Security
Act (“CARES Act”), was signed into law which was a stimulus bill
that, among other things, provided assistance to qualifying
businesses and individuals and included funding for the healthcare
system. We received $5.4 million in 2020 as part of the stimulus,
comprised of $2.6 million received under the Provider Relief Fund
(the “PRF”), and $2.8 million received under the Employee Retention
Credit (the “ERC”). In 2021, we received an additional $5.6 million
under the PRF.
Funds provided under the PRF to healthcare providers are not loans
and will not be required to be repaid; however, as a condition to
receiving these payments, providers must agree to certain terms and
conditions and submit sufficient documentation demonstrating that
the funds are being used for healthcare-related expenses or lost
revenue attributable to the COVID-19 pandemic. We have concluded it
is probable that all terms and conditions associated with the funds
received under the PRF distribution have been met. As a result, we
recorded the funds received under the PRF in other income in the
statements of operations and comprehensive loss during the periods
in which we received the funds.
Funds provided under the ERC are refundable tax credits for 50% of
qualified wages paid to employees during the pandemic. A company is
eligible for the ERC if it has not received a Paycheck Protection
Program loan under the CARES Act and (1) its operations have been
fully or partially suspended because of COVID-19 or (2) its gross
receipts in a calendar quarter in 2020 declined by more than 50%
from the same period in 2019. At the time of applying for the ERC,
we concluded that it was reasonably possible the eligibility
requirements would be met; however, due to a change in
circumstances, we are re-evaluating our position. As such, we
deferred the recognition of the funds received under the ERC and
recorded the proceeds in other liabilities on the condensed
consolidated balance sheets.
At this time, we are not certain of the availability, extent or
impact of any future relief provided under the CARES Act or other
stimulus initiatives.
Recent Developments
In January 2022, we and our wholly-owned subsidiaries, Orion Merger
Sub I, Inc., or Merger Sub I, and Orion Merger Sub II, LLC, or
Merger Sub II, entered into an Agreement and Plan of Merger and
Reorganization (which we refer to, as amended, as the “Merger
Agreement”), with GeneDx, Inc., a New Jersey corporation, or
GeneDx, and a wholly-owned subsidiary of OPKO Health, Inc., or
OPKO, GeneDx Holding 2, Inc., or Holdco, and OPKO to acquire 100%
of GeneDx (which we refer to as the “Acquisition”). Subject to the
terms and conditions of the Merger Agreement, we agreed to pay
consideration to OPKO for the Acquisition of (i) $150 million in
cash at the closing of the Acquisition, subject to
certain
adjustments as provided in the Merger Agreement, (ii) 80 million
shares of our Class A common stock to be issued at the closing of
the Acquisition and (iii) up to $150 million payable following the
closing of the Acquisition, if certain revenue-based milestones are
achieved for each of the fiscal years ending December 31, 2022 and
December 31, 2023. These milestone payments, if and to the extent
earned under the terms of the Merger Agreement, will be satisfied
through the payment and/or issuance of a combination of cash and
shares of our Class A common stock (valued at $4.86 per share),
with such mix to be determined in our sole discretion.
The Acquisition closed on April 29, 2022. We expect to leverage the
combined health information database of Sema4 and GeneDx to partner
with additional health systems and biopharma companies to transform
patient care and therapeutic development and enable precision
medicine for all.
Concurrently with the execution of the Merger Agreement, we entered
into subscription agreements with certain institutional investors,
pursuant to, and on the terms and subject to the conditions of
which, these investors collectively subscribed for 50 million
shares of our Class A common stock for an aggregate purchase price
equal to $200 million (which we refer to as the “Acquisition PIPE
Investment”). The Acquisition PIPE Investment was consummated
substantially concurrently with the closing of the
Acquisition.
Components of Results of Operations
Revenue
We derive the majority of our revenue from diagnostic testing
services, which primarily relate to Women’s Health, Oncology and
COVID-19. We also recognize revenue from collaboration service
agreements with Biopharma companies and other third parties
pursuant to which we provide diagnostic testing and related data
aggregation reporting services. As discussed above, we discontinued
COVID-19 testing services as of March 31, 2022 and no longer
provide such testing services.
We recognize revenue when control of the promised goods or services
is transferred to the customer in an amount that reflects the
consideration which we expect to be entitled to in exchange for
those goods or services.
Diagnostic Test Revenue
We primarily generate revenue from performing diagnostic testing
services for three groups of customers: healthcare professionals
working with patients with third-party insurance coverage or
without third-party insurance coverage or those who elect to
self-pay; and institutional clients, such as hospitals, clinics,
state governments and reference laboratories. Customers are billed
upon delivery of test results. The amount of revenue recognized for
diagnostic testing services depends on a number of factors, such as
contracted rates with our customers and third-party insurance
providers, insurance reimbursement policies, payor mix, historical
collection experience, price concessions and other business and
economic conditions and trends. To date, the majority of our
diagnostic test revenue has been earned from orders received for
patients with third-party insurance coverage.
Our ability to increase our diagnostic test revenue will depend on
our ability to increase our market penetration, obtain contracted
reimbursement coverage from third-party payers, enter into
contracts with institutions, and increase our reimbursement rate
for tests performed.
Other Revenue
We generate revenue from providing diagnostic testing and related
data aggregation reporting services under both short-term and
long-term project-based collaboration and service agreements with
third parties. The terms of these contracts generally include
non-refundable upfront payments, which we record as contract
liabilities, and variable payments based upon the achievement of
certain milestones during the contract term.
With respect to existing collaboration and service agreements, our
revenue may fluctuate period to period due to the pattern in which
we may deliver our services, our ability to achieve milestones, the
timing of costs incurred, changes in estimates of total anticipated
costs that we expect to incur during the contract period, and other
events that may not be within our control. Our ability to increase
our revenue will depend on our ability to enter into contracts with
third-party partners.
Cost of Services
The cost of services reflect the aggregate costs incurred in
performing services. These costs include expenses for reagents and
laboratory supplies, personnel-related expenses (comprising
salaries and benefits) and stock-based
compensation for employees directly involved in revenue generating
activities, shipping and handling fees, costs of third-party
reference lab testing and phlebotomy services and allocated genetic
counseling, facility and IT costs associated with delivery
services. Allocated costs include depreciation of laboratory
equipment, facility occupancy, and information technology costs.
The cost of services are recorded as the services are
performed.
We expect the cost of services to generally increase in line with
the anticipated growth in diagnostic testing volume and services we
provide under our collaboration service agreements. However, we
expect the cost per test to decrease over the long term due to the
efficiencies we may gain from improved utilization of our
laboratory capacity, automation, and other value engineering
initiatives. These expected reductions may be offset by new tests
which often have a higher cost per test during the introductory
phases before we can gain efficiencies. The cost per test may
fluctuate from period to period.
Research and Development Expenses
Research and development expenses represent costs incurred to
develop our technology and future test offerings. These costs are
principally associated with our efforts to develop the software we
use to analyze data and process customer orders. These costs
primarily consist of personnel-related expenses (comprising
salaries and benefits), stock-based compensation for employees
performing research and development, innovation and product
development activities, costs of reagents and laboratory supplies,
costs of consultants and third-party services, equipment and
related depreciation expenses, non-capitalizable software
development costs, research funding to our research partners as
part of research and development agreements and allocated facility
and information technology costs associated with genomics medical
research. Research and development costs are generally expensed as
incurred and certain non-refundable advanced payments provided to
our research partners are expensed as the related activities are
performed.
We generally expect our research and development expenses to
continue to increase as we innovate and expand the application of
our platforms. However, we expect research and development expenses
to decrease as a percentage of revenue in the long term, although
the percentage may fluctuate from period to period due to the
timing and extent of our development and commercialization efforts
and fluctuations in our compensation-related charges.
Selling and Marketing Expenses
Selling and marketing expenses primarily consist of
personnel-related expenses (comprising salaries, and benefits) and
stock-based compensation for employees performing commercial sales,
account management, marketing, and allocation of genetic counseling
services related to medical education. Selling and marketing costs
are expensed as incurred.
We generally expect our selling and marketing expenses will
continue to increase in absolute dollars as we expand our
commercial sales and marketing and counseling teams and increase
marketing activities. However, we expect selling and marketing
expenses to decrease as a percentage of revenue in the long term,
subject to fluctuations from period to period due to the timing and
magnitude of these expenses.
General and Administrative Expenses
General and administrative expenses primarily consist of
personnel-related expenses (comprising salaries and benefits) and
stock-based compensation for employees in executive leadership,
legal, finance and accounting, human resources, information
technology, strategy and other administrative functions. In
addition, these expenses include office occupancy and information
technology costs. General and administrative costs are expensed as
incurred.
We generally expect our general and administrative expenses to
continue to increase in absolute dollars as we increase headcount
and incur costs associated with operating as a public company,
including expenses related to legal, accounting, and regulatory
matters; maintaining compliance with requirements of Nasdaq and of
the SEC; director and officer insurance premiums and investor
relations. We expect these expenses to decrease as a percentage of
revenue in the long term as revenue increases, although the
percentage may fluctuate from period to period due to fluctuations
in our compensation-related charges.
Related Party Expenses
Related party expenses consist of amounts due to ISMMS for expenses
under our Transition Services Agreement, or TSA, with ISMMS which
expired at the end of the first quarter of 2021, and other service
agreements. Additional information can be found in the audited
financial statements in Note 7,
“Related Party Transactions”
included within our Annual Report on Form 10-K for the year ended
December 31, 2021, and our unaudited condensed consolidated
financial statements in Note 7,
“Related Party Transactions”
included within this Quarterly Report.
We generally expect related party expenses to decrease as we
establish our own internal and external resources to fulfill the
administrative and other services we have historically procured
from ISMMS.
Interest Income
Interest income consists of interest earned on money market
funds.
Interest Expense
Interest expense consists of interest costs related to our finance
leases and our long-term debt arrangements, including unused line
fee and the amortization of deferred transaction costs related to
the loan and security agreement entered into with Silicon Valley
Bank to provide a $125 million revolving credit facility described
elsewhere in this report. No amounts have been drawn under the
revolving credit facility as of March 31, 2022.
Other Income
Other income consists of funding received under the CARES Act. We
recognized $5.6 million of additional funding received under the
CARES Act during the first quarter of 2021 and the amount is
included in other income for the three months ended March 31,
2021.
Comparison of the three months ended March 31, 2022 and
2021
The following table sets forth our results of operations for the
periods presented (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 (1) |
|
(in thousands) |
Revenue |
|
|
|
Diagnostic test revenue
|
$ |
52,495 |
|
|
$ |
62,760 |
|
Other revenue
|
1,446 |
|
|
1,441 |
|
Total revenue
|
53,941 |
|
|
64,201 |
|
Cost of services |
48,316 |
|
|
68,524 |
|
Gross profit (loss)
|
5,625 |
|
|
(4,323) |
|
Research and development |
21,315 |
|
|
53,133 |
|
Selling and marketing |
29,547 |
|
|
35,366 |
|
General and administrative |
42,784 |
|
|
102,038 |
|
Related party expenses |
1,284 |
|
|
1,797 |
|
Loss from operations
|
(89,305) |
|
|
(196,657) |
|
|
|
|
|
Other income (expense), net: |
|
|
|
Change in fair market value of warrant and earn-out contingent
liabilities |
13,190 |
|
|
— |
|
Interest income
|
27 |
|
|
21 |
|
Interest expense
|
(808) |
|
|
(723) |
|
Other income
|
— |
|
|
5,584 |
|
Total other income (expense), net
|
12,409 |
|
|
4,882 |
|
Loss before income taxes |
(76,896) |
|
|
(191,775) |
|
Income tax provision |
— |
|
|
— |
|
Net loss and comprehensive loss
|
$ |
(76,896) |
|
|
$ |
(191,775) |
|
(1)
As previously disclosed in Note 2, “Summary of Significant
Accounting Policies” to our consolidated financial statements
included in our Annual Report on Form 10-K for the year ended
December 31, 2021, certain adjustments were made to reclassify
certain expenses between cost of services and operating expenses.
The adjustments are reflected as disclosed.
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
Three months ended March 31, |
|
2021 to 2022 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
(dollars in thousands) |
Diagnostic test revenue |
$ |
52,495 |
|
|
$ |
62,760 |
|
|
$ |
(10,265) |
|
|
(16) |
% |
Other revenue |
1,446 |
|
|
1,441 |
|
|
5 |
|
|
— |
% |
Total revenue |
$ |
53,941 |
|
|
$ |
64,201 |
|
|
$ |
(10,260) |
|
|
(16) |
% |
Total revenue decreased by $10.3 million, or 16%, to $53.9 million
for the three months ended March 31, 2022, from $64.2 million
for the three months ended March 31, 2021.
Diagnostic test revenue decreased by $10.3 million, or 16%, to
$52.5 million for the three months ended March 31, 2022, from
$62.8 million for the three months ended March 31, 2021. The
decrease was primarily attributable to a decrease in COVID-19 test
volumes of 61%. Lower demand and the absence of new contracts
during the three months ended March 31, 2022, a result of the
decision to discontinue COVID-19 testing services at the end of the
first quarter of 2022, were the key contributors for the decline in
COVID-19 revenue. This was partially offset by oncology testing
volumes, which increased by 159%. Women’s health testing volume,
including carrier screening and NIPT testing, increased by 23%,
which was partially offset by a lower average selling
price.
Other revenue increased by a nominal amount for the three months
ended March 31, 2022, from the three months ended
March 31, 2021.
Cost of Services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
Three months ended March 31, |
|
2021 to 2022 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
(dollars in thousands) |
Cost of services |
$ |
48,316 |
|
|
$ |
68,524 |
|
|
$ |
(20,208) |
|
|
(29) |
% |
Cost of services decreased by $20.2 million, or 29%, to $48.3
million for the three months ended March 31, 2022, from $68.5
million for the three months ended March 31, 2021. The
decrease was primarily driven by the following components: a $17.1
million decrease in stock-based compensation expense due to the
higher expense recorded in the first quarter of 2021 as a result of
the increased fair value of the awards and related expenses
recorded in the first quarter of 2021 under liability accounting; a
$1.8 million decrease in the inventory obsolescence write-off as a
result of discontinuing COVID-19 testing; and a $1.3 million
decrease in overall personnel-related expenses driven by
reallocation of certain costs between departments during the fourth
quarter of 2021 as a result of a change in estimate.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
Three months ended March 31, |
|
2021 to 2022 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
(dollars in thousands) |
Research and development |
$ |
21,315 |
|
|
$ |
53,133 |
|
|
$ |
(31,818) |
|
|
(60) |
% |
Research and development expense decreased by $31.8 million, or
60%, to $21.3 million for the three months ended March 31,
2022, from $53.1 million for the three months ended March 31,
2021. The decrease was primarily attributable to a $33.8 million
decrease in stock-based compensation expense due to the higher
expense recorded in the first quarter of 2021 as a result of the
increased fair value of the awards and related expenses recorded in
the first quarter of 2021 under liability accounting and a decrease
in cost incurred for reagents and laboratory supplies and
laboratory software of $1.6 million for research and development
activities. These decreases were offset by a $2.6 million increase
in other personnel-related expenses driven by headcount and a $0.6
million increase in depreciation expense.
Selling and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
Three months ended March 31, |
|
2021 to 2022 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
(dollars in thousands) |
Selling and marketing |
$ |
29,547 |
|
|
$ |
35,366 |
|
|
$ |
(5,819) |
|
|
(16) |
% |
Selling and marketing expense decreased by $5.8 million, or 16%, to
$29.5 million for the three months ended March 31, 2022, from
$35.4 million for the three months ended March 31, 2021. The
decrease was primarily attributable to a $15.8 million decrease in
stock-based compensation expense due to the higher expense recorded
in the first quarter of 2021 as a result of the increased fair
value of the awards and related expenses recorded in the first
quarter of 2021 under liability accounting. This decrease was
partially offset by a $5.9 million increase in other
personnel-related expenses driven by an increase in headcount, a
$1.3 million increase in consulting service expenses to support
revenue cycle transformation initiatives and a $1.2 million
increase in travel and business expenses due to the lifting of
COVID-19 travel restrictions. Additionally, there was an increase
of $0.6 million in other lab services for genetic counseling
related to medical education, and an increase of $0.5 million in
information technology-related expenses.
General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
Three months ended March 31, |
|
2021 to 2022 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
(dollars in thousands) |
General and administrative |
$ |
42,784 |
|
|
$ |
102,038 |
|
|
$ |
(59,254) |
|
|
(58) |
% |
General and administrative expense decreased by $59.2 million, or
58%, to $42.8 million for the three months ended March 31,
2022, from $102.0 million for the three months ended March 31,
2021. The decrease was primarily attributable to a $80.6 million
decrease in stock-based compensation expense due to the higher
expense recorded in the first quarter of 2021 as a result of the
increased fair value of the awards and related expenses recorded in
the first quarter of 2021 under liability accounting. This was
partially offset by an increase in expenses of $6.5 million for
professional services incurred in connection with the Acquisition
that are not capitalized, an increase in personnel-related costs of
$10.0 million driven by an increase in headcount, a $2.4 million
increase in information technology related expenses due to
increased cloud storage requirements, a $1.7 million increase in
insurance expenses driven by the commencement of director’s
insurance policy, and a $0.5 million increase due to reallocation
of certain costs between departments during the fourth quarter of
2021 as a result of a change in estimate.
Related Party Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
Three months ended March 31, |
|
2021 to 2022 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
(dollars in thousands) |
Related party expenses |
$ |
1,284 |
|
|
$ |
1,797 |
|
|
$ |
(513) |
|
|
(29) |
% |
Related party expenses decreased by $0.5 million, or 29%, to $1.3
million for the three months ended March 31, 2022, from $1.8
million for the three months ended March 31, 2021. The
decrease was primarily attributable to the discontinued fees
related to information technology support pursuant to the TSA with
ISMMS as a result of the termination of the agreement after the
first quarter of 2021 and a decrease in rent and facility expenses
driven by a reduction of office and lab space leased from ISMMS
pursuant to the TSA.
Interest Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
Three months ended March 31, |
|
2021 to 2022 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
(dollars in thousands) |
Interest income |
$ |
27 |
|
|
$ |
21 |
|
|
$ |
6 |
|
|
29 |
% |
Interest income increased by a nominal amount for the three months
ended March 31, 2022 from the three months ended
March 31, 2021.
Interest Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
Three months ended March 31, |
|
2021 to 2022 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
(dollars in thousands) |
Interest expense |
$ |
(808) |
|
|
$ |
(723) |
|
|
$ |
(85) |
|
|
12 |
% |
Interest expense increased by $0.1 million, or 12%, to $0.8 million
for the three months ended March 31, 2022, from $0.7 million
for the three months ended March 31, 2021. The increase was
driven by the unused line fee and amortization of deferred
transaction costs related to the loan and security agreement
entered into with Silicon Valley Bank at the end of
2021.
Other Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
Three months ended March 31, |
|
2021 to 2022 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
(dollars in thousands) |
Other income
|
$ |
— |
|
|
$ |
5,584 |
|
|
$ |
(5,584) |
|
|
(100) |
% |
Other income decreased by $5.6 million, to zero for the three
months ended March 31, 2022, from $5.6 million for the three
months ended March 31, 2021. This was attributable to the $5.6
million in funding that was received and recognized as other income
under the CARES Act in the first quarter of 2021.
Reconciliation of Non-GAAP Financial Measures
In addition to our results determined in accordance with GAAP, we
believe the following non-GAAP measures are useful in evaluating
our operating performance. We use the following non-GAAP financial
information to evaluate our ongoing operations and for internal
planning and forecasting purposes. We believe that non-GAAP
financial information, when taken collectively, may be helpful to
investors because it provides consistency and comparability with
past financial performance. However, non-GAAP financial information
is presented for supplemental informational purposes only and
should not be considered in isolation or as a substitute for
financial information presented in accordance with GAAP. In
addition, other companies, including companies in our industry, may
calculate similarly-titled non-GAAP measures differently or may use
other measures to evaluate their performance, all of which could
reduce the usefulness of our non-GAAP financial measures as tools
for comparison. A reconciliation is provided below for each
non-GAAP financial measure to the most directly comparable
financial measure stated in accordance with GAAP. Investors are
encouraged to review the related GAAP financial measures and the
reconciliation of these non-GAAP financial measures to their most
directly comparable GAAP financial measures, and not to rely on any
single financial measure to evaluate our business.
Non-GAAP financial measures have limitations as analytical tools
and you should not consider them in isolation, or as substitutes
for analysis of our results as reported under GAAP. We may in the
future incur expenses similar to the adjustments in the
presentation of Non-GAAP financial measures. Other limitations
include that Non-GAAP financial measures do not
reflect:
•all
expenditures or future requirements for capital expenditures or
contractual commitments;
•changes
in our working capital needs;
•provision
for income taxes, which may be a necessary element of our costs and
ability to operate;
•the
costs of replacing the assets being depreciated, which will often
have to be replaced in the future;
•the
non-cash component of employee compensation expense;
and
•the
impact of earnings or charges resulting from matters we consider
not to be reflective, on a recurring basis, of our ongoing
operations.
Adjusted Gross Profit and Adjusted Gross Margin
Adjusted Gross Profit is a non-GAAP financial measure that we
define as revenue less cost of services, excluding stock-based
compensation expense and restructuring costs. We define Adjusted
Gross Margin as our Adjusted Gross Profit divided by our revenue.
We believe these non-GAAP financial measures are useful in
evaluating our operating performance compared to that of other
companies in our industry, as these metrics generally eliminate the
effects of certain items that may vary from company to company for
reasons unrelated to overall operating performance.
The following is a reconciliation of revenue to our Adjusted Gross
Profit and Adjusted Gross Margin for the three months ended
March 31, 2022 and 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 |
|
(in thousands) |
Revenue |
$53,941 |
|
$64,201 |
Cost of services |
48,316 |
|
68,524 |
Gross Profit (Loss)
|
5,625 |
|
(4,323) |
Gross Margin |
10% |
|
(7)% |
Add: |
|
|
|
Stock-based compensation expense |
1,381 |
|
18,475 |
Restructuring costs
(1)
|
106 |
|
— |
Adjusted Gross Profit
|
$7,112 |
|
$14,152 |
Adjusted Gross Margin
|
13% |
|
22% |
__________________
(1)Represents
costs incurred for restructuring activities, which include
severance packages offered to impacted employees and third party
consulting costs incurred in the first quarter of
2022.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure that we define as
net loss adjusted for interest expense, net, depreciation and
amortization, stock-based compensation expenses, transaction and
acquisition costs, restructuring costs, change in fair market value
of warrant and earn-out contingent liabilities and other income. We
believe Adjusted EBITDA is useful in evaluating our operating
performance compared to that of other companies in our industry, as
this metric
generally eliminates the effects of certain factors that may vary
from company to company for reasons unrelated to overall operating
performance.
The following is a reconciliation of our net loss to Adjusted
EBITDA for the three months ended March 31, 2022 and
2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 |
|
(in thousands) |
Net loss |
$ |
(76,896) |
|
|
$ |
(191,775) |
|
Interest expense, net
(1)
|
781 |
|
702 |
|
Depreciation and amortization |
5,803 |
|
|
4,902 |
|
Stock-based compensation expense |
17,559 |
|
|
164,962 |
|
Transaction and acquisition costs
(2)
|
4,337 |
|
|
1,954 |
|
Restructuring costs
(3)
|
2,729 |
|
|
— |
|
Change in fair market value of warrant and earn-out contingent
liabilities
(4)
|
(13,190) |
|
|
— |
|
Other income
(5)
|
— |
|
|
(5,584) |
|
Adjusted EBITDA |
$ |
(58,877) |
|
|
$ |
(24,839) |
|
__________________
(1)Represents
the total of interest expense related to our finance leases and
interest-bearing loans and interest income on money market funds.
This also includes the unused line fee and amortization of deferred
transaction costs related to the loan and security agreement
entered into with Silicon Valley Bank.
(2)Represents
professional service costs incurred in connection with pursuing the
business combination transaction that did not meet the requirement
for capitalization in 2021. For the first quarter of 2022, this
represents professional service costs incurred in connection with
the Acquisition transaction, which include due diligence and legal
costs.
(3)Represents
costs incurred for restructuring activities, which include
severance packages offered to impacted employees and third party
consulting costs incurred in the first quarter of
2022.
(4)Represents
the change in fair market value of the liabilities associated with
our public warrants and private placement warrants and the earn-out
shares issuable under the terms of the merger agreement related to
our business combination with CMLS.
(5)For
the three months ended March 31, 2021, primarily consists of
funding received under the CARES Act Provider Relief
Fund.
Liquidity and Capital Resources
On July 22, 2021, we completed the business combination with
CMLS, consummated the related private placement financing, and
received net cash proceeds of $510 million. Management determined
that the cash proceeds received from the business combination
provides us with sufficient liquidity to meet our obligations for
at least twelve months from the date of this Quarterly
Report.
On November 15, 2021, we entered into a loan and security
agreement, or the SVB Agreement, with Silicon Valley Bank, or SVB,
whereby SVB agreed to provide a $125 million revolving credit
facility with a maturity date of November 15, 2024. No amounts were
drawn as of December 31, 2021. Advances under the SVB Agreement
will bear interest at a floating rate per annum equal to the
greater of (1) 4.00% and (2) the prime rate plus an applicable
margin.
Additionally, upon the closing of the Acquisition of GeneDx on
April 29, 2022, we received gross proceeds of $200 million from the
issuance of 50 million shares of our Class A common stock pursuant
to the Acquisition PIPE Investment. The gross proceeds were
partially used to pay for the cash consideration of the Acquisition
and transaction costs incurred in connection with the
Acquisition.
Accordingly, the condensed consolidated financial statements
included in this Quarterly Report have been prepared on a basis
that assumes we will continue as a going concern and which
contemplates the realization of assets and satisfaction of
liabilities and commitments in the ordinary course of business.
Nevertheless, we may also seek additional funding in the future
through the sale of common or preferred equity or convertible debt
securities, the entry into other credit facilities or another form
of third-party funding or by seeking other debt
financing.
Material Cash Requirements for Known Contractual Obligations and
Commitments
The following is a description of commitments for known and
reasonably likely cash requirements as of March 31, 2022 and
December 31, 2021. We anticipate fulfilling such commitments
with our existing cash and cash equivalents, which amounted to
$315.0 million and $400.6 million as of March 31, 2022 and
December 31, 2021, respectively, or through additional capital
raised to finance our operations; see
"Liquidity and Capital Resources".
Our future minimum payments under non-cancellable operating lease
agreements were $74.3 million as of March 31, 2022 and $68.3
million as of December 31, 2021. The timing of these future
payments, by year, can be found in our audited financial statements
in Note 9,
“Commitments and Contingencies”
included within our Annual Report on Form 10-K for the year ended
December 31, 2021, and our unaudited condensed consolidated
financial statements in Note 9,
“Leases,”
included within this Quarterly Report, respectively.
Our future payments under finance leases were $64.5 million as of
March 31, 2022. The timing of these future payments, by year,
can be found in our audited financial statements in Note 9,
“Commitments and Contingencies”
included within our Annual Report on Form 10-K for the year ended
December 31, 2021, and our unaudited condensed consolidated
financial statements in Note 9,
“Leases,”
included within this Quarterly Report, respectively.
Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
2022 |
|
2021 |
|
(in thousands) |
Net cash used in operating activities |
$ |
(81,494) |
|
|
$ |
(42,208) |
|
Net cash used in investing activities
|
(3,913) |
|
|
(4,994) |
|
Net cash used in financing activities |
(160) |
|
|
(2,278) |
|
Operating Activities
Net cash used in operating activities during the three months ended
March 31, 2022 was $81.5 million, which was primarily
attributable to a net loss of $76.9 million and a change in fair
value of the warrant and earn-out liabilities of $13.2 million,
partially offset by non-cash depreciation and amortization of $5.8
million and non-cash stock-based compensation expense of $17.6
million. The net change in our operating assets and liabilities
primarily reflected a $11.1 million increase in accounts receivable
primarily from institutional payors, a $2.9 million increase in
inventories driven by an increase in reagents, a $1.6 million
increase in prepaid expenses and other current assets mainly driven
by new insurance policy premiums purchased during the current
period, a $3.9 million increase in accounts payable and accrued
expenses due to the timing of vendor payments, and a $6.6 million
decrease in other current liabilities mainly driven by the decrease
in employee payroll and compensation related accruals.
Net cash used in operating activities during the three months ended
March 31, 2021 was $42.2 million, which was primarily attributable
to a net loss of $191.8 million and a net change in our operating
assets and liabilities of $22.3 million, partially offset by
non-cash depreciation and amortization of $4.9 million and non-cash
stock-based compensation expense of $165.0 million. The net change
in our operating assets and liabilities primarily reflected an $9.8
million increase in inventories driven by a higher volume of
purchases to support increasing testing volumes, a $6.3 million
increase in prepaid expenses and other current assets mainly driven
by professional services costs directly related to our business
combination with CMLS, a $4.0 million increase in accounts payable
and accrued expenses due to the timing of vendor payments, and a
$9.1 million decrease in other current liabilities mainly driven by
a decline in our bonus accrual following bonus payments in March
2021.
Investing Activities
Net cash used in investing activities during the three months ended
March 31, 2022 was $3.9 million, which was attributable to
$1.4 million in purchases of property and equipment and $2.5
million of costs related to development of internal-use software
assets.
Net cash used in investing activities during the three months ended
March 31, 2021 was $5.0 million, which was attributable to
$2.1 million in purchases of property and equipment and $2.9
million of costs related to development of internal-use software
assets.
Financing Activities
Net cash used in financing activities during the three months ended
March 31, 2022 was $0.2 million, which was attributable to
$0.9 million of finance lease principal payments which was offset
by proceeds of $0.7 million from the exercise of stock
options.
Net cash used in financing activities during the three months ended
March 31, 2021 was $2.3 million, which was attributable to $1.3
million in payments for deferred transaction costs related to our
business combination with CMLS, $1.0 million in principal payments
on our finance lease obligations and $0.4 million in principal
payments on our long-term debt obligations existed during the
period, offset by $0.4 million cash received from stock option
exercise.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition
and results of operations is based on our unaudited condensed
consolidated financial statements, which have been prepared in
accordance with U.S. GAAP. The preparation of these unaudited
condensed consolidated financial statements requires us to make
estimates and assumptions that affect the reported amounts of
assets and liabilities and the disclosure of contingent assets and
liabilities at the date of the unaudited condensed consolidated
financial statements, as well as the reported revenue generated and
expenses incurred during the reporting periods. Our estimates are
based on our historical experience and various other factors that
we believe are reasonable under the circumstances, the results of
which form the basis for making judgments about items that are not
readily apparent from other sources. Actual results may differ from
these estimates under different assumptions or
conditions.
Except as described in Note 2,
“Summary of Significant Accounting Policies–Recent Accounting
Pronouncement Issued but Not Yet Adopted,”
to our unaudited condensed consolidated financial statements
included in this Quarterly Report, there have been no material
changes to our critical accounting policies and estimates as
compared to the critical accounting policies and estimates
disclosed in our audited consolidated financial statements and
notes thereto included within our Annual Report on Form 10-K for
the year ended December 31, 2021.
JOBS Act Accounting Election
We are considered an “emerging growth company” within the meaning
of the JOBS Act. The JOBS Act allows an emerging growth company to
delay the adoption of new or revised accounting standards that have
different effective dates for public and private companies until
those standards apply to private companies. We have elected to use
this extended transition period and, as a result, our financial
statements may not be comparable to companies that comply with
public company effective dates. We also intend to rely on other
exemptions provided by the JOBS Act, including not being required
to comply with the auditor attestation requirements of Section
404(b) of the Sarbanes-Oxley Act.
Following the completion of the Business Combination, we will
remain an emerging growth company until the earliest of (1)
September 1, 2025, (2) the last day of the fiscal year in which we
have total annual gross revenue of at least $1.07 billion, (3) the
last day of the fiscal year in which we are deemed to be a “large
accelerated filer” as defined in Rule 12b-2 under the Exchange Act,
which would occur if the market value of our Class A common stock
held by non-affiliates exceeded $700.0 million as of the last
business day of the second fiscal quarter of such year or (4) the
date on which we have issued more than $1.0 billion in
non-convertible debt securities during the prior three-year
period.
Recent Accounting Pronouncements
Additional information on recent accounting pronouncements can be
found in the audited financial statements in Note 2,
“Summary of Significant Accounting Policies”
included within our Annual Report on Form 10-K for the year ended
December 31, 2021, and our unaudited condensed consolidated
financial statements in Note 2,
“Summary of Significant Accounting Policies”
included within this Quarterly Report.
Item 3. Quantitative and Qualitative Disclosures about Market
Risk
We are exposed to market risks in the ordinary course of our
business. These risks primarily relate to interest rates. Our cash,
cash equivalents, and restricted cash consists of bank deposits and
money market funds, which totaled $315.9 million at March 31, 2022
and $401.5 million as of December 31, 2021. Such interest-bearing
instruments carry a degree of risk; however, because our
investments are primarily high-quality credit instruments with
short-term durations with high-quality institutions, we have not
been exposed to, nor do we anticipate being exposed to, material
risks due to changes in interest rates. A 100 basis point change in
interest rates would not have a material effect on the fair market
value of our cash, cash equivalents and restricted
cash.
Our loan and financing obligation are recorded at amortized cost
and include variable interest rate term. Therefore, change in
interest rates can impact our interest payments we are obligated to
pay. Additional information on our long-term debt can be found in
Sema4’s audited financial statements in Note 8,
“Long-Term Debt”
and Sema4’s unaudited condensed consolidated financial statements
in Note 8,
“Long-Term Debt.”
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are controls and other
procedures that are designed to ensure that information required to
be disclosed in our reports filed or submitted under the Exchange
Act is recorded, processed, summarized and reported within the time
periods specified in the SEC’s rules and forms. Disclosure controls
and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed in our
reports filed or submitted under the Exchange Act is accumulated
and communicated to our management, including our Chief Executive
Officer and Chief Financial Officer, to allow timely decisions
regarding required disclosure.
As required by Rules 13a-15 and 15d-15 under the Exchange Act, our
Chief Executive Officer and Chief Financial Officer carried out an
evaluation of the effectiveness of the design and operation of our
disclosure controls and procedures as of March 31, 2022. Based on
that evaluation, our Chief Executive Officer and Chief Financial
Officer concluded that our disclosure controls and procedures were
not effective as of March 31, 2022 because of the material
weaknesses in internal control over financial reporting as of
December 31, 2021 that we previously identified in Item 9A.
“Controls and Procedures” of our Annual Report on Form 10-K for the
year ended December 31, 2021 and had not been fully remediated as
of March 31, 2022.
Notwithstanding the identified material weaknesses in internal
control over financial reporting, our management has concluded that
our condensed consolidated financial statements included in the
Quarterly Report on Form 10-Q are fairly stated in all material
respects in accordance with accounting principles generally
accepted in the United States of America.
Previously Reported Material Weaknesses
A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such
that there is a reasonable possibility that a material misstatement
of a company’s annual or interim financial statements will not be
prevented or detected on a timely basis.
As described in more detail in Item 9A. “Controls and Procedures”
of our Annual Report on Form 10-K for the year ended December 31,
2021, the material weaknesses identified related to the fact that
we did not design and maintain accounting policies, procedures and
controls to ensure complete, accurate and timely financial
reporting in accordance with U.S. GAAP.
Remediation Plan
Our management is actively engaged and committed to taking the
steps necessary to remediate the control deficiencies that
constituted the material weaknesses, and these remediation
activities are continuing in 2022. In addition to the remediation
actions undertaken during 2021 and described in more detail in Item
9A. “Controls and Procedures” of our Annual Report on Form 10-K for
the year ended December 31, 2021, we expect to engage in additional
activities, including, but not limited to:
•Hiring
more technical accounting resources to enhance our control
environment;
•Engaging
external consultants to provide support and to assist us in our
evaluation of more complex applications of GAAP, and to assist us
with documenting and assessing our accounting policies and
procedures until we have sufficient technical accounting
resources;
•Implementing
business process-level controls across all significant accounts and
information technology general controls across all relevant
systems. This includes providing training for control owners that
will present expectations as it relates to the control design,
execution and monitoring of such controls, including enhancements
to the documentation to evidence the execution of the controls;
and
•Implementing
improvements to our ERP system to enhance the accuracy of our
financial records, enable the enforcement of systematic segregation
of duties, and to improve our information technology general
controls environment.
We continue to enhance corporate oversight over process-level
controls and structures to ensure that there is appropriate
assignment of authority, responsibility, and accountability to
enable remediation of our material weaknesses. We believe that our
remediation plan will be sufficient to remediate the identified
material weaknesses and strengthen our controls. As we continue to
evaluate, and work to improve our controls, management may
determine that additional measures to address control deficiencies
or modifications to the remediation plan are
necessary.
While we have performed certain remediation activities to
strengthen our controls to address the identified material
weaknesses, control weaknesses are not considered remediated until
new internal controls have been operational for a period of time,
are tested, and management concludes that these controls are
operating effectively. We will continue to monitor the
effectiveness of our remediation measures in connection with our
future assessments of the effectiveness of internal control over
financial reporting and disclosure controls and procedures, and we
will make any changes to the design of our plan and take such other
actions that we deem appropriate given the
circumstances.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial
reporting that occurred during the three months ended March 31,
2022 covered by this Quarterly Report on Form 10-Q that has
materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting, other than as
described herein. We are continuing to take steps to remediate the
material weaknesses in our internal control over financial
reporting, as discussed above.
Inherent Limitation on the Effectiveness of Internal
Control
Our management, including our Chief Executive Officer and Chief
Financial Officer, does not expect that our disclosure controls and
procedures, or our internal controls, will prevent all error and
all fraud. A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that
the objectives of the control system are met. Further, the design
of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered
relative to their costs. Because of the inherent limitations in all
control systems, no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any,
within our Company have been detected.
Part II - Other Information
Item 1. Legal Proceedings
We, and our subsidiary, are currently not a party to, and our
property is not currently the subject of, any material pending
legal proceedings; however, we may become involved in various
claims and legal actions arising in the ordinary course of
business.
Item 1A. Risk Factors
You should carefully review and consider the following risk factors
and the other information contained in this Quarterly Report on
Form 10-Q before deciding whether to invest in our Class A common
stock. We cannot assure you that any of the events discussed below
will not occur. These events could have a material and adverse
impact on our business, financial condition, results of operations
and prospects. Unless otherwise indicated, references to our
business being harmed in these risk factors will include harm to
our business, reputation, financial condition, results of
operations, net revenue and future prospects. In such event, the
trading price of our Class A common stock could decline, and you
could lose all or part of your investment. We may face additional
risks and uncertainties that are not presently known to us, or that
we currently deem immaterial, which may also impair our business or
financial condition. The following discussion should be read in
conjunction with the unaudited condensed consolidated financial
statements and notes thereto included herein.
Risk Factors Summary
Our business is subject to a number of risks and uncertainties,
including those risks discussed at length below. These risks
include, among others, the following:
•The
ongoing COVID-19 pandemic has affected and may further materially
and adversely affect our business and financial
results.
•We
face intense competition. If we do not continue to innovate and
provide products and services that are useful to users, we may not
remain competitive, which could harm our business and operating
results.
•If
third-party payors, including managed care organizations, private
health insurers and government health plans, do not provide
adequate reimbursement for our tests, or seek to amend or
renegotiate their fee reimbursement schedules, or if we are unable
to comply with their requirements for reimbursement, our commercial
success could be negatively affected.
•We
have limited experience with the development and commercialization
of our databases and our health information and genomic
platforms.
•If
we fail to comply with federal and state laboratory licensing
requirements or standards, we could lose the ability to perform our
tests or experience disruptions to our business.
•We
rely on highly skilled personnel in a broad array of disciplines
and, if we are unable to hire, retain or motivate these
individuals, or maintain our corporate culture, we may not be able
to maintain the quality of our services or grow
effectively.
•We
need to scale our infrastructure in advance of demand for our
products and services, and our failure to generate sufficient
demand for our products and services would have a negative impact
on our business and our ability to attain
profitability.
•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 or service providers.
•We
rely on a limited number of product and service providers for data
infrastructure and analytics capabilities, and any disruption of,
or interference with, our use of data and workflow services could
adversely affect our business, financial condition, and results of
operations, and we may not be able to find replacements or
immediately transition to alternative products or service
providers.
•Our
projections are subject to significant risks, assumptions,
estimates and uncertainties, including assumptions regarding
adoption of our products and services. As a result, our projected
revenues, market share, expenses and profitability may differ
materially from our expectations in any given quarter or fiscal
year.
•Uncertainty
in the development and commercialization of our enhanced or new
tests or services could materially adversely affect our business,
financial condition and results of operations.
•We
currently use, and in the future expect to increase our use of,
information and rights from customers, strategic partners, and
collaborators for several aspects of our operations, and if we
cannot maintain current and enter new relationships with these
parties with adequate access and authorization to such information,
our business will suffer.
•Our
operating results could be subject to significant fluctuation,
which could increase the volatility of our stock and warrant prices
and cause losses to our stockholders.
•We
may need to raise additional capital to fund our existing
operations, develop additional products and services, commercialize
new products and services or expand our operations and may have
difficulties raising capital depending on financial market
conditions.
•We
expect to make significant investments in our continued research
and development of new products and services, which may not be
successful.
•We
have identified material weaknesses, some of which have a pervasive
effect across the organization, and may identify additional
material weaknesses or significant deficiencies, in our internal
controls over financial reporting. Our failure to remedy these
matters could result in a material misstatement of our financial
statements and we will incur increased costs and demands on
management as a result of compliance with internal control
requirements, which could harm our operating results.
•We
rely on third-party laboratories to perform certain elements of our
service offerings.
•As
a result of the Acquisition, OPKO became a substantial holder of
shares of our Class A common stock and sales by OPKO into the
market in the future could cause the market price of our Class A
common stock to drop significantly, even if our business is doing
well.
•Our
ability to be successful following the Acquisition is dependent
upon the efforts of our key personnel, including the key personnel
of GeneDx. The loss of key personnel could negatively impact our
operations and profitability our financial condition could suffer
as a result.
•Future
changes in FDA enforcement discretion for LDTs could subject our
operations to much more significant regulatory
requirements.
•Compliance
with the HIPAA security, privacy and breach notification
regulations may increase our costs.
•We
face uncertainty related to healthcare reform, pricing, coverage
and reimbursement, which could reduce our revenue.
•Our
inability to effectively protect our proprietary products,
processes, and technologies, including the confidentiality of our
trade secrets, could harm our competitive position.
•Security
breaches, privacy issues, loss of data and other incidents could
compromise sensitive, protected, or personal information related to
our business, could prevent it from accessing critical information,
and could expose it to regulatory liability, which could adversely
affect our business.
•We
will incur increased costs and demands on management as a result of
compliance with laws and regulations applicable to public
companies, which could harm our operating results.
Risks Related to Our Business, Industry and Operations
The ongoing COVID-19 pandemic has affected and may further
materially and adversely affect our business and financial
results.
The ongoing COVID-19 pandemic, together with related precautionary
measures in response to the initial outbreak and resurgences,
materially disrupted our business during certain periods in 2020
and 2021 and may continue to disrupt our business for an unknown
period of time. Since the initial outbreak, we experienced a
significant impact to our 2020 and 2021 operating results,
including our order volumes, revenues, margins, and cash
utilization, among other measures and may experience further
impacts in future periods depending on the evolution of the
COVID-19 pandemic.
Throughout 2020 and 2021, both we and our partners also undertook a
number of precautionary measures in response to the virus,
including requiring employees to work remotely, restricting travel
and limiting interactions in person, and we
expect to adjust our precautionary measures at our various
locations based on local recovery levels, vaccination rates and
applicable governmental regulations. Our business could be
negatively affected in the future if it takes excessive,
ineffective or inadequate precautions.
The ongoing COVID-19 pandemic has materially impacted our business
in 2020 and 2021 and may continue to impact our business for an
unknown period of time. Such impacts have included and may include
the following:
•Healthcare
providers or patients have canceled or delayed scheduling, and for
an extended period of time may continue to cancel or delay
scheduling, standard wellness visits and other non-emergency
appointments and procedures (including oncology and
pregnancy-related screenings), contributing to a decline in orders
for our products or services;
•Restrictions
on travel, commerce and shipping may prevent patients and
pathologists from shipping samples to our clinical
laboratories;
•Illnesses,
quarantines, financial hardships, restrictions on travel, commerce
and shipping, or other consequences of the pandemic, may disrupt
our supply chain or other business relationships, and we or other
parties may assert rights under force majeure clauses to excuse
performance;
•We
have experienced, and for an extended period of time may continue
to experience, reduced volumes at our clinical laboratories and we
may need to suspend operations at some or all of our clinical
laboratories;
•We
have taken, and may take additional, cost cutting measures, which
may hinder our efforts to commercialize our products or delay the
development of future products and services. Further, we might not
realize all of the cost savings we expect to achieve as a result of
those efforts;
•We
and our partners have postponed or cancelled clinical studies,
which may delay or prevent our launch of future products and
services;
•Some
or all of our workforce, much of which continues to work remotely
in an effort to reduce the spread of COVID-19, may be infected by
the virus or otherwise distracted;
•A
combination of factors, including infection from the virus, supply
shortfalls, and inability to obtain or maintain equipment, could
adversely affect our lab capacity and our ability to meet the
demand for our testing services; and
•We
may inaccurately estimate the duration or severity of the COVID-19
pandemic, which could cause us to misalign our staffing, spending,
activities and precautionary measures with current or future market
conditions.
Despite our efforts, the ultimate impact of the COVID-19 pandemic,
or the impact of the emergence of new strains of the virus and any
future resurgences of COVID-19 or variant strains, depends on
factors beyond our knowledge or control, including availability and
distribution of effective medical treatments and vaccines, the
duration and severity of the pandemic, third-party actions taken to
contain its spread and mitigate its public health effects and
short- and long-term changes in the behaviors of medical
professionals and patients resulting from the
pandemic.
Additionally, the economic consequences of the COVID-19 pandemic
have, and may continue to, adversely impacted financial markets,
resulting in high share price volatility, reduced market liquidity,
and substantial declines in the market prices of the securities of
many publicly traded companies. Volatile or declining markets for
equities could adversely affect our ability to raise capital in the
future when needed through the sale of shares of Class A common
stock or other equity or equity-linked securities. If these market
conditions persist when and if we need to raise capital, and if we
are able to sell shares of our Class A common stock under then
prevailing market conditions, we might have to accept lower prices
for our shares and issue a larger number of shares than might have
been the case under better market conditions, resulting in
significant dilution of the interests of our
stockholders.
Due to the high degree of uncertainty regarding the implementation
and impact of the CARES Act and other legislation related to
COVID-19, there can be no assurance that we will be able to comply
with the applicable terms and conditions of the CARES Act and
retain such assistance.
On March 27, 2020, the CARES Act was signed into law, aimed at
providing emergency assistance and health care for individuals,
families, and businesses affected by the COVID-19 pandemic and
generally supporting the U.S. economy. The CARES Act, among other
things, includes provisions relating to refundable payroll tax
credits, deferment of employer social security payments, net
operating loss carryback periods, alternative minimum tax credit
refunds, and modifications
to the net interest deduction limitations. The CARES Act and
similar legislation intended to provide assistance related to the
COVID-19 pandemic also authorized $175.0 billion in funding to be
distributed by the U.S. Department of Health and Human Services
(the “HHS”), to eligible health care providers. This funding, known
as the Provider Relief Fund, is designated to fund eligible
healthcare providers’ healthcare-related expenses or lost revenues
attributable to COVID-19. On December 27, 2020, the Consolidated
Appropriations Act, 2021 was signed into law, which adds $3.0
billion to the Provider Relief Fund. Payments from the Provider
Relief Fund are subject to certain eligibility criteria, as well as
reporting and auditing requirements, but do not need to be repaid
to the U.S. government if recipients comply with the applicable
terms and conditions.
In 2020, we received $5.4 million as part of the stimulus,
comprised of $2.6 million received under the PRF and $2.8 million
received under the ERC. In 2021, we received an additional $5.6
million under the PRF distribution. Funds provided under the PRF
distributions to healthcare providers are not loans and will not be
required to be repaid; however, as a condition to receiving these
payments, providers must agree to certain terms and conditions and
submit sufficient documentation demonstrating that the funds are
being used for healthcare-related expenses or lost revenue
attributable to the COVID-19 pandemic. Funds provided under the ERC
distributions are refundable tax credits for 50% of qualified wages
paid to employees during the pandemic. A company is eligible for
the ERC if it has not received a Paycheck Protection Program loan
under the Cares Act and (1) its operations have been fully or
partially suspended because of COVID-19 or (2) its gross receipts
in a calendar quarter in 2020 declined by more than 50% from the
same period in 2019. At the time of applying for the ERC, we
concluded that the eligibility requirements were met. However,
subsequent to the filing of the application, our revenue was
revised due to a change in estimate as a result of finalizing our
accounting records, which impacted the applicable periods and
calculations for determining eligibility, and may no longer meet
the eligibility requirements. As such, we have deferred the
recognition of the funds received under the ERC distribution and
recorded the proceeds in other liabilities on the balance sheets as
of March 31, 2022 and December 31, 2021.
Due to the high degree of uncertainty regarding the implementation
of the CARES Act, the Consolidated Appropriations Act, 2021 and
other stimulus legislation, and due to our revenue revisions, there
can be no assurance that the terms and conditions of the PRF, ERC
or other relief programs will not change or be interpreted in ways
that affect our ability to comply with such terms and conditions in
the future, which could affect our ability to retain such
assistance. We will continue to monitor our compliance with the
terms and conditions of the PRF, including demonstrating that the
distributions received have been used for healthcare-related
expenses or lost revenue attributable to COVID-19, and the ERC. If
we are unable to comply with current or future terms and
conditions, our ability to retain some or all of the distributions
received may be impacted, and we may be subject to actions
including payment recoupment, audits and inquiries by governmental
authorities, and criminal, civil or administrative
penalties.
Other companies or institutions may develop and market novel or
improved technologies, which may make our technologies less
competitive or obsolete.
We operate in a rapidly evolving and highly competitive industry.
There are a number of private and public companies that offer
products or services or have announced that they are developing
products or services that compete, or may one day compete, with our
products or services. Some of our current and potential competitors
possess greater brand recognition, financial and other resources
and development capabilities than we do. As the fields of genomic
analysis and health information become more widely known to the
public, we anticipate that competition will further increase. We
expect to compete with a broad range of organizations in the U.S.
and other countries that are engaged in the development, production
and commercialization of genetic screening products, including
women’s health and oncology screening products, health information
services, and analytics, and data science services, and other
diagnostic products. These competitors include:
•companies
that offer clinical, research and data clinical services, molecular
genetic testing and other clinical diagnostics, life science
research and drug discovery services, data services and healthcare
analytics, and consumer genetics products;
•academic
and scientific institutions;
•governmental
agencies; and
•public
and private research organizations.
We may be unable to compete effectively against our competitors
either because their products and services are superior or because
they may have more expertise, experience, financial resources, or
stronger business relationships. These competitors may have broader
product lines and greater name recognition than we do. Furthermore,
we must
compete successfully in our existing markets, including women’s
health and oncology, but also in any new markets we expand into.
Even if we successfully develop new marketable products or
services, our current and future competitors may develop products
and services that are more commercially attractive than ours, and
they may bring those products and services to market earlier or
more effectively than we are able to. If we are unable to compete
successfully against current or future competitors, we may be
unable to increase market acceptance for and sales of our tests and
services, which could prevent us from increasing or sustaining our
revenues or achieving sustained profitability.
We face intense competition. If we do not continue to innovate and
provide products and services that are useful to users, we may not
remain competitive, which could harm our business and operating
results.
Our business environment is rapidly evolving and intensely
competitive. Our businesses face changing technologies, shifting
provider and patient needs, and frequent introductions of rival
products and services. To compete successfully, we must accurately
anticipate technology developments and deliver innovative, relevant
and useful products, services, and technologies in a timely manner.
As our businesses evolve, the competitive pressure to innovate will
encompass a wider range of products and services. We must continue
to invest significant resources in research and development,
including through acquisitions and collaborations, joint ventures
and partnerships, in order to enhance our current diagnostics and
health information and data science technologies, and existing and
new products and services based off these
technologies.
We have many competitors in different industries. Our current and
potential domestic and international competitors range from large
and established companies to emerging start-ups in addition to
academic and scientific institutions, and public and private
research organizations. Some competitors have longer operating
histories in various sectors. They can use their experience and
resources in ways that could affect our competitive position,
including by making acquisitions, continuing to invest heavily in
research and development and in talent, initiating intellectual
property claims (whether or not meritorious), and continuing to
compete aggressively for our customers and partners in the market
for health information and data science products and services. Our
competitors may be able to innovate and provide products and
services faster than we can or may foresee the need for products
and services before we do.
Our operating results may also suffer if our products and services
are not responsive to the needs of our customers and partners. As
technologies continue to develop, our competitors may be able to
offer products and services that are, or that are seen to be,
substantially similar to or better than our current products and
services. This may force us to compete in different ways and expend
significant resources in order to remain competitive. If our
competitors are more successful than us in developing compelling
products and services for or in attracting and retaining customers
or partners in the market for health information and data science
products and services, our operating results could be
harmed.
If third-party payors, including managed care organizations,
private health insurers and government health plans, do not provide
adequate reimbursement for our tests, or seek to amend or
renegotiate their fee reimbursement schedules, or if we are unable
to comply with their requirements for reimbursement, our commercial
success could be negatively affected.
Our ability to increase the number of billable tests and our
revenue therefrom will depend on our success in achieving
reimbursement for our tests from third-party payors. Reimbursement
by a payor may depend on a number of factors, including a payer’s
determination that a test is appropriate, medically necessary,
cost-effective and has received prior authorization. The commercial
success of our current and future products, if approved, will
depend on the extent to which our customers receive coverage and
adequate reimbursement from third-party payors, including managed
care organizations and government payers (e.g., Medicare and
Medicaid).
Since each payer makes its own decision as to whether to establish
a policy or enter into a contract to cover our tests, as well as
the amount it will reimburse for a test, seeking these approvals is
a time-consuming and costly process. In addition, the determination
by a payer to cover and the amount it will reimburse for our tests
will likely be made on an indication-by-indication basis and may
consider our billing practices and reimbursements from other payors
and from our patient billing programs. To date, we have obtained
policy-level reimbursement approval or contractual reimbursement
for some indications for our tests from most of the large
commercial third-party payors in the United States, and the Centers
for Medicare & Medicaid Services (“CMS”) provides reimbursement
for our multi-gene tests for hereditary breast and ovarian
cancer-related disorders as well as other tests. We believe that
establishing adequate reimbursement from Medicare is an important
factor in gaining adoption from healthcare providers. Our claims
for reimbursement from third-party payors may be denied upon
submission, and we must appeal the claims. The appeals process is
time consuming and expensive and may not result in payment. In
cases where there is not a contracted rate for reimbursement, there
is typically a greater coinsurance or copayment requirement from
the patient, which may result in further delay or decreased
likelihood of collection.
A significant portion of the payments for our tests are paid or
reimbursed under insurance programs with third-party payors. To
contain reimbursement and utilization rates, third-party payors
often attempt to, or do in fact, amend or renegotiate their fee
reimbursement schedules. Loss of revenue caused by third-party
payor cost containment efforts or an inability to negotiate
satisfactory reimbursement rates could have a material adverse
effect on our revenue and results of operations.
Furthermore, in cases where we or our partners have established
reimbursement rates with third-party payors, we face additional
challenges in complying with their procedural requirements for
reimbursement. These requirements often vary from payer to payer
and are reassessed by third party payors on a regular basis, and we
have needed additional time and resources to comply with them. We
have also experienced, and may continue to experience, delays in or
denials of coverage if we do not adequately comply with these
requirements. Our third-party payors have also requested, and in
the future may request, audits of the amounts paid to us. We have
been required to repay certain amounts to payers as a result of
such audits, and we could be adversely affected if we are required
to repay other payers for alleged overpayments due to lack of
compliance with their reimbursement policies. In addition, we have
experienced, and may continue to experience, delays in
reimbursement when we transition to being an in-network provider
with a payer.
We expect to continue to focus our resources on increasing adoption
of, and expanding coverage and reimbursement for, our current tests
and any future tests we may develop or acquire. If we fail to
expand and maintain broad adoption of, and coverage and
reimbursement for, our tests, our ability to generate revenue could
be harmed and our future prospects and our business could
suffer.
We have limited experience with the development and
commercialization of our databases and our health information and
genomic platforms.
We have limited experience with the development or
commercialization of clinical or research products in connection
with the databases we manage and to which we have access, including
our Centrellis and Traversa platforms. Our partners’ usage of an
advanced machine learning engine for therapeutic decision-making
are at an early stage of development and usage under current and
proposed collaborations, and we are continuing to develop new
processes that may support the development of new therapeutics
applications such as the delivery of personalized clinically
actionable insights into clinical reports, clinical trial matching,
real-world evidence trials, and clinical decision support, via an
advanced programmable interface layer. Although our partners have
invested significant financial resources to develop and utilize new
technologies to support preclinical studies and other early
research and development activities, and provide general and
administrative support for these operations, our future success is
dependent on our current and future partners’ ability to
successfully derive actionable insights from the database and our
platform, and our partners’ ability, where applicable, to obtain
regulatory approval for new therapeutic solutions based off
existing models or to obtain regulatory approval and marketing for,
and to successfully commercialize, new therapeutics. The use of our
platform and the databases it manages and to which it has access
for these purposes will require additional regulatory investments
for Centrellis, such as “good practice” quality guidelines and
regulations (“GxP”), and data quality and integrity
controls.
Ethical, legal and social concerns related to the use of genomic
medicine and health information analysis could reduce demand for
our tests.
Genomic medicine and health information analysis has raised
ethical, legal and social issues regarding privacy rights and the
appropriate uses of the resulting information. Domestic and
international governmental and regulatory authorities could, for
social or other purposes, such as data privacy, limit or regulate
the use of health information or health information testing or
prohibit testing for specific information derived from health
information testing, including, for example, data on genetic
predisposition to certain conditions, particularly for those that
have no known cure. Similarly, these concerns may lead patients to
refuse to use, or clinicians to be reluctant to order, genomic
tests as part of health information assessment even if permissible,
or lead patients to withhold or withdraw consent for our use of
their data. These and other ethical, legal and social concerns may
limit market acceptance of our tests or services or reduce the
potential markets for our tests, or services either of which could
have an adverse effect on our business, research, financial
condition or results of operations.
If we fail to comply with federal and state laboratory licensing
requirements or standards, we could lose the ability to perform our
tests or experience disruptions to our business.
We are subject to Clinical Laboratory Improvement Amendments of
1988 (“CLIA”), a federal law that regulates clinical laboratories
that perform testing on specimens derived from humans for the
purpose of providing information for the diagnosis, prevention or
treatment of disease. CLIA regulations establish specific standards
with respect to personnel qualifications, facility administration,
proficiency testing, quality control, quality assurance and
inspections. CLIA
certification is also required in order for us to be eligible to
bill state and federal healthcare programs, as well as many private
third-party payors, for our tests. We have current CLIA, CAP, and
other certifications to conduct our tests at our laboratories in
Connecticut. To renew these certifications, we are subject to
survey and inspection on a regular basis and at the request of the
certifying bodies. Moreover, CLIA inspectors may make random
inspections of our clinical reference laboratories.
We would also be required to maintain in-state licenses if we were
to conduct testing in other states. Several states require the
licensure of out-of-state laboratories that accept specimens from
certain states.
In addition to having laboratory licenses in New York, our clinical
reference laboratories are approved on test-specific bases for the
tests they run as laboratory-developed tests (“LDTs”), by the New
York State Department of Health (“NYDOH”). Other states may adopt
similar licensure requirements in the future, which may require us
to modify, delay or stop our operations in such jurisdictions. We
may also be subject to regulation in foreign jurisdictions as we
seek to expand international utilization of our tests or such
jurisdictions adopt new licensure requirements, which may require
review of our tests in order to offer them or may have other
limitations such as restrictions on the transport of samples
necessary for us to perform our tests that may limit our ability to
make our tests available outside of the United States. Complying
with licensure requirements in new jurisdictions may be expensive,
time-consuming, and subject us to significant and unanticipated
delays.
Failure to comply with applicable clinical laboratory licensure
requirements or standards may result in a range of enforcement
actions, including license suspension, limitation, or revocation,
directed plan of action, onsite monitoring, civil monetary
penalties, criminal sanctions, and cancellation of the laboratory’s
approval to receive Medicare and Medicaid payment for our services,
as well as significant adverse publicity. Any sanction imposed
under CLIA, its implementing regulations, or state or foreign laws
or regulations governing clinical laboratory licensure, or our
failure to renew our CLIA certifications, a state or foreign
license, or accreditation, could have a material adverse effect on
our business, financial condition and results of operations. Even
if we were able to bring our laboratory back into compliance, we
could incur significant expenses and potentially lose revenue in
doing so.
The College of American Pathologists (“CAP”), maintains a clinical
laboratory accreditation program. CAP asserts that its program is
“designed to go well beyond regulatory compliance” and helps
laboratories achieve the highest standards of excellence to
positively impact patient care. While not required to operate a
CLIA-certified laboratory, many private insurers require CAP
accreditation as a condition to contracting with clinical
laboratories to cover their tests. In addition, some countries
outside the United States require CAP accreditation as a condition
to permitting clinical laboratories to test samples taken from
their citizens. We have CAP accreditations for our laboratories.
Failure to maintain CAP accreditation could have a material adverse
effect on the sales of our tests and the results of our
operations.
Additional Risks Related to GeneDx’s Business and
Operations
GeneDx needs to scale its infrastructure in advance of demand for
its tests, and its failure to generate sufficient demand for its
tests would have a negative impact on its business and its ability
to attain profitability.
GeneDx’s success depends in large part on its ability to extend its
market position, to provide customers with high-quality test
reports quickly and at a lower price than its competitors, and to
achieve sufficient test volume to realize economies of scale.
GeneDx’s overall test volumes grew from approximately 134 thousand
to 169 thousand tests processed during the years ended December 31,
2020 and 2021. In addition, GeneDx regularly evaluates and refines
its testing process, often significantly updating its workflows,
including with respect to exome sequencing and whole genome
sequencing. In order to execute GeneDx’s business model, it intends
to continue to invest heavily in order to significantly scale its
infrastructure, including GeneDx’s testing capacity, particularly,
with respect to exome sequencing and whole genome sequencing to
supplement its panel testing capabilities, and information systems,
expand its commercial operations, customer service, billing and
systems processes and enhance its internal quality assurance
program. GeneDx expects that much of this growth will be in advance
of demand for its tests. GeneDx’s and Sema4’s current and future
expense levels are to a large extent fixed and are largely based on
investment plans and estimates of future revenue. Because the
timing and amount of revenue from GeneDx’s tests is difficult to
forecast, when revenue does not meet expectations, GeneDx may not
be able to adjust its spending promptly or reduce spending to
levels commensurate with its revenue. Even if GeneDx successfully
scales its infrastructure and operations, there can be no assurance
that tests will increase at levels consistent with the growth of
GeneDx’s infrastructure. If GeneDx fails to generate demand
commensurate with this growth or if it fails to scale its
infrastructure sufficiently in advance of demand to successfully
meet such demand, its business, prospects, financial condition and
results of operations could be adversely affected.
If GeneDx is not able to continue to generate substantial demand of
its tests, its commercial success will be negatively
affected.
GeneDx’s business model assumes that it will be able to generate
significant test volume, particularly with respect to exome
sequencing and whole genome sequencing in addition to its panel
testing offerings, and it may not succeed in continuing to drive
adoption of its tests to achieve sufficient volumes. Inasmuch as
detailed genetic data from exome and whole genome sequencing has
only recently become available at relatively affordable prices, the
continued pace and degree of clinical acceptance of the utility of
such testing is uncertain. Specifically, it is uncertain how much
genetic data will be accepted as necessary or useful, as well as
how detailed that data should be, particularly since medical
practitioners may have become accustomed to genetic testing that is
specific to one or a few genes and may not embrace the utility of
exome sequencing and whole genome sequencing. Given the substantial
amount of additional information available from a broad-based
testing panel such as GeneDx’s, there may be distrust as to the
reliability of such information when compared with more limited and
focused genetic tests. To generate further demand for GeneDx’s
tests, GeneDx will need to continue to make clinicians aware of the
benefits of its tests, including the price, the breadth of its
testing options, and the benefits of having additional genetic data
available from which to make treatment decisions. A lack of or
delay in clinical acceptance of GeneDx’s exome sequencing and whole
genome sequencing testing, or its legacy broad-based panels
testing, would negatively impact sales and market acceptance of
GeneDx’s tests and limit its revenue growth and potential
profitability. Genetic testing is expensive and many potential
customers may be sensitive to pricing. In addition, potential
customers may not adopt GeneDx’s tests if adequate reimbursement is
not available, or if GeneDx is not able to maintain low prices
relative to its competitors.
If GeneDx is not able to generate demand for its tests at
sufficient volume, or if it takes significantly more time to
generate this demand than GeneDx anticipates, GeneDx’s business,
prospects, financial condition and results of operations could be
materially harmed.
GeneDx has devoted a portion of its resources to the development
and commercialization of exome sequencing and whole genome
sequencing, and to research and development activities related to
such sequencing and the analysis thereof, including clinical and
regulatory initiatives to obtain diagnostic clearance and marketing
approval. The demand for these regulated products is relatively
unproven, and GeneDx may not be successful in achieving market
awareness and demand for these products through its and, following
completion of the Acquisition, Sema4’s sales and marketing
operations.
If GeneDx’s laboratories become inoperable due to disasters, health
epidemics or for any other reasons, it will be unable to perform
tests and its business will be harmed.
GeneDx performs all of its tests at its production facilities in
Gaithersburg, Maryland. GeneDx’s laboratories and the equipment it
uses to perform its tests would be costly to replace and could
require substantial lead time to replace and qualify for use.
GeneDx’s laboratories may be harmed or rendered inoperable by
natural or man-made disasters, including flooding, fire and power
outages, or by health epidemics, which may render it difficult or
impossible for GeneDx to perform its tests for some period of time.
The inability to perform GeneDx’s tests or the backlog that could
develop if its laboratories are inoperable for even a short period
of time may result in the loss of customers or harm its reputation.
Although GeneDx maintains insurance for damage to its property and
the disruption of its business, this insurance may not be
sufficient to cover all potential losses and may not continue to be
available to GeneDx on acceptable terms, if at all.
Risks Related to Our Business Model
We rely on highly skilled personnel in a broad array of disciplines
and, if we are unable to hire, retain or motivate these
individuals, or maintain our corporate culture, we may not be able
to maintain the quality of our services or grow
effectively.
Our performance, including our research and development programs
and laboratory operations, largely depends on our continuing
ability to identify, hire, develop, motivate and retain highly
skilled personnel for all areas of our organization, including
software developers, geneticists, biostatisticians,
bioinformaticians, data scientists, certified laboratory directors
and technicians and other scientific and technical personnel to
process and interpret our tests and related data. In addition, we
may need to continue to expand our sales force with qualified and
experienced personnel. Competition in our industry for qualified
employees is intense, and we may not be able to attract or retain
qualified personnel in the future due to the competition for
qualified personnel among life science and technology businesses as
well as universities and public and private research institutions,
particularly in the New York City and the tri-state area. Further,
we may be unable to obtain the necessary visas for foreign
personnel to work in the United States. In addition, our
compensation arrangements, such as our equity award programs, may
not always be successful in attracting new employees and retaining
and motivating our
existing employees. If we are not able to attract and retain the
necessary personnel to accomplish our business objectives, we may
experience constraints that could adversely affect our ability to
scale our business, support our research and development efforts
and our clinical laboratories. We believe that our corporate
culture fosters innovation, creativity and teamwork. However, as
our organization grows, we may find it increasingly difficult to
maintain the beneficial aspects of our corporate culture. This
could negatively impact our ability to retain and attract employees
and our future success.
The loss of any member or change in structure of our senior
management team could adversely affect our business.
Our success depends in large part upon the skills, experience and
performance of members of our executive management team and others
in key leadership positions. The efforts of these persons will be
critical to us as we continue to develop our technologies and test
processes and focus on scaling our business. If we were to lose one
or more key executives, including our Chief Executive Officer,
Katherine Stueland, and our founder, President and Chief Research
& Development Officer, Dr. Eric Schadt, we may experience
difficulties in competing effectively, developing our tests and
technologies and implementing our business strategy. Only certain
of our executives have employment contracts, and the majority of
our employees are at-will, which means that either we or any
employee may terminate their employment at any time or in the
notice period set forth in an executive’s contract. In particular,
in connection with the closing of the Acquisition, Dr. Schadt
ceased serving as our Chief Executive Officer and we have not yet
entered into a new employment agreement with Dr. Schadt. We also do
not carry key person insurance for any of our executives or
employees. In addition, we do not have long-term retention
agreements in place with our executive officers. Furthermore, we
compete against other leading companies in the diagnostics, health
information, and data sciences markets for top talent. If such
competitors offer better compensation or opportunities, there is no
guarantee that we would be able to retain our key
executives.
Our founder, President and Chief Research & Development
Officer, Eric Schadt, and certain other of our employees have
performed, and will continue to perform, duties for or on behalf of
Mount Sinai.
Our founder, President and Chief Research & Development
Officer, Eric Schadt, and certain of our other employees continue
to perform duties for or on behalf of the Mount Sinai Health
System, which refer to together with its related entities as Mount
Sinai. In the case of Dr. Schadt, in addition to serving as our
president and Chief Research & Development Officer and as a
director, Dr. Schadt also serves as the Dean for Precision Medicine
and a professor at Icahn School of Medicine at Mount Sinai
(“ISMMS”). We expect Dr. Schadt to continue to devote a substantial
amount of time to the research and development responsibilities for
our company while maintaining certain duties for Mount Sinai.
Though we do not expect Dr. Schadt’s role as our President and
Chief Research & Development Officer and a director to conflict
with his roles at Mount Sinai, there can be no guarantee that such
conflicts will not occur in the future.
We may not be able to manage our future growth effectively, which
could make it difficult to execute our business
strategy.
Our expected future growth could create a strain on our
organizational, administrative and operational infrastructure,
including data and laboratory operations, quality control, customer
service, marketing and sales, and management. We may not be able to
maintain the quality of or expected turnaround times for our
products or services, or satisfy customer demand as it grows. We
may need to continue expanding our sales force to facilitate our
growth, and we may have difficulties locating, recruiting, training
and retaining sales personnel. Our ability to manage our growth
effectively will require us to continue to improve our operational,
financial and management controls, as well as our reporting systems
and procedures. As we grow, any failure of our controls or
interruption of our facilities or systems could have a negative
impact on our business and financial operations. We plan to develop
and launch new versions of our Centrellis and Traversa platforms
and our core diagnostic products, which will affect a broad range
of business processes and functional areas. The time and resources
required to implement these new systems is uncertain, and failure
to complete these activities in a timely and efficient manner could
adversely affect our operations. Future growth in our business
could also make it difficult for it to maintain our corporate
culture. If we are unable to manage our growth effectively, it may
be difficult for us to execute our business strategy and our
business could be harmed.
We need to scale our infrastructure in advance of demand for our
products and services, and our failure to generate sufficient
demand for our products and services would have a negative impact
on our business and our ability to attain
profitability.
Our success depends in large part on our ability to extend our
market position, to provide customers with high-quality health
reports and health information and data science services in a
manner that differentiates us from our competitors, and to deploy
technologies and achieve sufficient volumes to realize economies of
scale. In order to execute our business model, we intend to
continue to invest heavily in order to significantly scale our
infrastructure, including our lab infrastructure and testing
capacity and our information and computing systems, expand our
commercial operations,
customer service, billing and systems processes and enhance our
internal quality assurance program. We will also need to enhance
our capacity for data privacy management as we scale our
infrastructure. We expect that much of this growth will be in
advance of both demand for our products and services as well as our
ability to diversify our offerings, including services related to
Centrellis and Traversa and the databases we manage and to which we
have access, and our ability to find appropriate partners through
collaborations and acquisitions. Our current and future expense
levels are to a large extent fixed and are largely based on our
investment plans and our estimates of future revenue. Because the
timing and amount of revenue from our products and services are
difficult to forecast, when revenue does not meet our expectations,
we may not be able to adjust our spending promptly or reduce our
spending to levels commensurate with our revenue. Even if we are
able to successfully scale our infrastructure and operations while
successfully diversifying our offering, we cannot assure you that
demand for our products and services, including our Centrellis
platform, will increase at levels consistent with the growth of our
infrastructure. If we fail to generate demand commensurate with
this growth or if we fail to scale our infrastructure sufficiently
in advance of demand to successfully meet such demand, our
business, prospects, financial condition and results of operations
could be adversely affected.
International expansion of our business could expose us to
business, regulatory, political, operational, financial and
economic risks associated with doing business outside of the United
States.
When cleared, authorized or approved, we and our collaborators may
market, sell, and distribute our products and services outside of
the United States, and our business would be subject to risks
associated with doing business outside of the United States,
including an increase in our expenses and diversion of our
management’s attention from the development of future products and
services. Accordingly, our business and financial results in the
future could be adversely affected due to a variety of factors,
including:
•multiple,
conflicting and changing laws and regulations such as privacy,
security and data use regulations, tax laws, export and import
restrictions, economic sanctions and embargoes, employment laws,
anticorruption laws, regulatory requirements, reimbursement or
payer regimes and other governmental;
•approvals,
permits and licenses;
•failure
by us, our collaborators or our distributors to obtain regulatory
clearance, authorization or approval for the use of our products
and services in various countries;
•additional
potentially relevant third-party patent rights;
•complexities
and difficulties in obtaining intellectual property protection and
enforcing our intellectual property;
•difficulties
in staffing and managing foreign operations, including repatriating
foreign earned profits;
•complexities
associated with managing multiple payer reimbursement regimes,
government payers or patient self-pay systems;
•difficulties
in negotiating favorable reimbursement negotiations with
governmental authorities;
•logistics
and regulations associated with shipping samples, including
infrastructure conditions and transportation delays;
•limits
in our ability to penetrate international markets if we are not
able to conduct our clinical diagnostic services
locally;
•financial
risks, such as longer payment cycles, difficulty collecting
accounts receivable, the impact of local and regional financial
crises on demand and payment for our products and services and
exposure to foreign currency exchange rate
fluctuations;
•international
regulations and license requirements that may restrict foreign
investment in and operation of the internet, IT infrastructure,
data centers and other sectors, and international transfers of
data;
•natural
disasters, political and economic instability, including wars,
terrorism and political unrest, and outbreak of
disease;
•boycotts,
curtailment of trade and other business restrictions;
and
•regulatory
and compliance risks that relate to maintaining accurate
information and control over sales and distributors’ activities
that may fall within the purview of the Foreign Corrupt Practices
Act of 1977 (“FCPA”), its books and records provisions, or its
anti-bribery provisions or laws similar to the FCPA in other
jurisdictions in which we may in the future operate, such as the
United Kingdom’s Bribery Act of 2010 and anti-bribery requirements
of member states in the European Union (“EU”).
Any of these factors could significantly harm our future
international expansion and operations and, consequently, our
revenue and results of operations.
Unfavorable U.S. or global economic conditions could adversely
affect our business, financial condition or results of
operations.
Our results of operations could be adversely affected by general
conditions in the global economy and financial markets. A severe or
prolonged economic downturn or increase in inflation rates could
result in a variety of risks to our business, including weakened
demand for our products and services and our ability to raise
additional capital when needed on favorable terms, if at all. A
weak declining or inflationary economy could strain our
collaborators and suppliers, possibly resulting in supply
disruption, or cause delays in their payments to us. Any of the
foregoing could harm our business and we cannot anticipate all of
the ways in which the current economic climate and financial market
conditions could adversely impact our business.
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 or service providers.
We have sourced and will continue to source components of our
diagnostic testing workflow, including sequencers and other
laboratory equipment, reagents, lab supplies and other laboratory
services and materials and related services, from third
parties.
Our failure to maintain a continued supply of our sequencers and
other laboratory equipment, reagents, lab supplies and other
laboratory services and materials, along with the right to use
certain hardware and software and related services, would adversely
impact our business, financial condition, and results of
operations. In particular, while we are seeking to validate our
tests on additional sequencing platforms we have not, to date,
validated a viable alternative sequencing platform on which our
testing could be run in a commercially viable manner. These efforts
will require significant resources, expenditures and time and
attention of management, and there is no guarantee that we will be
successful in implementing any such sequencing platforms in a
commercially sustainable way. We also cannot guarantee that we will
appropriately prioritize or select alternative sequencing platforms
on which to focus our efforts, in particular given our limited
product and research and development resources and various business
initiatives, which could result in increased costs and delayed
timelines or otherwise adversely impact our business and results of
operations.
Because we rely on third-party manufacturers, we do not control the
manufacture of these components, including whether such components
will meet our quality control requirements, nor the ability of our
suppliers to comply with applicable legal and regulatory
requirements. In many cases, our suppliers are not contractually
required to supply these components to the quality or performance
standards that we require. If the supply of components we receive
does not meet our quality control or performance standards, we may
not be able to use the components, or if we use them not knowing
that they are of inadequate quality, which occasionally occurs with
respect to certain reagents, our tests may not work properly or at
all, or may provide erroneous results, and we may be subject to
significant delays caused by interruption in production or
manufacturing or to lost revenue from such interruption or from
spoiled tests. In addition, any natural or other disaster, acts of
war or terrorism, shipping embargoes, labor unrest, political
instability, outbreak of disease or similar events at our
third-party manufacturers' facilities that cause a loss of
manufacturing capacity would heighten the risks that it
faces.
In the event of any adverse developments with our sole suppliers,
or if any of our sole suppliers modifies any of the components they
supply to us, our ability to supply our products may be
interrupted, and obtaining substitute components could be difficult
or require us to re-design or re-validate our products. Our failure
to maintain a continued supply of components, or a supply that
meets our quality control requirements, or changes to or
termination of our agreements or inability to renew our agreements
with these parties or enter into new agreements with other
suppliers could result in the loss of access to important
components of our tests and impact our test performance or affect
our ability to perform our tests in a timely manner or at all,
which could impair, delay or suspend our commercialization
activities. In the event that we transition to a new supplier from
any of our sole suppliers, doing so could be time-consuming and
expensive, may result in interruptions in our ability to supply our
products to the market, could affect the performance of our tests
or could
require that we re-validate our affected tests using replacement
equipment and supplies, which could delay the performance of our
tests, impact diagnostic solutions and heath information derived
from such tests, and result in increased costs. Any of these
occurrences could have a material adverse effect on our business,
financial condition and results of operations.
We rely on a limited number of product and service providers for
data infrastructure and analytics capabilities, and any disruption
of, or interference with, our use of data and workflow services
could adversely affect our business, financial condition, and
results of operations, and we may not be able to find replacements
or immediately transition to alternative products or service
providers.
We currently rely upon third-party services for data storage and
workflow management, including cloud storage solution providers,
such as Amazon Web Services, or AWS, and Google Cloud Platform, or
GCP. We rely on each of AWS and GCP features to complete several
vital workflows in our health information and data science service
delivery. To varying degrees some of those services are proprietary
to how each platform performs in connection with our current usage
of the services. Further, we have also built several proprietary
workflows with our vendor and partner Command Health where we
maintain versions of developed software on such
platforms.
Nearly all of our data storage and analytics are conducted on, and
the data and content we generate on our platforms are processed
through, servers hosted by these providers, particularly AWS and
GCP. We also rely on email service providers, bandwidth providers,
internet service providers and mobile networks to deliver
communications to patients, physicians and partners and to allow
patients, physicians and our partners to access various offerings
from our platforms. If our third-party vendors are unable or
unwilling to provide the services necessary to support our
business, or if our agreements with such vendors are terminated,
our operations could be significantly disrupted. Some of our vendor
agreements may be unilaterally terminated by the licensor for
convenience, including with respect to AWS or GCP, and if such
agreements are terminated, we may not be able to enter into similar
relationships in the future on reasonable terms or at
all.
Any damage to, or failure of, our systems or the systems of our
third-party data centers or our other third-party providers could
result in interruptions to the availability or functionality of
database and platforms. As a result, we could lose health
information data and miss opportunities to acquire and retain
patients, physicians and partners including health systems and
pharmaceutical and biotech companies, which could result in
decreased revenue. If for any reason our arrangements with our data
centers or third-party providers are terminated or interrupted,
such termination or interruption could adversely affect our
business, financial condition and results of operations. We
exercise little control over these providers, which increases our
vulnerability to problems with the services they provide. We could
incur additional expense in arranging for new or redesigned
facilities, technology, services and support. In addition, the
failure of our third-party data centers or any other third-party
providers to meet our capacity needs or any system failure as a
result of reliance on third parties, including network, software or
hardware failure, which causes a delay or interruption in our
services and products, including our ability to handle existing or
increased processing of data on our platforms, could have a
material adverse effect on our business, revenues, operating
results and financial condition.
Our current and future products and services may never achieve
significant commercial market acceptance.
Our success depends on the market’s confidence that we can provide
data-driven research and diagnostic products and services that
improve clinical outcomes, lower healthcare costs and enable better
product development by Biopharma companies. Failure of our products
and services, or those jointly developed with our collaborators, to
perform as expected or to be updated to meet market demands could
significantly impair our operating results and our reputation. We
believe patients, health systems, clinicians, academic institutions
and Biopharma companies are likely to be particularly sensitive to
defects, errors, inaccuracies and delays with our products and
services. Furthermore, inadequate performance of these products or
services may result in lower confidence in our Centrellis platform
in general.
We and our collaborators may not succeed in achieving significant
commercial market acceptance for our current or future products and
services due to a number of factors, including:
•Our
ability to demonstrate the utility of our platforms including
Centrellis and Traversa, and related products and services and
their potential advantages over existing clinical artificial
intelligence technology, life sciences research, clinical
diagnostic and drug discovery technologies to academic
institutions, Biopharma companies and the medical
community;
•Our
ability, and that of our collaborators, to perform clinical trials
or other research to gather adequate evidence and/or to secure and
maintain FDA and other regulatory clearance authorization or
approval for our products or products developed based off our
platform;
•the
agreement by third-party payors to reimburse our products or
services, the scope and extent of which will affect patients’
willingness or ability to pay for our products or services and will
likely heavily influence physicians’ decisions to recommend our
products or services;
•the
rate of adoption of our platforms and related products and services
by academic institutions, clinicians, patients, key opinion
leaders, advocacy groups and Biopharma companies; and
•the
impact of our investments in product and services, and
technological innovation and commercial growth.
Additionally, our customers and collaborators, including Mount
Sinai, may decide to decrease or discontinue their use of our
products and services due to changes in their research and
development plans, failures in their clinical trials, financial
constraints, the regulatory environment, negative publicity about
our products and services, competing products or the reimbursement
landscape, all of which are circumstances outside of our control.
We may not be successful in addressing these or other factors that
might affect the market acceptance of our products, services and
technologies. Failure to achieve widespread market acceptance of
our platform and related products and services would materially
harm our business, financial condition and results of
operations.
Our projections are subject to significant risks, assumptions,
estimates and uncertainties, including assumptions regarding
adoption of our products and services. As a result, our projected
revenues, market share, expenses and profitability may differ
materially from our expectations in any given quarter or fiscal
year.
We operate in rapidly changing and competitive industries and our
projections are subject to the risks and assumptions made by our
management with respect to these industries. Operating results are
difficult to forecast as they generally depend on our assessment of
the timing of adoption of our current and future products and
services, which is uncertain. Furthermore, as we invest in the
continued development of new businesses that have yet to achieve
significant commercial success, whether because of competition or
otherwise, we may not recover the often substantial up-front costs
of developing and marketing those products and services or recover
the opportunity cost of diverting management and financial
resources away from other products or services. Additionally, our
business may be affected by reductions in customer or partner
demand as a result of a number of factors which may be difficult to
predict. Similarly, our assumptions and expectations with respect
to margins and the pricing of our products and services may not
prove to be accurate as a result of competitive pressures or
customer or partner demands. This may result in decreased revenue,
and we may be unable to adopt measures in a timely manner to
compensate for any unexpected shortfall in revenue. This inability
could cause our operating results in a given quarter or year to be
higher or lower than expected. Any failure to achieve our projected
operating results could harm the trading price of our securities
and our financial position.
We have estimated the sizes of the markets for our current and
future products and services, and these markets may be smaller than
we estimate.
Our estimates of the annual addressable markets for our current
products and services and those under development are based on a
number of internal and third-party estimates, including, without
limitation, the number of patients who have developed one or more
of a broad range of cancers, the number of individuals who are at a
higher risk for developing one or more of a broad range of cancers,
the number of individuals who have developed or are at a higher
risk of developing certain disorders, the number of individuals
with certain infectious diseases. The estimates also depend on
whether we or our collaborators are able to engage, diagnose or
treat patients through or using our products and services, the
number of potential clinical tests utilized per treatment course
per patient, the ongoing engagement by patients, physicians and
health systems on our platforms, and the assumed prices at which we
can sell our current and future products and services for markets
that have not been established. While we believe our assumptions
and the data underlying our estimates are reasonable, these
assumptions and estimates may not be correct and the conditions
supporting our assumptions or estimates may change at any time,
thereby reducing the predictive accuracy of these underlying
factors. As a result, our estimates of the annual addressable
market for our current or future products and services may prove to
be incorrect. If the actual number of patients who would benefit
from our products or services, the price at which we can sell
future products and services or the annual addressable market for
our products or services is smaller than we have estimated, it may
impair our sales growth and have an adverse impact on our
business.
Uncertainty in the development and commercialization of our
enhanced or new tests or services could materially adversely affect
our business, financial condition and results of
operations.
Our success will depend in part on our ability to effectively
introduce enhanced or new offerings. The focus of our research and
development efforts has expanded beyond our current products and
services, focused substantially on women’s health and oncology, as
we are now also applying our expertise in processing and analyzing
new areas, such as
rare diseases. In recent years we have developed and/or launched
several new products or enhanced versions of existing products,
including products leveraging alternative sequencing technologies,
and we expect to continue our efforts in all of these areas and
more. The development and launch of enhanced or new tests requires
the completion of certain clinical development and
commercialization activities that are complex, costly,
time-intensive and uncertain, and requires us to accurately
anticipate patients', clinicians', payors' and other
counterparties' attitudes and needs as well as emerging technology
and industry trends. This process is conducted in various stages,
and each stage presents the risk that we will not achieve our
goals.
We have relatively limited experience developing and
commercializing products and services outside of the fields of
women’s health and oncology diagnostics, and we may not be
successful in our current or future efforts to do so. We also have
limited experience forecasting our future financial performance
from our new products and services, and our actual results may fall
below our financial guidance or other projections, or the
expectations of analysts or investors, which could cause the price
of our Class A common stock and warrants to decline. We may
experience research and development, regulatory, marketing and
other difficulties that could delay or prevent our introduction of
enhanced or new tests and result in increased costs and the
diversion of management's attention and resources from other
business matters, such as from our current product and service
offerings, which currently represent the significant majority of
our current revenues. For example, any tests that we may enhance or
develop may not prove to be clinically effective in clinical trials
or commercially, or may not meet our desired target product
profile, be offered at acceptable cost and with the sensitivity,
specificity and other test performance metrics necessary to address
the relevant clinical need or commercial opportunity; our test
performance in commercial experience may be inconsistent with our
validation or other clinical data; we may not be successful in
achieving market awareness and demand, whether through our own
sales and marketing operations or through collaborative
arrangements; healthcare providers may not order or use, or
third-party payors may not reimburse for, any tests that we may
enhance or develop; or we may otherwise have to abandon a test or
service in which we have invested substantial resources. For
example, we are subject to the risk that the biological
characteristics of the genetic mutations we seek to target, and
upon which our technologies rely, are uncertain and difficult to
predict. We may also experience unforeseen difficulties when
implementing updates to our processes.
We cannot assure you that we can successfully complete the
development of any new or enhanced product, or that we can
establish or maintain the collaborative relationships that may be
essential to our collaborators’ goals, including clinical
development or commercialization efforts. For example, clinical
development requires large numbers of patient specimens and, for
certain products, may require large, prospective, and controlled
clinical trials. We may not be able to identify and help enroll
patients or collect a sufficient amount of appropriate health data
in a timely manner; or we may experience delays during data
analysis process due to slower than anticipated supplies of patient
data, or due to changes in study design or inputs, or other
unforeseen circumstances; or we or our collaborators may be unable
to afford or manage the large-sized clinical trials that some of
our planned future products may require. Further, the publication
of clinical data in peer-reviewed journals is a crucial step in
commercializing and obtaining reimbursement for certain diagnostic
solutions such as the ones offered by us, and our inability to
control when, if ever, results are published may delay or limit our
ability to derive sufficient revenues from any diagnostic solution
that is the subject of or component in a study. Peer-reviewed
publications regarding our products may be limited by many factors,
including delays in the completion of, poor design of, or lack of
compelling data from, clinical studies, as well as delays in the
review, acceptance and publication process. If our diagnostic
solutions or the technology underlying our current and future
diagnostic solutions do not receive sufficient favorable exposure
in peer-reviewed publications, the rate of clinician adoption of
our diagnostic solutions and positive reimbursement coverage
determinations for our diagnostic solutions could be negatively
affected.
In addition, development of the data necessary to obtain regulatory
clearance and approval of tests is time-consuming and carries with
it the risk of not yielding the desired results. The performance
achieved in published studies may not be repeated in later studies
that may be required to obtain premarket clearance or approval from
the U.S. Food and Drug Administration (“FDA”). Limited results from
earlier-stage verification studies may not predict results from
studies in larger numbers of subjects drawn from more diverse
populations over longer periods of time. Unfavorable results from
ongoing preclinical and clinical studies may delay, limit or
prevent regulatory approvals or clearances or commercialization of
our product candidates, or could result in delays, modifications or
abandonment of ongoing analytical or future clinical studies, or
abandonment of a product development program, any of which could
have a material adverse effect on our business, operating results
or financial condition.
These and other factors beyond our control could result in delays
or other difficulties in the research and development, approval,
production, launch, marketing or distribution of enhanced or new
tests and could adversely affect our competitive position and
results of operations.
We currently use, and in the future expect to increase our use of,
information and rights from customers, strategic partners, and
collaborators for several aspects of our operations, and if we
cannot maintain current and enter new relationships with these
parties with adequate access and authorization to such information,
our business will suffer.
Accessing, combining, curating, and analyzing health information,
including longitudinal patient medical history data and genetic
data, are core features of the Centrellis platform and key elements
of our long term business model. The regulatory landscape around
the storage, processing and deidentification of genetic data is
evolving globally and greatly impacts the ability of us, our
strategic partners and collaborators to process and use the data in
connection with our products and services.
We have limited resources to conduct our health information
services, data analysis, life sciences research, clinical
diagnostics and drug discovery operations and have not yet fully
established infrastructure for sales, marketing or distribution in
connection with our products and services. Accordingly, we have
entered into service and collaboration agreements under which our
partners, including health systems, have provided, and may in the
future provide, funding, data access, and other resources for
developing and potentially commercializing our products and
services. These collaborations may result in us incurring
significant expenses in pursuit of potential products and services,
and we may not be successful in identifying, developing or
commercializing any potential products or services.
Our future success depends in part on our ability to maintain and
grow our existing relationships, including with Mount Sinai, and to
establish new relationships. Many factors may impact the success of
such collaborations, including our ability to perform our
obligations, our collaborators’ satisfaction with our products and
services, our collaborators’ performance of their obligations to
us, our collaborators’ internal priorities, resource allocation
decisions and competitive opportunities, the ability to obtain
regulatory approvals, disagreements with collaborators, the costs
required of either party to the collaboration and related financing
needs, and operating, legal and other risks in any relevant
jurisdiction. Our ability to support such collaborations may also
depend on factors outside of our control including the willingness
of patients to engage with us and share their data, societal
perspectives on privacy, and the willingness of health systems to
establish collaborations, relationships and programs utilizing
their data, all of which may impact the utility of these databases
and the insights we will be able to generate from expanding
datasets. In addition to reducing our revenue or delaying the
development of our future products and services, the loss of one or
more of these relationships may reduce our access to research,
longitudinal patient health data, clinical trials or computing
technologies that facilitate the collection and incorporation of
new information into the databases we manage and to which we have
access. All of the risks relating to product and service
development, regulatory clearance, authorization or approval and
commercialization described herein apply to us derivatively through
the activities of our collaborators. We engage in conversations
with companies regarding potential collaborations on an ongoing
basis. These conversations may not result in a commercial
agreement. Even if an agreement is reached, the resulting
relationship may not be successful, and any products and services
developed as part of the collaboration may not produce successful
outcomes. Speculation in the industry about our existing or
potential collaborations can be a catalyst for adverse speculation
about us, or our products or services, which can adversely affect
our reputation and our business.
If our products and services do not perform as expected, we may not
realize the expected benefits of such products and
services.
The success of our products depends on the market’s confidence that
we can provide reliable products and services that enable high
quality diagnostic testing and health information services with
high sensitivity and specificity and short turnaround times. There
is no guarantee that the accuracy and reproducibility we have
demonstrated to date will continue as our product deliveries
increase and our product and service portfolio
expands.
Our products and services use a number of complex and sophisticated
biochemical and bioinformatics processes, many of which are highly
sensitive to external factors. An operational, technological or
other failure in one of these complex processes or fluctuations in
external variables may result in sensitivity or specificity rates
that are lower than we anticipate or result in longer than expected
turnaround times. In addition, labs are required to validate their
processes before using our products for clinical purposes. These
validations are outside of our control. If our products do not
perform, or are perceived to not have performed, as expected or
favorably in it to competitive products, our operating results,
reputation, and business will suffer, and we may also be subject to
legal claims arising from product limitations, errors, or
inaccuracies.
If our sales and development or other collaborations and commercial
relationships are not successful and we are not able to offset the
resulting impact through our own efforts or through agreements with
new partners, our commercialization activities may be impaired and
our financial results could be adversely affected.
Part of our business strategy is to develop relationships with
health systems, biopharma companies, and other partners to utilize
our products and to provide access to data. Developing and
commercializing products with third parties reduces our control
over such development and commercialization efforts and subjects us
to the various risks inherent in a joint effort with a third party,
such as delays, operational issues, technical difficulties and
other contingencies outside of our influence or control. The
financial condition of these third parties could weaken, or they
could terminate their relationship with us and/or stop sharing data
or other information; reduce their marketing efforts relating to
our products; develop and commercialize, or otherwise utilize
competing products in addition to or in lieu of our tests; merge
with or be acquired by a competitor of us or a company that chooses
to de-prioritize the efforts to utilize our products or provide us
with adequate data; or otherwise breach their agreements with us.
Further, we must expend resources to operationalize our existing
collaborations with our health system partners, which requires
substantial effort in areas such as integrations for testing
workflow, EMR, consents, marketing, and billing. To the extent, we
are not successful at operationalizing existing collaborations with
health partners, we may not be able to further improve or pursue
new agreements with additional partners. Furthermore, our partners
may misappropriate our trade secrets or use our proprietary
information in such a way as to expose us to litigation and
potential liability; and our compliance risk may increase to the
extent that we are responsible for our partners' activities.
Disagreements or disputes with our health systems and other
partners, including disagreements over customers, proprietary or
other rights or our or their compliance with financial or other
contractual obligations, might cause delays or impair the
development or commercialization of our products, services, and
technologies, lead to additional responsibilities for us with
respect to new products, services and technologies, or result in
litigation or arbitration, any of which would divert management
attention and resources and be time-consuming and expensive. As is
typical for companies in our industry, it is continually evaluating
and pursuing various strategic or commercial relationships, some of
which may involve the sale and issuance of our Class A common
stock, which could result in additional dilution of the percentage
ownership of our stockholders and could cause the price of our
Class A common stock and warrants to decline.
If our relationships are not successful, our ability to develop and
improve of products, services and technologies, and to successfully
execute our commercial strategy regarding such products, services
and technologies, could be compromised.
If we are unable to deploy and maintain effective sales, marketing
and medical affairs capabilities, we will have difficulty achieving
market awareness and selling our products and
services.
To achieve commercial success for our tests and our future products
and services, we must continue to develop and grow our sales,
marketing and medical affairs organizations to effectively explain
to healthcare providers the reliability, effectiveness and benefits
of our current and future products and services as compared to
alternatives. We may not be able to successfully manage our
dispersed or inside sales forces or our sales force may not be
effective. Because of the competition for their services, we may be
unable to hire, partner with or retain additional qualified sales
representatives or marketing or medical affairs personnel, either
as our employees or independent contractors or through independent
sales or other third-party organizations. Market competition for
commercial, marketing and medical affairs talent is significant,
and we may not be able to hire or retain such talent on
commercially reasonable terms, if at all.
Establishing and maintaining sales, marketing and medical affairs
capabilities will be expensive and time-consuming. Our expenses
associated with maintaining our sales force may be disproportionate
to the revenues we may be able to generate on sales of the certain
tests or any future products or services.
We may never become profitable.
Sema4 has incurred losses since Sema4 was formed and we expect to
continue to generate significant operating losses for the
foreseeable future. As of March 31, 2022 and December 31, 2021, we
have an accumulated deficit of approximately $652.3 million and
$575.4 million, respectively. We expect to continue investing
significantly toward development and commercialization of our
health information technology and other products and services. If
our revenue does not grow significantly, we will not be profitable.
We cannot be certain that the revenue from the sale of any products
or services based on our technologies will be sufficient to make us
profitable.
Our operating results could be subject to significant fluctuation,
which could increase the volatility of our stock and warrant prices
and cause losses to our stockholders.
Our revenues and results of operations may fluctuate significantly,
depending on a variety of factors, including the
following:
•our
success in marketing and selling, and changes in demand for, our
tests, and the level of reimbursement and collection obtained for
such tests;
•seasonal
and environmental variations affecting healthcare provider
recommendations for our tests and patient compliance with
healthcare provider recommendations, including without limitation
holidays, weather events, and circumstances such as the outbreak of
coronavirus or influenza that may limit patient access to medical
practices for diagnostic tests and preventive
services;
•our
success in collecting payments from third-party payors, patients
and collaborative partners, variation in the timing of these
payments and recognition of these payments as
revenues;
•the
pricing of our tests, including potential changes in CMS or other
reimbursement rates;
•circumstances
affecting our ability to provide our tests, including weather
events, supply shortages, or regulatory or other circumstances that
adversely affect our ability to manufacture our tests or process
tests in our clinical laboratories;
•circumstances
affecting our ability to provide health information and data
science services to biopharma partners, including software or
hardware failures, insufficient capacity, regulatory changes or
other circumstances that adversely affect the ability of us to
deliver these services;
•fluctuations
in the amount and timing of our selling and marketing costs and our
ability to manage costs and expenses and effectively implement our
business;
•our
research and development activities, including the timing of
clinical trials; and
•our
ability to collect, use, and commercialize data in a changing
regulatory environment at a time when the public is growing
increasingly concerned about privacy.
Our revenue growth rate could decline over time, and it may
experience downward pressure on our operating margins in the
future.
Our revenue growth rate could decline over time as a result of a
number of factors, including increasing competition and the
continued expansion of our business into a variety of new fields.
Changes in geographic mix and product and service mix and an
increasing competition for tests may also affect our revenue growth
rate. We may also experience a decline in our revenue growth rate
as our revenues increase to higher levels, if there is a decrease
in the rate of adoption of our products, services, and
technologies, among other factors.
In addition to a decline in our revenue growth rate, we may also
experience downward pressure on our gross operating margins
resulting from a variety of factors, such as the continued
expansion of our business into new fields, including new products
and services, as well as significant investments in new areas, all
of which may have margins lower than those that we generate from
testing. We may also experience downward pressure on our gross
operating margins from increasing competition and increased costs
for many aspects of our business. We may also pay increased fees to
our partners as well as increased acquisition costs. We may also
face an increase in infrastructure costs, supporting other
businesses. Additionally, our expenditures to promote new products
and services or to distribute certain products and services or
increased investment in our innovation efforts across our
Centrellis platform may affect our operating margins.
Due to these factors and the evolving nature of our business, our
historical projected revenue growth rate and historical gross
operating margins may not be indicative of our future
performance.
We may need to raise additional capital to fund our existing
operations, develop additional products and services, commercialize
new products and services or expand our operations.
Sema4 has incurred net losses and negative cash flows from
operations since its inception, including net losses of $245.4
million, $241.3 million and $29.7 million for the years ended
December 31, 2021, 2020 and 2019, respectively. The net loss was
$76.9 million for the three months ended March 31, 2022. As of
March 31, 2022, we had an accumulated deficit of $652.3 million. We
expect to continue to generate significant operating losses for the
foreseeable future, and we may therefore also seek to sell common
or preferred equity or convertible debt securities, enter into a
credit facility or another form of third-party funding or seek
other debt financing.
We may also consider raising additional capital in the future to
expand our business, to pursue strategic investments, to take
advantage of financing opportunities or for other reasons,
including to:
•increase
our sales and marketing efforts to drive market adoption of our
current and future products and services;
•fund
development efforts for our current and future products and
services;
•expand
our products and services into other disease indications and
clinical applications;
•acquire,
license or invest in technologies;
•acquire
or invest in complementary businesses or assets; and
•finance
capital expenditures and general and administrative
expenses.
Our present and future funding requirements will depend on many
factors, including:
•our
ability to achieve revenue growth;
•our
rate of progress in establishing payer coverage and reimbursement
arrangements with commercial third-party payors and government
payers;
•the
cost of expanding our laboratory operations and offerings,
including our sales and marketing efforts;
•our
rate of progress in, and cost of the sales and marketing activities
associated with, establishing adoption of our Centrellis
solution;
•our
rate of progress in, and cost of research and development
activities associated with, products and services in research and
early development;
•the
effect of competing technological, product and market
developments;
•costs
related to international expansion; and
•the
potential cost of and delays in product development as a result of
any regulatory oversight applicable to our products and
services.
The various ways we could raise additional capital carry potential
risks. If we raise funds by issuing equity securities, dilution to
our stockholders could result. Any preferred equity securities
issued also could provide for rights, preferences or privileges
senior to those of holders of our Class A common stock. If we raise
funds by issuing debt securities, those debt securities would have
rights, preferences and privileges senior to those of holders of
our Class A common stock. The terms of debt securities issued or
borrowings pursuant to a credit agreement could impose significant
restrictions on our operations. If we raise funds through
collaborations and licensing arrangements, we might be required to
relinquish significant rights to our technologies or products and
services or grant licenses on terms that are not favorable to
us.
We expect to make significant investments in our continued research
and development of new products and services, which may not be
successful.
We are seeking to leverage and deploy our Centrellis and Traversa
platforms to develop a pipeline of future disease-specific
research, diagnostic and therapeutic products and services. For
example, we are attempting to extend current products into
additional indications and sample types, and we are developing our
population health program, and our pharmacogenomics solutions with
a view toward advancing the development of tests designed to
identify genetic variants for drug response that are associated
with medically actionable and clinically relevant data to make more
informed treatment decisions. We expect to incur significant
expenses to advance these development efforts, but they may not be
successful.
Developing new products and services is a speculative and risky
endeavor. Products or services that initially show promise may fail
to achieve the desired results or may not achieve acceptable levels
of analytical accuracy or clinical utility. We may need to alter
our products in development and repeat analysis or clinical studies
before we identify a potentially successful product or service.
Product development is expensive, may take years to complete and
can have uncertain outcomes. Failure can occur at any stage of the
development. If, after development, a product or service
appears
successful, we or our collaborators may, depending on the nature of
the product or service, still need to obtain FDA and other
regulatory clearances, authorizations or approvals before we can
market it. In the case of clinical products, the FDA’s clearance,
authorization or approval pathways are likely to involve
significant time, as well as additional research, development and
clinical study expenditures. The FDA may not clear, authorize or
approve any future product or service we develop. Even if we
develop a product or service that receives regulatory clearance,
authorization or approval, or succeeds in initial product testing,
we or our collaborators would need to commit substantial resources
to commercialize, sell and market it before it could be profitable,
and the product or service may never be commercially successful.
Additionally, development of any product or service may be
disrupted or made less viable by the development of competing
products or services.
New potential products and services may fail at any stage of
development or recalled after commercialization and if we determine
that any of our current or future products or services are unlikely
to succeed, we may abandon them without any return on our
investment. If we are unsuccessful in developing additional
products or services, our potential for growth may be
impaired.
We have identified material weaknesses, some of which have a
pervasive effect across the organization, and may identify
additional material weaknesses or significant deficiencies, in our
internal controls over financial reporting. Our failure to remedy
these matters could result in a material misstatement of our
financial statements.
In the course of preparing Legacy Sema4’s financial statements for
2020, 2019 and 2018, we identified material weaknesses in our
internal control over financial reporting as of December 31, 2020,
which could, if not remediated, result in material misstatements in
our financial statements. These material weaknesses had not been
fully remediated as of March 31, 2022. In addition, during 2021,
management identified a misclassification related to certain costs
included within cost of services for the years ended December 31,
2021, 2020 and 2019. A material weakness is a deficiency, or
combination of deficiencies, in internal control over financial
reporting, such that there is a reasonable possibility that a
material misstatement of the annual or interim financial statements
will not be prevented or detected on a timely basis. The material
weaknesses identified related to the fact that we did not design
and maintain accounting policies, procedures and controls to ensure
complete, accurate and timely financial reporting in accordance
with U.S. GAAP. Specifically, the material weaknesses identified
included the following:
•We
did not design and maintain accounting policies, processes and
controls to analyze, account for and report our revenue
arrangements in accordance with ASC 606, Revenue from Contracts
with Customers, and ASC 605, Revenue Recognition.
•We
did not design and maintain formal accounting policies, procedures
and controls to achieve complete, accurate and timely financial
accounting, reporting and disclosures, including controls over the
preparation and review of account reconciliations and journal
entries; the accounting for cost capitalization policies in
accordance with ASC 330, Inventory, and ASC 350-40, Intangibles –
Goodwill and Other – Internal-Use Software; and the application of
ASC 840, Leases.
•We
had not developed and effectively communicated to our employees our
accounting policies and procedures, which resulted in inconsistent
practices. Since these entity level programs have a pervasive
effect across the organization, management has determined that
these circumstances constitute a material weakness.
•Our
accounting and operating systems lacked controls over access, and
program change management that are needed to ensure access to
financial data is adequately restricted to appropriate
personnel.
•We
do not have sufficient, qualified finance and accounting staff with
the appropriate U.S. GAAP technical accounting expertise to
identify, evaluate and account for accounting and financial
reporting, and effectively design and implement systems and
processes that allow for the timely production of accurate
financial information in accordance with internal financial
reporting timelines, commensurate with our size and the nature and
complexity of our operations. As a result, we did not design and
maintain formal accounting policies, processes and controls related
to complex transactions necessary for an effective financial
reporting process.
Our management is in the process of implementing a remediation plan
that is expected to include policies and procedures to support
internal control over financial reporting for a public company as
well as supplementing the accounting and finance function with
robust technical accounting and financial reporting experience and
training. However, we cannot guarantee that the steps we have taken
or may subsequently take have been or will be sufficient to
remediate the material weaknesses or ensure that our internal
controls are effective. For a discussion of our remediation plan
and actions, see “Item 4. Controls and Procedures.” However, as
noted above, as
of March 31, 2022, the material weaknesses have not yet been fully
remediated.
Furthermore, as a public company, we are required to comply with
certain rules and requirements related to our disclosure controls
and procedures and our internal control over financial reporting.
Any failure to develop or maintain effective controls as a public
company, any deficiencies found in the technology system we use to
support our controls, or any difficulties encountered in their
implementation or improvement, could harm our operating results or
cause us to fail to meet our reporting obligations and may result
in a restatement of our financial statements for prior periods. For
more information, see “Risks
Related to Being a Public Company—Our internal controls over
financial reporting may not be effective and our independent
registered public accounting firm may not be able to certify as to
their effectiveness, which could have a significant and adverse
effect on our business and reputation.”
Our ability to use our net operating loss carry forwards and
certain other tax attributes may be limited.
At December 31, 2021, our total gross deferred tax assets were
$160.5 million. Due to our lack of earnings history, future
deductible temporary differences related to compensation and
uncertainties surrounding our ability to generate future taxable
income, our net deferred tax assets have been fully offset by a
valuation allowance. The deferred tax assets are primarily
comprised of federal and state tax net operating losses and tax
credit carryforwards, stock-based compensation and other tax
deductible temporary differences.
Furthermore, under Section 382 of the Internal Revenue Code of
1986, as amended (“Internal Revenue Code“), if a corporation
undergoes an “ownership change,” the corporation’s ability to use
its pre-change net operating loss carryforwards (“NOLs”), and other
pre-change tax attributes (such as research tax credits) to offset
its future taxable income may be limited. In general, an “ownership
change” occurs if there is a cumulative change in its ownership by
“5% shareholders” that exceeds 50 percentage points over a rolling
three-year period. Our existing NOLs and tax credit carryovers may
be subject to limitations arising from previous ownership changes,
and if we undergo one or more ownership changes in connection with
completed acquisitions, including the business combination with
CMLS or the Acquisition, or future transactions in our stock, our
ability to utilize NOLs and tax credit carryovers could be further
limited by Section 382 of the Internal Revenue Code. As a result,
if we earn future taxable income, our ability to use our pre-change
net operating loss and tax credit carryforwards to offset U.S.
federal taxable income may be subject to limitations, which could
potentially result in increased future tax liability to us. In
addition, the Tax Cuts and Jobs Act limits the deduction for NOLs
to 80% of current year taxable income and eliminates NOL
carrybacks. Further, there may also be periods during which the use
of NOLs is suspended or otherwise limited, which could accelerate
or permanently increase state liability.
Risks Related to Our Key Relationships
We rely on third-party laboratories to perform certain elements of
our service offerings.
A limited but meaningful portion of our genomic analysis services
is performed by third-party laboratories and service providers,
while the remaining portion is performed in our laboratories. The
third-party laboratories are subject to contractual obligations to
perform these services for us, but are not otherwise under our
control. We therefore do not control the capacity and quality
control efforts of these third-party laboratories other than
through our ability to enforce contractual obligations on volume
and quality systems, and we have no control over such laboratories’
compliance with applicable legal and regulatory requirements. We
also have no control over the timeliness of such laboratories’
performance of their obligations to us, and the third-party
laboratories that we have contracted with have in the past had, and
occasionally continue to have, issues with delivering results to us
or resolving issues with us within the time frames we expected or
established in our contracts with them, which sometimes results in
longer than expected turnaround times for, or negatively impacts
the performance of, these tests and services. In the event of any
adverse developments with these third-party laboratories or their
ability to perform their obligations in a timely manner and in
accordance with the standards that we and our customers expect, our
ability to service customers may be delayed, interrupted or
otherwise adversely affected, which could result in a loss of
customers and harm to our reputation. Furthermore, when these
issues arise, we have had to expend time, management’s attention
and other resources to address and remedy such issues.
We may not have sufficient alternative backup if one or more of the
third-party laboratories that we contract with are unable to
satisfy their obligations to us with sufficient performance,
quality and timeliness, including as a result of the ongoing
COVID-19 pandemic. Any natural or other disaster, acts of war or
terrorism, shipping embargoes, labor unrest, political instability,
outbreaks of disease or similar events at one or more of these
third-party laboratories’ facilities that causes a loss of capacity
would heighten the risks that we face. Changes to or termination of
agreements or inability to renew agreements with these third-party
laboratories or enter into new agreements with other laboratories
that are able to perform such portions of our service offerings
could impair, delay or suspend our efforts to market and sell these
services.
In addition, certain third-party payors, including some state
Medicaid payers, that we are under contract with may take the
position that sending out testing to third-party laboratories and
billing for such tests is contrary to the terms of its provider
agreement and may refuse to pay us for the testing. If any of these
events occur, our business, financial condition and results of
operations could suffer. Further, some state laws impose
anti-markup restrictions that prevent an entity from realizing a
profit margin on outsourced testing. If we are unable to markup
outsourced testing, our revenues and operating margins may
suffer.
We rely on Mount Sinai, a related party, and its clinicians for a
portion of our test volume in connection with our diagnostic
solutions and for data programs, and we have entered into certain
other arrangements with Mount Sinai.
We rely on Mount Sinai, which is a related party, and its
clinicians for a portion of our test volumes in connection with our
diagnostic solutions and for a significant portion of the
de-identified clinical records in our databases. In addition, we
sublease certain facilities from Mount Sinai, we provide certain
research and data services to Mount Sinai, and we and Mount Sinai
have entered into certain collaborative and commercial
arrangements. Furthermore, we may in the future enter into other
contracts for services or other engagements with Mount
Sinai.
Mount Sinai is primarily made up of not-for-profit hospitals, a
medical and graduate school and employed clinicians. The charitable
missions of the Mount Sinai entities include patient care, teaching
and research. As such, the Mount Sinai entities are required to
deal with us strictly on an arms-length, fair market value basis,
and the interests of Mount Sinai may not necessarily be aligned
with our interests or those of our other stockholders.
We are subject to risks as a result of our reliance on Mount Sinai,
and if our transactions and relationship with Mount Sinai were to
cease, our business could be disrupted and it could have a material
adverse effect on our business, research, financial condition and
results of operations.