ChromaDex Corp. - Quarter Report: 2016 October (Form 10-Q)
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 October 1, 2016
Commission
File Number: 000-53290
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
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92618
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(Address of
Principal Executive Offices)
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(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 or smaller reporting
company. See definition of “large accelerated filer,
accelerated filer and smaller reporting company” in Rule
12b-2 of the Exchange Act. (Check one):
Large
accelerated filer
____
Accelerated filer
X
Non-accelerated
filer
____ Smaller
reporting company ____
(Do not
check if smaller reporting company)
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 November 9, 2016 there were 37,904,534 shares of the
registrant’s common stock issued and
outstanding.
CHROMADEX
CORPORATION
QUARTERLY
REPORT ON FORM 10-Q
TABLE OF CONTENTS
PART I –
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FINANCIAL
INFORMATION (UNAUDITED)
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1
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1
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2
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4
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5
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6
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16
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23
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24
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PART II –
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OTHER
INFORMATION
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25
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25
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38
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38
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38
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38
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39
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40
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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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October
1, 2016 and January 2, 2016
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October
1, 2016
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January 2,
2016
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Assets
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Current
assets
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Cash
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$2,264,756
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$5,549,672
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Trade receivables,
net of allowances of $603,000 and $367,000,
respectively
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6,511,439
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2,450,591
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Inventories
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6,312,909
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8,173,799
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Prepaid expenses
and other assets
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401,902
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373,567
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Total
current assets
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15,491,006
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16,547,629
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Leasehold
improvements and equipment, net
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2,495,215
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1,788,645
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Deposits and
other
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261,215
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58,883
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Intangible assets,
net
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495,936
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354,052
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Longterm
investment
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20,318
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-
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Total
assets
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$18,763,690
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$18,749,209
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Liabilities
and stockholders' equity
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Current
liabilities
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Accounts
payable
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$4,098,778
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$6,223,958
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Accrued
expenses
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1,709,662
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1,302,865
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Current maturities
of loan payable
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-
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1,528,578
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Current maturities
of capital lease obligations
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217,308
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219,689
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Customer deposits
and other
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277,615
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272,002
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Deferred rent,
current
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52,734
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39,529
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Total
current liabilities
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6,356,097
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9,586,621
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Loan payable, less
current maturities, net
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-
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3,345,335
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Capital lease
obligations, less current maturities
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282,820
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444,589
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Deferred rent, less
current
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267,419
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97,990
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Total
liabilities
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6,906,336
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13,474,535
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Commitments and
contingencies
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Stockholders'
equity
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Common stock, $.001
par value; authorized 50,000,000 shares;
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issued and
outstanding October 1, 2016 37,543,198 and
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January 2, 2016
36,003,589 shares
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37,543
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36,004
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Additional paid-in
capital
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54,896,632
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47,534,059
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Accumulated
deficit
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(43,076,821)
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(42,295,389)
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Total
stockholders' equity
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11,857,354
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5,274,674
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Total
liabilities and stockholders' equity
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$18,763,690
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$18,749,209
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See Notes to
Condensed 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 October 1, 2016 and October 3,
2015
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October
1, 2016
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October 3,
2015
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Sales,
net
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$5,007,450
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$6,287,309
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Cost of
sales
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2,964,980
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3,805,679
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Gross
profit
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2,042,470
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2,481,630
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Operating
expenses:
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Sales and
marketing
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447,985
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550,878
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Research and
development
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772,799
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188,690
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General and
administrative
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1,768,402
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1,564,932
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Operating
expenses
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2,989,186
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2,304,500
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Operating
income (loss)
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(946,716)
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177,130
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Nonoperating income
(expense):
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Interest
income
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565
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976
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Interest
expense
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(11,392)
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(181,822)
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Nonoperating
expenses
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(10,827)
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(180,846)
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Loss before
taxes
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(957,543)
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(3,716)
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Provision for
taxes
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3,153
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-
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Net
loss
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$(954,390)
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$(3,716)
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Basic and diluted
loss per common share
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$(0.03)
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$(0.00)
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Basic and diluted
weighted average common shares outstanding
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37,868,672
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35,814,305
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See Notes to
Condensed 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 Nine Month Periods Ended October 1, 2016 and October 3,
2015
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October
1, 2016
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October 3,
2015
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Sales,
net
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$21,168,974
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$17,649,660
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Cost of
sales
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11,547,638
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10,769,714
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Gross
profit
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9,621,336
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6,879,946
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Operating
expenses:
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Sales and
marketing
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1,690,738
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1,776,403
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Research and
development
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1,988,597
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485,195
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General and
administrative
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6,063,520
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5,531,362
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Operating
expenses
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9,742,855
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7,792,960
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Operating
loss
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(121,519)
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(913,014)
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Nonoperating income
(expense):
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Interest
income
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1,997
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2,339
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Interest
expense
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(345,311)
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(433,748)
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Loss on debt
extinguishment
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(313,099)
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-
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Nonoperating
expenses
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(656,413)
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(431,409)
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Loss before
taxes
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(777,932)
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(1,344,423)
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Provision for
taxes
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(3,500)
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-
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Net
loss
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$(781,432)
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$(1,344,423)
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Basic and diluted
loss per common share
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$(0.02)
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$(0.04)
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Basic and diluted
weighted average common shares outstanding
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37,090,916
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35,783,490
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See
Notes to Condensed 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 Nine Month Period Ended October 1, 2016
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Common
Stock
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Additional
Paid-In
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Accumulated
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Total
Stockholder's
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Shares
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Amount
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Capital
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Deficit
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Equity
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Balance, January 2,
2016
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36,003,589
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$36,004
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$47,534,059
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$(42,295,389)
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$5,274,674
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Issuance of common
stock, net of offering costs of
$20,000
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128,205
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128
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479,872
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-
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480,000
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Exercise of stock
options
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47,055
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47
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93,825
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-
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93,872
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Share-based
compensation
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-
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-
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324,035
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-
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324,035
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Vested restricted
stock
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2,000
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2
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(2)
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-
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-
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Net
income
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-
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-
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-
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255,625
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255,625
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Balance, April 2,
2016
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36,180,849
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$36,181
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$48,431,789
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$(42,039,764)
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$6,428,206
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1 for 3 reverse
stock split, issuance due to fractional shares round
up
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1,632
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2
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(2)
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-
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-
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Issuance of common
stock, net of offering costs of
$10,000
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1,117,022
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1,117
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5,238,883
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-
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5,240,000
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Exercise of stock
options
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185,081
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185
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528,327
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-
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528,512
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Share-based
compensation
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-
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-
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333,602
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-
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333,602
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Vested restricted
stock
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5,330
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5
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(5)
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-
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-
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Net
loss
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-
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-
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-
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(82,667)
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(82,667)
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Balance, July 2,
2016
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37,489,914
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$37,490
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$54,532,594
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$(42,122,431)
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$12,447,653
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Reconciliation of
offering costs
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-
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-
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(2,526)
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-
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(2,526)
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Exercise of stock
options
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47,950
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48
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94,180
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-
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94,228
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Share-based
compensation
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-
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-
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272,389
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-
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272,389
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Vested restricted
stock
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5,334
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5
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(5)
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-
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-
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Net
loss
|
-
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-
|
-
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(954,390)
|
(954,390)
|
|
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|
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Balance,
October 1, 2016
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37,543,198
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$37,543
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$54,896,632
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$(43,076,821)
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$11,857,354
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|
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|
See Notes to
Condensed 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 Nine Month Periods Ended October 1, 2016 and October 3,
2015
|
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October
1, 2016
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October 3,
2015
|
|
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Cash Flows From
Operating Activities
|
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Net
loss
|
$(781,432)
|
$(1,344,423)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
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Depreciation
of leasehold improvements and equipment
|
234,408
|
209,754
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Amortization
of intangibles
|
63,116
|
32,236
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Share-based
compensation expense
|
930,026
|
1,656,504
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Allowance
for doubtful trade receivables
|
235,591
|
5,429
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Loss
from disposal of equipment
|
-
|
19,643
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Loss
on debt extinguishment
|
313,099
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-
|
Non-cash
financing costs
|
94,080
|
139,780
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Changes
in operating assets and liabilities:
|
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Trade
receivables
|
(4,296,439)
|
(1,883,261)
|
Inventories
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1,840,572
|
(429,287)
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Prepaid
expenses and other assets
|
(230,667)
|
(86,183)
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Accounts
payable
|
(2,125,180)
|
108,961
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Accrued
expenses
|
406,797
|
361,481
|
Customer
deposits and other
|
5,613
|
2,393
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Deferred
rent
|
182,634
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(50,589)
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Net
cash used in operating activities
|
(3,127,782)
|
(1,257,562)
|
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Cash Flows From
Investing Activities
|
|
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Purchases
of leasehold improvements and equipment
|
(940,978)
|
(242,765)
|
Purchases
of intangible assets
|
(205,000)
|
(107,500)
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Net
cash used in investing activities
|
(1,145,978)
|
(350,265)
|
|
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Cash Flows From
Financing Activities
|
|
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Proceeds
from issuance of common stock, net of issuance costs
|
5,717,474
|
-
|
Proceeds
from exercise of stock options
|
716,612
|
25,266
|
Proceeds
from loan payable
|
-
|
2,500,000
|
Payment
of debt issuance cost
|
-
|
(15,000)
|
Principal
payments on loan payable
|
(5,000,000)
|
-
|
Cash
paid for debt extinguishment costs
|
(281,092)
|
-
|
Principal
payments on capital leases
|
(164,150)
|
(158,547)
|
Net
cash provided by financing activities
|
988,844
|
2,351,719
|
|
|
|
Net (decrease)
increase in cash
|
(3,284,916)
|
743,892
|
|
|
|
Cash Beginning of
Period
|
5,549,672
|
3,964,750
|
|
|
|
Cash Ending of
Period
|
$2,264,756
|
$4,708,642
|
|
|
|
Supplemental
Disclosures of Cash Flow Information
|
|
|
Cash
payments for interest
|
$251,231
|
$293,968
|
|
|
|
Supplemental
Schedule of Noncash Investing Activity
|
|
|
Capital
lease obligation incurred for purchases of equipment
|
$-
|
$303,933
|
Inventory
supplied to Healthspan Research, LLC for equity interest, at
cost
|
$20,318
|
$-
|
Retirement
of fully depreciated equipment - cost
|
$28,083
|
$8,181
|
Retirement
of fully depreciated equipment - accumulated
depreciation
|
$(28,083)
|
$(8,181)
|
|
|
|
See
Notes to Condensed Consolidated Financial Statements.
|
Note
1. Interim
Financial Statements
The
accompanying financial statements of ChromaDex Corporation (the
“Company”) and its wholly owned subsidiaries,
ChromaDex, Inc., ChromaDex Analytics, Inc. and Spherix Consulting,
Inc. 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 October 1, 2016 and
results of operations and cash flows for the three and nine months
ended October 1, 2016 and October 3, 2015. 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 January 2, 2016 appearing in the Company’s
Annual Report on Form 10-K filed with the Securities and Exchange
Commission (the “Commission”) on March 17, 2016.
Operating results for the nine months ended October 1, 2016 are not
necessarily indicative of the results to be achieved for the full
year ending on December 31, 2016. 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 January 2, 2016 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
leverages its complementary business units to discover, acquire,
develop and commercialize patented and proprietary ingredient
technologies that address the dietary supplement, food, beverage,
skin care and pharmaceutical markets. In addition to our ingredient
technologies unit, we also have business units focused on natural
product fine chemicals (known as "phytochemicals"), chemistry and
analytical testing services, and product regulatory and safety
consulting (known as Spherix Consulting). As a result of our
relationships with leading universities and research institutions,
we are able to discover and license early stage, Intellectual
Property-backed ingredient technologies. We then utilize our
in-house chemistry, regulatory and safety consulting business units
to develop commercially viable ingredients. Our ingredient
portfolio is backed with clinical and scientific research, as well
as extensive Intellectual Property protection.
Liquidity: The Company has
incurred loss from operations of approximately $122,000 and net
loss of approximately $781,000 for the nine-month period ended
October 1, 2016. As of October 1, 2016, the cash and cash
equivalents totaled approximately $2,265,000.
Subsequent to the
period ended October 1, 2016, the Company entered into a business
financing agreement with Western Alliance Bank, in order to
establish a formula based revolving credit line up to $5.0 million.
While we anticipate that our current cash, cash equivalents, cash
to be generated from operations and the established $5.0 million
revolving credit line will be sufficient to meet our projected
operating plans through at least November 11, 2017, 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.
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
the Saturday closest to December 31. Every fifth or sixth fiscal
year, the inclusion of an extra week occurs due to the
Company’s floating year-end date. The fiscal year 2015 ended
on January 2, 2016 consisted of normal 52 weeks. The fiscal year
2016 ending on December 31, 2016 will also include the normal 52
weeks.
Changes in accounting
principle: In September 2016, the Financial Accounting
Standards Board (“FASB”) issued Accounting Standards
Update (“ASU”) No. 2016-15, Statement of Cash Flows:
Classification of Certain Cash Receipts and Cash Payments. The ASU
is issued to clarify whether certain items, including debt
prepayments and extinguishment costs, should be categorized as
operating, investing or financing in the statement of cash flows,
The amendments in this ASU clarify that debt extinguishment costs
should be classified as financing cash outflows.
The
Company early adopted the amendments in this ASU effective as of
October 1, 2016. For the nine-month period ended October 1, 2016,
the Company incurred loss of approximately $313,000 on debt
extinguishment and approximately $281,000 were paid in cash. The
Company had previously presented these cash paid costs as operating
cash outflows in its consolidated statement of cash flows for the
six-month period ended July 2, 2016 in the Company’s
Quarterly Report on Form 10-Q filed with the Commission on August
11, 2016. The early adoption has resulted in adjustments to the
Company’s consolidated statement of cash flows for the
six-month period ended July 2, 2016, by reclassifying the cash paid
for debt extinguishment costs as financing cash
outflows.
Below
are the effects of the change on the consolidated statement of cash
flows for the six-month period ended July 2, 2016.
ChromaDex
Corporation and Subsidiaries
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Cash Flows (Unaudited)
|
|
|
|
For
the Six Month Period Ended July 2, 2016
|
|
|
|
|
|
|
|
|
Previously
Reported
|
Adjustments
|
As
Adjusted
|
|
|
|
|
Cash Flows From
Operating Activities
|
|
|
|
Net
income
|
$172,958
|
$-
|
$172,958
|
Adjustments to
reconcile net income to net cash used in operating
activities:
|
1,011,158
|
281,092
|
1,292,250
|
Changes
in operating assets and liabilities:
|
(4,171,503)
|
-
|
(4,171,503)
|
Net
cash used in operating activities
|
(2,987,387)
|
281,092
|
(2,706,295)
|
|
|
|
|
Cash Flows From
Investing Activities
|
|
|
|
Purchases
of leasehold improvements and equipment
|
(231,201)
|
-
|
(231,201)
|
Purchases
of intangible assets
|
(195,000)
|
-
|
(195,000)
|
Net
cash used in investing activities
|
(426,201)
|
-
|
(426,201)
|
|
|
|
|
Cash Flows From
Financing Activities
|
|
|
|
Proceeds
from issuance of common stock, net of issuance costs
|
5,720,000
|
-
|
5,720,000
|
Proceeds
from exercise of stock options
|
622,384
|
-
|
622,384
|
Principal
payments on loan payable
|
(5,000,000)
|
-
|
(5,000,000)
|
Cash
paid for debt extinguishment costs
|
-
|
(281,092)
|
(281,092)
|
Principal
payments on capital leases
|
(108,249)
|
-
|
(108,249)
|
Net
cash provided by financing activities
|
1,234,135
|
(281,092)
|
953,043
|
|
|
|
|
Net decrease in
cash
|
(2,179,453)
|
-
|
(2,179,453)
|
|
|
|
|
Cash Beginning of
Period
|
5,549,672
|
-
|
5,549,672
|
|
|
|
|
Cash Ending of
Period
|
$3,370,219
|
$-
|
$3,370,219
|
Inventories: Inventories are comprised of raw materials,
work-in-process and finished goods. They are stated at the lower of
cost, determined by the first-in, first-out method
(“FIFO”) method, or market. Labor and overhead has been
added to inventory that was manufactured or characterized by the
Company. The amounts of major classes of inventory as of October 1,
2016 and January 2, 2016 are as follows:
|
October
1, 2016
|
January 2,
2016
|
Natural product
fine chemicals
|
$1,024,213
|
$1,239,338
|
Bulk
ingredients
|
5,388,696
|
7,195,461
|
|
6,412,909
|
8,434,799
|
Less valuation
allowance
|
(100,000)
|
(261,000)
|
|
$6,312,909
|
$8,173,799
|
Note
4. Reverse
Stock Split
On
April 13, 2016, the Company effected a 1-for-3 reverse stock split.
All information presented herein has been retrospectively adjusted
to reflect the reverse stock split as if they took place as of the
earliest period presented. An additional 1,632 shares were issued
to round up fractional shares as a result of the reverse stock
split.
Note
5. 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 and nine
months ended October 1, 2016 and October 3, 2015:
|
Three
Months Ended
|
Nine
Months Ended
|
||
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Oct.
1, 2016
|
Oct.
3, 2015
|
|
|
|
|
|
Net
loss
|
$(954,390)
|
$(3,716)
|
$(781,432)
|
$(1,344,423)
|
|
|
|
|
|
Basic and diluted
loss per common share
|
$(0.03)
|
$(0.00)
|
$(0.02)
|
$(0.04)
|
|
|
|
|
|
Weighted average
common shares outstanding (1):
|
37,868,672
|
35,814,305
|
37,090,916
|
35,783,490
|
|
|
|
|
|
Potentially
dilutive securities, total (2):
|
|
|
|
|
Stock
options
|
5,217,508
|
5,279,868
|
5,217,508
|
5,279,868
|
Warrants
|
487,111
|
156,340
|
487,111
|
156,340
|
Convertible
debt
|
-
|
257,798
|
-
|
257,798
|
|
|
|
|
|
(1) Includes
approximately 0.4 million nonvested restricted stock for all
periods presented, 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
6. Loan
Payable
On June
14, 2016, the Company repaid $4,851,542 owed to Hercules Funding II
LLC (“Hercules”), under the Company’s loan and
security agreement with Hercules dated as of September 29, 2014
(the “Loan Agreement”).
The
payoff amount was comprised of the following:
Payoff Amount
|
|
|
|
Principal
|
$4,554,659
|
Accrued
interest
|
15,790
|
End
of term charge
|
187,500
|
Prepayment
fee
|
91,093
|
Other
fees
|
2,500
|
|
|
Total
|
$4,851,542
|
Upon
receipt of the Payoff Amount, the Loan Agreement
terminated.
The
Loan Agreement initially provided the Company with access to a term
loan of up to $5 million. The first $2.5 million of the term loan
was funded at the closing of the Loan Agreement, and was repayable
in installments over 30 months, following an initial interest-only
period of twelve months after closing. The Company drew down the
remaining $2.5 million of the term loan on June 17, 2015 and the
interest-only period was extended to March 31, 2016. In connection
with the loan, the Company paid an aggregate of $65,000 in facility
charges to Hercules and granted Hercules first priority liens and a
security interest in substantially all of its assets.
The
Loan Agreement also provided (i) a borrower option to repay
principal in common stock up to an aggregate amount of $500,000 at
a conversion price of $3.879 per share and (ii) a lender option to
receive principal repayments in common stock up to an aggregate
amount of $500,000 at a conversion price of $3.879 per share,
subject to certain conditions. However, no principal was repaid in
common stock. On the commitment date, no separate accounting was
required for the conversion feature.
In
connection with the termination of the Loan Agreement,
Hercules’s commitments to extend further credit to the
Company terminated, all obligations, covenants, debts and
liabilities of the Company under the Loan Agreement were satisfied
and discharged in full, all documents entered into in connection
with the Loan Agreement, other than a warrant issued pursuant to
the Loan Agreement, were terminated, all liens or security
interests granted to secure the obligations under the Loan
Agreement terminated and all guaranties of the Company’s
obligations under the Loan Agreement terminated.
The
payoff amount, excluding the accrued interest to date, was
$4,835,752 and the net carrying amount of the debt on the
extinguishment date was $4,522,653. The difference of $313,099 was
recognized as a non-operating loss in the statement of operations
during the nine months ended October 1, 2016.
Net Carrying
Amount
|
|
Payoff Amount (Excluding Interest)
|
||
|
|
|
|
|
Principal
|
$4,554,659
|
|
Principal
|
$4,554,659
|
Accrued
end of term charge
|
103,909
|
|
End
of term charge
|
187,500
|
Deferred
financing cost
|
(45,606)
|
|
Prepayment
fee
|
91,093
|
Warrant
discount
|
(90,309)
|
|
Other
fees
|
2,500
|
|
|
|
|
|
Total
|
$4,522,653
|
|
Total
|
$4,835,752
|
|
(A)
|
|
|
(B)
|
Loss
on debt extinguishment
|
$(313,099)
|
|
|
|
|
(A) - (B)
|
|
|
|
Note
7. Employee
Share-Based Compensation
Service Period Based
Stock Options
The
following table summarizes activity of service period based stock
options granted to employees at October 1, 2016 and changes during
the nine months then ended:
|
|
Weighted
Average
|
|
||
|
|
|
Remaining
|
|
Aggregate
|
|
Number
of
|
Exercise
|
Contractual
|
Fair
|
Intrinsic
|
|
Shares
|
Price
|
Term
|
Value
|
Value
|
Outstanding at
January 2, 2016
|
4,314,264
|
$3.50
|
6.44
|
|
|
|
|
|
|
|
|
Options
Granted
|
579,148
|
4.27
|
10.00
|
$2.71
|
|
Options
Exercised
|
(238,423)
|
2.67
|
|
|
$502,000
|
Options
Forfeited
|
(326,663)
|
4.15
|
|
|
|
Outstanding at
October 1, 2016
|
4,328,326
|
$3.60
|
6.20
|
|
$684,000
|
|
|
|
|
|
|
Exercisable at
October 1, 2016
|
3,314,918
|
$3.46
|
5.31
|
|
$668,000
|
The
aggregate intrinsic values in the table above are based on the
Company’s stock price of $2.98, which is the closing price of
the Company’s stock on the last day of business for the
period ended October 1, 2016.
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 nine months ended October 1,
2016.
Nine Months Ended
October 1, 2016
|
|
Expected
term
|
6.0
years
|
Expected
volatility
|
73%
|
Expected
dividends
|
0.00%
|
Risk-free
rate
|
1.33%
|
As of
October 1, 2016, there
was approximately $2,271,000 of total unrecognized compensation
expected to be recognized over a weighted average period of 3.0
years.
Employee Share-Based Compensation
The
Company recognized compensation expense of approximately $260,000
and $881,000 in general and administrative expenses in the
statement of operations for the three and nine months ended October
1, 2016, respectively, and approximately $418,000 and $1,238,000
for the three and nine months ended October 3, 2015,
respectively.
Note
8. Stock
Issuance
On
March 11, 2016, the Company entered into a Securities Purchase
Agreement (“SPA”) to raise $500,000 in a registered
direct offering. Pursuant to the SPA, the Company sold a total of
128,205 Units at a purchase price of $3.90 per Unit, with each Unit
consisting of one share of the Company’s common stock and a
warrant to purchase one half of a share of common stock (64,103
total) with an exercise price of $4.80 and a term of 3 years. The
estimated fair value of the warrant was approximately $108,000 and
the warrant was determined to be classified as equity. The fair
value was estimated at the date of issuance using the Black-Scholes
based valuation model. The table below outlines the assumptions for
the warrant issued.
|
March 11,
2016
|
Fair value of
common stock
|
$4.41
|
Contractual
term
|
3.0
years
|
Volatility
|
60%
|
Risk-free
rate
|
1.16%
|
Expected
dividends
|
0.00%
|
On June
3, 2016, the Company entered into additional SPAs to raise
$5,250,000 in a registered direct offering. Pursuant to the SPAs,
the Company sold a total of 1,117,022 shares of the Company’s
common stock at a purchase price of $4.70 per share.
Note
9. Business
Segments
The
Company has the following three reportable segments:
●
Ingredients segment
develops and commercializes proprietary-based ingredient
technologies and supplies these ingredients 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 supply of phytochemical
reference standards, which are small quantities of plant-based
compounds typically used to research an array of potential
attributes, reference materials and related contract
services.
●
Scientific and
regulatory consulting segment which provides scientific and
regulatory consulting to the clients in the food, supplement and
pharmaceutical industries to manage potential health and regulatory
risks.
The
“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.
Three months
ended
October 1,
2016
|
|
Core
Standards and
|
Scientific
and
|
|
|
|
Ingredients
|
Contract
Services
|
Regulatory
Consulting
|
|
|
|
segment
|
segment
|
segment
|
Other
|
Total
|
|
|
|
|
|
|
Net
sales
|
$2,663,095
|
$2,052,135
|
$292,220
|
$-
|
$5,007,450
|
Cost of
sales
|
1,287,421
|
1,548,268
|
129,291
|
-
|
2,964,980
|
|
|
|
|
|
|
Gross
profit
|
1,375,674
|
503,867
|
162,929
|
-
|
2,042,470
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales and
marketing
|
199,130
|
245,255
|
3,600
|
-
|
447,985
|
Research and
development
|
760,299
|
12,500
|
-
|
-
|
772,799
|
General and
administrative
|
-
|
-
|
-
|
1,768,402
|
1,768,402
|
Operating
expenses
|
959,429
|
257,755
|
3,600
|
1,768,402
|
2,989,186
|
|
|
|
|
|
|
Operating
income (loss)
|
$416,245
|
$246,112
|
$159,329
|
$(1,768,402)
|
$(946,716)
|
Three months
ended
October 3,
2015
|
|
Core
Standards and
|
Scientific
and
|
|
|
Ingredients
|
Contract
Services
|
Regulatory
Consulting
|
|
|
|
|
segment
|
segment
|
segment
|
Other
|
Total
|
|
|
|
|
|
|
Net
sales
|
$4,146,597
|
$1,875,296
|
$265,416
|
$-
|
$6,287,309
|
Cost of
sales
|
2,157,183
|
1,533,402
|
115,094
|
-
|
3,805,679
|
|
|
|
|
|
|
Gross
profit
|
1,989,414
|
341,894
|
150,322
|
-
|
2,481,630
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales and
marketing
|
259,874
|
287,901
|
3,103
|
-
|
550,878
|
Research and
development
|
188,690
|
-
|
-
|
-
|
188,690
|
General and
administrative
|
-
|
-
|
-
|
1,564,932
|
1,564,932
|
Operating
expenses
|
448,564
|
287,901
|
3,103
|
1,564,932
|
2,304,500
|
|
|
|
|
|
|
Operating
income (loss)
|
$1,540,850
|
$53,993
|
$147,219
|
$(1,564,932)
|
$177,130
|
Nine months
ended
October 1,
2016
|
|
Core
Standards and
|
Scientific
and
|
|
|
|
Ingredients
|
Contract
Services
|
RegulatoryConsulting
|
|
|
|
segment
|
segment
|
segment
|
Other
|
Total
|
|
|
|
|
|
|
Net
sales
|
$13,505,470
|
$7,110,783
|
$552,721
|
$-
|
$21,168,974
|
Cost of
sales
|
6,420,972
|
4,781,539
|
345,127
|
-
|
11,547,638
|
|
|
|
|
|
|
Gross
profit
|
7,084,498
|
2,329,244
|
207,594
|
-
|
9,621,336
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales and
marketing
|
930,573
|
749,165
|
11,000
|
-
|
1,690,738
|
Research and
development
|
1,961,097
|
27,500
|
-
|
-
|
1,988,597
|
General and
administrative
|
-
|
-
|
-
|
6,063,520
|
6,063,520
|
Operating
expenses
|
2,891,670
|
776,665
|
11,000
|
6,063,520
|
9,742,855
|
|
|
|
|
|
|
Operating
income (loss)
|
$4,192,828
|
$1,552,579
|
$196,594
|
$(6,063,520)
|
$(121,519)
|
Nine months
ended
October 3,
2015
|
|
Core
Standards and
|
Scientific
and
|
|
|
|
Ingredients
|
Contract
Services
|
Regulatory
Consulting
|
|
|
|
segment
|
segment
|
segment
|
Other
|
Total
|
|
|
|
|
|
|
Net
sales
|
$10,238,574
|
$6,546,816
|
$864,270
|
$-
|
$17,649,660
|
Cost of
sales
|
5,629,564
|
4,742,480
|
397,670
|
-
|
10,769,714
|
|
|
|
|
|
|
Gross
profit
|
4,609,010
|
1,804,336
|
466,600
|
-
|
6,879,946
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales and
marketing
|
832,779
|
935,237
|
8,387
|
-
|
1,776,403
|
Research and
development
|
485,195
|
-
|
-
|
-
|
485,195
|
General and
administrative
|
-
|
-
|
-
|
5,531,362
|
5,531,362
|
Operating
expenses
|
1,317,974
|
935,237
|
8,387
|
5,531,362
|
7,792,960
|
|
|
|
|
|
|
Operating
income (loss)
|
$3,291,036
|
$869,099
|
$458,213
|
$(5,531,362)
|
$(913,014)
|
|
|
Core
Standards and
|
Scientific
and
|
|
|
At October 1,
2016
|
Ingredients
|
Contract
Services
|
Regulatory
Consulting
|
|
|
|
segment
|
segment
|
segment
|
Other
|
Total
|
|
|
|
|
|
|
Total
assets
|
$12,051,865
|
$3,645,554
|
$166,027
|
$2,900,244
|
$18,763,690
|
|
|
Core
Standards and
|
Scientific
and
|
|
|
At January 2,
2016
|
Ingredients
|
Contract
Services
|
Regulatory
Consulting
|
|
|
|
segment
|
segment
|
segment
|
Other
|
Total
|
|
|
|
|
|
|
Total
assets
|
$9,105,502
|
$3,306,624
|
$111,765
|
$6,225,318
|
$18,749,209
|
Disclosure of major customers
Major
customers who accounted for more than 10% of the Company’s
total sales were as follows:
|
Percentage of the
Company's Total Sales
|
|||
|
Three Months
Ended
|
Nine Months
Ended
|
||
Major
Customers
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Oct.
1, 2016
|
Oct.
3, 2015
|
|
|
|
|
|
Customer D
(Ingredients and Core segment)
|
12.3%
|
*
|
*
|
*
|
Customer C
(Ingredients segment)
|
*
|
*
|
24.5%
|
*
|
Customer B
(Ingredients segment)
|
*
|
19.1%
|
*
|
13.8%
|
|
|
|
|
|
* 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
|
At
October 1, 2016
|
At
January 2, 2016
|
|
|
|
Customer
D (Ingredients and Core segment)
|
*
|
22.8%
|
Customer
C (Ingredients segment)
|
48.8%
|
*
|
Customer
A (Ingredients segment)
|
*
|
14.7%
|
|
|
|
*
Represents less than 10%.
|
|
|
Note
10. Related-Party
Transactions
On
August 28, 2015, the Company entered into an Exclusive Supply
Agreement (the “Supply Agreement”) with Healthspan
Research, LLC (“Healthspan”). Under the terms of the
Supply Agreement, Healthspan agreed to purchase NIAGEN® from
the Company and the Company granted to Healthspan worldwide rights
for resale of specific dietary supplements containing NIAGEN®
in certain direct response channels.
Pursuant to the
terms of the Supply Agreement, in exchange for a 4% equity interest
in Healthspan, the Company agreed to initially supply NIAGEN®
to Healthspan up to a certain amount, and in exchange for an
additional 5% equity interest in Healthspan, the Company will grant
to Healthspan certain exclusive rights to resell NIAGEN®.
Healthspan will pay the Company royalties on the cumulative
worldwide net sales of its finished products containing
NIAGEN®. The exclusivity rights will remain for so long as
Healthspan meets certain minimum purchase requirements. In the
event that, during the initial term, the Company terminates the
exclusivity rights due to failure to meet the minimum purchase
requirements or for any reason other than a material breach of the
Supply Agreement by Healthspan, then the 5% equity interest shall
be automatically redeemed for a purchase price of $1.00 effective
upon the date of termination of the exclusivity
rights.
In
connection with the foregoing, also on August 28, 2015, the Company
and Healthspan entered into an interest purchase agreement and
limited liability company agreement pursuant to which the Company
was issued 9% of the outstanding equity interests of Healthspan.
Rob Fried, a director of the Company, is the manager of Healthspan
and owns 91% of the outstanding equity interests of Healthspan. The
Supply Agreement, interest purchase agreement and limited liability
company agreement were unanimously approved by the independent
directors of the Company.
During
the nine months ended October 1, 2016, the Company shipped
NIAGEN® to Healthspan to satisfy part of our obligation to
supply a certain amount of NIAGEN® in exchange for the 4%
equity interest in Healthspan, which our cost was approximately
$20,000. This was recorded as a long-term investment at our
cost.
The
Company accounts for its ownership interest under the cost method
of accounting as the Company does not have an ability to exercise
significant influence on Healthspan.
Note
11. Commitments
and Contingencies
Operating Leases
On
February 29, 2016, the Company entered into a lease amendment to
extend the term of the lease for its laboratory facility located in
Boulder, Colorado through April 2023. Pursuant to the
lease amendment, the Company will make monthly lease payments
ranging from $23,472 to $27,210, as the payments escalate during
the term of the lease.
On
March 4, 2016, the Company entered into a lease amendment to lease
an office space located in Rockville, Maryland through April
2021. Pursuant to the lease amendment, the Company will
make monthly lease payments ranging from $3,450 to $3,883, as the
payments escalate during the term of the lease.
On
April 14, 2016, the Company entered into a lease to lease an office
and laboratory space located in Longmont, Colorado through
September 2023. Pursuant to the lease, the Company will make
monthly lease payments ranging from $8,586 to $11,518, as payments
escalate during the term of the lease. The Company also agreed to
pay additional lease payments of approximately $800 per month as
the landlord will provide additional improvements to the leased
premises.
Payments
and future commitments for these leases entered in 2016 are as
follows:
Payments due by period
|
|||||
2016
|
2017
|
2018
|
2019
|
2020
|
Thereafter
|
|
|
|
|
|
|
$241,000
|
$439,000
|
$451,000
|
$466,000
|
$481,000
|
$1,146,000
|
Note
12. Subsequent
Events
Subsequent to the
period ended October 1, 2016, the Company entered into a business
financing agreement (“Financing Agreement”) with
Western Alliance Bank (“Western Alliance”), in order to
establish a formula based revolving credit line pursuant to which
the Company may borrow an aggregate principal amount of up to
$5,000,000, subject to the terms and conditions of the Financing
Agreement. Upon execution of the Financing Agreement, the Company
paid a $25,000 facility fee and a $900 due diligence fee to Western
Alliance.
The
interest rate will be calculated at a floating rate per month equal
to (a) the greater of (i) 3.50% per year or (ii) 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 (b) 2.50 percentage
points, plus an additional 5.00 percentage points during any period
that an event of default has occurred and is continuing. The
Company’s obligations under the Financing Agreement are
secured by a security interest in substantially all of the
Company’s current and future personal property assets,
including intellectual property.
Any
borrowings, interest or other fees or obligations that the Company
owes Western Alliance pursuant to the Financing Agreement (the
“Obligations”) will be become due and payable on
November 4, 2018. If the Financing Agreement is terminated prior to
November 4, 2017, the Company will pay a termination fee of $50,000
to Western Alliance, provided that such termination fee will be
waived in the event that the Company refinances with Western
Alliance.
The
Financing Agreement includes quick ratio, EBDAS and minimum revenue
financial covenants.
Pursuant to an
exclusive placement and advisory agreement by and among the
Company, Trump Securities LLC (“Trump”) and Credo 180,
LLC, the Company paid Trump a consulting fee of $100,000 in
connection with the execution of the Financing
Agreement.
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 January 2, 2016 filed with the Securities and
Exchange Commission on March 17, 2016 (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 and nine months ended October 1, 2016 compared with the
three and nine months ended October 3, 2015 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 Corp., and depending on the
context, its subsidiaries.
Overview
The
Company leverages its complementary business units to discover,
acquire, develop and commercialize patented and proprietary
ingredient technologies that address the dietary supplement, food,
beverage, skin care and pharmaceutical markets. In addition to the
Company’s ingredient technologies unit, the Company also has
business units focused on natural product fine chemicals, chemistry
and analytical testing services, and product regulatory and safety
consulting. As a result of the Company’s relationships with
leading universities and research institutions, the Company is able
to discover and license early stage, Intellectual Property-backed
ingredient technologies. We utilize our in-house chemistry,
regulatory and safety consulting business units to develop
commercially viable ingredients. The Company’s ingredient
portfolio is backed with clinical and scientific research, as well
as extensive Intellectual Property protection.
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
October 1, 2016, the Company had approximately $2,265,000 cash and
cash equivalents on hand. Subsequent to the period ended October 1,
2016, the Company entered into a business financing agreement with
Western Alliance Bank, in order to establish a formula based
revolving credit line up to $5.0 million. We anticipate that our
current cash, cash equivalents, cash to be generated from
operations and the established $5.0 million revolving credit line
will be sufficient to meet our projected operating plans through at
least November 11, 2017. We may, however, seek additional capital
prior to November 11, 2017, both to meet our projected operating
plans after November 11, 2017 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. If we are unable to
establish small to medium scale production capabilities through our
own plant or though collaboration, we may be unable to fulfill our
customers’ requirements. This may cause a loss of future
revenue streams as well as require us to look for third-party
vendors to provide these services. These vendors may not be
available, or charge fees that prevent us from pricing
competitively within our markets.
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 FDA, FTC 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.
Results of Operations
Our net
sales and net loss for the three- and nine-month periods ending on
October 1, 2016 and October 3, 2015 were as follows:
|
Three months
ending
|
Nine
months ending
|
||
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Oct.
1, 2016
|
Oct.
3, 2015
|
|
|
|
|
|
Net
sales
|
$5,007,000
|
$6,287,000
|
$21,169,000
|
$17,650,000
|
Net
loss
|
(954,000)
|
(4,000)
|
(781,000)
|
(1,344,000)
|
|
|
|
|
|
Basic and diluted
loss per common share
|
$(0.03)
|
$(0.00)
|
$(0.02)
|
$(0.04)
|
During
the nine months ended October 1, 2016, we have invested
approximately $629,000 in a pilot plant facility in Longmont,
Colorado, which the Company recently entered into a lease for,
effective from July 2016 through September 2023. Over the next six
months, we plan to invest approximately additional $600,000 in this
pilot plant facility. The pilot plant facility will have the
capability of manufacturing, at a process scale, products that we
are planning to take to market as well as enable us to explore cost
savings processes for existing products. In addition, subject to
available financial resources, we plan to continue to increase
research and development efforts for our line of proprietary
ingredients.
Net
Sales
Net
sales consist of gross
sales less discounts and returns.
|
Three months
ending
|
Nine
months ending
|
||||
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Net
sales:
|
|
|
|
|
|
|
Ingredients
|
$2,663,000
|
$4,147,000
|
-36%
|
$13,505,000
|
$10,239,000
|
32%
|
Core
standards and contract services
|
2,052,000
|
1,875,000
|
9%
|
7,111,000
|
6,547,000
|
9%
|
Scientific
and regulatory consulting
|
292,000
|
265,000
|
10%
|
553,000
|
864,000
|
-36%
|
|
|
|
|
|
|
|
Total
net sales
|
$5,007,000
|
$6,287,000
|
-20%
|
$21,169,000
|
$17,650,000
|
20%
|
●
The decrease in
sales for the ingredients segment for the three months ended
October 1, 2016 is mainly due to decreased sales of
“NIAGEN®.” Certain customers that placed large
orders during the period ended October 3, 2015 did not place orders
of similar size during the three months ended October 1, 2015. For
the nine months ended October 1, 2016, the sales increased compared
to the previous year due to increased sales of
“NIAGEN®” and
“PTEROPURE®.”
●
The increase in
sales for the core standards and contract services segment is
primarily due to increased sales of analytical testing and contract
services.
●
The increase in
sales for the scientific and regulatory consulting segment for the
three months ended October 1, 2016 is due to the timing of
completion of consulting projects for customers. The decrease in
sales for the nine months ended October 1, 2016 is primarily due to
a further emphasis on intercompany work supporting our ingredients
segment.
Cost
of Sales
Cost of
sales include raw materials, labor, overhead, and
delivery costs.
|
Three months
ending
|
Nine
months ending
|
||||||
|
|
October 3,
2015
|
October
1, 2016
|
October 3,
2015
|
||||
|
Amount
|
% of
net sales
|
Amount
|
% of
net sales
|
Amount
|
% of
net sales
|
Amount
|
% of
net sales
|
Cost
of sales:
|
|
|
|
|
|
|
|
|
Ingredients
|
$1,288,000
|
48%
|
$2,157,000
|
52%
|
$6,421,000
|
48%
|
$5,630,000
|
55%
|
Core standards and
contract services
|
1,548,000
|
75%
|
1,534,000
|
82%
|
4,782,000
|
67%
|
4,742,000
|
72%
|
Scientific and
regulatory consulting
|
129,000
|
44%
|
115,000
|
43%
|
345,000
|
62%
|
398,000
|
46%
|
|
|
|
|
|
|
|
|
|
Total
cost of sales
|
$2,965,000
|
59%
|
$3,806,000
|
61%
|
$11,548,000
|
55%
|
$10,770,000
|
61%
|
The
cost of sales, as a percentage of net sales, decreased 2% and 6%
for the three- and nine-month periods ended October 1, 2016,
respectively, compared to the comparable periods in
2015.
●
The decrease in
cost of sales, as a percentage of net sales, for the ingredients
segment is largely due to price reductions from our suppliers
through increased purchase volumes.
●
The cost of sales,
as a percentage of net sales for the core standards and contract
services segment, decreased 7% and 5% for the three- and nine-month
periods ended October 1, 2016, respectively, compared to the
comparable periods in 2015. The increase in analytical testing and
contract services sales led to a higher labor utilization rate,
which resulted in lowering our cost of sales as a percentage of net
sales.
●
The percentage
increase in cost of sales for the scientific and regulatory
consulting segment is largely due to a further emphasis on
intercompany work. Fixed labor costs make up the majority of costs
for the consulting segment.
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.
|
Three months
ending
|
Nine
months ending
|
||||
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Gross
profit:
|
|
|
|
|
|
|
Ingredients
|
$1,375,000
|
$1,990,000
|
-31%
|
$7,084,000
|
$4,609,000
|
54%
|
Core standards and
contract services
|
504,000
|
341,000
|
48%
|
2,329,000
|
1,805,000
|
29%
|
Scientific and
regulatory consulting
|
163,000
|
150,000
|
9%
|
208,000
|
466,000
|
-55%
|
|
|
|
|
|
|
|
Total
gross profit
|
$2,042,000
|
$2,481,000
|
-18%
|
$9,621,000
|
$6,880,000
|
40%
|
●
The decreased gross
profit for the ingredients segment for the three months ended
October 1, 2016 is due to the decreased sales of
“NIAGEN®.” For the nine months ended October 1,
2016, the gross profit for the ingredients segment increased due to
the increased sales of the ingredient portfolio we offer, coupled
with lower prices from our suppliers due to increased purchase
volumes.
●
The increased gross
profit for the core standards and contract services segment is
largely due to the increased sale of analytical testing and
contract services. Fixed labor costs make up the majority of costs
for analytical testing and contract services and these fixed labor
costs did not increase in proportion to sales, hence yielding
higher profit margin.
●
The decreased gross
profit for the scientific and regulatory consulting segment for the
nine months ended October 1, 2016 is largely due to a greater focus
on intercompany work supporting our ingredients
segment.
Operating
Expenses-Sales and Marketing
Sales
and Marketing Expenses consist of salaries, advertising
and marketing expenses.
|
Three months
ending
|
Nine
months ending
|
||||
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Sales
and marketing expenses:
|
|
|
|
|
|
|
Ingredients
|
$199,000
|
$260,000
|
-23%
|
$931,000
|
$833,000
|
12%
|
Core standards and
contract services
|
245,000
|
288,000
|
-15%
|
749,000
|
935,000
|
-20%
|
Scientific and
regulatory consulting
|
4,000
|
3,000
|
33%
|
11,000
|
8,000
|
38%
|
|
|
|
|
|
|
|
Total
sales and marketing expenses
|
$448,000
|
$551,000
|
-19%
|
$1,691,000
|
$1,776,000
|
-5%
|
●
For the ingredients
segment, the decrease for the three months ended October 1, 2016 is
largely due to reduction in payroll expense as certain employees
resigned. Subsequent to the period ended October 1, 2016, the
Company hired a new employee to replace their positions. In
addition, there was a decrease in third party commission expenses,
as sales to certain customers that Company pays commissions on
decreased. For the nine months ended October 1, 2016, the increase
is largely due to increased marketing efforts to raise the consumer
awareness for our line of proprietary ingredients.
●
For the core
standards and contract services segment, the decrease is largely
due to making certain operational changes as certain personnel who
were previously assigned to sales and marketing group were moved to
an administrative group. We do anticipate increased expenses going
forward as we increase marketing efforts and hire additional
staff.
●
For the scientific
and regulatory consulting segment, we had limited sales and
marketing expenses.
Operating
Expenses-Research and Development
Research and
Development Expenses mainly consist of clinical trials and process
development expenses.
|
Three months
ending
|
Nine
months ending
|
||||
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Research
and development expenses:
|
|
|
|
|
|
|
Ingredients
|
$760,000
|
$189,000
|
302%
|
$1,961,000
|
$485,000
|
304%
|
Core
standards and contract services
|
13,000
|
-
|
|
28,000
|
-
|
|
|
|
|
|
|
|
|
Total
research and development expenses
|
$773,000
|
$189,000
|
309%
|
$1,989,000
|
$485,000
|
310%
|
●
For the ingredients
segment, we increased our research and development efforts with a
focus on our “NIAGEN®” brand. Subject to available
financial resources, we plan to continue to increase research and
development efforts for our line of proprietary
ingredients.
●
For the core
standards and contract services segment, we explored processes to
develop certain compounds at a larger scale during the three and
nine months ended October 1, 2016.
Operating
Expenses-General and Administrative
General
and Administrative Expenses consist of general
company administration, IT, accounting and executive
management.
|
Three months
ending
|
Nine
months ending
|
||||
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
|
|
|
|
|
|
|
General
and administrative
|
$1,768,000
|
$1,565,000
|
13%
|
$6,064,000
|
$5,531,000
|
10%
|
●
The increase was
primarily related to patent maintenance. For the three- and
nine-month periods ended October 1, 2016, our patent maintenance
expense increased to approximately $133,000 and $476,000, compared
to approximately $70,000 and $226,000 for the comparable periods in
2015, respectively.
●
Another factor that
contributed to the increase for the three- and nine-month periods
ended October 1, 2016 was an increase of approximately $126,000 and
$380,000, respectively, in expenses associated with administrative
staff. We made certain operational changes as certain personnel who
were previously assigned to our sales and marketing group were
moved to an administrative group in 2016.
●
Another factor that
contributed to the increase in general and administrative expense
was an increase in royalties we pay to patent holders as the sales
for licensed products increased in 2016. For the nine-month period
ended October 1, 2016, royalty expense increased to approximately
$519,000, compared to approximately $430,000 for the comparable
period in 2015.
●
Also, during the
nine-month period ended October 1, 2016, there were one-time
expenses of approximately $89,000 associated with the initial
listing of the Company’s stock in the NASDAQ Capital
Market.
●
These increases in
expenses were offset by the decrease in share-based compensation
expense. For the three- and nine-month periods ended October 1,
2016, our share-based compensation expense decreased to
approximately $272,000 and $930,000, compared to approximately
$433,000 and $1,657,000 for the comparable periods in 2015,
respectively.
Non-operating
income- Interest Income
Interest income
consists of interest earned on money market accounts. Interest
income for the nine-month period ended October 1, 2016 was
approximately $2,000, identical compared to approximately $2,000
for the nine-month period ended October 3, 2015.
Non-operating
Expenses- Interest Expense
Interest expense
consists of interest on loan payable and capital
leases.
|
Three months
ending
|
Nine
months ending
|
||||
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
Oct.
1, 2016
|
Oct.
3, 2015
|
Change
|
|
|
|
|
|
|
|
Interest
expense
|
$11,000
|
$182,000
|
-94%
|
$345,000
|
$434,000
|
-21%
|
●
The decrease in
interest expense was mainly related to the Loan Agreement, from
which the Company drew down an initial $2.5 million on September
29, 2014 and a second $2.5 million on June 18, 2015. The Company
fully repaid the loan on June 14, 2016.
Income
Taxes
At
October 1, 2016 and October 3, 2015, 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
nine-month periods ended October 1, 2016 and October 3,
2015.
Depreciation
and Amortization
Depreciation
expense for the nine-month period ended October 1, 2016 was
approximately $234,000 as compared to $210,000 for the nine-month
period ended October 3, 2015. 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 nine-month period ended
October 1, 2016 was approximately $63,000 as compared to $32,000
for the nine-month period ended October 3, 2015. 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 and through October 1, 2016, we have incurred aggregate
losses of approximately $43 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.
Subsequent to the
period ended October 1, 2016, the Company entered into a business
financing agreement with Western Alliance Bank, in order to
establish a formula based revolving credit line up to $5.0 million.
While, we anticipate that our current cash, cash equivalents, cash
to be generated from operations and the established $5.0 million
revolving credit line will be sufficient to meet our projected
operating plans through at least November 11, 2017, we may seek
additional capital prior to November 11, 2017, both to meet our
projected operating plans through and after November 11, 2017 and
to fund our longer term strategic objectives. To the extent we are
unable to raise additional cash or generate sufficient revenue to
meet our projected operating plans prior to November 11, 2017, we
will revise our projected operating plans accordingly.
Net cash used in operating activities
Net
cash used in operating activities for the nine months ended October
1, 2016 was approximately $3,128,000 as compared to approximately
$1,258,000 for the nine months ended October 3, 2015. An increase
in trade receivables and a decrease in accounts payable were the
largest uses of cash during the nine-month period ended October 1,
2016, partially offset by the decrease in inventories. Net cash
used in operating activities for the nine months ended October 3,
2015 largely reflects an increase in trade receivables and
inventories along with the net loss.
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 $1,146,000 for
the nine months ended October 1, 2016, compared to approximately
$350,000 for the nine months ended October 3, 2015. Net cash used
in investing activities for the nine months ended October 1, 2016
consisted of purchases of leasehold improvements and equipment and
intangible assets. Net cash used in investing activities for the
nine months ended October 3, 2015 also consisted of purchases of
leasehold improvements and equipment and intangible
assets.
Net cash provided by financing activities
Net
cash provided by financing activities was approximately $989,000
for the nine months ended October 1, 2016, compared to
approximately $2,352,000 for the nine months ended October 3, 2015.
Net cash provided by financing activities for the nine months ended
October 1, 2016 mainly consisted of proceeds from issuances of our
common stock and warrants through a private offering to our
existing stockholders and exercise of stock options, offset by
principal payments on loan payable and capital leases. Net cash
provided by financing activities for the nine months ended October
3, 2015 mainly consisted of proceeds from loan
payable.
Contractual
Obligations and Commitments
During
the nine months ended October 1, 2016, 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 nine months ended October 1, 2016, we had no significant
off-balance sheet arrangements other than ordinary operating leases
as disclosed in “Item 1 Financial Statements” of this
Quarterly Report and the “Financial Statements and
Supplementary Data” section of our Annual
Report.
ITEM 3. QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk
Our
capital lease obligations bear interest at a fixed rate and
therefore have no exposure to changes in interest
rates.
The
Company’s cash investments consist of short term, high 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, or our operating results or 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.
Effects of Inflation
We do
not believe that inflation and changing prices during the nine
months ended October 1, 2016 and October 3, 2015 had a significant
impact on our results of operations.
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,
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 October 1, 2016, 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 SEC
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 Securities Exchange Act of
1934, as amended) 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 third 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
We are
not involved in any legal proceedings which management believes may
have a material adverse effect on our business, financial
condition, operations, cash flows, or prospects. The Company from
time to time is involved in legal proceedings in the ordinary
course of our business, which can include employment claims,
product claim, patent infringement, etc. We do not believe that any
of these claims and proceedings against us as they arise are likely
to have, individually or in the aggregate, a material adverse
effect on our financial condition or results of
operations.
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 our 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 of 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 and we may need additional
financing to meet our future long-term capital
requirements.
We have
recorded a net loss of approximately $781,000 for the nine months
ended October 1, 2016, 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 $2,771,000,
$5,388,000 and $4,420,000 for the years ended January 2, 2016,
January 3, 2015 and December 28, 2013, respectively. As of October
1, 2016, our accumulated deficit was approximately $43.1 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.
Subsequent to the
period ended October 1, 2016, we entered into a business financing
agreement with Western Alliance Bank, in order to establish a
formula based revolving credit line up to $5.0 million. While, we
anticipate that our current cash, cash equivalents, cash to be
generated from operations and the established $5.0 million
revolving credit line will be sufficient to meet our projected
operating plans through at least November 11, 2017, 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. In the event that we are unable to
obtain additional financing, we may be unable to implement our
business plan. Even with such financing, we have a history of
operating losses and there can be no assurance that we will be able
to continue to achieve and sustain profitability.
*Our short-term capital needs are uncertain and we may need to
raise additional funds. Based on current market conditions, such
funds may not be available on acceptable terms or at
all.
Subsequent to the
period ended October 1, 2016, we entered into a business financing
agreement with Western Alliance Bank, in order to establish a
formula based revolving credit line up to $5.0 million. We
anticipate that our current cash, cash equivalents, cash to be
generated from operations and the established $5.0 million
revolving credit line will be sufficient to meet our projected
operating plans through at least November 11, 2017. 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.
As a
result of these factors, we may seek to raise additional capital
prior to November 11, 2017 both to meet our projected operating
plans after November 11, 2017 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 currently have a disagreement with a significant customer, and
a disruption in sales to or the ability to collect from this
customer, or other significant customers in the future, could
materially harm our financial results.
We
currently have a disagreement over the interpretation of certain
terms of a supply agreement with a customer that we expect will
represent greater than 10% of our net sales for the year
ending December 31, 2016. Because of the disagreement,
this customer has not paid us approximately $3.0 million for
previous purchase orders. We may not collect the full amount owed
to us by this customer, we may have to discount future sales to
this customer and we may have to spend money, time and effort to
resolve this disagreement. If we don’t come to a satisfactory
resolution, we cannot guarantee that the customer will continue to
make purchases at previous volumes or prices, which may harm our
future sales if we cannot replace their volume with other existing
and new customers and which may materially affect our future
financial results.
Going
forward, we may have additional customers which we become highly
dependent on. Factors that could influence our relationship with
our significant customer and other customers which we may become
highly dependent on 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.
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 line 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 can provide no assurance that we will successfully expand
operations.
Our
significant increase in the scope and the scale of our product
launch, 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 its
results of operations.
The success of our 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.
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 particular 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, whether or not 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 an
ingredient supplier, marketer and manufacturer of 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.
We depend on key personnel, the loss of any of which could
negatively affect our business.
We
depend greatly on Frank L. Jaksch, Jr., Thomas C. Varvaro and Troy
A. Rhonemus who are our Chief Executive Officer, Chief Financial
Officer and Chief Operating Officer, 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;
●
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.
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 upon 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.
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.
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. 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 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. 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
product 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. Without access to these technologies or suitable
design-around or alternative technology options, our ability to
conduct our business could be impaired significantly.
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 these claims, litigation
could result in substantial costs and be a distraction to our
management. If we fail to defend such claims, in addition to paying
monetary damages, we may lose valuable intellectual property rights
or personnel. A loss of key personnel or their work product could
hamper or prevent our ability to market existing or new products,
which could severely harm our business.
Litigation may harm our business.
Substantial,
complex or extended litigation could cause us to incur significant
costs and distract our management. For example, lawsuits by
employees, stockholders, collaborators, distributors, customers,
competitors or others could be very costly and substantially
disrupt our business. Disputes from time to time with such
companies, organizations or individuals are not uncommon, and we
cannot assure you that we will always be able to resolve such
disputes or on terms favorable to us. Unexpected results could
cause us to have financial exposure in these matters in excess of
recorded reserves and insurance coverage, requiring us to provide
additional reserves to address these liabilities, therefore
impacting profits.
If we are unable to establish or maintain sales, marketing and
distribution capabilities or enter into and maintain arrangements
with third parties to sell, market and distribute our products, our
business may be harmed.
To
achieve commercial success for our products, we must sell rights to
our product lines and/or technologies at favorable prices, develop
a sales and marketing force, or enter into arrangements with others
to market and sell our products. In addition to being expensive,
developing and maintaining such a sales force is time-consuming,
and could delay or limit the success of any product launch. We may
not be able to develop this capacity on a timely basis or at all.
Qualified direct sales personnel with experience in the
phytochemical industry are in high demand, and there can be no
assurance that we will be able to hire or retain an effective
direct sales team. Similarly, qualified independent sales
representatives both within and outside the United States are in
high demand, and we may not be able to build an effective network
for the distribution of our product through such representatives.
There can be no assurance that we will be able to enter into
contracts with representatives on terms acceptable to us.
Furthermore, there can be no assurance that we will be able to
build an alternate distribution framework should we attempt to do
so.
We may
also need to contract with third parties in order to market our
products. To the extent that we enter into arrangements with third
parties to perform marketing and distribution services, our product
revenue could be lower and our costs higher than if we directly
marketed our products. Furthermore, to the extent that we enter
into co-promotion or other marketing and sales arrangements with
other companies, any revenue received will depend on the skills and
efforts of others, and we do not know whether these efforts will be
successful. If we are unable to establish and maintain adequate
sales, marketing and distribution capabilities, independently or
with others, we will not be able to generate product revenue, and
may not become profitable.
Our sales and results of operations depend on our customers’
research and development efforts and their ability to obtain
funding for these efforts.
Our
customers include researchers at pharmaceutical and biotechnology
companies, chemical and related companies, academic institutions,
government laboratories and private foundations. Fluctuations in
the research and development budgets of these researchers and their
organizations could have a significant effect on the demand for our
products. Our customers determine their research and development
budgets based on several factors, including the need to develop new
products, the availability of governmental and other funding,
competition and the general availability of resources. As we
continue to expand our international operations, we expect research
and development spending levels in markets outside of the United
States will become increasingly important to us.
Research and
development budgets fluctuate due to changes in available
resources, spending priorities, general economic conditions,
institutional and governmental budgetary limitations and mergers of
pharmaceutical and biotechnology companies. Our business could be
seriously harmed by any significant decrease in life science and
high technology research and development expenditures by our
customers. In particular, a small portion of our sales has been to
researchers whose funding is dependent on grants from government
agencies such as the United States National Institute of Health,
the National Science Foundation, the National Cancer Institute and
similar agencies or organizations. Government funding of research
and development is subject to the political process, which is often
unpredictable. Other departments, such as Homeland Security or
Defense, or general efforts to reduce the United States federal
budget deficit could be viewed by the government as a higher
priority. Any shift away from funding of life science and high
technology research and development or delays surrounding the
approval of governmental budget proposals may cause our customers
to delay or forego purchases of our products and services, which
could seriously damage our business.
Some of
our customers receive funds from approved grants at a particular
time of year, many times set by government budget cycles. In the
past, such grants have been frozen for extended periods or have
otherwise become unavailable to various institutions without
advance notice. The timing of the receipt of grant funds may affect
the timing of purchase decisions by our customers and, as a result,
cause fluctuations in our sales and operating results.
Demand for our products and services are subject to the commercial
success of our customers’ products, which may vary for
reasons outside our control.
Even if
we are successful in securing utilization of our products in a
customer’s manufacturing process, sales of many of our
products and services remain dependent on the timing and volume of
the customer’s production, over which we have no control. The
demand for our products depends on regulatory approvals and
frequently depends on the commercial success of the
customer’s supported product. Regulatory processes are
complex, lengthy, expensive, and can often take years to
complete.
We may bear financial risk if we under-price our contracts or
overrun cost estimates.
In
cases where our contracts are structured as fixed price or
fee-for-service with a cap, we bear the financial risk if we
initially under-price our contracts or otherwise overrun our cost
estimates. Such under-pricing or significant cost overruns could
have a material adverse effect on our business, results of
operations, financial condition and cash flows.
We rely on single or a limited number of third-party suppliers for
the raw materials required for the production of our
products.
Our
dependence on a limited number of third-party suppliers or on a
single supplier, and the challenges we may face in obtaining
adequate supplies of raw materials, involve several risks,
including limited control over pricing, availability, quality and
delivery schedules. We cannot be certain that our current suppliers
will continue to provide us with the quantities of these raw
materials that we require or satisfy our anticipated specifications
and quality requirements. Any supply interruption in limited or
sole sourced raw materials could materially harm our ability to
manufacture our products until a new source of supply, if any,
could be identified and qualified. Although we believe there are
other suppliers of these raw materials, we may be unable to find a
sufficient alternative supply channel in a reasonable time or on
commercially reasonable terms. Any performance failure on the part
of our suppliers could delay the development and commercialization
of our products, or interrupt production of then existing products
that are already marketed, which would have a material adverse
effect on our business.
We may need to increase the size of our organization, and we may be
unable to manage rapid growth effectively.
Our
failure to manage growth effectively could have a material and
adverse effect on our business, results of operations and financial
condition. We anticipate that a period of significant expansion
will be required to address possible acquisitions of business,
products, or rights, and potential internal growth to handle
licensing and research activities. This expansion will place a
significant strain on management, operational and financial
resources. To manage the expected growth of our operations and
personnel, we must both improve our existing operational and
financial systems, procedures and controls and implement new
systems, procedures and controls. We must also expand our finance,
administrative, and operations staff. Our current personnel,
systems, procedures and controls may not adequately support future
operations. Management may be unable to hire, train, retain,
motivate and manage necessary personnel or to identify, manage and
exploit existing and potential strategic relationships and market
opportunities.
We may not be successful in acquiring complementary businesses on
favorable terms.
As part
of our business strategy, we intend to consider acquisitions of
similar or complementary businesses. No assurance can be given that
we will be successful in identifying attractive acquisition
candidates or completing acquisitions on favorable terms. In
addition, any future acquisitions will be accompanied by the risks
commonly associated with acquisitions. These risks include
potential exposure to unknown liabilities of acquired companies or
to acquisition costs and expenses, the difficulty and expense of
integrating the operations and personnel of the acquired companies,
the potential disruption to the business of the combined company
and potential diversion of our management's time and attention, the
impairment of relationships with and the possible loss of key
employees and clients as a result of the changes in management, the
incurrence of amortization expenses and dilution to the
shareholders of the combined company if the acquisition is made for
stock of the combined company. In addition, successful completion
of an acquisition may depend on consents from third parties,
including regulatory authorities and private parties, which
consents are beyond our control. There can be no assurance that
products, technologies or businesses of acquired companies will be
effectively assimilated into the business or product offerings of
the combined company or will have a positive effect on the combined
company's revenues or earnings. Further, the combined company may
incur significant expense to complete acquisitions and to support
the acquired products and businesses. Any such acquisitions may be
funded with cash, debt or equity, which could have the effect of
diluting or otherwise adversely affecting the holdings or the
rights of our existing stockholders.
We
depend on information systems throughout our company to control our
manufacturing processes, process orders, manage inventory, process
and bill shipments and collect cash from our customers, respond to
customer inquiries, contribute to our overall internal control
processes, maintain records of our property, plant and equipment,
and record and pay amounts due vendors and other creditors. If we
were to experience a prolonged disruption in our information
systems that involve interactions with customers and suppliers, it
could result in the loss of sales and customers and/or increased
costs, which could adversely affect our overall business
operation.
Risks
Related to Regulatory Approval of Our Products and Other Government
Regulations
We are subject to regulation by various federal, state and foreign
agencies that require us to comply with a wide variety of
regulations, including those regarding the manufacture of products,
advertising and product label claims, the distribution of our
products and environmental matters. Failure to comply with these
regulations could subject us to fines, penalties and additional
costs.
Some of
our operations are subject to regulation by various United States
federal agencies and similar state and international agencies,
including the Department of Commerce, the FDA, the FTC, the
Department of Transportation and the Department of Agriculture.
These regulations govern a wide variety of product activities, from
design and development to labeling, manufacturing, handling, sales
and distribution of products. If we fail to comply with any of
these regulations, we may be subject to fines or penalties, have to
recall products and/or cease their manufacture and distribution,
which would increase our costs and reduce our sales.
We are
also subject to various federal, state, local and international
laws and regulations that govern the handling, transportation,
manufacture, use and sale of substances that are or could be
classified as toxic or hazardous substances. Some risk of
environmental damage is inherent in our operations and the products
we manufacture, sell, or distribute. Any failure by us to comply
with the applicable government regulations could also result in
product recalls or impositions of fines and restrictions on our
ability to carry on with or expand in a portion or possibly all of
our operations. If we fail to comply with any or all of these
regulations, we may be subject to fines or penalties, have to
recall products and/or cease their manufacture and distribution,
which would increase our costs and reduce our sales.
Government regulations of our customer’s business are
extensive and are constantly changing. Changes in these regulations
can significantly affect customer demand for our products and
services.
The
process by which our customer’s industries are regulated is
controlled by government agencies and depending on the market
segment can be very expensive, time-consuming, and uncertain.
Changes in regulations or the enforcement practices of current
regulations could have a negative impact on our customers and, in
turn, our business. At this time, it is unknown how the FDA will
interpret and to what extent it will enforce GMPs, regulations that
will likely affect many of our customers. These uncertainties may
have a material impact on our results of operations, as lack of
enforcement or an interpretation of the regulations that lessens
the burden of compliance for the dietary supplement marketplace may
cause a reduced demand for our products and services.
Changes in government regulation or in practices relating to the
pharmaceutical, dietary supplement, food and cosmetic industry
could decrease the need for the services we provide.
Governmental
agencies throughout the world, including the United States,
strictly regulate these industries. Our business involves helping
pharmaceutical and biotechnology companies navigate the regulatory
drug approval process. Changes in regulation, such as a relaxation
in regulatory requirements or the introduction of simplified drug
approval procedures, or an increase in regulatory requirements that
we have difficulty satisfying or that make our services less
competitive, could eliminate or substantially reduce the demand for
our services. Also, if the government makes efforts to contain drug
costs and pharmaceutical and biotechnology company profits from new
drugs, our customers may spend less, or reduce their spending on
research and development. If health insurers were to change their
practices with respect to reimbursements for pharmaceutical
products, our customers may spend less, or reduce their spending on
research and development.
If we should in the future become required to obtain regulatory
approval to market and sell our goods we will not be able to
generate any revenues until such approval is received.
The
pharmaceutical industry is subject to stringent regulation by a
wide range of authorities. While we believe that, given our present
business, we are not currently required to obtain regulatory
approval to market our goods because, among other things, we do not
(i) produce or market any clinical devices or other products, or
(ii) sell any medical products or services to the customer, we
cannot predict whether regulatory clearance will be required in the
future and, if so, whether such clearance will at such time be
obtained for any products that we are developing or may attempt to
develop. Should such regulatory approval in the future be required,
our goods may be suspended or may not be able to be marketed and
sold in the United States until we have completed the regulatory
clearance process as and if implemented by the FDA. Satisfaction of
regulatory requirements typically takes many years, is dependent
upon the type, complexity and novelty of the product or service and
would require the expenditure of substantial
resources.
If
regulatory clearance of a good that we propose to propose to market
and sell is granted, this clearance may be limited to those
particular states and conditions for which the good is demonstrated
to be safe and effective, which would limit our ability to generate
revenue. We cannot ensure that any good that we develop will meet
all of the applicable regulatory requirements needed to receive
marketing clearance. Failure to obtain regulatory approval will
prevent commercialization of our goods where such clearance is
necessary. There can be no assurance that we will obtain regulatory
approval of our proposed goods that may require it.
Risks
Related to the Securities Markets and Ownership of our Equity
Securities
*The market price of our common stock may be volatile and adversely
affected by several factors.
The
market price of our common stock could fluctuate significantly in
response to various factors and events, including, but not limited
to:
●
our ability to
integrate operations, technology, products and
services;
●
our ability to
execute our business plan;
●
our operating
results are below expectations;
●
our issuance of
additional securities, including debt or equity or a combination
thereof,;
●
announcements of
technological innovations or new products by us or our
competitors;
●
media coverage
regarding our industry or us;
●
loss of any
strategic relationship;
●
industry
developments, including, without limitation, changes in healthcare
policies or practices;
●
economic and other
external factors;
●
reductions in
purchases from our large customers;
●
period-to-period
fluctuations in our financial results; and
●
whether an active
trading market in our common stock develops and is
maintained.
In
addition, the securities markets have from time to time experienced
significant price and volume fluctuations that are unrelated to the
operating performance of particular companies. These market
fluctuations may also materially and adversely affect the market
price of our common stock.
Our common stock is and likely will remain subject to the
SEC’s “penny stock” rules, which may make our
shares more difficult to sell.
Because
the price of our common stock is currently and may remain less than
$5.00 per share, it is expected to be classified as a “penny
stock.” The SEC’s rules regarding penny stocks have the
effect of reducing trading activity in our shares, making it more
difficult for investors to sell them. Under these rules,
broker-dealers who recommend such securities to persons other than
institutional accredited investors must:
●
make a
special written suitability determination for the
purchaser;
●
receive the
purchaser’s written agreement to a transaction prior to
sale;
●
provide the
purchaser with risk disclosure documents which identify certain
risks associated with investing in “penny stocks” and
which describe the market for these “penny stocks” as
well as a purchaser’s legal remedies;
●
obtain
a signed and dated acknowledgment from the purchaser demonstrating
that the purchaser has received the required risk disclosure
document before a transaction in a “penny stock” can be
completed; and
●
give
bid and offer quotations and broker and salesperson compensation
information to the customer orally or in writing before or with the
confirmation.
These
rules make it more difficult for broker-dealers to effectuate
customer transactions and trading activity in our securities and
may result in a lower trading volume of our common stock and lower
trading prices.
*Our shares of common stock may be thinly traded, so you may be
unable to sell at or near ask prices or at all.
We
cannot predict the extent to which an active public market for our
common stock will develop or be sustained. This situation may be
attributable to a number of factors, including the fact that we are
a small company that is relatively unknown to stock analysts, stock
brokers, institutional investors and others in the investment
community who generate or influence sales volume, and that even if
we came to the attention of such persons, they tend to be risk
averse and would be reluctant to follow an unproven company such as
ours or purchase or recommend the purchase of our shares until such
time as we have become more seasoned and viable. As a consequence,
there may be periods of several days or weeks when trading activity
in our shares is minimal or non-existent, as compared to a seasoned
issuer which has a large and steady volume of trading activity that
will generally support continuous sales without an adverse effect
on share price. We cannot assure you that a broader or more active
public trading market for our common stock will develop or be
sustained, or that current trading levels will be sustained or not
diminish.
We have not paid cash dividends in the past and do not expect to
pay cash dividends in the foreseeable future. Any return on
investment may be limited to the value of our common
stock.
We have
never paid cash dividends on our capital stock and do not
anticipate paying cash dividends on our capital stock in the
foreseeable future. The payment of dividends on our capital stock
will depend on our earnings, financial condition and other business
and economic factors affecting us at such time as the board of
directors may consider relevant. If we do not pay dividends, our
common stock may be less valuable because a return on your
investment will only occur if the common stock price
appreciates.
Stockholders may experience significant dilution if future equity
offerings are used to fund operations or acquire complementary
businesses.
If
future operations or acquisitions are financed through the issuance
of additional equity securities, stockholders could experience
significant dilution. Securities issued in connection with future
financing activities or potential acquisitions may have rights and
preferences senior to the rights and preferences of our common
stock. In addition, the issuance of shares of our common stock upon
the exercise of outstanding options or warrants may result in
dilution to our stockholders.
The
stock market in general, and the stocks of early stage companies in
particular, have experienced extreme price and volume fluctuations.
These fluctuations have often been unrelated or disproportionate to
the operating performance of the companies involved. If these
fluctuations occur in the future, the market price of our shares
could fall regardless of our operating performance. In the past,
following periods of volatility in the market price of a particular
company’s securities, securities class action litigation has
often been brought against that company. If the market price or
volume of our shares suffers extreme fluctuations, then we may
become involved in this type of litigation, which would be
expensive and divert management’s attention and resources
from managing our business.
As a
public company, we may also from time to time make forward-looking
statements about future operating results and provide some
financial guidance to the public markets. The management has
limited experience as a management team in a public company and as
a result projections may not be made timely or set at expected
performance levels and could materially affect the price of our
shares. Any failure to meet published forward-looking statements
that adversely affect the stock price could result in losses to
investors, stockholder lawsuits or other litigation, sanctions or
restrictions issued by the SEC.
*We have a significant number of outstanding options and warrants,
and future sales of these shares could adversely affect the market
price of our common stock.
As of
October 1, 2016, we had outstanding options exercisable for an
aggregate of 5,217,508 shares of common stock at a weighted
average exercise price of $3.54 per share and outstanding warrants
exercisable for an aggregate of 487,111 shares of common stock at a
weighted average exercise price of $4.12 per share. The holders may
sell many of these shares in the public markets from time to time,
without limitations on the timing, amount or method of sale. As and
when our stock price rises, if at all, more outstanding options and
warrants will be in-the-money and the holders may exercise their
options and warrants and sell a large number of shares. This could
cause the market price of our common stock to decline.
ITEM 2. UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR
SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM 5. OTHER
INFORMATION
None.
ITEM 6. EXHIBITS
Exhibit
No
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|
Description of
Exhibits
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2.1
|
|
Agreement and Plan
of Merger, dated as of May 21, 2008, by and among Cody Resources,
Inc., CDI Acquisition, Inc. and ChromaDex, Inc., as amended on June
10, 2008 (incorporated by reference to, and filed as Exhibit 2.1 to
the Registrant’s Current Report on Form 8-K filed with the
Commission on June 24, 2008)
|
3.1
|
|
Amended
and Restated Certificate of Incorporation of the Registrant
(incorporated by reference to, and filed as Appendix A to the
Registrant’s Definitive Proxy Statement on Schedule 14A filed
with the Commission on May 4, 2010)
|
3.2
|
|
Bylaws
of the Registrant (incorporated by reference to, and filed as
Exhibit 3.2 to the Registrant’s Current Report on Form 8-K
filed with the Commission on June 24, 2008)
|
3.3
|
|
Certificate of
Amendment to the Amended and Restated Certificate of Incorporation
of the Registrant (incorporated by reference to, and filed as
Exhibit 3.1 to the Registrant’s Current Report on Form 8-K
filed with the Commission on April 12, 2016)
|
3.4
|
|
Amendment to Bylaws
of the Registrant (incorporated by reference to, and filed as
Exhibit 3.1 to the Registrant’s Current Report on Form 8-K
filed with the Commission on July 19, 2016)
|
4.1
|
|
Form of
Stock Certificate representing shares of the Registrant’s
Common Stock (incorporated by reference to, and filed as Exhibit
4.1 to the Registrant’s Annual Report on Form 10-K filed with
the Commission on April 3, 2009)
|
4.2
|
|
Investor’s
Rights Agreement, effective as of December 31, 2005, by and between
The University of Mississippi Research Foundation and the
Registrant (incorporated by reference to, and filed as Exhibit 4.1
to the Registrant’s Current Report on Form 8-K filed with the
Commission on June 24, 2008)
|
4.3
|
|
Tag-Along Agreement
effective as of December 31, 2005, by and among the Registrant,
Frank Louis Jaksch, Snr. & Maria Jaksch, Trustees of the Jaksch
Family Trust, Margery Germain, Lauren Germain, Emily Germain, Lucie
Germain, Frank Louis Jaksch, Jr., and the University of Mississippi
Research Foundation (incorporated by reference to, and filed as
Exhibit 4.2 to the Registrant’s Current Report on Form 8-K
filed with the Commission on June 24, 2008)
|
4.4
|
|
Form of
Stock Certificate representing shares of the Registrant’s
Common Stock effective as of January 1, 2016 (incorporated by
reference to, and filed as Exhibit 4.4 to the Registrant’s
Annual Report on Form 10-K filed with the Commission on March 17,
2016)
|
10.1
|
|
Addendum to the
Nicotinamide Riboside Supply Agreement, dated July 24, 2015, by and
between ChromaDex, Inc. and Thorne Research, Inc. (1)
|
10.2
|
|
Second
Addendum to the Nicotinamide Riboside Supply Agreement, dated
September 14, 2016, by and between ChromaDex, Inc. and Thorne
Research, Inc. (1)
|
10.3
|
|
Exclusive License
Agreement, dated July 13, 2012 between Dartmouth College and
ChromaDex, Inc.
|
10.4
|
|
Exclusive License
Agreement, dated March 7, 2013 between Washington University and
ChromaDex, Inc.
|
10.5 |
|
Amendment #1 to
Exclusive License Agreement, effective as of December 15, 2015,
between Washington University and ChromaDex,
Inc.
|
10.6
|
|
License
Agreement, made as of August 1, 2013, between Green Molecular S.L.,
Inc. and ChromaDex, Inc.
|
10.7
|
|
First
Amendment to Exclusive License Agreement, effective as of July 6,
2015, between University of Mississippi and ChromaDex,
Inc.
|
10.8 |
|
Second
Amendment to the License Agreement, effective as of December 31,
2015, between the Regents of the University of California and
ChromaDex, Inc. (1)
|
10.9 |
|
Second Addendum to Supply Agreement, effective as of January 28, 2016, between Nectar7 LLC and ChromaDex, Inc. (1) |
10.10 |
|
First Amendment to Exclusive License Agreement, effective as of June 13, 2016, between Dartmouth College and ChromaDex, Inc. (1) |
|
|
|
31.1
|
|
Certification of
the Chief Executive Officer pursuant to Rule 13a-14(A) of the
Securities Exchange Act of 1934, as amended
|
31.2
|
|
Certification of
the Chief Financial Officer pursuant to Rule 13a-14(A) of the
Securities Exchange Act of 1934, as amended
|
32.1
|
|
Certification
pursuant to 18 U.S.C. Section 1350 (as adopted pursuant to Section
906 of the Sarbanes−Oxley Act of 2002)
|
101.INS
|
|
XBRL
Instance Document
|
101.SCH
|
|
XBRL
Taxonomy Extension Schema Document
|
101.CAL
|
|
XBRL
Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
|
XBRL
Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
|
XBRL
Taxonomy Extension Label Linkbase Document
|
101.PRE
|
|
XBRL
Taxonomy Extension Presentation Linkbase Document
|
(1)
A redacted version
of this Exhibit is filed herewith. An un-redacted version of this
Exhibit has been separately filed with the Commission pursuant to
an application for confidential treatment. The confidential
portions of the Exhibit have been omitted and are marked by an
asterisk.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
|
|
CHROMADEX
CORPORATION
|
Date: November 10, 2016 |
|
/s/ THOMAS C. VARVARO
|
|
Thomas C.
Varvaro
Chief
Financial Officer
|
|
|
|
|
|
|
(principal financial and accounting officer and duly authorized on
behalf of the registrant)
|
|
|
|
-40-