Blueprint
UNITED STATES SECURITIES AND EXCHANGE
COMMISSION
FORM 10-Q
[ X ]
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2018
Commission
File Number: 001-37752
CHROMADEX
CORPORATION
(Exact
Name of Registrant as Specified in its Charter)
Delaware
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26-2940963
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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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10005
Muirlands Blvd. Suite G, Irvine, California
(Address of
Principal Executive Offices)
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92618
(Zip
Code)
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Registrant's
telephone number, including area code: (949) 419-0288
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
Indicate
by check mark whether the registrant has submitted electronically
and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405
of Regulation S-T (Section 232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes X No
Indicate
by check mark whether the registrant is a large accelerated filer,
accelerated filer, non-accelerated filer, smaller reporting company
or emerging growth company. See definition of “large
accelerated filer, accelerated filer, smaller reporting company and
emerging growth company” in Rule 12b-2 of the Exchange Act.
(Check one):
Large accelerated
filer ___
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Accelerated filer
X
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Non-accelerated
filer ___
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Smaller reporting
company ___
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(Do not check if
smaller reporting company)
|
Emerging growth
company ___
|
If an
emerging growth company, indicate by checkmark 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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act).
Yes __
No
X
As of May 9, 2018 there were 54,866,512 shares of the
registrant’s common stock issued and
outstanding.
CHROMADEX CORPORATION
QUARTERLY REPORT ON
FORM 10-Q
PART I - FINANCIAL INFORMATION (UNAUDITED)
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ITEM
1. FINANCIAL STATEMENTS:
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1
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Condensed
Consolidated Balance Sheets as of March 31, 2018 and December 30,
2017
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1
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Condensed
Consolidated Statements of Operations for the three months ended
March 31, 2018 and April 1, 2017
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2
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Condensed
Consolidated Statements of Stockholders Equity for the three months
ended March 31, 2018
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3
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Condensed
Consolidated Statements of Cash Flows for the three months ended
March 31, 2018 and April 1, 2017
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4
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Notes
to Condensed Consolidated Financial Statements
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5
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ITEM
2. ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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15
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ITEM
3. ITEM 3. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
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22
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ITEM 4.
ITEM 4. CONTROLS AND PROCEDURES
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23
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PART II
- OTHER INFORMATION
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24
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ITEM
1. LEGAL PROCEEDINGS
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24
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ITEM
1A. RISK FACTORS
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24
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ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND
USE OF PROCEEDS
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41
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ITEM
3. DEFAULTS UPON SENIOR
SECURITIES
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41
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ITEM
4. MINE SAFETY DISCLOSURES
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41
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ITEM
5. OTHER INFORMATION
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41
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ITEM 6.
EXHIBITS
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42
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SIGNATURES
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44
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PART I – FINANCIAL INFORMATION (UNAUDITED)
ITEM 1. FINANCIAL STATEMENTS
ChromaDex Corporation and Subsidiaries
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Condensed Consolidated Balance Sheets
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March 31, 2018 and December 30, 2017
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(In thousands, except per share data)
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Assets
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Current
Assets
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Cash
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$41,037
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$45,389
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Trade receivables, net of allowances of $0.6 million and $0.7
million, respectively;
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Receivables
from Related Party: $0.8 million and $1.5 million,
respectively
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4,770
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5,338
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Contract
assets
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53
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-
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Receivable held at escrow
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750
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-
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Inventories
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5,063
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5,796
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Prepaid
expenses and other assets
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909
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655
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Total current assets
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52,582
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57,178
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Leasehold
Improvements and Equipment, net
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2,911
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2,872
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Deposits
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359
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272
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Receivable
Held at Escrow
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-
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750
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Intangible
Assets, net
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1,593
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1,652
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Total assets
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$57,445
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$62,724
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Liabilities and Stockholders' Equity
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Current
Liabilities
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Accounts
payable
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$5,856
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$3,719
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Accrued
expenses
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3,709
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3,645
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Current
maturities of capital lease obligations
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200
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196
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Contract
liabilities and customer deposits
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202
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314
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Deferred
rent, current
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117
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114
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Due
to officer
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-
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100
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Total current liabilities
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10,084
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8,088
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Capital
Lease Obligations, Less Current Maturities
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258
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310
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Deferred
Rent, Less Current
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439
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492
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Total liabilities
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10,781
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8,890
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Commitments
and Contingencies
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Stockholders'
Equity
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Common
stock, $.001 par value; authorized 150,000 shares;
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issued
and outstanding March 31, 2018 54,681 shares and
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December
30, 2017 54,697 shares
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55
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55
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Additional
paid-in capital
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111,489
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110,380
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Accumulated
deficit
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(64,880)
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(56,601)
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Total stockholders' equity
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46,664
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53,834
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Total liabilities and stockholders' equity
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$57,445
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$62,724
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See Notes to Consolidated Financial Statements.
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ChromaDex Corporation and Subsidiaries
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Condensed Consolidated Statements of Operations
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For the Three Month Periods Ended March 31, 2018 and April 1,
2017
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(In thousands, except per share data)
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Sales,
net
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$6,567
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$3,368
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Cost
of sales
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3,430
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1,750
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Gross profit
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3,137
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1,618
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Operating
expenses:
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Sales
and marketing
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3,269
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405
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Research
and development
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1,439
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664
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General
and administrative
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6,828
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2,322
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Operating expenses
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11,536
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3,391
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Operating loss
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(8,399)
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(1,773)
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Nonoperating
expense:
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Interest
expense, net
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(44)
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(28)
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Nonoperating expenses
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(44)
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(28)
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Loss from continuing operations
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(8,443)
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(1,801)
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Loss from discontinued operations
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-
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(128)
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Net loss
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$(8,443)
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$(1,929)
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Basic
and diluted loss per common share:
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Loss
from continuing operations
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$(0.15)
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$(0.05)
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Loss
from discontinued operations
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$-
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$(0.00)
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Basic
and diluted loss per common share
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$(0.15)
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$(0.05)
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Basic
and diluted weighted average common shares outstanding
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54,858
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38,031
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See Notes to Consolidated Financial Statements.
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ChromaDex Corporation and Subsidiaries
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Condensed Consolidated Statement of Stockholders'
Equity
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For the Three Month Period Ended March 31, 2018
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(In thousands)
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Additional
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Balance,
December 30, 2017
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54,697
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$55
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$110,380
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$(56,601)
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53,834
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Adjustment
to retained earnings:
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cumulative
effect of initially applying ASC 606
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-
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-
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-
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164
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164
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Exercise
of stock options
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57
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-
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255
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-
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255
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Repurchase
of common stock
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(75)
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-
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(404)
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-
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(404)
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Vested
restricted stock
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2
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-
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-
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-
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-
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Share-based
compensation
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-
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-
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1,258
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-
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1,258
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Net
loss
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-
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-
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-
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(8,443)
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(8,443)
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Balance, March 31, 2018
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54,681
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$55
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$111,489
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$(64,880)
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$46,664
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See Notes to Consolidated Financial Statements.
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ChromaDex Corporation and Subsidiaries
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Condensed Consolidated Statements of Cash Flows
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For the Three Month Periods Ended March 31, 2018 and April 1,
2017
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(In thousands)
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Cash
Flows From Operating Activities
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Net loss
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$(8,443)
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$(1,929)
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Adjustments to reconcile net loss to net cash used in
operating activities:
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Depreciation of leasehold improvements and
equipment
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121
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129
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Amortization of intangibles
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58
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24
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Share-based compensation expense
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1,258
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320
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Allowance for doubtful trade
receivables
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(112)
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(3)
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Loss from disposal of equipment
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1
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-
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Non-cash financing costs
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32
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25
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Changes in operating assets and liabilities:
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Trade receivables
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679
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822
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Contract assets
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3
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-
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Inventories
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733
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(965)
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Prepaid expenses and other assets
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(367)
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(95)
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Accounts payable
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2,138
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1,783
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Accrued expenses
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64
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(180)
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Customer deposits and other
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(4)
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10
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Deferred rent
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(50)
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40
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Due to officer
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(100)
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(32)
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Net cash used in operating activities
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(3,989)
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(51)
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Cash
Flows From Investing Activities
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Purchases of leasehold improvements and equipment
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(161)
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(162)
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Purchases of intangible assets
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-
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(184)
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Net cash used in investing activities
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(161)
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(346)
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Cash
Flows From Financing Activities
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Proceeds from exercise of stock options
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255
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7
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Repurchase of common stock
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(404)
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-
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Payment of debt issuance costs
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(6)
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-
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Principal payments on capital leases
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(47)
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(67)
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Net cash used in financing activities
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(202)
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(60)
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Net decrease in cash
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(4,352)
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(457)
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Cash
Beginning of Period
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45,389
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1,642
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Cash
Ending of Period
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$41,037
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$1,185
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Supplemental
Disclosures of Cash Flow Information
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Cash payments for interest
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$12
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$13
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Supplemental
Schedule of Noncash Operating Activity
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Adjustment to retained earnings - cumulative effect of initially
applying ASC 606
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$164
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$-
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Supplemental
Schedule of Noncash Investing Activity
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Noncash
consideration transferred for the acquisition of Healthspan
Research LLC
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$-
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$1,187
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Capital
lease obligation incurred for the purchase of
equipment
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$-
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$109
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Retirement
of fully depreciated equipment - cost
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$-
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$15
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Retirement
of fully depreciated equipment - accumulated
depreciation
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$-
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$(15)
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See Notes to Consolidated Financial Statements.
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Note
1. Interim Financial Statements
The
accompanying financial statements of ChromaDex Corporation and its
wholly owned subsidiaries, ChromaDex, Inc., Healthspan Research,
LLC and ChromaDex Analytics, Inc (collectively referred to herein
as “ChromaDex” or the “Company” or, in the
first person as “we”, “us” and
“our”) include all adjustments, consisting of normal
recurring adjustments and accruals, that, in the opinion of the
management of the Company, are necessary for a fair presentation of
the Company’s financial position as of March 31, 2018 and
results of operations and cash flows for the three months ended
March 31, 2018 and April 1, 2017. These unaudited interim financial
statements should be read in conjunction with the Company’s
audited financial statements and the notes thereto for the year
ended December 30, 2017 appearing in the Company’s Annual
Report on Form 10-K filed with the Securities and Exchange
Commission (the “Commission”) on March 15, 2018.
Operating results for the three months ended March 31, 2018 are not
necessarily indicative of the results to be achieved for the full
year ending on December 31, 2018. The preparation of financial
statements in conformity with accounting principles generally
accepted in the United States of America (“GAAP”)
requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosures of
contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during
the period. Actual results could differ from those
estimates.
The
balance sheet at December 30, 2017 has been derived from the
audited financial statements at that date, but does not include all
of the information and footnotes required by GAAP for complete
financial statements.
Note
2. Nature of Business and Liquidity
Nature of business: The Company is an integrated, global
nutraceutical company devoted to improving the way people
age. ChromaDex scientists partner with leading
universities and research institutions worldwide to uncover the
full potential of NAD and identify and develop novel, science-based
ingredients. Its flagship
ingredient, NIAGEN® nicotinamide riboside, sold
directly to consumers as TRU NIAGEN®, is backed with
clinical and scientific research, as well as extensive intellectual
property protection.
Liquidity: The Company's net cash outflow from operating
activities was approximately $4.0 million for the three-month
period ended March 31, 2018. As of March 31, 2018, cash and cash
equivalents totaled approximately $41.0 million.
The
Company anticipates that its current cash, cash equivalents and
cash to be generated from operations will be sufficient to meet its
projected operating plans through at least May 11, 2019. The
Company may, however, seek additional capital prior to May 11,
2019, both to meet its projected operating plans after May 11, 2019
and/or to fund its longer term strategic objectives.
Note
3. Significant Accounting Policies
Basis of presentation: The financial statements and
accompanying notes have been prepared on a consolidated basis and
reflect the consolidated financial position of the Company and its
wholly owned subsidiaries. All significant intercompany balances
and transactions have been eliminated from these financial
statements. The Company’s fiscal year ends on December
31.
Recently adopted accounting standards: Effective the first
day of our fiscal year 2018, the Company adopted Accounting
Standards Update No. 2014-09, Revenue from Contracts with
Customers: Topic 606 ("ASC 606"). ASC 606 supersedes nearly all
existing revenue recognition guidance under U.S. Generally Accepted
Accounting Principles ("GAAP"). The core principle of ASC 606 is to
recognize revenues when promised goods or services are transferred
to customers in an amount that reflects the consideration that is
expected to be received for those goods or services. ASC 606
defines a five step process to achieve this core principle and, in
doing so, it is possible more judgment and estimates may be
required within the revenue recognition process than required under
existing GAAP including identifying performance obligations in the
contract, estimating the amount of variable consideration to
include in the transaction price and allocating the transaction
price to each separate performance obligation.
The
Company adopted ASC 606 using the modified retrospective transition
method. Under this method, the Company elected to apply the
modified retrospective method to contracts that are not complete as
of the first day of our fiscal year 2018. The adoption of ASC 606
resulted in an adjustment to opening retained earnings of $164,000.
See Note 7, Contract Assets and Contract Liabilities for additional
disclosure regarding the opening balance adjustment.
For the
first quarter 2018, approximately $6.4 million of the Company's
total revenue of $6.6 million, or 97% of the total revenue, was as
a result of shipping physical goods to the customers. For such
revenue streams, the performance obligations are typically
satisfied upon shipment of physical goods. Typical payment terms
for such revenue streams are upon shipment or net 30 to 60 days. We
require customers that are not creditworthy to make advance
payments prior to shipment. The Company is taking the practical
expedient on not adjusting the promised amount of consideration for
the effects of a significant financing component, since the Company
expects the customer to pay for the transferred goods within one
year. There are obligations for the Company to accept returns and
provide refunds for the goods that are shipped, if the customer
claims that the Company has not fully fulfilled the performance
obligations. Returns, refunds and allowances related to sales
including a reserve for estimated variable consideration for the
returns, refunds and allowances are recorded as reduction of
revenue. The Company uses historical rates when estimating returns,
refunds and allowances.
The
Company also has revenue streams for providing consulting services
to its clients. For the first quarter 2018, our revenue from these
streams was approximately $0.2 million, or 3% of the total revenue.
For these consulting services, the performance obligations are
typically satisfied over time as the consulting services are
performed. Payment terms for these projects vary based on the
nature of the projects, from advance payment at the beginning of
the project to net 30 days from the completion of the project. The
Company typically requires advance payments from customers for
large-scale consulting projects that have a contract duration of 30
days or longer. The original expected duration of these contracts
are typically one year or less. As such, the Company is applying an
optional exemption from ASC 606 to not make the disclosures related
to the remaining performance obligations. The Company is also
taking the practical expedient on not adjusting the promised amount
of consideration for the effects of a significant financing
component, since the Company expects the customer to pay for the
transferred services within one year. If contracts are terminated
prior to the completion, the Company typically has a right to bill
the customer for all services that have been performed through the
termination date.
These
consulting projects typically have one common performance
obligation for our clients, thus the Company typically does not
allocate the transaction price over many performance obligations.
Some of these consulting projects require measurement of the
progress toward complete satisfaction of the performance
obligation. The Company uses a cost-to-cost method to measure such
progress, which is an input method that recognizes revenue on the
bases of direct measurements for the costs incurred to date in
relation to the total estimated costs to complete the performance
obligation. Any costs that do not depict the Company's performance
in transferring control of the consulting services to the customer
have been excluded.
Recently issued accounting standards: In February 2016, the
FASB issued ASU 2016-02, Leases (Topic 842). ASU 2016-02 requires
that a lessee recognize the assets and liabilities that arise from
operating leases. A lessee should recognize in the statement of
financial position a liability to make lease payments (the lease
liability) and a right-of-use asset representing its right to use
the underlying asset for the lease term. For leases with a term of
12 months or less, a lessee is permitted to make an accounting
policy election by class of underlying asset not to recognize lease
assets and lease liabilities. In transition, lessees and lessors
are required to recognize and measure leases at the beginning of
the earliest period presented using a modified retrospective
approach. Public business entities should apply the amendments in
ASU 2016-02 for fiscal years beginning after December 15, 2018,
including interim periods within those fiscal years. Early
application is permitted for all public business entities and all
nonpublic business entities upon issuance. We are currently
evaluating the impact of our pending adoption of ASU 2016-02 on our
consolidated financial statements.
Note
4. Earnings Per Share Applicable to Common
Stockholders
The
following table sets forth the computations of earnings per share
amounts applicable to common stockholders for the three months
ended March 31, 2018 and April 1, 2017:
|
|
(In
thousands, except per share data)
|
|
|
|
|
|
Net
loss
|
$(8,443)
|
$(1,929)
|
|
|
|
Basic
and diluted loss per common share
|
$(0.15)
|
$(0.05)
|
|
|
|
Basic
and diluted weighted average common shares outstanding(1):
|
54,858
|
38,031
|
|
|
|
Potentially
dilutive securities (2):
|
|
|
Stock options
|
7,521
|
5,757
|
Warrants
|
470
|
470
|
(1)
Includes approximately 0.2 million and 0.4 million nonvested
restricted stock for the three month periods ending March 31, 2018
and April 1, 2017, respectively, which are participating securities
that feature voting and dividend rights.
(2)
Excluded from
the computation of loss per share as their impact is
antidilutive.
Note
5. Related Party Transactions
Sale of consumer products
|
Net sales
Three months ended
March 31, 2018
|
Net sales
Three months ended
April 1, 2017
|
Trade receivable at
March 31, 2018
|
Customer
G*
|
$0.8
million
|
-
|
|
|
|
-
|
-
|
Total
|
|
-
|
|
|
|
|
* Customer G & H are related parties through common ownership
of an enterprise that owns beneficially more than 10% of the common
stock of the Company.
Note
6. Inventories
The
amounts of major classes of inventory as of March 31, 2018 and
December 30, 2017 are as follows:
(In
thousands)
|
|
|
Bulk
ingredients
|
$2,198
|
$4,159
|
Reference
standards
|
990
|
1,027
|
Consumer Products -
Finished Goods
|
421
|
503
|
Consumer Products -
Work in Process
|
1,588
|
249
|
|
5,197
|
5,938
|
Less valuation
allowance
|
(134)
|
(142)
|
|
$5,063
|
$5,796
|
Note
7. Contract Assets and Contract Liabilities
Our
contract assets consist of unbilled amounts typically resulting
from sales under contracts when the cost-to-cost method of revenue
recognition is utilized and revenue recognized exceeds the amount
billed to the customer. Our contract liabilities consist of advance
payments and billings in excess of costs incurred and deferred
revenue.
Net
contract assets (liabilities) consisted of the
following:
(In
thousands)
|
|
Opening
Balance
Adjustment
|
|
|
|
|
Contract
Assets
|
$-
|
$56
|
$56
|
$(117)
|
$114
|
$53
|
Contract
Liabilities - Open Projects (3)
|
186
|
(108)
|
78
|
(26)
|
34
|
86
|
Contract
Liabilities - Other Customer Deposits (4)
|
128
|
-
|
128
|
(20)
|
8
|
116
|
Net
Contract Assets (Liabilities)
|
$(314)
|
$164
|
$(150)
|
$(71)
|
$72
|
$(149)
|
(1)
For
contract assets, the amount represents amount billed to the
customer. For contract liabilities, the amount represents
reductions for revenue recognized.
(2)
For
contract assets, the amount represents revenue recognized during
the period using the cost-to-cost method. For contract liabilities,
the amount represents advance payments received during the
period.
(3)
Contract
liablities from ongoing consulting projects.
(4)
Other
customer deposts include payments received for orders not fulfilled
and other advance payments.
In the
first quarter of 2018, we recognized revenue of approximately
$46,000 related to our adjusted contract liabilities at the
beginning of the fiscal year 2018.
Note
8. Employee Share-Based Compensation
Stock Option Plans
On June
20, 2017, the stockholders of the Company approved the ChromaDex
Corporation 2017 Equity Incentive Plan (the "2017 Plan"). The
Company's Board of Directors amended the 2017 Plan in January 2018
to increase the number of shares reserved for issuance under the
2017 plan by 500,000 shares (the "Inducement Shares"). The 2017
Plan is intended to be the successor to the ChromaDex Corporation
Second Amended and Restated 2007 Equity Incentive Plan (the "2007
Plan"). Under the 2017 Plan, the Company is authorized to issue
stock options that total no more than the sum of (i) 3,000,000 new
shares, (ii) approximately 384,000 unallocated shares remaining
available for the grant of new awards under the 2007 Plan, (iii)
any returning shares from the 2007 Plan or the 2017 Plan, such as
forfeited, cancelled, or expired shares and (iv) the 500,000
Inducement Shares.
Under
both 2007 Plan and 2017 Plan, the total number of shares the
Company may grant, excluding returned shares, was approximately
11.3 million shares. The remaining amount available for issuance
under the 2017 Plan totaled approximately 0.9 million shares at
March 31, 2018.
Service Period Based Stock Options
The
following table summarizes activity of service period based stock
options granted to employees at March 31, 2018 and changes during
the three months then ended (in thousands except per share data and
remaining contractual term):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at Dec.
30, 2017
|
4,451
|
$3.46
|
6.7
|
|
|
Options
Granted
|
1,047
|
5.66
|
10.0
|
$3.52
|
|
Options
Exercised
|
(57)
|
4.47
|
|
|
$64
|
Options
Forfeited
|
(3)
|
3.96
|
|
|
|
Outstanding at Mar.
31, 2018
|
5,438
|
$3.87
|
7.2
|
|
$3,795*
|
|
|
|
|
|
|
Exercisable at Mar.
31, 2018
|
3,173
|
$3.50
|
5.5
|
|
$2,854*
|
*
The
aggregate intrinsic values in the table above are based on the
Company’s stock price of $4.20, which is the closing price of
the Company’s stock on the last day of business for the
period ended March 31, 2018.
The
fair value of the Company’s stock options was estimated at
the date of grant using the Black-Scholes option pricing model. The
table below outlines the weighted average assumptions for options
granted to employees during the three months ended March 31,
2018.
Three Months
Ended March 31, 2018
|
|
Expected
term
|
|
Expected
volatility
|
69%
|
Expected
dividends
|
0%
|
Risk-free
rate
|
2%
|
As of
March 31, 2018, there
was approximately $8.2 million of total unrecognized compensation
expense related to non-vested share-based compensation arrangements
granted under the plans for employee stock options. That cost is
expected to be recognized over a weighted average period of 2.5
years.
Employee Share-Based Compensation
The
Company recognized compensation expense of approximately $1.2
million and $0.3 million in the statement of operations for the
three months ended March 31, 2018 and April 1, 2017,
respectively.
Note
9. Business Segments
The
Company has the following three reportable segments for the
three-month period ended March 31, 2018:
●
Consumer products
segment: provides finished dietary supplement products that contain
the Company's proprietary ingredients directly to consumers as well
as to distributors.
●
Ingredients
segment: develops and commercializes proprietary-based ingredient
technologies and supplies these ingredients as raw materials to the
manufacturers of consumer products in various industries including
the nutritional supplement, food and beverage and animal health
industries.
●
Core
standards and contract services segment: includes (i) supply of
phytochemical reference standards, (ii) scientific and regulatory
consulting and (iii) other research and development
services.
The
“Corporate and other” classification includes corporate
items not allocated by the Company to each reportable segment.
Further, there are no intersegment sales that require elimination.
The Company evaluates performance and allocates resources based on
reviewing gross margin by reportable segment. The discontinued
operations are not included in following statement of operations
for business segments.
Three
months ended
March
31, 2018
|
|
|
Core
Standards and Contract Services
|
|
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
$3,031
|
$2,368
|
$1,168
|
$-
|
$6,567
|
Cost
of sales
|
1,108
|
1,497
|
825
|
-
|
3,430
|
|
|
|
|
|
|
Gross profit
|
1,923
|
871
|
343
|
-
|
3,137
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales
and marketing
|
2,727
|
316
|
226
|
-
|
3,269
|
Research
and development
|
829
|
610
|
-
|
-
|
1,439
|
General
and administrative
|
|
-
|
-
|
6,828
|
6,828
|
Operating expenses
|
3,556
|
926
|
226
|
6,828
|
11,536
|
|
|
|
|
|
|
Operating income (loss)
|
$(1,633)
|
$(55)
|
$117
|
$(6,828)
|
$(8,399)
|
Three months ended
April
1, 2017
|
|
|
Core
Standards andContract Services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
$14
|
$2,070
|
$1,284
|
$-
|
$3,368
|
Cost
of sales
|
3
|
911
|
836
|
-
|
1,750
|
|
|
|
|
|
|
Gross profit
|
11
|
1,159
|
448
|
-
|
1,618
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales
and marketing
|
9
|
296
|
100
|
-
|
405
|
Research
and development
|
-
|
664
|
-
|
-
|
664
|
General
and administrative
|
-
|
-
|
-
|
2,322
|
2,322
|
Operating expenses
|
9
|
960
|
100
|
2,322
|
3,391
|
|
|
|
|
|
|
Operating income (loss)
|
$2
|
$199
|
$348
|
$(2,322)
|
$(1,773)
|
At
March 31, 2018
|
|
|
Core
Standards andContract Services
|
|
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
$4,353
|
$6,222
|
$1,438
|
$45,432
|
$57,445
|
|
|
|
|
|
|
At
December 30, 2017
|
|
|
Core
Standards andContract Services
|
|
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
$3,399
|
$9,742
|
$2,559
|
$47,024
|
$62,724
|
|
|
|
|
|
|
Disaggregation of revenue
We
disaggregate our revenue from contracts with customers by type of
goods or services for each of our segments, as we believe it best
depicts how the nature, amount, timing and uncertainty of our
revenue and cash flows are affected by economic factors. See
details in the tables below.
Three
Months Ended March 31, 2018
(In
thousands)
|
Consumer
Products
Segment
|
|
Core
Standards
and
Contract Services
Segment
|
|
|
|
|
|
|
TRU
NIAGEN®, Consumer Product
|
$3,031
|
$-
|
$-
|
$3,031
|
NIAGEN®
Ingredient
|
-
|
1,263
|
-
|
1,263
|
Subtotal
NIAGEN Related
|
$3,031
|
$1,263
|
$-
|
$4,294
|
|
|
|
|
|
Other
Ingredients
|
-
|
1,105
|
-
|
1,105
|
Reference
Standards
|
-
|
-
|
919
|
919
|
Consulting
and Other
|
-
|
-
|
249
|
249
|
Subtotal
Other Goods and Services
|
$-
|
$1,105
|
$1,168
|
$2,273
|
|
|
|
|
|
Total
Net Sales
|
$3,031
|
$2,368
|
$1,168
|
$6,567
|
Three
Months Ended April 1, 2017
(In
thousands)
|
Consumer
Products
Segment
|
|
Core
Standards
and
Contract Services
Segment
|
|
|
|
|
|
|
TRU
NIAGEN®, Consumer Product
|
$14
|
$-
|
$-
|
$14
|
NIAGEN®
Ingredient
|
-
|
968
|
-
|
968
|
Subtotal
NIAGEN Related
|
$14
|
$968
|
$-
|
$982
|
|
|
|
|
|
Other
Ingredients
|
-
|
1,102
|
-
|
1,102
|
Reference
Standards
|
-
|
-
|
833
|
833
|
Consulting
and Other
|
-
|
-
|
451
|
451
|
Subtotal
Other Goods and Services
|
$-
|
$1,102
|
$1,284
|
$2,386
|
|
|
|
|
|
Total
Net Sales
|
$14
|
$2,070
|
$1,284
|
$3,368
|
Disclosure of major customers
Major
customers who accounted for more than 10% of the Company’s
total sales were as follows:
|
|
Major
Customers
|
|
|
|
|
|
Customer
G - Related Party
|
12.3%
|
*
|
Customer
I
|
11.2%
|
*
|
Customer
J
|
*
|
10.5%
|
|
|
|
*
Represents less than 10%.
|
|
|
Major
customers who accounted for more than 10% of the Company’s
total trade receivables were as follows:
|
Percentage
of the Company's Total Trade Receivables
|
Major
Customers
|
|
|
|
|
|
Customer
G - Related Party
|
16.9%
|
18.1%
|
Customer
D
|
*
|
13.4%
|
Customer
C (1)
|
46.8%
|
41.8%
|
|
|
|
*
Represents less than 10%.
|
|
|
(1) There is ongoing litigation with Customer C
|
|
Note
10. Commitments and Contingencies
Legal proceedings
On
December 29, 2016, ChromaDex, Inc. filed a complaint (the
“Complaint”) in the United States District Court for
the Central District of California, naming Elysium Health, Inc.
(together with Elysium Health, LLC, “Elysium”) as
defendant. Among other allegations, ChromaDex, Inc. alleged in the
Complaint that (i) Elysium breached the Supply Agreement, dated
June 26, 2014, by and between ChromaDex, Inc. and Elysium (the
“pTeroPure® Supply Agreement”), by failing to make
payments to ChromaDex, Inc. for purchases of pTeroPure®
pursuant to the pTeroPure® Supply Agreement, (ii) Elysium
breached the Supply Agreement, dated February 3, 2014, by and
between ChromaDex, Inc. and Elysium, as amended (the
“NIAGEN® Supply Agreement”), by failing to make
payments to ChromaDex, Inc. for purchases of NIAGEN® pursuant
to the NIAGEN® Supply Agreement, (iii) Elysium breached the
Trademark License and Royalty Agreement, dated February 3, 2014, by
and between ChromaDex, Inc. and Elysium (the “License
Agreement”), by failing to make payments to ChromaDex, Inc.
for royalties due pursuant to the License Agreement and (iv)
certain officers of Elysium made false promises and representations
to induce ChromaDex, Inc. into providing large supplies of
pTeroPure® and NIAGEN® to Elysium pursuant to the
pTeroPure® Supply Agreement and NIAGEN® Supply Agreement.
ChromaDex, Inc. is seeking punitive damages, money damages and
interest.
On
January 25, 2017, Elysium filed an answer and counterclaims (the
“Counterclaim”) in response to the Complaint. Among
other allegations, Elysium alleges in the Counterclaim that (i)
ChromaDex, Inc. breached the NIAGEN® Supply Agreement by not
issuing certain refunds or credits to Elysium and for violating
certain confidential information provisions, (ii) ChromaDex, Inc.
breached the implied covenant of good faith and fair dealing
pursuant to the NIAGEN® Supply Agreement, (iii) ChromaDex,
Inc. breached certain confidential provisions of the
pTeroPure® Supply Agreement, (iv) ChromaDex, Inc. fraudulently
induced Elysium into entering into the License Agreement (the
“Fraud Claim”), (v) ChromaDex, Inc.’s conduct
constitutes misuse of its patent rights (the “Patent
Claim”) and (vi) ChromaDex, Inc. has engaged in unlawful or
unfair competition under California state law (the “Unfair
Competition Claim”). Elysium is seeking damages for
ChromaDex, Inc.’s alleged breaches of the NIAGEN® Supply
Agreement and pTeroPure® Supply Agreement, and compensatory
damages, punitive damages and/or rescission of the License
Agreement and restitution of any royalty payments conveyed by
Elysium pursuant to the License Agreement, and a declaratory
judgment that ChromaDex, Inc. has engaged in patent
misuse.
On
February 15, 2017, ChromaDex, Inc. filed an amended complaint. In
the amended complaint, ChromaDex, Inc. re-alleges the claims in the
Complaint, and also alleges that Elysium willfully and maliciously
misappropriated ChromaDex, Inc.’s trade secrets. On February
15, 2017, ChromaDex, Inc. also filed a motion to dismiss the Fraud
Claim, the Patent Claim and the Unfair Competition Claim. On March
1, 2017, Elysium filed a motion to dismiss ChromaDex, Inc.'s fraud
and trade secret misappropriation causes of action. On March 6,
2017, Elysium filed a first amended counterclaim. On March 20,
2017, ChromaDex, Inc. moved to dismiss Elysium's amended fraud,
declaratory judgment of patent misuse and the Unfair Competition
Claim. On May 10, 2017, the court ruled on the motions to dismiss,
denying ChromaDex, Inc.’s motion as to Elysium’s fraud
and declaratory judgment claims and granting ChromaDex,
Inc.’s motion with prejudice as to Elysium’s Unfair
Competition Claim. With respect to Elysium’s motion, the
court granted the motion with prejudice as to ChromaDex,
Inc.’s fraud claim and granted with leave to amend the motion
as to ChromaDex, Inc.’s trade secret misappropriation claims.
On May 24, 2017, ChromaDex, Inc. answered the first amended
counterclaim and asserted several affirmative defenses. Also on May
24, 2017, ChromaDex, Inc. filed a second amended complaint,
amending the trade secret misappropriation claims and addressing
Elysium’s declaratory judgment of patent misuse counterclaim.
On June 7, 2017, ChromaDex, Inc. filed a third amended complaint
dismissing the trade secret misappropriation claims and asserting
two breach of contract claims for Elysium’s failure to pay
for the product delivered. On June 16, 2017, Elysium answered the
third amended complaint. On August 14, 2017, ChromaDex, Inc. moved
for judgment on the pleadings as to Elysium’s declaratory
judgment of patent misuse counterclaim. On September 26, 2017, the
court denied ChromaDex’s motion without prejudice and
directed Elysium to file an amended counterclaim if it intended to
maintain its declaratory judgment counterclaim. On October 11,
2017, Elysium filed a second amended counterclaim, re-alleging the
claims in the first amended counterclaim and adding a claim for
unjust enrichment and restitution of the royalties Elysium paid to
ChromaDex, Inc. pursuant to the License Agreement. On October 25,
2017, ChromaDex, Inc. filed a motion to dismiss the declaratory
judgment of patent misuse and unjust enrichment claims and/or
strike allegations in the unjust enrichment claim contained in the
second amended counterclaim. On November 28, 2017, the court denied
the motion. ChromaDex, Inc. answered the second amended
counterclaim on December 12, 2017.
On
March 30, 2018, the court granted Elysium leave to file amended
counterclaims alleging additional breaches of the NIAGEN®
Supply Agreement and Elysium filed its third amended counterclaims
the same day ChromaDex filed an answer on April 13, 2018. The
parties are currently in discovery.
On July
17, 2017, Elysium filed petitions with the U.S. Patent and
Trademark Office for inter
partes review of U.S. Patents 8,197,807 (the
“’807 Patent”) and 8,383,086 (the
“’086 Patent”), patents to which ChromaDex, Inc.
is the exclusive licensee. The Patent Trial and Appeal Board
(“PTAB”) denied institution of the inter partes review for the ’807
Patent on January 18, 2018. On January 29, 2018, the PTAB granted
institution of the inter
partes review as to claims 1, 3, 4, and 5 and denied
institution as to claim 2 of the ’086 Patent. Based upon a
recent U.S. Supreme Court decision, and solely on a procedural
basis, the PTAB has now included claim 2 in the trial of the
inter partes
review.
On
September 27, 2017, Elysium Health Inc. ("Elysium Health") filed a
complaint in the United States District Court for the Southern
District of New York, against ChromaDex, Inc. (the “SDNY
Complaint”). Elysium Health alleges in the SDNY Complaint
that ChromaDex, Inc. made false and misleading statements in a
citizen petition to the Food and Drug Administration it filed on or
about August 18, 2017. Among other allegations, Elysium Health
avers that the citizen petition made Elysium Health’s product
appear dangerous, while casting ChromaDex, Inc.’s own product
as safe. The SDNY Complaint asserts four claims for relief: (i)
false advertising under the Lanham Act, 15 U.S.C. § 1125(a);
(ii) trade libel; (iii) deceptive business practices under New York
General Business Law § 349; and (iv) tortious interference
with prospective economic relations. ChromaDex, Inc. denies the
claims in the SDNY Complaint and intends to defend against them
vigorously. On October 26, 2017, ChromaDex, Inc. moved to dismiss
the SDNY Complaint on the grounds that, inter alia, its statements
in the citizen petition are immune from liability under the
Noerr-Pennington Doctrine, the litigation privilege, and New
York’s Anti-SLAPP statute, and that the SDNY Complaint failed
to state a claim. Elysium Health opposed the motion on November 2,
2017. ChromaDex, Inc. filed its reply on November 9, 2017. The
motion is currently pending.
On
October 26, 2017, ChromaDex, Inc. filed a complaint in the United
States District Court for the Southern District of New York against
Elysium Health (the “ChromaDex SDNY Complaint”).
ChromaDex alleges that Elysium Health made material false and
misleading statements to consumers in the promotion, marketing, and
sale of its health supplement product, Basis, and asserts five
claims for relief: (i) false advertising under the Lanham Act, 15
U.S.C. §1125(a); (ii) unfair competition under 15 U.S.C.
§ 1125(a); (iii) deceptive practices under New York General
Business Law § 349; (iv) deceptive practices under New York
General Business Law § 350; and (v) tortious interference with
prospective economic advantage. On November 16, 2017, Elysium
Health moved to dismiss for failure to state a claim. ChromaDex,
Inc. opposed the motion on November 30, 2017 and Elysium Health
filed a reply on December 7, 2017. On November 3, 2017, the Court
consolidated the SDNY Complaint and the ChromaDex SDNY Complaint
actions under the caption In re Elysium Health-ChromaDex
Litigation, 17-cv-7394, and stayed discovery in the consolidated
action pending a Court-ordered mediation. The mediation was
unsuccessful and the motion is currently pending.
The
Company is unable to predict the outcome of these matters and, at
this time, cannot reasonably estimate the possible loss or range of
loss with respect to the legal proceedings discussed herein. As of
March 31, 2018, ChromaDex, Inc. did not accrue a potential loss for
the Counterclaim or the SDNY Complaint because ChromaDex, Inc.
believes that the allegations are without merit and thus it is not
probable that a liability has been incurred.
From
time to time we are involved in legal proceedings arising in the
ordinary course of our business. We believe that there is no other
litigation pending that is likely to have, individually or in the
aggregate, a material adverse effect on our financial condition or
results of operations.
Lease
On
February 7, 2018, the Company entered into a lease amendment to
lease additional office space located in Los Angeles, California
through October 2021. Pursuant to the lease, the Company will make
additional monthly lease payments ranging from approximately $9,000
to $11,000, as the payments escalate during the term of the
lease.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF
OPERATIONS
Certain statements in this Management's Discussion and Analysis
(“MD&A”), other than purely historical information,
including estimates, projections, statements relating to our
business plans, objectives and expected operating results, and the
assumptions upon which those statements are based, are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934, as amended. Forward-looking statements generally can
be identified by the use of forward-looking terminology such as
“may,” “would,” “expect,”
“intend,” “could,” “estimate,”
“should,” “anticipate,” or
“believe,” and similar
expressions. Forward-looking statements are based on
current expectations and assumptions that are subject to risks and
uncertainties which may cause actual results to differ materially
from the forward-looking statements. We undertake no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events,
or otherwise. Readers should carefully review the risk
factors and related notes set forth below in Part II,
Item 1A, “Risk Factors” and included under Part I, Item
1A, “Risk Factors” of our Annual Report on Form 10-K
for the year ended December 30, 2017 filed with the Securities and
Exchange Commission on March 15, 2018 (our “Annual
Report”).
The following MD&A is intended to help readers understand the
results of our operation and financial condition, and is provided
as a supplement to, and should be read in conjunction with, our
Interim Unaudited Financial Statements and the accompanying Notes
to Interim Unaudited Financial Statements under Part 1, Item 1 of
this Quarterly Report on Form 10-Q.
Growth and percentage comparisons made herein generally refer to
the three months ended March 31, 2018 compared with the three
months ended April 1, 2017 unless otherwise noted. Unless otherwise
indicated or unless the context otherwise requires, all references
in this document to “we,” “us,”
“our,” the “Company,” and similar
expressions refer to ChromaDex Corporation, and depending on the
context, its subsidiaries.
Company Overview
ChromaDex
is a science-based integrated nutraceutical company devoted to
pioneering technologies that improve the way people age. ChromaDex
engages with and supports many of the world's leading research
institutions and scientists that are diligently working to
understand the full potential of nicotinamide adenine dinucleotide
("NAD") and its impact on human health.
NAD is
an essential coenzyme and a key regulator of cellular metabolism.
Best known for its role in cellular adenosine triphosphate ("ATP")
production, NAD is now thought to play an important role in healthy
aging. Many cellular functions related to health and healthy aging
are sensitive to levels of locally available NAD and this
represents an active area of research in the field of
NAD.
NAD
levels are not constant, and in humans, NAD levels have been shown
to decline by more than 50% from young adulthood to middle age. NAD
continues to decline as humans grow older. There are other causes
of reduced NAD levels such as over-nutrition, alcohol consumption
and a number of disease states. NAD may also be increased,
including through calorie restriction and exercise. Healthy aging,
mitochondria and NAD continue to be areas of focus in the research
community. In 2017, there were over 150 studies on
NAD.
In
2013, ChromaDex commercialized NIAGEN® nicotinamide riboside
("NR"), a novel form of vitamin B3. Data from numerous animal
studies, and confirmed in human clinical trials, show that NR is a
highly efficient NAD precursor that significantly raises NAD
levels. NIAGEN® is safe for human consumption with no adverse
side effects. NIAGEN® has twice been successfully reviewed
under FDA's new dietary ingredient (“NDI”) notification
program, and has also been successfully notified to the FDA as
generally recognized as safe (“GRAS”). Animal studies
of NIAGEN® have demonstrated a variety of outcomes ranging
from increased NAD levels, increased cellular metabolism and energy
production to improvements in insulin sensitivity. NIAGEN® is
the trade name for our proprietary ingredient NR, and protected by
patents to which we are the exclusive licensee.
ChromaDex
is the world leader in the emerging NAD space. ChromaDex has over
150 partnerships with leading universities and research
institutions around the world including the National Institutes of
Health, Cornell, Dartmouth, Harvard, Scripps Research Institute and
the Mayo Clinic. Other relationships are currently being
developed.
Our
scientific advisory board is led by Chairman Dr. Roger Kornberg,
Nobel Laureate Stanford Professor, Dr. Charles Brenner, one of the
world’s recognized experts in NAD and inventor of
nicotinamide riboside, Dr. Rudi Tanzi, the co-chair of the
department of neurology at Harvard Medical School and one of the
world’s leading experts in food and nutrition, Dr. Bruce
German, Chairman of food, nutrition and health at the University of
California, Davis, Dr. Robert Beudeker, Vice President of
Innovation, who leads the innovation program for human nutrition
and health at DSM, Dr. Matthew Roberts, Chief Technical and Quality
Officer at Pharmavite, who has over 25 years of success at Abbott,
Nestle and Nature's Bounty Co. and Sir John Walker, Nobel Laureate
Emeritus Director and Professor at the MRC Mitochondrial Biology
Unit at Cambridge.
Financial Condition and Results of
Operations
The
discussion and analysis of our financial condition and results of
operations is based on our financial statements, which have been
prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”). The preparation of these financial
statements requires our management 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 financial statements, as well as the reported
revenues, if any, and expenses during the reporting periods. On an
ongoing basis, we evaluate such estimates and judgments, including
those described in greater detail below. We base our estimates on
historical experience and on various other factors that we believe
are reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying value of assets
and liabilities that are not readily apparent from other sources.
Actual results may differ from these estimates under different
assumptions or conditions.
As of
March 31, 2018, the Company had approximately $41.0 million cash
and cash equivalents on hand. We anticipate that our current cash,
cash equivalents and cash to be generated from operations will be
sufficient to meet our projected operating plans through at least
May 11, 2019. We may, however, seek additional capital prior to May
11, 2019, both to meet our projected operating plans after May 11,
2019 and/or to fund our longer term strategic
objectives.
Additional
capital may come from public and/or private stock or debt
offerings, borrowings under lines of credit or other sources. These
additional funds may not be available on favorable terms, or at
all. Further, if we issue equity or debt securities to raise
additional funds, our existing stockholders may experience dilution
and the new equity or debt securities we issue may have rights,
preferences and privileges senior to those of our existing
stockholders. In addition, if we raise additional funds through
collaboration, licensing or other similar arrangements, it may be
necessary to relinquish valuable rights to our products or
proprietary technologies, or to grant licenses on terms that are
not favorable to us. If we cannot raise funds on acceptable terms,
we may not be able to develop or enhance our products, obtain the
required regulatory clearances or approvals, achieve long term
strategic objectives, take advantage of future opportunities, or
respond to competitive pressures or unanticipated customer
requirements. Any of these events could adversely affect our
ability to achieve our development and commercialization goals,
which could have a material and adverse effect on our business,
results of operations and financial condition.
Some of
our operations are subject to regulation by various state and
federal agencies. In addition, we expect a significant increase in
the regulation of our target markets. Dietary supplements are
subject to Food and Drug Administration (the "FDA"), Federal Trade
Commission and U.S. Department of Agriculture regulations relating
to composition, labeling and advertising claims. These regulations
may in some cases, particularly with respect to those applicable to
new ingredients, require a notification that must be submitted to
the FDA along with evidence of safety. There are similar
regulations related to food additives.
Our net
sales and net loss for the three-month periods ending on March 31,
2018 and April 1, 2017 were as follows:
|
|
(In
thousands)
|
|
|
|
|
|
Net
sales
|
$6,567
|
$3,368
|
Net
loss
|
(8,443)
|
(1,929)
|
|
|
|
Basic and diluted
loss per common share
|
$(0.15)
|
$(0.05)
|
Over
the next two years, we plan to continue to increase marketing,
research and development efforts for our flagship ingredient,
NIAGEN® nicotinamide riboside, and our consumer branded
product TRU NIAGEN®.
Net Sales
Net
sales consist of gross
sales less discounts and returns.
|
|
(In
thousands)
|
|
|
|
Net sales:
|
|
|
|
Consumer
products
|
$3,031
|
$14
|
Not Meaningful
|
Ingredients
|
2,368
|
2,070
|
14%
|
Core
standards and contract services
|
1,168
|
1,284
|
-9%
|
|
|
|
|
Total net sales
|
$6,567
|
$3,368
|
95%
|
●
The
Company's TRU NIAGEN® sales for consumer products segment
increased after the Company's strategic shift towards consumer
products. The Company expects the sales for the consumer products
segment to continue to grow over the next twelve
months.
●
The
increase in sales for the ingredients segment is mainly due to
increased sales of “NIAGEN®.”
●
The
decrease in sales for the core standards and contract services
segment is primarily due to decreased sales of regulatory
consulting and other services as fewer consulting and service
projects were completed.
Cost of Sales
Cost of
sales include raw materials, labor, overhead, and
delivery costs.
|
|
(In
thousands)
|
|
|
|
|
|
|
|
Cost of sales:
|
|
|
|
|
Consumer
products
|
$1,108
|
37%
|
$3
|
21%
|
Ingredients
|
1,497
|
63%
|
911
|
44%
|
Core
standards and contract services
|
825
|
71%
|
836
|
65%
|
|
|
|
|
|
Total cost of sales
|
$3,430
|
52%
|
$1,750
|
52%
|
The
cost of sales, as a percentage of net sales, stayed flat for the
three-month period ended March 31, 2018, compared to the
three-month period ended April 1, 2017.
●
The
cost of sales, as a percentage of net sales, for the consumer
products segment was 37% for the three-month period ended March 31,
2018. Compared to the other segments, the consumer products
segment experienced better margins due to the positive impact of
TRU NIAGEN® consumer product sales.
●
The
cost of sales, as a percentage of net sales, for the ingredients
segment increased 19%. This increase as a percentage of net sales
was primarily due to a write off of our NIAGEN® related
inventory of approximately $312,000 in the first quarter of
2018.
●
The
cost of sales, as a percentage of net sales for the core standards
and contract services segment, increased 6%. The decrease in
consulting and other services sales for the three-month period
ended March 31, 2018 led to a lower labor utilization rate, which
resulted in increasing our cost of sales as a percentage of net
sales.
Gross Profit
Gross
profit is net sales less the cost of sales and is affected by a
number of factors including product mix, competitive pricing and
costs of products and services.
|
|
(In
thousands)
|
|
|
|
Gross profit:
|
|
|
|
Consumer
products
|
$1,923
|
$11
|
Not Meaningful
|
Ingredients
|
871
|
1,159
|
-25%
|
Core
standards and contract services
|
343
|
448
|
-23%
|
|
|
|
|
Total gross profit
|
$3,137
|
$1,618
|
94%
|
●
The
consumer products segment posted gross profit of $1.9 million for
the three-month period ending March 31, 2018. The Company expects
the sales and gross profit for consumer products segment to
continue to grow over the next twelve months.
●
The
decreased gross profit for the ingredients segment was largely due
to a write off of our NIAGEN® related inventory of
approximately $312,000 in the first quarter of 2018.
●
The
decreased gross profit for the core standards and contract services
segment is largely due to the decreased sale of regulatory
consulting and other services. Fixed labor costs make up the
majority of costs of regulatory consulting and other services and
these fixed labor costs did not decrease in proportion to sales,
hence yielding lower profit margin.
Operating Expenses-Sales and Marketing
Sales
and marketing expenses consist of salaries, advertising
and marketing expenses.
|
|
(In
thousands)
|
|
|
|
Sales and marketing expenses:
|
|
|
|
Consumer
products
|
$2,727
|
$9
|
Not Meaningful
|
Ingredients
|
316
|
296
|
7%
|
Core
standards and contract services
|
226
|
100
|
126%
|
|
|
|
|
Total sales and marketing
expenses
|
$3,269
|
$405
|
707%
|
●
For the
consumer products segment, we have increased staffing as well as
direct marketing expenses associated with social media and other
customer awareness and acquisition programs. Over the next twelve
months, we plan to continue to invest in building out our own
global branded consumer product business.
●
For the
ingredients segment, the increase is largely due to increased
marketing efforts to raise consumer awareness for our line of
proprietary ingredients.
●
For the
core standards and contract services segment, the increase is
mainly due to our increased marketing efforts.
Operating Expenses-Research and Development
Research
and development expenses mainly consist of clinical trials and
process development expenses.
|
|
(In
thousands)
|
|
|
|
Research and development expenses:
|
|
|
|
Consumer
products
|
$829
|
$-
|
-
|
Ingredients
|
610
|
664
|
-8%
|
|
|
|
|
Total sales and marketing
expenses
|
$1,439
|
$664
|
117%
|
●
In the
second quarter of 2017, we began allocating the research and
development expenses related to our NIAGEN® branded ingredient
to the consumer products and ingredients segment, based on revenues
recorded. Previously, these expenses were recorded all in the
ingredients segment. Overall, we increased our research and
development efforts and we plan to continue to increase research
and development efforts for our flagship ingredient, NIAGEN®
nicotinamide riboside. In the first quarter of 2018, we
focused on technology development to lower production costs as well
as obtaining international regulatory approvals.
Operating Expenses-General and Administrative
General
and administrative expenses consist of general
company administration, legal, IT, accounting and executive
management expenses.
|
|
(In
thousands)
|
|
|
|
|
|
|
|
General and
administrative
|
$6,828
|
$2,322
|
194%
|
The
following expenses contributed to the increase in general and
administrative expenses in the first quarter of 2018:
●
An
increase in legal expenses. Our legal expenses increased to
approximately $3.0 million in the first quarter of 2018 compared to
approximately $0.6 million in the first quarter of 2017. The
ongoing litigation with Elysium and our increased efforts to file
and maintain patents related to the proprietary ingredient
technologies were the main reasons for the increase in legal
expenses.
●
An
increase in share-based compensation. Our share-based compensation
recorded as general and administrative expense for the first
quarter of 2018 increased to approximately $1.1 million compared to
approximately $0.3 million for the first quarter of
2017.
●
An
increase of approximately $0.3 million in expenses associated with
information and technology. We invested in additional staff as well
as external consulting in developing and maintaining our Ecommerce
platform, which we use to sell our branded consumer product TRU
NIAGEN®.
Non-operating Expenses- Interest Expense, net
Interest
expense consists of interest on loan payable and capital
leases.
|
|
(In
thousands)
|
|
|
|
|
|
|
|
Interest expense, net
|
$44
|
$28
|
57%
|
The
increase in interest expense was mainly due to the costs related to
maintaining the line of credit the Company established with Western
Alliance Bank. Under the line of credit, the Company may borrow an
aggregate principal amount up to $5 million.
Income Taxes
At
March 31, 2018 and April 1, 2017, the Company maintained a full
valuation allowance against the entire deferred income tax balance
which resulted in an effective tax rate of approximately 0% for the
three-month periods ended March 31, 2018 and April 1, 2017,
respectively.
Depreciation and Amortization
Depreciation
expense for the three-month period ended March 31, 2018 was
approximately $121,000 as compared to $129,000 for the three-month
period ended April 1, 2017. We depreciate our assets on a
straight-line basis, based on the estimated useful lives of the
respective assets.
Amortization
expense of intangible assets for the three-month period ended March
31, 2018 was approximately $58,000 as compared to $24,000 for the
three-month period ended April 1, 2017. We amortize intangible
assets using a straight-line method, generally over 10 years. For
licensed patent rights, the useful lives are 10 years or the
remaining term of the patents underlying licensing rights,
whichever is shorter. The useful lives of subsequent milestone
payments that are capitalized are the remaining useful life of the
initial licensing payment that was capitalized.
Liquidity and Capital Resources
From
inception through March 31, 2018, we have incurred aggregate losses
of approximately $65 million. These losses are primarily due to
expenses associated with the development and expansion of our
operations. These operations have been financed through capital
contributions, the issuance of common stock and warrants through
private placements, and the issuance of debt.
Our
board of directors periodically reviews our capital requirements in
light of our proposed business plan. Our future capital
requirements will remain dependent upon a variety of factors,
including cash flow from operations, the ability to increase sales,
increasing our gross profits from current levels, reducing selling
and administrative expenses as a percentage of net sales, continued
development of customer relationships, and our ability to market
our new products successfully. However, based on our results from
operations, we may determine that we need additional financing to
implement our business plan. There can be no assurance that any
such financing will be available on terms favorable to us or at
all. Without adequate financing we may have to further delay or
terminate product and service expansion and curtail certain
selling, general and administrative expenses. Any inability to
raise additional financing would have a material adverse effect on
us.
While
we anticipate that our current cash, cash equivalents and cash to
be generated from operations will be sufficient to meet our
projected operating plans through at least May 11, 2019, we may
require additional funds, either through additional equity or debt
financings or collaborative agreements or from other sources. We
have no commitments to obtain such additional financing, and we may
not be able to obtain any such additional financing on terms
favorable to us, or at all. If adequate financing is not available,
the Company will further delay, postpone or terminate product and
service expansion and curtail certain selling, general and
administrative operations. The inability to raise additional
financing may have a material adverse effect on the future
performance of the Company.
Net cash used in operating activities
Net
cash used in operating activities for the three months ended March
31, 2018 was approximately $3,989,000 as compared to approximately
$51,000 for the three months ended April 1, 2017. Along with the
net loss, an increase in prepaid expenses was the largest use of
cash during the three-month period ended March 31, 2018, partially
offset by an increase in accounts payable and a decrease in trade
receivables and inventories. Net cash used in operating activities
for the three months ended April 1, 2017 largely reflects an
increase in inventories along with the net loss, partially offset
by an increase in accounts payable.
We
expect our operating cash flows to fluctuate significantly in
future periods as a result of fluctuations in our operating
results, shipment timetables, accounts receivable collections,
inventory management, and the timing of our payments, among other
factors.
Net cash used in investing activities
Net
cash used in investing activities was approximately $161,000 for
the three months ended March 31, 2018, compared to approximately
$346,000 for the three months ended April 1, 2017. Net cash used in
investing activities for the three months ended March 31, 2018
consisted of purchases of leasehold improvements and equipment. Net
cash used in investing activities for the three months ended April
1, 2017 consisted of purchases of leasehold improvements and
equipment and intangible assets.
Net cash used in financing activities
Net
cash used in financing activities was approximately $202,000 for
the three months ended March 31, 2018, compared to approximately
$60,000 for the three months ended April 1, 2017. Net cash used in
financing activities for the three months ended March 31, 2018
primarily consisted of repurchase of common stock, partially offset
by proceeds from exercise of stock options. Net cash used in
financing activities for the three months ended April 1, 2017
mainly consisted of principal payments on capital
leases.
Contractual Obligations and Commitments
During
the three months ended March 31, 2018, there were no material
changes outside of the ordinary course of business in the specified
contractual obligations disclosed in “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations,” as contained in our Annual Report, other than as
disclosed in “Item 1 Financial Statements” of this
Quarterly Report.
Off-Balance Sheet Arrangements
During
the three months ended March 31, 2018, we had no material
off-balance sheet arrangements other than with respect to ordinary
operating leases as disclosed in the “Financial Statements
and Supplementary Data” section of our Annual
Report.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
Interest Rate Risk
We may
become exposed to risks associated with changes in interest rates
in connection with our credit facility with Western Alliance. As of
March 31, 2018, we did not have an outstanding loan payable
balance, however, we established a formula based revolving credit
line with Western Alliance Bank, pursuant to which we may borrow an
aggregate principal amount of up to $5,000,000, subject to certain
terms and conditions. If we decide to borrow from this credit line,
the interest rate will be calculated at a floating rate per month
equal to the greater of 3.50% per year or the Prime Rate published
in the Money Rates section of the Western Edition of The Wall
Street Journal, or such other rate of interest publicly announced
by Lender as its Prime Rate, plus 2.50 percentage points, plus an
additional 5.00 percentage points during any period that an event
of default has occurred and is continuing. If the Prime Rate rises,
we will incur more interest expenses. Any borrowing, interest or
other fees or obligations that we owe Western Alliance will become
due and payable on November 4, 2018.
Our
capital lease obligations bear interest at a fixed rate and
therefore have no exposure to changes in interest
rates.
The
Company’s cash consists of short term, highly liquid
investments in money market funds managed by banks. Due to the
short-term duration of our investment portfolio and the relatively
low risk profile of our investments, a sudden change in interest
rates would not have a material effect on either the fair market
value of our portfolio, our operating results or our cash
flows.
Foreign Currency Risk
All of
our long-lived assets are located within the United States and we
do not hold any foreign currency denominated financial instruments
that are material.
Effects of Inflation
We do
not believe that inflation has had a material effect on our results
of operations or financial condition during the periods
presented.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the supervision of our Chief Executive Officer
and Chief Financial Officer (our principal executive officer and
principal financial officer, respectively), evaluated the
effectiveness of our disclosure controls and procedures pursuant to
Rule 13a-15 under the Securities Exchange Act of 1934, as amended
(the "Exchange Act"), as of the end of the period covered by this
Quarterly Report on Form 10-Q. In designing and evaluating the
disclosure controls and procedures, management recognizes that any
controls and procedures, no matter how well designed and operated,
can provide only reasonable assurance of achieving the desired
control objectives. In addition, the design of disclosure controls
and procedures must reflect the fact that there are resource
constraints and that management is required to apply its judgment
in evaluating the benefits of possible controls and procedures
relative to their costs.
Based on our evaluation, our Chief Executive Officer and Chief
Financial Officer concluded that, as of March 31, 2018, our
disclosure controls and procedures are designed at a reasonable
assurance level and are effective to provide reasonable assurance
that information we are required to disclose in reports that we
file or submit under the Exchange Act is recorded, processed,
summarized, and reported within the time periods specified in
Securities and Exchange Commission rules and forms, and that such
information is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer,
as appropriate, to allow timely decisions regarding required
disclosure.
Changes in Internal Control over Financial Reporting
An
evaluation was also performed under the supervision and with the
participation of our management, including our Chief Executive
Officer and Chief Financial Officer, of any change in our internal
control over financial reporting (as defined in Rule
13a−15(f) promulgated under the Exchange Act) that occurred
during our last fiscal quarter and that has materially affected, or
is reasonably likely to materially affect, our internal control
over financial reporting. There were no changes in internal control
over financial reporting that occurred during the Company’s
first fiscal quarter that have materially affected, or are
reasonably likely to materially affect, our internal control over
financial reporting.
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
For a
description of our legal proceedings, see Note 10, Commitments and
Contingencies, Legal Proceedings of the Notes to Consolidated
Financial Statements, included in Item 1 of this Quarterly Report
on Form 10-Q.
ITEM 1A. RISK FACTORS
Investing in our common stock involves a high degree of risk.
Current investors and potential investors should consider carefully
the risks and uncertainties described below and in our Annual
Report, together with all other information contained in this Form
10-Q and our Annual Report, including our financial statements, the
related notes and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations,” before
making investment decisions with respect to our common stock. If
any of the following risks actually occur, our business, financial
condition, results of operations and future growth prospects would
likely be materially and adversely affected. Under these
circumstances, the trading price and value of our common stock
could decline, and you may lose all or part of your investment. The
risks and uncertainties described in this Form 10-Q and in our
Annual Report are not the only ones facing our Company. Additional
risks and uncertainties of which we are not presently aware, or
that we currently consider immaterial, may also impair our business
operations. The risk factors set forth below that are marked with
an asterisk (*) contain changes to the similarly titled risk
factors included in Part I, Item 1A of our Annual
Report.
Risks Related to our Company and our Business
*We have a history of operating losses, may need additional
financing to meet our future long-term capital requirements and may
be unable to raise sufficient capital on favorable terms or at
all.
We have
recorded a net loss of approximately $8.4 million for the three
months ended March 31, 2018, and we have a history of losses and
may continue to incur operating and net losses for the foreseeable
future. We incurred net losses of approximately $11.4 million, $2.9
million and $2.8 million for the years ended December 30, 2017,
December 31, 2016 and January 2, 2016, respectively. As of March
31, 2018, our accumulated deficit was approximately $65 million. We
have not achieved profitability on an annual basis. We may not be
able to reach a level of revenue to continue to achieve and sustain
profitability. If our revenues grow slower than anticipated, or if
operating expenses exceed expectations, then we may not be able to
achieve and sustain profitability in the near future or at all,
which may depress our stock price.
As of
March 31, 2018, our cash and cash equivalents totaled approximately
$41.0 million. While we anticipate that our current cash, cash
equivalents and cash to be generated from operations will be
sufficient to meet our projected operating plans through at least
May 2019, we may require additional funds, either through
additional equity or debt financings or collaborative agreements or
from other sources. We have no commitments to obtain such
additional financing, and we may not be able to obtain any such
additional financing on terms favorable to us, or at all. If
adequate financing is not available, the Company will further
delay, postpone or terminate product and service expansion and
curtail certain selling, general and administrative operations. The
inability to raise additional financing may have a material adverse
effect on the future performance of the Company.
*Our capital requirements will depend on many factors.
Our
capital requirements will depend on many factors,
including:
●
the
revenues generated by sales of our products;
●
the
costs associated with expanding our sales and marketing efforts,
including efforts to hire independent agents and sales
representatives and obtain required regulatory approvals and
clearances;
●
the
expenses we incur in developing and commercializing our products,
including the cost of obtaining and maintaining regulatory
approvals; and
●
unanticipated
general and administrative expenses, including expenses involved
with our ongoing litigation with Elysium.
Because
of these factors, we may seek to raise additional capital prior to
May 2019 both to meet our projected operating plans after May 2019
and to fund our longer term strategic objectives. Additional
capital may come from public and private equity or debt offerings,
borrowings under lines of credit or other sources. These additional
funds may not be available on favorable terms, or at all. There can
be no assurance we will be successful in raising these additional
funds. Furthermore, if we issue equity or debt securities to raise
additional funds, our existing stockholders may experience dilution
and the new equity or debt securities we issue may have rights,
preferences and privileges senior to those of our existing
stockholders. In addition, if we raise additional funds through
collaboration, licensing or other similar arrangements, it may be
necessary to relinquish valuable rights to our products or
proprietary technologies, or grant licenses on terms that are not
favorable to us. If we cannot raise funds on acceptable terms, we
may not be able to develop or enhance our products, obtain the
required regulatory clearances or approvals, execute our business
plan, take advantage of future opportunities, or respond to
competitive pressures or unanticipated customer requirements. Any
of these events could adversely affect our ability to achieve our
development and commercialization goals, which could have a
material and adverse effect on our business, results of operations
and financial condition.
*We are currently engaged in substantial and complex litigation
with Elysium Health, Inc. and Elysium Health LLC ("Elysium"), the
outcome of which could materially harm our business and financial
results.
We are currently engaged in litigation with Elysium, a customer
that represented 19% of our net sales for the year
ended December 31, 2016. Elysium has made no purchases
from us since August 9, 2016. The litigation includes multiple
complaints and counterclaims by us and Elysium in venues in
California and New York, as well as a petition by Elysium with the
U.S. Patent and Trademark Office for inter partes review of one
patent to which we are the exclusive licensee. For further details
on this litigation, please refer to Part II, Item 1 of this
Quarterly Report on Form 10-Q.
The litigation is substantial and complex, and it has and
could continue to cause us to incur significant costs, as well as
distract our management over an extended period. The litigation may
substantially disrupt our business and we cannot assure you that we
will be able to resolve the litigation on terms favorable to us.
If we are unsuccessful in resolving
the litigation on favorable terms to us, we may be forced to pay
compensatory and punitive damages and restitution for any royalty
payments that we received from Elysium, which payments could
materially harm our business, or be subject to other remedies,
including injunctive relief. Further, if we are unsuccessful in
resolving the Patent Claim on favorable terms, or if the U.S.
Patent and Trademark Office invalidates the patent subject to the
inter partes review, we may lose the competitive advantage that is
provided by the subject intellectual property rights, which would
have a material adverse effect on our business. In addition,
Elysium has not paid us approximately $2.7 million for previous
purchase orders. We may not collect the full amount owed to us by
Elysium, and as a result, we may have to write off a large portion
of that amount as uncollectible expense. We cannot predict the
outcome of our litigation with Elysium, which could have any of the
results described above or other results that could materially harm
our business.
*Interruptions in our relationships or declines in our business
with major customers could materially ham our business and
financial results.
Two of our customers accounted for approximately 24% of our sales
during the quarter ended March 31, 2018. Any interruption in our
relationship or decline in our business with these customers or
other customers upon whom we become highly dependent could cause
harm to our business. Factors that could influence our relationship
with our customers upon whom we may become highly dependent
include:
●
our
ability to maintain our products at prices that are competitive
with those of our competitors;
●
our
ability to maintain quality levels for our products sufficient to
meet the expectations of our customers;
●
our
ability to produce, ship and deliver a sufficient quantity of our
products in a timely manner to meet the needs of our
customers;
●
our
ability to continue to develop and launch new products that our
customers feel meet their needs and requirements, with respect to
cost, timeliness, features, performance and other
factors;
●
our
ability to provide timely, responsive and accurate customer support
to our customers; and
●
the
ability of our customers to effectively deliver, market and
increase sales of their own products based on ours.
*In an effort to promote and better market our consumer products,
we have made a strategic decision to not ship NIAGEN® to
certain ingredient segment customers, which could potentially harm
our overall sales.
By
developing and selling TRU NIAGEN®, our own consumer standalone
NIAGEN® supplement product, we are in direct competition with
some of our current ingredients segment customers that use
NIAGEN® in the products that are sold to consumers. In an
effort to promote and better market our consumer product, we have
made a strategic decision not to ship NIAGEN® to certain
ingredients segment customers, which will have a negative effect on
our ingredient segment sales. For example, sales for our
ingredients segment for the year ended December 30, 2017 decreased
34% compared to the year ended December 31, 2016. Additionally, as
our own consumer product becomes more prominent and widely adopted
by consumers, the competition with our consumer product could
potentially further harm the sales of our ingredients segment
business, and our sales of NIAGEN® for our ingredients segment
may further decrease. The sales of our consumer product may not
outweigh the decrease in sales of our ingredients segment, which
would lead to an overall decrease in our sales. Sales for our
ingredients segment represented approximately 36% of the
Company’s revenue for the first quarter of 2018, and sales of
NIAGEN® accounted for approximately 53% of our ingredient
segment’s total sales in the first quarter of 2018, or 19% of
our overall revenue, so any harm to our NIAGEN® ingredient
sales, if not compensated for by sales of our consumer product, may
materially and negatively affect our business.
Our future success largely depends on sales of our TRU
NIAGEN®
product.
In
connection with our strategic shift from an ingredient and testing
company to a consumer focused company, we expect to generate a
significant percentage of our future revenue from sales of our TRU
NIAGEN® product. As a result, the market acceptance of TRU
NIAGEN® is critical to our continued success, and if we are
unable to expand market acceptance of TRU NIAGEN®, our
business, results of operations, financial condition, liquidity and
growth prospects would be adversely affected.
Decline in the state of the global
economy and financial market conditions could adversely affect our
ability to conduct business and our results of
operations.
Global
economic and financial market conditions, including disruptions in
the credit markets and the impact of the global economic
deterioration may materially impact our customers and other parties
with whom we do business. These conditions could negatively affect
our future sales of our ingredient lines as many consumers consider
the purchase of nutritional products discretionary. Decline in
general economic and financial market conditions could materially
adversely affect our financial condition and results of operations.
Specifically, the impact of these volatile and negative conditions
may include decreased demand for our products and services, a
decrease in our ability to accurately forecast future product
trends and demand, and a negative impact on our ability to timely
collect receivables from our customers. The foregoing economic
conditions may lead to increased levels of bankruptcies,
restructurings and liquidations for our customers, scaling back of
research and development expenditures, delays in planned projects
and shifts in business strategies for many of our customers. Such
events could, in turn, adversely affect our business through loss
of sales.
We may need to increase the size of our organization, and we can
provide no assurance that we will successfully expand operations or
manage growth effectively.
Our
significant increase in the scope and the scale of our product
launches, including the hiring of additional personnel, has
resulted in significantly higher operating expenses. As a result,
we anticipate that our operating expenses will continue to
increase. Expansion of our operations may also cause a significant
demand on our management, finances and other resources. Our ability
to manage the anticipated future growth, should it occur, will
depend upon a significant expansion of our accounting and other
internal management systems and the implementation and subsequent
improvement of a variety of systems, procedures and controls. There
can be no assurance that significant problems in these areas will
not occur. Any failure to expand these areas and implement and
improve such systems, procedures and controls in an efficient
manner at a pace consistent with our business could have a material
adverse effect on our business, financial condition and results of
operations. There can be no assurance that our attempts to expand
our marketing, sales, manufacturing and customer support efforts
will be successful or will result in additional sales or
profitability in any future period. As a result of the expansion of
our operations and the anticipated increase in our operating
expenses, as well as the difficulty in forecasting revenue levels,
we expect to continue to experience significant fluctuations in our
results of operations.
Changes in our business strategy, including entering the consumer
product market, or restructuring of our businesses may increase our
costs or otherwise affect the profitability of our
businesses.
As
changes in our business environment occur we may adjust our
business strategies to meet these changes or we may otherwise
decide to restructure our operations or businesses or assets. In
addition, external events including changing technology, changing
consumer patterns and changes in macroeconomic conditions may
impair the value of our assets. When these changes or events occur,
we may incur costs to change our business strategy and may need to
write down the value of assets. In any of these events, our costs
may increase, we may have significant charges associated with the
write-down of assets or returns on new investments may be lower
than prior to the change in strategy or restructuring. For example,
if we are not successful in developing our consumer product
business, our sales may decrease and our costs may
increase.
The success of our consumer product and ingredient business is
linked to the size and growth rate of the vitamin, mineral and
dietary supplement market and an adverse change in the size or
growth rate of that market could have a material adverse effect on
us.
An
adverse change in the size or growth rate of the vitamin, mineral
and dietary supplement market could have a material adverse effect
on our business. Underlying market conditions are subject to change
based on economic conditions, consumer preferences and other
factors that are beyond our control, including media attention and
scientific research, which may be positive or
negative.
Our future growth and profitability of our consumer product
business will depend in large part upon the effectiveness and
efficiency of our marketing efforts and our ability to select
effective markets and media in which to advertise.
Our consumer products business success depends on our ability to
attract and retain customers, which significantly depends on our
marketing practices. Our future growth and profitability will
depend in large part upon the effectiveness and efficiency of our
marketing efforts, including our ability to:
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create greater awareness of our brand;
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identify the most effective and efficient levels of spending in
each market, media and specific media vehicle;
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determine the appropriate creative messages and media mix for
advertising, marketing and promotional expenditures;
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effectively manage marketing costs (including creative and media)
to maintain acceptable customer acquisition costs;
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acquire cost-effective television advertising;
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select the most effective markets, media and specific media
vehicles in which to advertise; and
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convert consumer inquiries into actual orders.
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Unfavorable publicity or consumer perception of our products and
any similar products distributed by other companies could have a
material adverse effect on our business.
We
believe the nutritional supplement market is highly dependent upon
consumer perception regarding the safety, efficacy and quality of
nutritional supplements generally, as well as of products
distributed specifically by us. Consumer perception of our products
can be significantly influenced by scientific research or findings,
regulatory investigations, litigation, national media attention and
other publicity regarding the consumption of nutritional
supplements. We cannot assure you that future scientific research,
findings, regulatory proceedings, litigation, media attention or
other favorable research findings or publicity will be favorable to
the nutritional supplement market or any product, or consistent
with earlier publicity. Future research reports, findings,
regulatory proceedings, litigation, media attention or other
publicity that are perceived as less favorable than, or that
question, such earlier research reports, findings or publicity
could have a material adverse effect on the demand for our products
and consequently on our business, results of operations, financial
condition and cash flows.
Our
dependence upon consumer perceptions means that adverse scientific
research reports, findings, regulatory proceedings, litigation,
media attention or other publicity, if accurate or with merit,
could have a material adverse effect on the demand for our products, the
availability and pricing of our ingredients, and our business,
results of operations, financial condition and cash flows. Further,
adverse public reports or other media attention regarding the
safety, efficacy and quality of nutritional supplements in general,
or our products specifically, or associating the consumption of
nutritional supplements with illness, could have such a material
adverse effect. Any such adverse public reports or other
media attention could arise even if the adverse effects associated
with such products resulted from consumers’ failure to
consume such products appropriately or as directed and the content
of such public reports and other media attention may be beyond our
control.
We may incur material product
liability claims, which could increase our costs and adversely
affect our reputation, revenues and operating
income.
As a
consumer product and ingredient supplier we market and manufacture
products designed for human and animal consumption, we are subject
to product liability claims if the use of our products is alleged
to have resulted in injury. Our products consist of vitamins,
minerals, herbs and other ingredients that are classified as foods,
dietary supplements, or natural health products, and, in most
cases, are not necessarily subject to pre-market regulatory
approval in the United States. Some of our products contain
innovative ingredients that do not have long histories of human
consumption. Previously unknown adverse reactions resulting from
human consumption of these ingredients could occur. In addition,
the products we sell are produced by third-party manufacturers. As
a marketer of products manufactured by third parties, we also may
be liable for various product liability claims for products we do
not manufacture. We may, in the future, be subject to various
product liability claims, including, among others, that our
products include inadequate instructions for use or inadequate
warnings concerning possible side effects and interactions with
other substances. A product liability claim against us could result
in increased costs and could adversely affect our reputation with
our customers, which, in turn, could have a materially adverse
effect on our business, results of operations, financial condition
and cash flows.
We acquire a significant amount of
key ingredients for our products from foreign suppliers, and may be
negatively affected by the risks associated with international
trade and importation issues.
We
acquire a significant amount of key ingredients for a number of our
products from suppliers outside of the United States, particularly
India and China. Accordingly, the acquisition of these
ingredients is subject to the risks generally associated with
importing raw materials, including, among other factors, delays in
shipments, changes in economic and political conditions, quality
assurance, nonconformity to specifications or laws and regulations,
tariffs, trade disputes and foreign currency fluctuations. While we
have a supplier certification program and audit and inspect our
suppliers’ facilities as necessary both in the United States
and internationally, we cannot assure you that raw materials
received from suppliers outside of the United States will conform
to all specifications, laws and regulations. There have
in the past been quality and safety issues in our industry with
certain items imported from overseas. We may incur
additional expenses and experience shipment delays due to
preventative measures adopted by the Indian and U.S. governments,
our suppliers and our company.
The insurance industry has become
more selective in offering some types of coverage and we may not be
able to obtain insurance coverage in the
future.
The
insurance industry has become more selective in offering some types
of insurance, such as product liability, product recall, property
and directors’ and officers’ liability insurance. Our
current insurance program is consistent with both our past level of
coverage and our risk management policies. However, we cannot
assure you that we will be able to obtain comparable insurance
coverage on favorable terms, or at all, in the
future. Certain of our customers as well as prospective
customers require that we maintain minimum levels of coverage for
our products. Lack of coverage or coverage below these minimum
required levels could cause these customers to materially change
business terms or to cease doing business with us
entirely.
If we experience product recalls, we may incur significant and
unexpected costs, and our business reputation could be adversely
affected.
We may be exposed to product recalls and adverse public relations
if our products are alleged to be mislabeled or to cause injury or
illness, or if we are alleged to have violated governmental
regulations. A product recall could result in substantial and
unexpected expenditures, which would reduce operating profit and
cash flow. In addition, a product recall may require significant
management attention. Product recalls may hurt the value of our
brands and lead to decreased demand for our products. Product
recalls also may lead to increased scrutiny by federal, state or
international regulatory agencies of our operations and increased
litigation and could have a material adverse effect on our
business, results of operations, financial condition and cash
flows.
We depend on key personnel, the
loss of any of which could negatively affect our
business.
We
depend greatly on Frank L. Jaksch Jr., Robert N. Fried, Kevin M.
Farr, Mark J. Friedman and Troy A. Rhonemus, who are our Chief
Executive Officer, President and Chief Operating Officer, Chief
Financial Officer, General Counsel and Executive Vice President,
respectively. We also depend greatly on other key employees,
including key scientific and marketing personnel. In general, only
highly qualified and trained scientists have the necessary skills
to develop our products and provide our services. Only marketing
personnel with specific experience and knowledge in health care are
able to effectively market our products. In addition,
some of our manufacturing, quality control, safety and compliance,
information technology, sales and e-commerce related positions are
highly technical as well. We face intense competition for these
professionals from our competitors, customers, marketing partners
and other companies throughout the industries in which we
compete. Our success will depend, in part, upon our ability to
attract and retain additional skilled personnel, which will require
substantial additional funds. There can be no assurance that we
will be able to find and attract additional qualified employees or
retain any such personnel. Our inability to hire qualified
personnel, the loss of services of our key personnel, or the loss
of services of executive officers or key employees that may be
hired in the future may have a material and adverse effect on our
business.
Our operating results may fluctuate significantly as a result of a
variety of factors, many of which are outside of our
control.
We are
subject to the following factors, among others, that may negatively
affect our operating results:
●
the
announcement or introduction of new products by our
competitors;
●
our
ability to upgrade and develop our systems and infrastructure to
accommodate growth;
●
the
decision by significant customers to reduce purchases;
●
disputes and
litigation with competitors;
●
our
ability to attract and retain key personnel in a timely and
cost-effective manner;
●
technical
difficulties;
●
the
amount and timing of operating costs and capital expenditures
relating to the expansion of our business, operations and
infrastructure;
●
regulation by
federal, state or local governments; and
●
general economic
conditions as well as economic conditions specific to the
healthcare industry.
As a
result of our limited operating history and the nature of the
markets in which we compete, it is extremely difficult for us to
make accurate forecasts. We have based our current and future
expense levels largely on our investment plans and estimates of
future events although certain of our expense levels are, to a
large extent, fixed. Assuming our products reach the market, we may
be unable to adjust spending in a timely manner to compensate for
any unexpected revenue shortfall. Accordingly, any significant
shortfall in revenues relative to our planned expenditures would
have an immediate adverse effect on our business, results of
operations and financial condition. Further, as a strategic
response to changes in the competitive environment, we may from
time to time make certain pricing, service or marketing decisions
that could have a material and adverse effect on our business,
results of operations and financial condition. Due to the foregoing
factors, our revenues and operating results are and will remain
difficult to forecast.
We face significant competition, including changes in
pricing.
The
markets for our products and services are both competitive and
price sensitive. Many of our competitors have significant
financial, operations, sales and marketing resources and experience
in research and development. Competitors could develop new
technologies that compete with our products and services or even
render our products obsolete. If a competitor develops superior
technology or cost-effective alternatives to our products and
services, our business could be seriously harmed.
The
markets for some of our products are also subject to specific
competitive risks because these markets are highly price
competitive. Our competitors have competed in the past by lowering
prices on certain products. If they do so again, we may be forced
to respond by lowering our prices. This would reduce sales revenues
and increase losses. Failure to anticipate and respond to price
competition may also impact sales and aggravate
losses.
We
believe that customers in our markets display a significant amount
of loyalty to their supplier of a particular product. To the extent
we are not the first to develop, offer and/or supply new products,
customers may buy from our competitors or make materials
themselves, causing our competitive position to
suffer.
Many of our competitors are larger and have greater financial and
other resources than we do.
Our
products compete and will compete with other similar products
produced by our competitors. These competitive products could be
marketed by well-established, successful companies that possess
greater financial, marketing, distributional, personnel and other
resources than we possess. Using these resources, these companies
can implement extensive advertising and promotional campaigns, both
generally and in response to specific marketing efforts by
competitors, and enter into new markets more rapidly to introduce
new products. In certain instances, competitors with greater
financial resources also may be able to enter a market in direct
competition with us, offering attractive marketing tools to
encourage the sale of products that compete with our products or
present cost features that consumers may find
attractive.
We may never develop any additional products to
commercialize.
We have
invested a substantial amount of our time and resources in
developing various new products. Commercialization of these
products will require additional development, clinical evaluation,
regulatory approval, significant marketing efforts and substantial
additional investment before they can provide us with any revenue.
Despite our efforts, these products may not become commercially
successful products for a number of reasons, including but not
limited to:
●
we
may not be able to obtain regulatory approvals for our products, or
the approved indication may be narrower than we seek;
●
our
products may not prove to be safe and effective in clinical
trials;
●
we
may experience delays in our development program;
●
any
products that are approved may not be accepted in the
marketplace;
●
we
may not have adequate financial or other resources to complete the
development or to commence the commercialization of our products or
will not have adequate financial or other resources to achieve
significant commercialization of our products;
●
we
may not be able to manufacture any of our products in commercial
quantities or at an acceptable cost;
●
rapid
technological change may make our products obsolete;
●
we
may be unable to effectively protect our intellectual property
rights or we may become subject to claims that our activities have
infringed the intellectual property rights of others; and
●
we
may be unable to obtain or defend patent rights for our
products.
We may not be able to partner with others for technological
capabilities and new products and services.
Our
ability to remain competitive may depend, in part, on our ability
to continue to seek partners that can offer technological
improvements and improve existing products and services that are
offered to our customers. We are committed to attempting to keep
pace with technological change, to stay abreast of technology
changes and to look for partners that will develop new products and
services for our customer base. We cannot assure prospective
investors that we will be successful in finding partners or be able
to continue to incorporate new developments in technology, to
improve existing products and services, or to develop successful
new products and services, nor can we be certain that newly
developed products and services will perform satisfactorily or be
widely accepted in the marketplace or that the costs involved in
these efforts will not be substantial.
If we fail to maintain adequate quality standards for our products
and services, our business may be adversely affected and our
reputation harmed.
Dietary
supplement, nutraceutical, food and beverage, functional food,
analytical laboratories, pharmaceutical and cosmetic customers are
often subject to rigorous quality standards to obtain and maintain
regulatory approval of their products and the manufacturing
processes that generate them. A failure to maintain, or, in some
instances, upgrade our quality standards to meet our
customers’ needs, could cause damage to our reputation and
potentially substantial sales losses.
*Our ability to protect our intellectual property and proprietary
technology through patents and other means is uncertain and may be
inadequate, which would have a material and adverse effect on
us.
Our
success depends significantly on our ability to protect our
proprietary rights to the technologies used in our products. We
rely on patent protection, as well as a combination of copyright,
trade secret and trademark laws and nondisclosure, confidentiality
and other contractual restrictions to protect our proprietary
technology, including our licensed technology. However, these legal
means afford only limited protection and may not adequately protect
our rights or permit us to gain or keep any competitive advantage.
For example, our pending United States and foreign patent
applications may not issue as patents in a form that will be
advantageous to us or may issue and be subsequently successfully
challenged by others and invalidated. In addition, our pending
patent applications include claims to material aspects of our
products and procedures that are not currently protected by issued
patents. Both the patent application process and the process of
managing patent disputes can be time consuming and expensive.
Competitors may be able to design around our patents or develop
products which provide outcomes which are comparable or even
superior to ours. Steps that we have taken to protect our
intellectual property and proprietary technology, including
entering into confidentiality agreements and intellectual property
assignment agreements with some of our officers, employees,
consultants and advisors, may not provide us with meaningful
protection for our trade secrets or other proprietary information
in the event of unauthorized use or disclosure or other breaches of
the agreements. Furthermore, the laws of foreign countries may not
protect our intellectual property rights to the same extent as do
the laws of the United States.
In the
event a competitor infringes our licensed or pending patent or
other intellectual property rights, enforcing those rights may be
costly, uncertain, difficult and time consuming. Even if
successful, litigation to enforce our intellectual property rights
or to defend our patents against challenge could be expensive and
time consuming and could divert our management’s attention.
As further described in Part II, Item 1 of this Quarterly Report on
Form 10-Q, we are currently involved in patent litigation, as
Elysium is claiming that we misused certain patent rights, and has
filed a petition with the U.S. Patent and Trademark Office for
inter partes review of two patents to which we are the exclusive
licensee. The U.S. Patent Trial and
Appeal Board denied institution of an inter partes review for one
patent, but granted institution on an inter partes review as to
certain claims for the other patent. If we are unsuccessful
in resolving the patent misuse claim on favorable terms, or if the
U.S. Patent and Trademark Office invalidates the patent still
subject to the inter partes review, we may lose the competitive
advantage that is provided by the subject intellectual property
rights, which could have a material adverse effect on our business.
We may not have sufficient resources to enforce our intellectual
property rights or to defend our patents rights against a
challenge. The failure to obtain patents and/or protect our
intellectual property rights could have a material and adverse
effect on our business, results of operations and financial
condition.
*Our patents and licenses may be subject to challenge on validity
grounds, and our patent applications may be rejected.
We rely
on our patents, patent applications, licenses and other
intellectual property rights to give us a competitive advantage.
Whether a patent is valid, or whether a patent application should
be granted, is a complex matter of science and law, and therefore
we cannot be certain that, if challenged, our patents, patent
applications and/or other intellectual property rights would be
upheld. If one or more of those patents, patent applications,
licenses and other intellectual property rights are invalidated,
rejected or found unenforceable, that could reduce or eliminate any
competitive advantage we might otherwise have had. For example, as
further described in Part II, Item 1 of this Quarterly Report on
Form 10-Q, we are currently involved in patent litigation, as
Elysium is claiming that we misused certain patent rights, and has
filed a petition with the U.S. Patent and Trademark Office for
inter partes review of two patents to which we are the exclusive
licensee. The U.S. Patent Trial and
Appeal Board denied institution of an inter partes review for one
patent, but granted institution on an inter partes review as to
certain claims for the other patent. If we are unsuccessful
in resolving the patent misuse claim on favorable terms, or if the
U.S. Patent and Trademark Office invalidates the patent subject to
the inter partes review, we may lose the competitive advantage that
is provided by the subject intellectual property rights, which
could have a material adverse effect on our business.
We may become subject to claims of infringement or misappropriation
of the intellectual property rights of others, which could prohibit
us from developing our products, require us to obtain licenses from
third parties or to develop non-infringing alternatives and subject
us to substantial monetary damages.
Third
parties could, in the future, assert infringement or
misappropriation claims against us with respect to products we
develop. Whether a product infringes a patent or misappropriates
other intellectual property involves complex legal and factual
issues, the determination of which is often uncertain. Therefore,
we cannot be certain that we have not infringed the intellectual
property rights of others. There may be third-party patents or
patent applications with claims to materials, formulations, methods
of manufacture or methods for use related to the use or manufacture
of our products, and our potential competitors may assert that some
aspect of our product infringes their patents. Because patent
applications may take years to issue, there also may be
applications now pending of which we are unaware that may later
result in issued patents upon which our products could infringe.
There also may be existing patents or pending patent applications
of which we are unaware upon which our products may inadvertently
infringe.
Any
infringement or misappropriation claim could cause us to incur
significant costs, place significant strain on our financial
resources, divert management’s attention from our business
and harm our reputation. If the relevant patents in such claim were
upheld as valid and enforceable and we were found to infringe them,
we could be prohibited from manufacturing or selling any product
that is found to infringe unless we could obtain licenses to use
the technology covered by the patent or are able to design around
the patent. We may be unable to obtain such a license on terms
acceptable to us, if at all, and we may not be able to redesign our
products to avoid infringement, which could materially impact our
revenue. A court could also order us to pay compensatory damages
for such infringement, plus prejudgment interest and could, in
addition, treble the compensatory damages and award attorney fees.
These damages could be substantial and could harm our reputation,
business, financial condition and operating results. A court also
could enter orders that temporarily, preliminarily or permanently
enjoin us and our customers from making, using, or selling
products, and could enter an order mandating that we undertake
certain remedial activities. Depending on the nature of the relief
ordered by the court, we could become liable for additional damages
to third parties.
*The prosecution and enforcement of patents licensed to us by third
parties are not within our control. Without these technologies, our
products may not be successful and our business would be harmed if
the patents were infringed on or misappropriated without action by
such third parties.
We have
obtained licenses from third parties for patents and patent
application rights related to the products we are developing,
allowing us to use intellectual property rights owned by or
licensed to these third parties. We do not control the maintenance,
prosecution, enforcement or strategy for many of these patents or
patent application rights and as such are dependent in part on the
owners of the intellectual property rights to maintain their
viability. If any third party licensor is unable to successfully
maintain, prosecute or enforce the licensed patents and/or patent
application rights related to our products, we may become subject
to infringement or misappropriate claims or lose our competitive
advantage. Without access to these technologies or suitable
design-around or alternative technology options, our ability to
conduct our business could be impaired significantly. As further
described in Part II, Item 1 of this Quarterly Report on Form 10-Q,
Elysium has filed a petition with the U.S. Patent and Trademark
Office for inter partes review of two patents to which we are the
exclusive licensee. The U.S. Patent
Trial and Appeal Board denied institution of an inter partes review
for one patent, but granted institution on an inter partes review
as to certain claims for the other patent. Pursuant to the
exclusive license agreement with the Trustees of Dartmouth College
(“Dartmouth”), Dartmouth controls all future
preparation, filing, prosecution and maintenance of the patent
subject to such inter partes review.
We may be subject to damages resulting from claims that we, our
employees, or our independent contractors have wrongfully used or
disclosed alleged trade secrets of others.
Some of
our employees were previously employed at other dietary supplement,
nutraceutical, food and beverage, functional food, analytical
laboratories, pharmaceutical and cosmetic companies. We may also
hire additional employees who are currently employed at other such
companies, including our competitors. Additionally, consultants or
other independent agents with which we may contract may be or have
been in a contractual arrangement with one or more of our
competitors. We may be subject to claims that these employees or
independent contractors have used or disclosed such other
party’s trade secrets or other proprietary information.
Litigation may be necessary to defend against these claims. Even if
we are successful in defending against thes