ChromaDex Corp. - Quarter Report: 2017 September (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 September 30, 2017
Commission
File Number: 001-37752
CHROMADEX CORPORATION
(Exact
Name of Registrant as Specified in its Charter)
Delaware
|
|
26-2940963
|
(State
or other jurisdiction of incorporation or
organization)
|
|
(I.R.S.
Employer Identification No.)
|
10005 Muirlands Blvd. Suite G, Irvine, California
(Address
of Principal Executive Offices)
|
|
92618
(Zip
Code)
|
Registrant's
telephone number, including area code: (949) 419-0288
Indicate
by check mark whether the registrant (1) has filed all reports
required to be filed by section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes X No
Indicate
by check mark whether the registrant has submitted electronically
and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405
of Regulation S-T (Section 232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes X No
Indicate
by check mark whether the registrant is a large accelerated filer,
accelerated filer, non-accelerated filer, smaller reporting company
or emerging growth company. See definition of “large
accelerated filer, accelerated filer, smaller reporting company and
emerging growth company” in Rule 12b-2 of the Exchange Act.
(Check one):
Large
accelerated filer ____
|
Accelerated filer
X
|
Non-accelerated
filer ____
|
Smaller reporting
company ____
|
(Do
not check if smaller reporting company)
|
Emerging growth
company ____
|
If an
emerging growth company, indicate by checkmark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act).
Yes ___
No
X
As of November 8, 2017 there were 48,187,298 shares of the
registrant’s common stock issued and
outstanding.
CHROMADEX CORPORATION
QUARTERLY
REPORT ON FORM 10-Q
TABLE OF CONTENTS
PART I - FINANCIAL INFORMATION (UNAUDITED)
|
|
|
|
ITEM 1. FINANCIAL STATEMENTS: |
1
|
Condensed
Consolidated Balance Sheets as of September 30, 2017 and December
31, 2016
|
1
|
|
|
Condensed
Consolidated Statements of Operations for the three months ended
September 30, 2017 and October 1, 2016
|
2
|
|
Condensed
Consolidated Statements of Operations for the nine months ended
September 30, 2017 and October 1, 2016
|
3
|
|
Condensed
Consolidated Statements of Stockholders Equity for the nine months
ended September 30, 2017
|
4
|
|
Condensed
Consolidated Statements of Cash Flows for the nine months ended
September 30, 2017 and October 1, 2016
|
5
|
|
Notes
to Condensed Consolidated Financial Statements
|
6
|
|
ITEM
2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
20
|
|
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
|
28
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|
ITEM 4.
CONTROLS AND PROCEDURES
|
28
|
|
|
|
PART
II - OTHER INFORMATION
|
29
|
|
|
ITEM
1. LEGAL PROCEEDINGS
|
29
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|
ITEM
1A. RISK FACTORS
|
31
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|
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND
USE OF PROCEEDS
|
47
|
|
ITEM
3. DEFAULTS UPON SENIOR
SECURITIES
|
47
|
|
ITEM
4. MINE SAFETY DISCLOSURES
|
47
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|
ITEM
5. OTHER INFORMATION
|
47
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|
ITEM 6.
EXHIBITS
|
48
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|
SIGNATURES
|
49
|
- i
-
PART I – FINANCIAL INFORMATION (UNAUDITED)
ITEM 1. FINANCIAL STATEMENTS
ChromaDex Corporation and Subsidiaries
|
|
|
Condensed Consolidated Balance Sheets
|
|
|
September 30, 2017 and December 31, 2016
|
|
|
|
|
|
|
Sep. 30, 2017
|
Dec.
31, 2016
|
Assets
|
|
|
|
|
|
Current
Assets
|
|
|
Cash
|
$23,999,633
|
$1,642,429
|
Trade receivables, net of allowances of $0.5 million and $1.1
million, respectively;
|
|
|
Receivables
from Related Party: $1.5 million and $0, respectively
|
4,919,768
|
5,852,030
|
Inventories
|
6,615,245
|
7,912,630
|
Prepaid
expenses and other assets
|
724,388
|
311,539
|
Current
assets held for sale
|
-
|
18,315
|
Total current assets
|
36,259,034
|
15,736,943
|
|
|
|
Leasehold
Improvements and Equipment, net
|
2,690,527
|
1,778,171
|
Deposits
|
392,342
|
377,532
|
Receivable
held at escrow
|
750,000
|
-
|
Intangible
assets, net
|
1,709,609
|
486,226
|
Longterm
investment
|
-
|
20,318
|
Noncurrent
assets held for sale
|
-
|
1,352,878
|
|
|
|
Total assets
|
$41,801,512
|
$19,752,068
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
Current
Liabilities
|
|
|
Accounts
payable
|
$4,346,700
|
$5,978,288
|
Accrued
expenses
|
2,129,583
|
2,170,172
|
Current
maturities of capital lease obligations
|
190,892
|
255,461
|
Customer
deposits and other
|
321,119
|
389,010
|
Deferred
rent, current
|
120,894
|
76,219
|
Due
to officer
|
100,000
|
-
|
Total current liabilities
|
7,209,188
|
8,869,150
|
|
|
|
Capital
lease obligations, less current maturities
|
360,748
|
343,589
|
Deferred
rent, less current
|
493,735
|
380,205
|
Noncurrent
liabilities held for sale
|
-
|
184,766
|
|
|
|
Total liabilities
|
8,063,671
|
9,777,710
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
Common
stock, $.001 par value; authorized 150,000,000 shares;
|
|
|
issued
and outstanding September 30, 2017 47,650,252 shares
and
|
|
|
December
31, 2016 37,544,531 shares
|
47,650
|
37,545
|
Additional
paid-in capital
|
81,469,567
|
55,160,387
|
Accumulated
deficit
|
(47,779,376)
|
(45,223,574)
|
Total stockholders' equity
|
33,737,841
|
9,974,358
|
|
|
|
Total liabilities and stockholders' equity
|
$41,801,512
|
$19,752,068
|
|
|
|
See
Notes to Consolidated Financial Statements.
|
|
|
- 1 -
ChromaDex Corporation and Subsidiaries
|
|
|
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Condensed Consolidated Statements of Operations
|
|
|
For the Three Month Periods Ended September 30, 2017 and October 1,
2016
|
||
|
|
|
|
Sep. 30, 2017
|
Oct. 1, 2016
|
|
|
|
Sales,
net
|
$6,084,690
|
$3,937,286
|
Cost
of sales
|
3,169,321
|
2,074,325
|
|
|
|
Gross profit
|
2,915,369
|
1,862,961
|
|
|
|
Operating
expenses:
|
|
|
Sales
and marketing
|
1,103,157
|
286,941
|
Research
and development
|
1,040,561
|
772,799
|
General
and administrative
|
3,948,435
|
1,727,383
|
Operating expenses
|
6,092,153
|
2,787,123
|
|
|
|
Operating loss
|
(3,176,784)
|
(924,162)
|
|
|
|
Nonoperating
expense:
|
|
|
Interest
expense, net
|
(44,508)
|
(2,260)
|
Nonoperating expenses
|
(44,508)
|
(2,260)
|
|
|
|
Loss from continuing operations
|
(3,221,292)
|
(926,422)
|
|
|
|
Loss
before taxes from discontinued operations
|
(108,899)
|
(31,121)
|
Gain
on sale of discontinued operations
|
5,467,268
|
-
|
Provision
for taxes
|
-
|
3,153
|
|
|
|
Income (loss) from discontinued operations, net
|
5,358,369
|
(27,968)
|
|
|
|
Net income (loss)
|
$2,137,077
|
$(954,390)
|
|
|
|
Basic
earnings (loss) per common share:
|
|
|
Loss
from continuing operations
|
$(0.07)
|
$(0.02)
|
Earnings
(loss) from discontinued operations
|
$0.12
|
$(0.01)
|
|
|
|
Basic
earnings (loss) per common share
|
$0.05
|
$(0.03)
|
|
|
|
Diluted
earnings (loss) per common share:
|
|
|
Loss
from continuing operations
|
$(0.07)
|
$(0.02)
|
Earnings
(loss) from discontinued operations
|
$0.11
|
$(0.01)
|
|
|
|
Diluted
earnings (loss) per common share
|
$0.04
|
$(0.03)
|
|
|
|
Basic
weighted average common shares outstanding
|
47,065,009
|
37,868,672
|
|
|
|
Diluted
weighted average common shares outstanding
|
47,556,697
|
37,868,672
|
|
|
|
See
Notes to Consolidated Financial Statements.
|
|
|
- 2 -
ChromaDex Corporation and Subsidiaries
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
|
|
|
For the Nine Month Periods Ended September 30, 2017 and October 1,
2016
|
|
|
|
|
|
|
Sep. 30, 2017
|
Oct. 1, 2016
|
|
|
|
Sales,
net
|
$13,670,646
|
$17,211,865
|
Cost
of sales
|
7,028,340
|
8,831,400
|
|
|
|
Gross profit
|
6,642,306
|
8,380,465
|
|
|
|
Operating
expenses:
|
|
|
Sales
and marketing
|
2,058,178
|
1,190,013
|
Research
and development
|
2,554,713
|
1,988,597
|
General
and administrative
|
8,882,821
|
5,935,139
|
Other
|
745,773
|
-
|
Operating expenses
|
14,241,485
|
9,113,749
|
|
|
|
Operating loss
|
(7,599,179)
|
(733,284)
|
|
|
|
Nonoperating
expense:
|
|
|
Interest
expense, net
|
(108,751)
|
(314,926)
|
Loss
on debt extinguishment
|
-
|
(313,099)
|
Nonoperating expenses
|
(108,751)
|
(628,025)
|
|
|
|
Loss
before income taxes
|
(7,707,930)
|
(1,361,309)
|
Provision
for taxes
|
-
|
(3,500)
|
|
|
|
Loss from continuing operations
|
(7,707,930)
|
(1,364,809)
|
|
|
|
Income
(loss) from discontinued operations
|
(315,140)
|
583,377
|
Gain
on sale of discontinued operations
|
5,467,268
|
-
|
|
|
|
Income from discontinued operations, net
|
5,152,128
|
583,377
|
|
|
|
Net loss
|
$(2,555,802)
|
$(781,432)
|
|
|
|
Basic
and diluted earnings (loss) per common share:
|
|
|
Loss
from continuing operations
|
$(0.18)
|
$(0.04)
|
Earnings
from discontinued operations
|
$0.12
|
$0.02
|
|
|
|
Basic
and diluted loss per common share
|
$(0.06)
|
$(0.02)
|
|
|
|
Basic
and diluted weighted average common shares outstanding
|
42,405,616
|
37,090,916
|
|
|
|
See
Notes to Consolidated Financial Statements.
|
|
|
- 3 -
ChromaDex Corporation and Subsidiaries
|
|
|
|
|
|
Condensed Consolidated Statement of Stockholders'
Equity
|
|
|
|
|
|
For the Nine Month Period Ended September 30, 2017
|
|
|
|
|
|
|
|
|
|
Total
|
|
Common Stock
|
Additional
|
Accumulated
|
Stockholders'
|
|
|
Shares
|
Amount
|
Paid-in Capital
|
Deficit
|
Equity
|
Balance,
January 1, 2017
|
37,544,531
|
$37,545
|
$55,160,387
|
$(45,223,574)
|
9,974,358
|
|
|
|
|
|
|
Issuance
of common stock associated with
|
|
|
|
|
|
the
acquisition of Healthspan Research LLC
|
367,648
|
367
|
999,635
|
-
|
1,000,002
|
|
|
|
|
|
|
Exercise
of stock options
|
3,202
|
3
|
6,620
|
-
|
6,623
|
|
|
|
|
|
|
Vested
restricted stock
|
2,667
|
3
|
(3)
|
-
|
-
|
|
|
|
|
|
|
Share-based
compensation
|
-
|
-
|
319,830
|
-
|
319,830
|
|
|
|
|
|
|
Net
loss
|
-
|
-
|
-
|
(1,928,755)
|
(1,928,755)
|
|
|
|
|
|
|
Balance,
April 1, 2017
|
37,918,048
|
$37,918
|
$56,486,469
|
$(47,152,329)
|
$9,372,058
|
|
|
|
|
|
|
Issuance
of common stock,
|
|
|
|
|
|
net
of offering costs of $1,184,000
|
7,649,968
|
7,650
|
18,698,634
|
-
|
18,706,284
|
|
|
|
|
|
|
Exercise
of stock options
|
1,875
|
2
|
5,342
|
-
|
5,344
|
|
|
|
|
|
|
Vested
restricted stock
|
2,000
|
2
|
(2)
|
-
|
-
|
|
|
|
|
|
|
Share-based
compensation
|
-
|
-
|
399,861
|
-
|
399,861
|
|
|
|
|
|
|
Net
loss
|
-
|
-
|
-
|
(2,764,124)
|
(2,764,124)
|
|
|
|
|
|
|
Balance,
July 1, 2017
|
45,571,891
|
$45,572
|
$75,590,304
|
$(49,916,453)
|
$25,719,423
|
|
|
|
|
|
|
Issuance
of common stock,
|
|
|
|
|
|
net
of offering costs of $103,000
|
1,965,417
|
1,965
|
5,005,512
|
-
|
5,007,477
|
|
|
|
|
|
|
Exercise
of stock options
|
111,611
|
112
|
382,935
|
-
|
383,047
|
|
|
|
|
|
|
Vested
restricted stock
|
1,333
|
1
|
(1)
|
-
|
-
|
|
|
|
|
|
|
Share-based
compensation
|
-
|
-
|
490,817
|
-
|
490,817
|
|
|
|
|
|
|
Net
income
|
-
|
-
|
-
|
2,137,077
|
2,137,077
|
|
|
|
|
|
|
Balance, September 30, 2017
|
47,650,252
|
$47,650
|
$81,469,567
|
$(47,779,376)
|
$33,737,841
|
|
|
|
|
|
|
See
Notes to Consolidated Financial Statements.
|
|
|
|
|
|
- 4 -
ChromaDex Corporation and Subsidiaries
|
|
|
|
|
|
Condensed Consolidated Statements of Cash Flows
|
|
|
For the Nine Month Periods Ended September 30, 2017 and October 1,
2016
|
|
|
|
|
|
|
Sep. 30, 2017
|
Oct. 1, 2016
|
|
|
|
Cash
Flows From Operating Activities
|
|
|
Net
loss
|
$(2,555,802)
|
$(781,432)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation
of leasehold improvements and equipment
|
396,000
|
234,408
|
Amortization
of intangibles
|
148,005
|
63,116
|
Share-based
compensation expense
|
1,210,508
|
930,026
|
Allowance
for doubtful trade receivables
|
(547,811)
|
235,591
|
Gain from disposal of assets
|
(5,467,268)
|
-
|
Loss
from disposal of equipment
|
4,649
|
-
|
Loss
on debt extinguishment
|
-
|
313,099
|
Non-cash
financing costs
|
89,481
|
94,080
|
Changes
in operating assets and liabilities:
|
|
|
Trade
receivables
|
1,491,529
|
(4,296,439)
|
Inventories
|
1,358,299
|
1,840,572
|
Prepaid
expenses and other assets
|
(480,353)
|
(230,667)
|
Accounts
payable
|
(1,735,361)
|
(2,125,180)
|
Accrued
expenses
|
(43,796)
|
406,797
|
Customer
deposits and other
|
(61,071)
|
5,613
|
Deferred
rent
|
188,290
|
182,634
|
Due
to officer
|
(32,500)
|
-
|
Net cash used in operating activities
|
(6,037,201)
|
(3,127,782)
|
|
|
|
Cash
Flows From Investing Activities
|
|
|
Proceeds
from disposal of assets, net of transaction costs
|
5,953,390
|
-
|
Purchases
of leasehold improvements and equipment
|
(872,215)
|
(940,978)
|
Purchases
of intangible assets
|
(183,958)
|
(205,000)
|
Net cash provided by (used in) investing activities
|
4,897,217
|
(1,145,978)
|
|
|
|
Cash
Flows From Financing Activities
|
|
|
Proceeds
from issuance of common stock, net of issuance costs
|
23,713,762
|
5,717,474
|
Proceeds
from exercise of stock options
|
395,014
|
716,612
|
Payment
of debt issuance costs
|
(49,279)
|
-
|
Principal
payment on loan payable
|
-
|
(5,000,000)
|
Cash
paid for debt extinguisment costs
|
-
|
(281,092)
|
Principal
payments on capital leases
|
(562,309)
|
(164,150)
|
Net cash provided by financing activities
|
23,497,188
|
988,844
|
|
|
|
Net
increase (decrease) in cash
|
22,357,204
|
(3,284,916)
|
|
|
|
Cash
Beginning of Period
|
1,642,429
|
5,549,672
|
|
|
|
Cash
Ending of Period
|
$23,999,633
|
$2,264,756
|
|
|
|
Supplemental
Disclosures of Cash Flow Information
|
|
|
Cash
payments for interest
|
$43,912
|
$251,231
|
|
|
|
Supplemental
Schedule of Noncash Investing Activity
|
|
|
Noncash
consideration transferred for the acquisition of Healthspan
Research LLC
|
$1,187,430
|
$-
|
Capital
lease obligation incurred for the purchase of
equipment
|
$514,899
|
$-
|
Receivable
from disposal of assets held at escrow
|
$750,000
|
$-
|
Inventory
supplied to Healthspan Research LLC for equity interest, at
cost
|
$-
|
$20,318
|
Retirement
of fully depreciated equipment - cost
|
$55,947
|
$28,083
|
Retirement
of fully depreciated equipment - accumulated
depreciation
|
$(55,947)
|
$(28,083)
|
|
|
|
See
Notes to Consolidated Financial Statements.
|
|
|
- 5 -
Note
1. Interim
Financial Statements
The
accompanying financial statements of ChromaDex Corporation and its
wholly owned subsidiaries, ChromaDex, Inc., Healthspan Research,
LLC, ChromaDex Analytics, Inc. and ChromaPharma, Inc. (collectively
referred to herein as “ChromaDex” or the
“Company” or, in the first person as “we”,
“us” and “our”) include all adjustments,
consisting of normal recurring adjustments and accruals, that, in
the opinion of the management of the Company, are necessary for a
fair presentation of the Company’s financial position as of
September 30, 2017 and results of operations and cash flows for the
three and nine months ended September 30, 2017 and October 1, 2016.
These unaudited interim financial statements should be read in
conjunction with the Company’s audited financial statements
and the notes thereto for the year ended December 31, 2016
appearing in the Company’s Annual Report on Form 10-K filed
with the Securities and Exchange Commission (the
“Commission”) on March 16, 2017. Operating results for
the nine months ended September 30, 2017 are not necessarily
indicative of the results to be achieved for the full year ending
on December 30, 2017. The preparation of financial statements in
conformity with accounting principles generally accepted in the
United States of America (“GAAP”) requires management
to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosures of contingent assets and
liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the period. Actual
results could differ from those estimates.
The
balance sheet at December 31, 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 is a natural products
company that discovers, acquires, develops and commercializes
patented and proprietary ingredient technologies that address the
dietary supplement, food, beverage, skin care and pharmaceutical
markets. Through the Company's ingredients segment, the Company
offers its branded ingredients such as NIAGEN®, nicotinamide
riboside, and pTeroPure®, pterostilbene.
With
the acquisition of Healthspan Research, LLC in March 2017, the
Company established a consumer product segment, which offers
finished bottled dietary supplement products that contain
NIAGEN®. The Company also has a core standards and contract
services segment, which focuses on natural product fine chemicals
(known as “phytochemicals”) and regulatory consulting
services. As a result of the Company’s relationships with
leading universities and research institutions, the Company
discovers and licenses early stage, intellectual property-backed
ingredient technologies. The Company then utilizes its business to
develop commercially viable proprietary ingredients. The
Company’s proprietary ingredient portfolio is backed with
clinical and scientific research, as well as extensive intellectual
property protection.
On
September 5, 2017, the Company completed the sale of its operating
assets (the "Lab Business Disposition") that were used with the
Company's quality verification program testing and analytical
chemistry business for food and food related products (the "Lab
Business") to Covance Laboratories Inc. ("Covance"). With the Lab
Business Disposition, the Company will focus on accelerating the
expansion of nicotinamide riboside and its other proprietary
ingredient technologies.
Liquidity: The Company has incurred loss from continuing
operations of approximately $7.7 million and net loss of
approximately $2.6 million for the nine-month period ended
September 30, 2017. As of September 30, 2017, cash and cash
equivalents totaled approximately $24.0 million.
In
consideration for the sale of the Lab Business, the Company
received net proceeds of approximately $6.0 million, net of
transaction costs from Covance. Additional cash consideration of
$0.8 million is held in escrow to satisfy any indemnification
claims by Covance.
Subsequent
to the period ended September 30, 2017, the Company entered into a
securities purchase agreement under which it agreed to sell
approximately $23.0 million of its common stock in a private
placement, in return for which the purchaser will receive. The
Company agreed to sell approximately 5.6 million shares at a per
share price of $4.10. The private placement is expected to close on
or about November 17, 2017, subject to the satisfaction of
customary closing conditions.
- 6 -
While
we anticipate that our current cash, cash equivalents, cash to be
generated from operations and cash to be received from the private
placement described above will be sufficient to meet our projected
operating plans into 2019, we may require additional funds, either
through additional equity or debt financings or collaborative
agreements or from other sources. We have no commitments to obtain
such additional financing, and we may not be able to obtain any
such additional financing on terms favorable to us, or at all. If
adequate financing is not available, the Company will further
delay, postpone or terminate product and service expansion and
curtail certain selling, general and administrative operations. The
inability to raise additional financing may have a material adverse
effect on the future performance of the Company.
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, and the Company's normal fiscal quarters
end on the Saturday 13 weeks after the last fiscal year end or
fiscal quarter end. 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 2016 ended on December 31, 2016
consisted of normal 52 weeks. The fiscal year 2017 ending on
December 30, 2017 will also include the normal 52
weeks.
Adopted Accounting Pronouncements Fiscal 2017: In January
2017, the Financial Accounting Standards Board (“FASB”)
issued Accounting Standards Update (“ASU”) No. 2017-01,
Business Combinations (Topic 805): Clarifying the Definition of a
Business. The ASU 2017-01 clarifies the definition of a business
with the objective of adding guidance to assist companies and other
reporting organizations with evaluating whether transactions should
be accounted for as acquisitions of assets or businesses. The
Company early adopted the amendments in this ASU effective as of
January 1, 2017. On March 12, 2017, the Company acquired all of the
outstanding equity interests of Healthspan Research, LLC
("Healthspan") pursuant to a Membership Interest Purchase Agreement
by and among (i) Robert Fried, Jeffrey Allen and Dr. Charles
Brenner (the “Sellers”) and (ii) ChromaDex Corporation.
Under ASU 2017-01, this transaction was treated as an acquisition
of assets, rather than a business. For details on the acquisition
of Healthspan, please refer to Note 5. Related Party Transactions
appearing later on this report.
In
March 2016, the FASB issued ASU 2016-09, Compensation - Stock
Compensation (Topic 718): Improvements to Employee Share-Based
Payment Accounting to simplify the accounting for stock
compensation. It focuses on income tax accounting, award
classification, estimating forfeitures, and cash flow presentation.
The Company adopted the amendments in this ASU effective as of
January 1, 2017. The adoption of ASU 2016-09 did not have a
material effect on our consolidated financial
statements.
In July
2015, the FASB issued ASU 2015-11, Inventory (Topic 330) -
Simplifying the Measurement of Inventory, which requires that
inventories, other than those accounted for under
Last-In-First-Out, will be reported at the lower of cost or net
realizable value. Net realizable value is the estimated selling
price less costs of completion, disposal and transportation. The
Company adopted the amendments in this ASU effective as of January
1, 2017. The adoption of ASU 2015-11 did not have a material effect
on our consolidated financial statements.
- 7 -
Recent accounting standards: In May 2014, the FASB issued
ASU No. 2014-09, Revenue from Contracts with Customers: Topic 606
(ASU 2014-09), to supersede nearly all existing revenue recognition
guidance under U.S. Generally Accepted Accounting Principles
("GAAP"). The core principle of ASU 2014-09 is to recognize
revenues when promised goods or services are transferred to
customers in an amount that reflects the consideration that is
expected to be received for those goods or services. ASU 2014-09
defines a five step process to achieve this core principle and, in
doing so, it is possible more judgment and estimates may be
required within the revenue recognition process than required under
existing U.S. GAAP including identifying performance obligations in
the contract, estimating the amount of variable consideration to
include in the transaction price and allocating the transaction
price to each separate performance obligation. ASU 2014-09 is
effective for us in our first quarter of fiscal 2018 using either
of two methods: (i) retrospective to each prior reporting period
presented with the option to elect certain practical expedients as
defined within ASU 2014-09; or (ii) retrospective with the
cumulative effect of initially applying ASU 2014-09 recognized at
the date of initial application and providing certain additional
disclosures as defined per ASU 2014-09. We are currently evaluating
the impact of our pending adoption of ASU 2014-09 on our
consolidated financial statements.
Note
4. Earnings
Per Share Applicable to Common Stockholders
The
following table sets forth the computations of earnings per share
amounts applicable to common stockholders for the three and nine
months ended September 30, 2017 and October 1, 2016:
|
Three Months Ended
|
Nine Months Ended
|
||
|
Sep. 30, 2017
|
Oct. 1, 2016
|
Sep. 30, 2017
|
Oct. 1, 2016
|
|
|
|
|
|
Net
income (loss)
|
$2,137,077
|
$(954,390)
|
$(2,555,802)
|
$(781,432)
|
|
|
|
|
|
Basic
weighted average common shares outstanding (1):
|
47,065,009
|
37,868,672
|
42,405,616
|
37,090,916
|
|
|
|
|
|
Basic
earnings (loss) per common share
|
$0.05
|
$(0.03)
|
$(0.06)
|
$(0.02)
|
|
|
|
|
|
Dilutive
effect of stock options, net
|
473,736
|
-
|
-
|
-
|
Dilutive
effect of warrants, net
|
17,952
|
-
|
-
|
-
|
|
|
|
|
|
Diluted
weighted average common shares outstanding :
|
47,556,697
|
37,868,672
|
42,405,616
|
37,090,916
|
|
|
|
|
|
Diluted
earnings (loss) per common share
|
$0.04
|
$(0.03)
|
$(0.06)
|
$(0.02)
|
|
|
|
|
|
Potentially
dilutive securities, total (2):
|
|
|
|
|
Stock
options
|
5,448,552
|
5,217,508
|
5,922,288
|
5,217,508
|
Warrants
|
452,492
|
487,111
|
470,444
|
487,111
|
|
|
|
|
|
(1)
Includes approximately 0.5 million weighted average nonvested
shares of restricted stock for the three and nine month
periods
ending September 30, 2017, respectively, and approximately 0.4
million weighted average nonvested shares or restricted stock
for
the three and nine month periods ending October 1, 2016,
respectively. These shares are participating securities that
feature
voting and dividend rights.
(2)
Excluded
from the computation of diluted earnings (loss) per share as their
impact is antidilutive.
- 8 -
Note
5. Related
Party Transactions
Asset acquisition
On
March 12, 2017, the Company acquired all of the outstanding equity
interests of Healthspan from Robert Fried, Jeffrey Allen and Dr.
Charles Brenner (the "Sellers"). Robert Fried is a member of the
Board of Directors ("Board") of the Company, a position he has held
since July 2015.
Upon
the closing of, and as consideration for, the acquisition, the
Company issued an aggregate of 367,648 shares of the
Company’s common stock to the Sellers. The fair value of
these shares was approximately $1.0 million based on the closing
price of $2.72 per share on March 12, 2017. Also on March 12, 2017,
the Company appointed Robert Fried as President and Chief Strategy
Officer, effective immediately. Mr. Fried continues to serve as a
member of the Board, but resigned as a member of the Nominating and
Corporate Governance Committee of the Board.
Healthspan
was formed in August 2015 to offer and sell finished bottle
products that contain NIAGEN® directly to consumers through
internet-based selling platforms. NIAGEN® is the leading
ingredient the Company currently sells. Prior to the acquisition,
the Company has supplied certain amount of NIAGEN® to
Healthspan as a raw material inventory in exchange for a 4% equity
interest in Healthspan. An additional 5% equity interest was
received for granting certain exclusive rights to resell
NIAGEN®.
The
Company acquired the consumer product business model that
Healthspan has established. Included in the business model acquired
is the know-how marketing to date, and the designs and procedures
needed to operate a consumer product business. This transaction was
accounted for as an acquisition of assets. An intangible asset of
approximately $1.35 million was recorded as a result of this
acquisition, which is the difference of consideration transferred
and the net amount of assets acquired and liabilities
assumed.
(A)
Consideration transferred
|
|
|
(B)
Net amount of assets and liabilities
|
|
|
Fair
value
|
|
Assets acquired
|
Fair
value
|
Common
Stock
|
$1,000,000
|
|
Cash
and cash equivalents
|
$19,000
|
Transaction
costs
|
178,000
|
|
Trade
receivables
|
11,000
|
Previously
held equity interest
|
20,000
|
|
Inventory
|
61,000
|
|
|
|
|
|
|
$1,198,000
|
|
Liabilities
assumed
|
|
|
|
|
Due
to officer
|
(132,000)
|
|
|
|
Accounts
payable
|
(74,000)
|
|
|
|
Credit
card payable
|
(30,000)
|
|
|
|
Other
accrued expenses
|
(3,000)
|
|
|
|
|
|
Consumer
product business model,
intangible asset (A) -(B)
|
$1,346,000
|
|
Net assets
|
$(148,000)
|
|
|
|
|
|
The
acquired intangible asset is considered to have a useful life of 10
years as we believe the economic benefits from the acquisition will
last at least 10 years. The expense is amortized using the
straight-line method over the useful life and the Company
recognized an amortization expense of approximately $75,000 for the
nine months ended September 30, 2017.
In
cancellation of a loan owed by Healthspan to Mr. Fried prior to the
acquisition, the Company repaid $32,500 to Mr. Fried on March 13,
2017 and will also repay $100,000 on March 12, 2018. No interest is
to be paid for the outstanding $100,000 due to Mr.
Fried.
- 9 -
Sale of consumer products
During
July 2017, the Company entered into an exclusivity agreement (the
"Customer G Agreement") with Customer G, whereby the Company agreed
to exclusively sell its TRU NIAGEN® dietary supplement product
to Customer G in certain territories in Asia. During the three
months ended September 30, 2017, the Company sold approximately
$2.3 million of TRU NIAGEN® dietary supplement product
pursuant to the Customer G Agreement. As of September 30, 2017, the
trade receivable from Customer G was approximately $1.5
million.
Li Ka
Shing, who beneficially owns more than 10% of the Company's common
stock, beneficially owns approximately 30% of Entity A and Entity A
beneficially owns approximately 75% of Customer G. In accordance
with the Company's Related-Person Transactions Policy, the Audit
Committee of the Company's Board of Directors ratified the
partnership with Customer G.
Note
6. Discontinued
Operations
On
September 5, 2017, the Company completed the sale of the Lab
Business to Covance. In consideration of the Lab Business sale, the
Company received $6.75 million from Covance and additional cash
consideration of $0.8 million is currently held in escrow to
satisfy any potential indemnification claims by Covance. Further,
the Company is eligible to receive an additional earnout payment
from Covance in an amount equal to up to $1.0 million, subject to
certain escrow provisions.
The
Company recorded a gain of approximately $5.5 million from the
disposal. The contingent earnout consideration up to $1.0 million
is tied to 2017 revenue of the Lab Business and the Company made an
election to record the contingent consideration portion when the
consideration is determined to be realizable and has not recorded
any contingent consideration to date.
(A) Consideration received
|
|
(C) Carrying value of the Lab Business
|
|
|
|
|
|
|
Amount
|
Assets
disposed
|
Carrying
value
|
Cash
payment
|
$6,750,000
|
Leasehold
improvements and equipment, net
|
$1,427,000
|
Cash
payment held in escrow (1)
|
750,000
|
Prepaid
expenses
|
11,000
|
Additional
earnout payment
|
-
|
Deposits
|
20,000
|
|
$7,500,000
|
|
|
|
|
Liabilities
disposed
|
|
(B) Selling costs
|
|
Deferred
revenue
|
(7,000)
|
|
|
Deferred
rent
|
(215,000)
|
|
Amount
|
|
|
Legal
|
$428,000
|
|
|
Financial
consulting
|
250,000
|
|
|
Other
|
118,000
|
|
|
|
$796,000
|
Net assets
|
$1,236,000
|
|
|
|
|
Gain from disposal (A) - (B) - (C)
|
$5,468,000
|
|
|
(1) $750,000 is expected to be held in escrow until March 2019 to
satisfy any indemnification claims.
The sale of the Lab
Business qualifies as a discontinued operation as the sale
represents a strategic shift that has (or will have) a major effect
on operations and financial results.
- 10 -
The
results of operations from the discontinued operations for the
three and nine months ended September 30, 2017 and October 1, 2016
are as follows:
|
Three Months Ended
|
Nine Months Ended
|
||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Sep. 30, 2017
|
Oct. 1,
2016
|
|
|
|
|
|
Sales
|
$650,610
|
$1,070,164
|
$2,820,631
|
$3,957,109
|
Cost
of sales
|
597,291
|
890,655
|
2,478,827
|
2,716,238
|
|
|
|
|
|
Gross profit
|
53,319
|
179,509
|
341,804
|
1,240,871
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Sales
and marketing
|
112,694
|
161,044
|
482,134
|
500,725
|
General
and administrative
|
43,838
|
41,019
|
150,171
|
128,381
|
Operating expenses
|
156,532
|
202,063
|
632,305
|
629,106
|
|
|
|
|
|
Operating income (loss)
|
(103,213)
|
(22,554)
|
(290,501)
|
611,765
|
|
|
|
|
|
Nonoperating
income (expense):
|
|
|
|
|
Interest
expense, net
|
(5,686)
|
(8,567)
|
(24,639)
|
(28,388)
|
Nonoperating expenses
|
(5,686)
|
(8,567)
|
(24,639)
|
(28,388)
|
|
|
|
|
|
Loss
before taxes from discontinued operations
|
(108,899)
|
(31,121)
|
(315,140)
|
583,377
|
Provision
for taxes
|
-
|
3,153
|
-
|
-
|
|
|
|
|
|
Income (loss) from discontinued operations
|
$(108,899)
|
$(27,968)
|
$(315,140)
|
$583,377
|
The
assets and liabilities that are classified as held for sale as of
December 31, 2016 are as follows:
|
Dec.
31, 2016
|
Current
assets held for sale
|
|
Prepaid
expenses
|
$18,135
|
|
|
Leasehold
Improvements and Equipment, net
|
1,333,203
|
Deposits
|
19,675
|
|
|
Total
assets held for sale
|
1,371,013
|
|
|
Deferred
rent
|
184,766
|
|
|
Total
liabilities held for sale
|
$184,766
|
Depreciation,
capital expenditures and significant noncash investing activities
of the discontinued operations for the nine months ended September
30, 2017 and October 1, 2016 are as follows:
Nine Months Ended September 30, 2017 and October 1,
2016
|
|
|
|
Sep. 30, 2017
|
Oct. 1,
2016
|
|
|
|
Depreciation
|
$169,250
|
$192,381
|
Purchase
of leasehod improvements and equipment
|
$111,232
|
$250,420
|
|
|
|
Noncash
investing activity
|
|
|
Retirement
of fully depreciated equipment - cost
|
$55,947
|
$13,330
|
Retirement
of fully depreciated equipment - accumulated
depreciation
|
$(55,947)
|
$(13,330)
|
- 11 -
Note
7. Trade
Receivables Allowances
The
allowance amounts for the periods ended September 30, 2017 and
December 31, 2016 are as follows:
|
Sep.
30, 2017
|
Dec.
31, 2016
|
Allowances related
to
|
|
|
Customer
C
|
$500,000
|
$800,000
|
Customer
E
|
-
|
198,000
|
Other
allowances
|
33,000
|
83,000
|
|
$533,000
|
$1,081,000
|
Note
8. Inventories
The
amounts of major classes of inventory as of September 30, 2017 and
December 31, 2016 are as follows:
|
Sep.
30, 2017
|
Dec.
31, 2016
|
Bulk
ingredients
|
$4,830,000
|
$7,044,000
|
Reference
standards
|
1,067,000
|
1,033,000
|
Dietary supplement
- finished bottles
|
9,000
|
-
|
Dietary supplement
- work-in-process
|
875,000
|
-
|
|
6,781,000
|
8,077,000
|
Less valuation
allowance
|
(166,000)
|
(164,000)
|
|
$6,615,000
|
$7,913,000
|
Note
9. Employee
Share-Based Compensation
Stock Option Plans
On June
20, 2017, the stockholders of the Company approved the ChromaDex
Corporation 2017 Equity Incentive Plan (the "2017 Plan"). The 2017
Plan is intended to be the successor to the ChromaDex Corporation
Second Amended and Restated 2007 Equity Incentive Plan (the "2007
Plan"). Under the 2017 Plan, the Company is authorized to issue
stock options that total no more than the sum of (i) 3,000,000 new
shares, (ii) approximately 384,000 unallocated shares remaining
available for the grant of new awards under the 2007 Plan, and
(iii) any returning shares from the 2007 Plan or the 2017 Plan,
such as forfeited, cancelled, or expired shares.
- 12 -
Service Period Based Stock Options
The
following table summarizes activity of service period based stock
options granted to employees at September 30, 2017 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 Dec.
31, 2016
|
4,281,151
|
$3.52
|
6.36
|
|
|
|
|
|
|
|
|
Options
Granted
|
773,334
|
2.93
|
10.00
|
$1.88
|
|
Options
Exercised
|
(114,813)
|
3.40
|
|
|
$104,000
|
Options
Expired
|
(3,334)
|
4.50
|
|
|
|
Options
Forfeited
|
(41,358)
|
3.54
|
|
|
|
Outstanding at Sep.
30, 2017
|
4,894,980
|
$3.43
|
6.19
|
|
$4,786,803
|
|
|
|
|
|
|
Exercisable at Sep.
30, 2017
|
3,496,750
|
$3.45
|
5.06
|
|
$3,433,000
|
|
|
|
|
|
|
The
aggregate intrinsic values in the table above are based on the
Company’s stock price of $4.30, which is the closing price of
the Company’s stock on the last day of business for the
period ended September 30, 2017.
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 September 30,
2017.
Nine Months Ended
Sep. 30, 2017
|
|
Expected
term
|
5.8
years
|
Expected
volatility
|
73%
|
Expected
dividends
|
0.00%
|
Risk-free
rate
|
2.11%
|
As of
September 30, 2017,
there was approximately $2.7 million of total unrecognized
compensation expected to be recognized over a weighted average
period of 2.3 years.
Employee Share-Based Compensation
The
Company recognized compensation expense of approximately $0.4
million and $1.1 million in general and administrative expenses in
the statement of operations for the three and nine months ended
September 30, 2017, respectively, and approximately $0.3 million
and $0.9 million for the three and nine months ended October 1,
2016, respectively.
- 13 -
Note
10. Stock
Issuance
On
April 26, 2017, the Company entered into a Securities Purchase
Agreement (the "SPA") with certain purchasers named therein,
pursuant to which the Company agreed to sell and issue up to $25.0
million of its common stock at a purchase price of $2.60 per share
in three tranches of approximately $3.5 million, $16.4 million and
$5.1 million, respectively. All three tranches closed during the
nine months ended September 30, 2017, whereby approximately 9.6
million shares were issued for proceeds of $23.7 million, net of
offering costs.
Subsequent
to the period ended September 30, 2017, the Company entered into a
securities purchase agreement for the sale of approximately $23.0
million of its common stock in a private placement, in return for
which the purchaser will receive approximately 5.6 million shares
at a per share price of $4.10. The private placement is expected to
close on or about November 17, 2017, subject to the satisfaction of
customary closing conditions.
Note
11. Business
Segments
Since
the year ended December 31, 2016, the Company has made operational
changes to merge its scientific and regulatory consulting segment
into core standards and contract services segment. Additionally,
with the acquisition of Healthspan in March 2017, the Company began
selling consumer products that contain the Company's branded
NIAGEN® ingredient. The Company made operational changes and
began segregating its financial results for consumer products
operations.
As a
result, the Company has the following three reportable
segments:
●
Ingredients segment
develops and commercializes proprietary-based ingredient
technologies and supplies these ingredients to consumers in
finished products or as raw materials to the manufacturers of
consumer products in various industries including the nutritional
supplement, food and beverage and animal health
industries.
●
Consumer products
segment provides directly to consumers as well as to distributors
finished dietary supplement products that contain the Company's
proprietary ingredients.
●
Core standards and
contract services segment includes (i) supply of phytochemical
reference standards, (ii) scientific and regulatory consulting and
(iii) other R&D services.
On
September 5, 2017, the Company completed the sale of the Lab
Business which was a part of the core standards and contract
services segment. The discontinued operations related to the Lab
Business are not included in following statement of operations for
business segments.
The
“Corporate and other” classification includes corporate
items not allocated by the Company to each reportable segment.
Further, there are no intersegment sales that require elimination.
The Company evaluates performance and allocates resources based on
reviewing gross margin by reportable segment.
Three months ended
September
30, 2017
|
Ingredients
|
Consumer
Products
|
Core
Standards and Contract
Services
|
Corporate
|
|
|
segment
|
segment
|
segment
|
and
other
|
Total
|
|
|
|
|
|
|
Net
sales
|
$2,459,905
|
$2,647,300
|
$977,485
|
|
$6,084,690
|
Cost
of sales
|
1,384,221
|
1,095,128
|
689,972
|
-
|
3,169,321
|
|
|
|
|
|
|
Gross profit
|
1,075,684
|
1,552,172
|
287,513
|
-
|
2,915,369
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales
and marketing
|
390,568
|
548,827
|
163,762
|
-
|
1,103,157
|
Research
and development
|
558,677
|
481,884
|
-
|
-
|
1,040,561
|
General
and administrative
|
-
|
-
|
-
|
3,948,435
|
3,948,435
|
Operating expenses
|
949,245
|
1,030,711
|
163,762
|
3,948,435
|
6,092,153
|
|
-
|
-
|
|
|
|
Operating income (loss)
|
$126,439
|
$521,461
|
$123,751
|
$(3,948,435)
|
$(3,176,784)
|
- 14 -
Three
months ended
October
1, 2016
|
Ingredients
|
Consumer
Products
|
Core
Standards and Contract Services
|
Corporate
|
|
|
segment
|
segment
|
segment
|
and
other
|
Total
|
|
|
|
|
|
|
Net
sales
|
$2,663,095
|
$-
|
$1,274,191
|
$-
|
$3,937,286
|
Cost
of sales
|
1,287,421
|
-
|
786,904
|
-
|
2,074,325
|
|
|
|
|
|
|
Gross profit
|
1,375,674
|
-
|
487,287
|
-
|
1,862,961
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales
and marketing
|
199,130
|
-
|
87,811
|
-
|
286,941
|
Research
and development
|
760,299
|
-
|
12,500
|
-
|
772,799
|
General
and administrative
|
-
|
-
|
-
|
1,727,383
|
1,727,383
|
Operating expenses
|
959,429
|
-
|
100,311
|
1,727,383
|
2,787,123
|
|
|
|
|
|
|
Operating income (loss)
|
$416,245
|
$-
|
$386,976
|
$(1,727,383)
|
$(924,162)
|
Nine months ended
September
30, 2017
|
Ingredients
|
Consumer
Products
|
Core
Standards and Contract
Services
|
Corporate
|
|
|
segment
|
segment
|
segment
|
and
other
|
Total
|
|
|
|
|
|
|
Net
sales
|
$7,393,389
|
$2,802,875
|
$3,474,382
|
$-
|
$13,670,646
|
Cost
of sales
|
3,615,097
|
1,135,864
|
2,277,379
|
-
|
7,028,340
|
|
|
|
|
|
|
Gross profit
|
3,778,292
|
1,667,011
|
1,197,003
|
-
|
6,642,306
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales
and marketing
|
959,761
|
738,647
|
359,770
|
-
|
2,058,178
|
Research
and development
|
2,022,151
|
532,562
|
-
|
-
|
2,554,713
|
General
and administrative
|
-
|
-
|
-
|
8,882,821
|
8,882,821
|
Other
|
745,773
|
-
|
-
|
-
|
745,773
|
Operating expenses
|
3,727,685
|
1,271,209
|
359,770
|
8,882,821
|
14,241,485
|
|
|
|
|
|
|
Operating income (loss)
|
$50,607
|
$395,802
|
$837,233
|
$(8,882,821)
|
$(7,599,179)
|
|
|
|
|
|
|
Nine months ended
October
1, 2016
|
Ingredients
|
Consumer
Products
|
Core
standards and Contract
Services
|
Corporate
|
|
|
segment
|
segment
|
segment
|
and
other
|
Total
|
|
|
|
|
|
|
Net
sales
|
$13,505,470
|
$-
|
$3,706,395
|
$-
|
$17,211,865
|
Cost
of sales
|
6,420,972
|
-
|
2,410,428
|
-
|
8,831,400
|
|
|
|
|
|
|
Gross profit
|
7,084,498
|
-
|
1,295,967
|
-
|
8,380,465
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Sales
and marketing
|
930,573
|
-
|
259,440
|
-
|
1,190,013
|
Research
and development
|
1,961,097
|
-
|
27,500
|
-
|
1,988,597
|
General
and administrative
|
-
|
-
|
-
|
5,935,139
|
5,935,139
|
Operating expenses
|
2,891,670
|
-
|
286,940
|
5,935,139
|
9,113,749
|
|
|
|
|
|
|
Operating income (loss)
|
$4,192,828
|
$-
|
$1,009,027
|
$(5,935,139)
|
$(733,284)
|
- 15 -
|
|
|
Core
Standards
|
|
|
At
September 30, 2017
|
Ingredients
|
Consumer
Products
|
and
Contract Services
|
Corporate
|
|
|
segment
|
segment
|
segment
|
and
other
|
Total
|
|
|
|
|
|
|
Total
assets
|
$9,761,568
|
$4,012,200
|
$2,589,857
|
$25,437,887
|
$41,801,512
|
|
|
|
|
|
|
At
December 31, 2016
|
Ingredients
|
Consumer
Products
|
Core
Standards and Contract Services
|
Corporate
|
|
|
segment
|
segment
|
segment
|
and
other
|
Total
|
|
|
|
|
|
|
Total
assets
|
$13,257,289
|
$-
|
$2,547,427
|
$3,947,352
|
$19,752,068
|
Disclosure of major customers
Major
customers who accounted for more than 10% of the Company’s
total sales were as follows:
|
Three
months ended
|
Nine
months ended
|
||
Major
Customers
|
Sep.
30, 2017
|
Oct. 1,
2016
|
Sep.
30, 2017
|
Oct. 1,
2016
|
|
|
|
|
|
Customer
G - Related Party
|
37.8%
|
*
|
16.8%
|
*
|
Customer
D
|
12.1%
|
12.3%
|
*
|
*
|
Customer
C
|
*
|
*
|
*
|
24.5%
|
|
|
|
|
|
*
Represents less than 10%.
|
|
|
|
|
Major
customers who accounted for more than 10% of the Company’s
total trade receivables were as follows:
|
Percentage
of the Company's Total Trade Receivables
|
|
Major
Customers
|
At
September 30, 2017
|
At
December 31, 2016
|
|
|
|
Customer
C
|
45.4%
|
45.8%
|
Customer
G - Related Party
|
30.3%
|
*
|
Customer
D
|
*
|
10.2%
|
|
|
|
*
Represents less than 10%.
|
|
|
- 16 -
Note
12. Commitments
and Contingencies
Legal proceedings
On
December 29, 2016, ChromaDex, Inc. filed a complaint (the
“Complaint”) in the United States District Court for
the Central District of California, naming Elysium Health,
Inc. (together with
Elysium Health, LLC, “Elysium”) as defendant.
Among other allegations, ChromaDex, Inc. alleged in the Complaint
that (i) Elysium breached the Supply Agreement, dated June 26,
2014, by and between ChromaDex, Inc. and Elysium (the
“pTeroPure® Supply Agreement”), by failing to make
payments to ChromaDex, Inc. for purchases of pTeroPure®
pursuant to the pTeroPure® Supply Agreement, (ii) Elysium
breached the Supply Agreement, dated February 3, 2014, by and
between ChromaDex, Inc. and Elysium, as amended (the
“NIAGEN® Supply Agreement”), by failing to make
payments to ChromaDex, Inc. for purchases of NIAGEN® pursuant
to the NIAGEN® Supply Agreement, (iii) Elysium breached the
Trademark License and Royalty Agreement, dated February 3, 2014, by
and between ChromaDex, Inc. and Elysium (the “License
Agreement”), by failing to make payments to ChromaDex, Inc.
for royalties due pursuant to the License Agreement and (iv)
certain officers of Elysium made false promises and representations
to induce ChromaDex, Inc. into providing large supplies of
pTeroPure® and NIAGEN® to Elysium pursuant to the
pTeroPure® Supply Agreement and NIAGEN® Supply Agreement.
ChromaDex, Inc. is seeking punitive damages, money damages and
interest.
On
January 25, 2017, Elysium filed an answer and counterclaims (the
“Counterclaim”) in response to the Complaint. Among
other allegations, Elysium alleges in the Counterclaim that (i)
ChromaDex, Inc. breached the NIAGEN® Supply Agreement by not
issuing certain refunds or credits to Elysium and for violating
certain confidential information provisions, (ii) ChromaDex, Inc.
breached the implied covenant of good faith and fair dealing
pursuant to the NIAGEN® Supply Agreement, (iii) ChromaDex,
Inc. breached certain confidential provisions of the
pTeroPure® Supply Agreement, (iv) ChromaDex, Inc. fraudulently
induced Elysium into entering into the License Agreement (the
“Fraud Claim”), (v) ChromaDex, Inc.’s conduct
constitutes misuse of its patent rights (the “Patent
Claim”) and (vi) ChromaDex, Inc. has engaged in unlawful or
unfair competition under California state law (the “Unfair
Competition Claim”). Elysium is seeking damages for
ChromaDex, Inc.’s alleged breaches of the NIAGEN® Supply
Agreement and pTeroPure® Supply Agreement, and compensatory
damages, punitive damages and/or rescission of the License
Agreement and restitution of any royalty payments conveyed by
Elysium pursuant to the License Agreement, and a declaratory
judgement that ChromaDex, Inc. has engaged in patent
misuse.
On
February 15, 2017, ChromaDex, Inc. filed an amended complaint. In
the amended complaint, ChromaDex, Inc. re-alleges the claims in the
Complaint, and also alleges that Elysium willfully and maliciously
misappropriated ChromaDex, Inc.’s trade secrets. On February
15, 2017, ChromaDex, Inc. also filed a motion to dismiss the Fraud
Claim, the Patent Claim and the Unfair Competition Claim. On March
1, 2017, Elysium filed a motion to dismiss ChromaDex, Inc.'s fraud
and trade secret misappropriation causes of action. On March 6,
2017, Elysium filed a first amended counterclaim. On March 20,
2017, ChromaDex, Inc. moved to dismiss Elysium's amended fraud,
patent misuse and the Unfair Competition Claim. On May 10, 2017,
the court ruled on the motions to dismiss, denying ChromaDex,
Inc.’s motion as to Elysium’s fraud and patent misuse
claims and granting ChromaDex, Inc.’s motion with prejudice
as to Elysium’s Unfair Competition Claim. With respect to
Elysium’s motion, the court granted the motion with prejudice
as to ChromaDex, Inc.’s fraud claim and granted with leave to
amend the motion as to ChromaDex, Inc.’s trade secret
misappropriation claims. On May 24, 2017, ChromaDex, Inc. answered
the first amended counterclaim and asserted several affirmative
defenses. Also on May 24, 2017, ChromaDex, Inc. filed a second
amended complaint, amending the trade secret misappropriation
claims and addressing Elysium’s patent misuse counterclaim.
On June 7, 2017, ChromaDex, Inc. filed a third amended complaint
dismissing the trade secret misappropriation claims and asserting
two breach of contract claims for Elysium’s failure to pay
for the product delivered. On June 16, 2017, Elysium answered the
third amended complaint. On August 14, 2017, ChromaDex, Inc. moved
for judgment on the pleadings as to Elysium’s declaratory
judgment of patent misuse counterclaim. On September 26, 2017, the
court denied ChromaDex’s motion without prejudice and
directed Elysium to file an amended counterclaim if it intended to
maintain its declaratory judgment counterclaim. On October 11,
2017, Elysium filed a second amended counterclaim, re-alleging the
claims in the first amended counterclaim and adding a claim for
unjust enrichment and restitution of the royalties Elysium paid to
ChromaDex, Inc. pursuant to the License Agreement. On October 25,
2017, ChromaDex, Inc. filed a motion to dismiss the declaratory
judgment of patent misuse and unjust enrichment claims and/or
strike allegations in the unjust enrichment claim contained in the
second amended counterclaim. The court has not yet ruled on the
motion.
- 17 -
On July
17, 2017, Elysium filed petitions with the U.S. Patent and
Trademark Office for inter partes review of U.S. Patent No.
8,197,807 and 8,383,086, patents to which ChromaDex, Inc. is the
exclusive licensee.
On September 27, 2017, Elysium filed a complaint in the United
States District Court for the Southern District of New York, naming
ChromaDex, Inc. as defendant (the “SDNY Complaint”).
Elysium alleges in the SDNY Complaint that ChromaDex, Inc. made
false and misleading statements in a citizen petition to the Food
and Drug Administration it filed on or about August 18, 2017. Among
other allegations, Elysium avers that the citizen petition was
filed with intent to injure Elysium’s position in the
marketplace, that it falsely described Elysium’s product as
dangerous, and that it misleadingly omitted material facts which
made Elysium’s product appear dangerous, while casting
ChromaDex, Inc.’s own products as safe. The SDNY Complaint
asserts four claims for relief: (i) false advertising under the
Lanham Act, 15 U.S.C. § 1125(a)(1); (ii) trade libel; (iii)
deceptive business practices under New York General Business Law
§ 349; and (iv) tortious interference with business relations.
ChromaDex, Inc. disputes the claims in the SDNY Complaint and
intends to defend against them vigorously. On October 19, 2017,
ChromaDex, Inc. filed a motion to dismiss the SDNY Complaint. In
its motion, ChromaDex, Inc. argued that the SDNY Complaint should
be dismissed because its statements in the citizen petition are
immunized from all of Elysium’s claims under the
Noerr-Pennington Doctrine, the litigation privilege, and New
York’s Anti-SLAPP statute, and because the SDNY Complaint
failed to state a claim under Federal Rule of Civil Procedure
12(b)(6). Elysium filed its opposition papers on November 2, 2017.
ChromaDex, Inc.’s reply, if any, is due on November 9,
2017.
On October 26, 2017, ChromaDex, Inc. filed a complaint in the
United States District Court for the Southern District of New York,
naming Elysium as defendant (the “ChromaDex SDNY
Complaint”). ChromaDex alleges in the ChromaDex SDNY
Complaint that Elysium made material false and misleading
statements to consumers in the promotion, marketing, and sale of
its health supplement product, Basis, by deceiving consumers into
erroneously believing: (1) the product is “safe” and
“pure” when its current Basis product has not been
sufficiently tested to support those claims; (2) the product has
been approved or otherwise endorsed by the Food and Drug
Administration; and (3) the product has been approved or endorsed
by prominent scientists and prestigious academic institutions,
among other allegations. The ChromaDex SDNY Complaint asserts five
claims for relief: (i) false advertising under the Lanham Act, 15
U.S.C. §1125(a); (ii) unfair competition under 15 U.S.C.
§ 1225(a); (iii) deceptive business practices under New York
General Business Law § 349; (iv) deceptive business practices
under New York General Business Law § 350; and (v) tortious
interference with prospective economic advantage. Elysium has
indicated that it intends on moving to dismiss the ChromaDex SDNY
Complaint. On November 3, 2017, the Court consolidated the SDNY
Complaint and the ChromaDex SDNY Complaint actions, and stayed
discovery in both actions pending a Court ordered mediation.
Briefing on the motion to dismiss the SDNY Complaint and the
expected motion to dismiss the ChromaDex SDNY Complaint will
continue in the interim.
As of
September 30, 2017, ChromaDex, Inc. did not accrue a potential loss
for the Counterclaim or the SDNY Complaint because ChromaDex, Inc.
believes that the allegations are without merit and thus it is not
probable that a liability had been incurred, and the amount of loss
cannot be reasonably estimated.
From
time to time we are involved in legal proceedings arising in the
ordinary course of our business. We believe that there is no other
litigation pending that is likely to have, individually or in the
aggregate, a material adverse effect on our financial condition or
results of operations.
Lease
On July
6, 2017, the Company entered into a lease for an office space
located in Los Angeles, California through September 2021. Pursuant
to the lease, the Company will make monthly lease payments ranging
from approximately $11,000 to $21,000, as the payments escalate
during the term of the lease.
Employment agreement with Robert Fried
On
March 12, 2017, the Company entered into an Employment Agreement
(the "Fried Agreement") with Robert Fried. Mr. Fried is entitled to
receive certain severance payments per the terms of the Fried
Agreement. The key terms of the Fried Agreement, including the
severance terms are as follows:
Mr.
Fried is entitled to: (i) an annual base salary of $300,000; (ii)
an annual cash bonus equal to (a) 1% of net direct-to-consumer
sales of products with nicotinamide riboside as a lead ingredient
by the Company plus (b) 2% of direct to consumer net sales of
products with nicotinamide riboside as a lead ingredient for the
portion of such sales that exceeded prior year sales plus (c) 1% of
the gross profit derived from nicotinamide riboside ingredient
sales to dietary supplement producers; (iii) an option to purchase
up to 500,000 shares of Common Stock under the 2007 plan, subject
to monthly vesting over a three-year period; and (iv) 166,667
shares of restricted Common Stock, subject to annual vesting over a
three-year period.
- 18 -
Subject
to Mr. Fried’s continuous service through such date, Mr.
Fried is also eligible to receive (i) on March 12, 2018, 166,667
shares of restricted Common Stock, subject to annual vesting over a
two-year period, (ii) on March 12, 2019, 166,666 shares of
restricted Common Stock that vest in full on the one year
anniversary of the grant date and (iii) up to 500,000 shares of
fully-vested restricted Common Stock that will be granted upon the
achievement of certain performance goals. Any unvested options or
shares of restricted stock will vest in full upon (a) a change in
control of the Company, (b) Mr. Fried’s death, (c) Mr.
Fried’s disability, (d) termination by the Company of Mr.
Fried’s employment without cause or (e) Mr. Fried’s
resignation for good reason, subject in each case to Mr.
Fried’s continuous service as an employee or consultant of
the Company or any of its subsidiaries though such
event.
The
severance terms of the Fried Agreement provide that if (i) Mr.
Fried’s employment is terminated by the Company without
cause, for death or disability, or Mr. Fried resigns for good
reason, or (ii) (a) a change in control of the Company occurs and
(b) within one month prior to the date of such change in control or
twelve months after the date of such change in control R.
Fried’s employment is terminated by the Company other than
for cause, then, subject to executing a release, Mr. Fried will
receive (w) continuation of his base salary for 12 months, (x)
health care continuation coverage payments premiums for 12 months,
(y) a prorated annual cash bonus earned for the fiscal year in
which such termination or resignation occurs, and (z) an extended
exercise period for his options.
Employment agreement with Kevin
Farr
Subsequent
to the period ended September 30, 2017, the Company entered into an
agreement with Thomas C. Varvaro whereby Mr. Varvaro will no longer
serve as the Company's Chief Financial Officer, Secretary,
principal financial officer and principal accounting officer. The
Company expects that Mr. Varvaro will transition from the Company
over the coming months to pursue other opportunities. During this
transition Mr. Varvaro will serve as the Company’s Senior
Vice President, Finance. Subsequent to the period ended September
30, 2017, the Company entered into an Employee Agreement (the Farr
Agreement) with Kevin M. Farr who was appointed by the Board to
serve as Chief Financial Officer, Secretary, principal accounting
officer and principal financial officer, to replace the vacancies
created by Mr. Varvaro's transition. Mr. Farr is entitled to
receive certain severance payments per the terms of the Farr
Agreement. The key terms of the Farr Agreement, including the
severance terms are as follows:
Mr. Farr is entitled to: (i) an annual base salary of $300,000 and
(ii) a discretionary annual bonus based on the achievement of
certain performance goals to be determined by the Board. Pursuant
to the Farr Agreement, Mr. Farr also received an option to purchase
up to 1,000,000 shares of ChromaDex common stock under the
ChromaDex 2017 Equity Incentive Plan, subject to monthly vesting
over a three-year period, with an exercise price equal to $4.24 per
share. The options will fully vest if the Company's stock price
equals or exceeds $10 per share for over the previous 20 trading
days.
If Mr.
Farr’s employment is terminated by the Company without cause
or Mr. Farr resigns for good reason, then, subject to executing a
release, Mr. Farr will receive (i) continuation of his base salary
for 12 months, (ii) COBRA premiums for 12 months, (iii) a prorated
annual cash bonus, based on the good faith determination of the
Board of the actual results and period of employment during the
year of such termination, (iv) accelerated vesting of time-based
equity that would have otherwise become vested by the one year
anniversary of such termination date and (v) an extended exercise
period for his options.
Note
13. Other
Expense
Loss from an ongoing litigation, Elysium
During
the nine months ended September 30, 2017, the Company, in relation
to the ongoing litigation, incurred a write-off of approximately
$746,000 in gross trade receivable from Elysium related to
royalties. As a result of this write-off and after further
analysis, the Company made an adjustment to the total allowance
amount from ($800,000) to ($500,000).
- 19 -
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF
OPERATIONS
Certain statements in this Management's Discussion and Analysis
(“MD&A”), other than purely historical information,
including estimates, projections, statements relating to our
business plans, objectives and expected operating results, and the
assumptions upon which those statements are based, are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934, as amended. Forward-looking statements generally can
be identified by the use of forward-looking terminology such as
“may,” “would,” “expect,”
“intend,” “could,” “estimate,”
“should,” “anticipate,” or
“believe,” and similar
expressions. Forward-looking statements are based on
current expectations and assumptions that are subject to risks and
uncertainties which may cause actual results to differ materially
from the forward-looking statements. We undertake no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events,
or otherwise. Readers should carefully review the risk
factors and related notes set forth below in Part II,
Item 1A, “Risk Factors” and included under Part I, Item
1A, “Risk Factors” of our Annual Report on Form 10-K
for the year ended December 31, 2016 filed with the Securities and
Exchange Commission on March 16, 2017 (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 September 30, 2017 compared with
the three and nine months ended October 1, 2016 unless otherwise
noted. Unless otherwise indicated or unless the context otherwise
requires, all references in this document to “we,”
“us,” “our,” the “Company,” and
similar expressions refer to ChromaDex Corporation, and depending
on the context, its subsidiaries.
Company Overview
The
business of ChromaDex Corporation is conducted by our principal
subsidiaries, ChromaDex, Inc., Healthspan Research, LLC, ChromaDex
Analytics, Inc. and ChromaPharma, Inc. The Company is a natural
products company that 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.
Through the Company's ingredients segment, the Company offers its
branded ingredients such as NIAGEN®, nicotinamide riboside,
and pTeroPure®, pterostilbene. With the acquisition of
Healthspan Research, LLC in March 2017, the Company established a
consumer product segment, which offers finished bottled dietary
supplement products that contain NIAGEN®. The Company also has
a core standards and contract services segment, which focuses on
natural product fine chemicals (known as
“phytochemicals”) and regulatory consulting services.
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. The Company then utilizes its business to
develop commercially viable proprietary ingredients. The
Company’s proprietary 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.
- 20 -
As of
September 30, 2017, the Company had approximately $24.0 million
cash and cash equivalents on hand. On April 26, 2017, the Company
entered into a Securities Purchase Agreement with certain
purchasers named therein, pursuant to which the Company agreed to
sell and issue up to $25.0 million of its Common Stock in three
tranches. All three tranches closed and the Company received
approximately $23.7 million net of offering costs. On September 5,
2017, the Company completed the sale of is operating assets that
were used with the Company's quality verification program testing
and analytical chemistry business for food and food related
products (the "Lab Business") to Covance Laboratories Inc.
("Covance"), and received net proceeds of approximately $6.0
million, net of transaction costs. Additional cash consideration of
$0.8 million is currently held in escrow to satisfy any potential
indemnification claims by Covance.
Subsequent
to the period ended September 30, 2017, the Company entered into a
securities purchase agreement for the sale of approximately $23.0
million of its common stock in a private placement, in return for
which the purchaser will receive approximately 5.6 million shares
at a per share price of $4.10. The private placement is expected to
close on or about November 17, 2017, subject to the satisfaction of
customary closing conditions.
We
anticipate that our current cash, cash equivalents, cash to be
generated from operations and cash to be received from the private
placement described above will be sufficient to meet our projected
operating plans into 2019. We may, however, seek additional capital
prior to 2019, both to meet our projected operating plans after
2018 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.
Financial Condition and Results of Operations
The
discussion and analysis of our financial condition and results of
operations is based on our financial statements, which have been
prepared in accordance with U.S. generally accepted accounting
principles (“GAAP”). The preparation of these financial
statements requires our management to make estimates and
assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities
at the date of the financial statements, as well as the reported
revenues, if any, and expenses during the reporting periods. On an
ongoing basis, we evaluate such estimates and judgments, including
those described in greater detail below. We base our estimates on
historical experience and on various other factors that we believe
are reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying value of assets
and liabilities that are not readily apparent from other sources.
Actual results may differ from these estimates under different
assumptions or conditions.
- 21 -
Some of
our operations are subject to regulation by various state and
federal agencies. In addition, we expect a significant increase in
the regulation of our target markets. Dietary supplements are
subject to Food and Drug Administration (the "FDA"), Federal Trade
Commission and U.S. Department of Agriculture regulations relating
to composition, labeling and advertising claims. These regulations
may in some cases, particularly with respect to those applicable to
new ingredients, require a notification that must be submitted to
the FDA along with evidence of safety. There are similar
regulations related to food additives.
Our net
sales from continuing operations and net income (loss) for the
three- and nine-month periods ending on September 30, 2017 and
October 1, 2016 were as follows:
|
Three
months ending
|
Nine
months ending
|
||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Sep. 30, 2017
|
Oct. 1,
2016
|
|
|
|
|
|
Net
sales
|
$6,085,000
|
$3,937,000
|
$13,671,000
|
17,212,000
|
Net
income (loss)
|
2,137,000
|
(954,000)
|
(2,556,000)
|
(781,000)
|
|
|
|
|
|
Basic
earnings (loss) per common share
|
$0.05
|
$(0.03)
|
$(0.06)
|
$(0.02)
|
Diluted
earnings (loss) per common share
|
$0.04
|
$(0.03)
|
$(0.06)
|
$(0.02)
|
|
|
|
|
|
Over
the next twelve months, we plan to continue to increase (i)
research and development efforts for our line of proprietary
ingredients and (ii) marketing efforts for our consumer products
that contain our proprietary ingredients, subject to available
financial resources.
Net Sales
Net
sales consist of gross
sales less discounts and returns.
|
Three
months ending
|
Nine
months ending
|
||||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Net sales:
|
|
|
|
|
|
|
Ingredients
|
$2,460,000
|
$2,663,000
|
-8%
|
$7,393,000
|
$13,506,000
|
-45%
|
Consumer
products
|
2,647,000
|
-
|
-
|
2,803,000
|
-
|
-
|
Core
standards and contract services
|
978,000
|
1,274,000
|
-23%
|
3,475,000
|
3,706,000
|
-6%
|
|
|
|
|
|
|
|
Total net sales
|
$6,085,000
|
$3,937,000
|
55%
|
$13,671,000
|
$17,212,000
|
-21%
|
●
The decrease in
sales for the ingredients segment for the three and nine months
ended September 30, 2017 is mainly due to decreased sales of
“NIAGEN®.” In
an effort to promote and better market the Company's TRU
NIAGENTM
branded consumer product, the Company made a strategic decision to
not ship NIAGEN® to certain customers in 2017.
●
With the
acquisition of Healthspan Research LLC in March 2017, the Company
began selling consumer products that contain the Company's branded
NIAGEN® ingredient. Segregation of the financial results for
the consumer products segment coincides with the Company's
strategic shift towards the consumer products segment which has
driven increased sales. The Company expects the sales for consumer
products segment to grow over the next twelve months.
●
The decrease in
sales for the core standards and contract services segment is
primarily due to decreased sales of regulatory consulting services
as fewer consulting projects were completed.
- 22 -
Cost of Sales
Cost of
sales include raw materials, labor, overhead, and
delivery costs.
|
Three
months ending
|
Nine
months ending
|
||||||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Sep. 30, 2017
|
Oct. 1,
2016
|
||||
|
Amount
|
%
of
net
sales
|
Amount
|
%
of
net
sales
|
Amount
|
%
of
net
sales
|
Amount
|
%
of
net
sales
|
Cost of sales:
|
|
|
|
|
|
|
|
|
Ingredients
|
$1,384,000
|
56%
|
$1,287,000
|
48%
|
$3,615,000
|
49%
|
$6,421,000
|
48%
|
Consumer
products
|
1,095,000
|
41%
|
-
|
-
|
1,136,000
|
41%
|
-
|
-
|
Core
standards and contract services
|
690,000
|
71%
|
787,000
|
62%
|
2,277,000
|
66%
|
2,410,000
|
65%
|
|
|
|
|
|
|
|
|
|
Total cost of sales
|
$3,169,000
|
52%
|
$2,074,000
|
53%
|
$7,028,000
|
51%
|
$8,831,000
|
51%
|
The
cost of sales, as a percentage of net sales, decreased 1% and
stayed flat for the three- and nine-month periods ended September
30, 2017, respectively, compared to the comparable periods in
2016.
●
The cost of sales,
as a percentage of net sales, for the ingredients segment increased
8% and 1% for the three- and nine-month periods, respectively.
During the three-month period ended September 30, 2017, we had
one-time write-off of our NIAGEN® related inventory of
approximately $183,000 which resulted in higher cost of
sales.
.●
The cost of sales,
as a percentage of net sales for the core standards and contract
services segment, increased 9% and 1% for the three- and nine-month
periods ended September 30, 2017, compared to the comparable
periods in 2016. The decrease in regulatory consulting sales for
the three-month period ended September 30, 2017 led to a lower
labor utilization rate, which resulted in increasing our cost of
sales as a percentage of net sales.
Gross Profit
Gross
profit is net sales less the cost of sales and is affected by a
number of factors including product mix, competitive pricing and
costs of products and services.
|
Three
months ending
|
Nine
months ending
|
||||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Gross profit:
|
|
|
|
|
|
|
Ingredients
|
$1,076,000
|
$1,376,000
|
-22%
|
$3,778,000
|
$7,084,000
|
-47%
|
Consumer
products
|
1,552,000
|
-
|
-
|
1,667,000
|
-
|
-
|
Core
standards and contract services
|
287,000
|
487,000
|
-41%
|
1,197,000
|
1,296,000
|
-8%
|
|
|
|
|
|
|
|
Total gross profit
|
$2,915,000
|
$1,863,000
|
56%
|
$6,642,000
|
$8,380,000
|
-21%
|
|
|
|
|
|
|
|
●
The decreased gross
profit for the ingredients segment for the three and nine months
ended September 30, 2017 is due to the decreased sales of
“NIAGEN®” in
connection with the strategic decision to not ship NIAGEN® to
certain customers in 2017 to better promote the Company's consumer
products.
●
The consumer
products segment posted gross profit of $1.6 million and $1.7
million, respectively for the three- and nine-month periods ending
in September 30, 2017. The Company expects the sales and gross
profit for consumer products segment to grow over the next twelve
months.
●
The decreased gross
profit for the core standards and contract services segment is
largely due to the decreased sale of regulatory consulting
services. Fixed labor costs make up the majority of costs of
regulatory consulting services and these fixed labor costs did not
decrease in proportion to sales, hence yielding lower profit
margin
- 23 -
Operating Expenses-Sales and Marketing
Sales
and marketing expenses consist of salaries, advertising
and marketing expenses.
|
Three
months ending
|
Nine
months ending
|
||||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Sales and marketing expenses:
|
|
|
|
|
|
|
Ingredients
|
$390,000
|
$199,000
|
96%
|
$960,000
|
$931,000
|
3%
|
Consumer
products
|
549,000
|
-
|
-
|
738,000
|
-
|
-
|
Core
standards and contract services
|
164,000
|
88,000
|
86%
|
360,000
|
259,000
|
39%
|
|
|
|
|
|
|
|
Total sales and marketing
expenses
|
$1,103,000
|
$287,000
|
284%
|
$2,058,000
|
$1,190,000
|
73%
|
|
|
|
|
|
|
|
●
For the consumer
products segment, we have increased staffing as well as direct
marketing expenses associated with social media and other customer
awareness and acquisition programs. We will continue to expand both
staffing as well as increase other marketing expense as we invest
in building out our own global branded consumer product
business.
●
For the ingredients
segment, the increase for the three months ended September 30, 2017
is largely due to the hiring of additional staff.
●
For the core
standards and contract services segment, the increase for the three
and nine months ended September 30, 2017 is mainly due to our
increased marketing efforts.
Operating Expenses-Research and Development
Research
and development expenses mainly consist of clinical trials and
process development expenses.
|
Three
months ending
|
Nine
months ending
|
||||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Research and development expenses:
|
|
|
|
|
|
|
Ingredients
|
$559,000
|
$760,000
|
-26%
|
$2,022,000
|
$1,961,000
|
3%
|
Consumer
products
|
482,000
|
-
|
-
|
$533,000
|
-
|
-
|
Core
standards and contract services
|
-
|
13,000
|
-100%
|
-
|
28,000
|
-100%
|
|
|
|
|
|
|
|
Total sales and marketing
expenses
|
$1,041,000
|
$773,000
|
35%
|
$2,555,000
|
$1,989,000
|
28%
|
|
|
|
|
|
|
|
●
In 2017, we began
allocating the research and development expenses related to our
"NIAGEN®" branded ingredient to the ingredients and consumer
products segment, based on revenues recorded. Previously, these
expenses were recorded all in the ingredients segment. Overall, we
increased our research and development efforts compared to 2016.
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.
- 24 -
Operating Expenses-General and Administrative
General
and administrative expenses consist of general
company administration, IT, accounting and executive management
expenses.
|
Three
months ending
|
Nine
months ending
|
||||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
|
|
|
|
|
|
|
General and administrative
|
$3,948,000
|
$1,727,000
|
129%
|
$8,883,000
|
$5,935,000
|
50%
|
●
The increase was
primarily related to legal expenses. For the three- and nine-month
periods ended September 30, 2017, our legal expenses increased to
approximately $1,415,000 and $2,686,000, respectively, compared to
approximately $312,000 and $735,000, respectively, for the
comparable periods in 2016. The ongoing litigation with Elysium
Health, Inc. and our increased efforts to file and maintain patents
related to the proprietary ingredient technologies were the main
reasons for the increase in legal expenses. We also incurred
significant legal expenses related to the sale of the Lab Business
as well as the private placement of equity, however, these expenses
were recorded as transaction costs.
●
In addition our
share-based compensation expense increased. For the three- and
nine-month periods ended September 30, 2017, our share-based
compensation expense increased to approximately $491,000 and
$1,211,000 compared to approximately $272,000 and $930,000 for the
comparable periods in 2016.
Operating Expense-Other
Other expense
consists of loss from an ongoing litigation.
|
Three months ending
|
Nine months ending
|
||||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
|
|
|
|
|
|
|
Other
|
$-
|
$-
|
|
$746,000
|
$-
|
|
●
During the nine
months ended September 30, 2017, the Company, in relation to the
ongoing litigation, incurred a write-off of approximately $746,000
in gross trade receivable from Elysium Health, Inc. related to
royalties.
Non-operating Expenses- Interest Expense, net
Interest
expense consists of interest on loan payable and capital
leases.
|
Three
months ending
|
Nine
months ending
|
||||
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
Sep. 30, 2017
|
Oct. 1,
2016
|
Change
|
|
|
|
|
|
|
|
Interest expense, net
|
$45,000
|
$2,000
|
2150%
|
$109,000
|
$315,000
|
-65%
|
The
decrease in interest expense for the nine months ended September
30, 2017 was mainly due to the term loan from Hercules Technology
II, L.P. 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.
- 25 -
Income Taxes
At
September 30, 2017 and October 1, 2016, 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 September 30, 2017 and October 1,
2016, respectively.
Depreciation and Amortization
Depreciation
expense for the nine-month period ended September 30, 2017 was
approximately $396,000 as compared to $234,000 for the nine-month
period ended October 1, 2016. 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
September 30, 2017 was approximately $148,000 as compared to
$63,000 for the nine-month period ended October 1, 2016. We
amortize intangible assets using a straight-line method, generally
over 10 years. For licensed patent rights, the useful lives are 10
years or the remaining term of the patents underlying licensing
rights, whichever is shorter. The useful lives of subsequent
milestone payments that are capitalized are the remaining useful
life of the initial licensing payment that was
capitalized.
Liquidity and Capital Resources
From
inception through September 30, 2017, we have incurred aggregate
losses of approximately $48 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 September 30, 2017, the Company
entered into a securities purchase agreement for the sale of
approximately $23.0 million of its common stock in a private
placement, in return for which the purchaser will receive
approximately 5.6 million shares at a per share price of $4.10. The
private placement is expected to close on or about November 17,
2017, subject to the satisfaction of customary closing
conditions.
While
we anticipate that our current cash, cash equivalents, cash to be
generated from operations and cash to be received from the private
placement described above will be sufficient to meet our projected
operating plans into 2019, we may require additional funds, either
through additional equity or debt financings or collaborative
agreements or from other sources. We have no commitments to obtain
such additional financing, and we may not be able to obtain any
such additional financing on terms favorable to us, or at all. If
adequate financing is not available, the Company will further
delay, postpone or terminate product and service expansion and
curtail certain selling, general and administrative operations. The
inability to raise additional financing may have a material adverse
effect on the future performance of the Company.
- 26 -
Net cash used in operating activities
Net
cash used in operating activities for the nine months ended
September 30, 2017 was approximately $6,037,000 as compared to
approximately $3,128,000 for the nine months ended October 1, 2016.
Along with the net loss, a decrease in accounts payable and an
increase in prepaid expenses were the largest uses of cash during
the nine-month period ended September 30, 2017, partially offset by
the decrease in trade receivables and inventories. Net cash used in
operating activities for the nine months ended October 1, 2016
largely reflects a decrease in accounts payable and an increase in
trade receivables 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 provided by (used in) investing activities
Net
cash provided by investing activities was approximately $4,897,000
for the nine months ended September 30, 2017, compared to
approximately $1,146,000 used in for the nine months ended October
1, 2016. Net cash provided by investing activities for the nine
months ended September 30, 2017 primarily consisted of net proceeds
from the sale of the Lab Business. 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 provided by financing activities
Net
cash provided by financing activities was approximately $23,497,000
for the nine months ended September 30, 2017, compared to
approximately $989,000 for the nine months ended October 1, 2016.
Net cash provided by financing activities for the nine months ended
September 30, 2017 mainly consisted of proceeds from issuance of
our common stock. Net cash provided by financing activities for the
nine months ended October 1, 2016 mainly consisted of proceeds from
the issuance 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.
Contractual Obligations and Commitments
During
the nine months ended September 30, 2017, 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 September 30, 2017, we had no material
off-balance sheet arrangements other than with respect to ordinary
operating leases as disclosed in the “Financial Statements
and Supplementary Data” section of our Annual
Report.
- 27 -
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 September 30, 2017 and October 1, 2016 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
(the "Exchange Act"), as of the end of the period covered by this
Quarterly Report on Form 10-Q. In designing and evaluating the
disclosure controls and procedures, management recognizes that any
controls and procedures, no matter how well designed and operated,
can provide only reasonable assurance of achieving the desired
control objectives. In addition, the design of disclosure controls
and procedures must reflect the fact that there are resource
constraints and that management is required to apply its judgment
in evaluating the benefits of possible controls and procedures
relative to their costs.
Based on our evaluation, our Chief Executive Officer and Chief
Financial Officer concluded that, as of September 30, 2017, 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 Exchange Act) that occurred
during our last fiscal quarter and that has materially affected, or
is reasonably likely to materially affect, our internal control
over financial reporting. There were no changes in internal control
over financial reporting that occurred during the Company’s
third fiscal quarter that have materially affected, or are
reasonably likely to materially affect, our internal control over
financial reporting.
- 28 -
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
As
previously disclosed, on December 29, 2016, ChromaDex, Inc. filed a
complaint (the “Complaint”) in the United States
District Court for the Central District of California, naming
Elysium Health, Inc. (together with
Elysium Health, LLC, “Elysium”) as defendant.
Among other allegations, ChromaDex, Inc. alleges in the Complaint
that (i) Elysium breached the Supply Agreement, dated June 26,
2014, by and between ChromaDex, Inc. and Elysium (the
“pTeroPure® Supply Agreement”), by failing to make
payments to ChromaDex, Inc. for purchases of pTeroPure®
pursuant to the pTeroPure® Supply Agreement, (ii) Elysium
breached the Supply Agreement, dated February 3, 2014, by and
between ChromaDex, Inc. and Elysium, as amended (the
“NIAGEN® Supply Agreement”), by failing to make
payments to ChromaDex, Inc. for purchases of NIAGEN® pursuant
to the NIAGEN® Supply Agreement, (iii) Elysium breached the
Trademark License and Royalty Agreement, dated February 3, 2014, by
and between ChromaDex, Inc. and Elysium (the “License
Agreement”), by failing to make payments to ChromaDex, Inc.
for royalties due pursuant to the License Agreement and (iv)
certain officers of Elysium made false promises and representations
to induce ChromaDex, Inc. into providing large supplies of
pTeroPure® and NIAGEN® to Elysium pursuant to the
pTeroPure® Supply Agreement and NIAGEN® Supply Agreement.
ChromaDex, Inc. is seeking punitive damages, money damages and
interest.
On
January 25, 2017, Elysium filed an answer and counterclaims (the
“Counterclaim”) in response to the Complaint. Among
other allegations, Elysium alleges in the Counterclaim that (i)
ChromaDex, Inc. breached the NIAGEN® Supply Agreement by not
issuing certain refunds or credits to Elysium and for violating
certain confidential information provisions, (ii) ChromaDex, Inc.
breached the implied covenant of good faith and fair dealing
pursuant to the NIAGEN® Supply Agreement, (iii) ChromaDex,
Inc. breached certain confidential provisions of the
pTeroPure® Supply Agreement, (iv) ChromaDex, Inc. fraudulently
induced Elysium into entering into the License Agreement (the
“Fraud Claim”), (v) ChromaDex, Inc.’s conduct
constitutes misuse of its patent rights (the “Patent
Claim”) and (vi) ChromaDex, Inc. has engaged in unlawful or
unfair competition under California state law (the “Unfair
Competition Claim”). Elysium is seeking damages for
ChromaDex, Inc.’s alleged breaches of the NIAGEN® Supply
Agreement and pTeroPure® Supply Agreement, and compensatory
damages, punitive damages and/or rescission of the License
Agreement and restitution of any royalty payments conveyed by
Elysium pursuant to the License Agreement, and a declaratory
judgment that ChromaDex, Inc. has engaged in patent
misuse.
On
February 15, 2017, ChromaDex, Inc. filed an amended complaint. In
the amended complaint, ChromaDex, Inc. re-alleges the claims in the
Complaint, and also alleges that Elysium willfully and maliciously
misappropriated ChromaDex, Inc.’s trade secrets. On February
15, 2017, ChromaDex, Inc. also filed a motion to dismiss the Fraud
Claim, the Patent Claim and the Unfair Competition Claim. On March
1, 2017, Elysium filed a motion to dismiss ChromaDex, Inc.'s fraud
and trade secret misappropriation causes of action. On March 6,
2017, Elysium filed a first amended counterclaim. On March 20,
2017, ChromaDex, Inc. moved to dismiss Elysium's amended fraud,
declaratory judgment of patent misuse and the Unfair Competition
Claim. On May 10, 2017, the court ruled on the motions to dismiss,
denying ChromaDex, Inc.’s motion as to Elysium’s fraud
and declaratory judgment claims and granting ChromaDex,
Inc.’s motion with prejudice as to Elysium’s Unfair
Competition Claim. With respect to Elysium’s motion, the
court granted the motion with prejudice as to ChromaDex,
Inc.’s fraud claim and granted with leave to amend the motion
as to ChromaDex, Inc.’s trade secret misappropriation claims.
On May 24, 2017, ChromaDex, Inc. answered the first amended
counterclaim and asserted several affirmative defenses. Also on May
24, 2017, ChromaDex, Inc. filed a second amended complaint,
amending the trade secret misappropriation claims and addressing
Elysium’s declaratory judgment of patent misuse counterclaim.
On June 7, 2017, ChromaDex, Inc. filed a third amended complaint
dismissing the trade secret misappropriation claims and asserting
two breach of contract claims for Elysium’s failure to pay
for the product delivered. On June 16, 2017, Elysium answered the
third amended complaint. On August 14, 2017, ChromaDex, Inc. moved
for judgment on the pleadings as to Elysium’s declaratory
judgment of patent misuse counterclaim. On September 26, 2017, the
court denied ChromaDex’s motion without prejudice and
directed Elysium to file an amended counterclaim if it intended to
maintain its declaratory judgment counterclaim. On October 11,
2017, Elysium filed a second amended counterclaim, re-alleging the
claims in the first amended counterclaim and adding a claim for
unjust enrichment and restitution of the royalties Elysium paid to
ChromaDex, Inc. pursuant to the License Agreement. On October 25,
2017, ChromaDex, Inc. filed a motion to dismiss the declaratory
judgment of patent misuse and unjust enrichment claims and/or
strike allegations in the unjust enrichment claim contained in the
second amended counterclaim. The court has not yet ruled on the
motion.
- 29 -
On July
17, 2017, Elysium filed petitions with the U.S. Patent and
Trademark Office for inter partes review of U.S. Patent No.
8,197,807 and 8,383,086, patents to which ChromaDex, Inc. is the
exclusive licensee.
On September 27, 2017, Elysium filed a complaint in the United
States District Court for the Southern District of New York, naming
ChromaDex, Inc. as defendant (the “SDNY Complaint”).
Elysium alleges in the SDNY Complaint that ChromaDex, Inc. made
false and misleading statements in a citizen petition to the Food
and Drug Administration it filed on or about August 18, 2017. Among
other allegations, Elysium avers that the citizen petition was
filed with intent to injure Elysium’s position in the
marketplace, that it falsely described Elysium’s product as
dangerous, and that it misleadingly omitted material facts which
made Elysium’s product appear dangerous, while casting
ChromaDex, Inc.’s own products as safe. The SDNY Complaint
asserts four claims for relief: (i) false advertising under the
Lanham Act, 15 U.S.C. § 1125(a)(1); (ii) trade libel; (iii)
deceptive business practices under New York General Business Law
§ 349; and (iv) tortious interference with business relations.
ChromaDex, Inc. disputes the claims in the SDNY Complaint and
intends to defend against them vigorously. On October 19, 2017,
ChromaDex, Inc. filed a motion to dismiss the SDNY Complaint. In
its motion, ChromaDex, Inc. argued that the SDNY Complaint should
be dismissed because its statements in the citizen petition are
immunized from all of Elysium’s claims under the
Noerr-Pennington Doctrine, the litigation privilege, and New
York’s Anti-SLAPP statute, and because the SDNY Complaint
failed to state a claim under Federal Rule of Civil Procedure
12(b)(6). Elysium filed its opposition papers on November 2, 2017.
ChromaDex, Inc.’s reply, if any, is due on November 9,
2017.
On October 26, 2017, ChromaDex, Inc. filed a complaint in the
United States District Court for the Southern District of New York,
naming Elysium as defendant (the “ChromaDex SDNY
Complaint”). ChromaDex alleges in the ChromaDex SDNY
Complaint that Elysium made material false and misleading
statements to consumers in the promotion, marketing, and sale of
its health supplement product, Basis, by deceiving consumers into
erroneously believing: (1) the product is “safe” and
“pure” when its current Basis product has not been
sufficiently tested to support those claims; (2) the product has
been approved or otherwise endorsed by the Food and Drug
Administration; and (3) the product has been approved or endorsed
by prominent scientists and prestigious academic institutions,
among other allegations. The ChromaDex SDNY Complaint asserts five
claims for relief: (i) false advertising under the Lanham Act, 15
U.S.C. §1125(a); (ii) unfair competition under 15 U.S.C.
§ 1225(a); (iii) deceptive business practices under New York
General Business Law § 349; (iv) deceptive business practices
under New York General Business Law § 350; and (v) tortious
interference with prospective economic advantage. Elysium has
indicated that it intends on moving to dismiss the ChromaDex SDNY
Complaint. On November 3, 2017, the Court consolidated the SDNY
Complaint and the ChromaDex SDNY Complaint actions, and stayed
discovery in both actions pending a Court ordered mediation.
Briefing on the motion to dismiss the SDNY Complaint and the
expected motion to dismiss the ChromaDex SDNY Complaint will
continue in the interim.
While
ChromaDex, Inc. expresses no opinion as to the ultimate outcome of
these matters, ChromaDex, Inc. believes Elysium’s allegations
are without merit and will vigorously defend against them. As of
September 30, 2017, ChromaDex, Inc. did not accrue a potential loss
for the Counterclaim or the SDNY Complaint because ChromaDex, Inc.
believes that the allegations are without merit and thus it is not
probable that a liability had been incurred, and the amount of loss
cannot be reasonably estimated.
From
time to time we are involved in legal proceedings arising in the
ordinary course of our business. We believe that there is no other
litigation pending that is likely to have, individually or in the
aggregate, a material adverse effect on our financial condition or
results of operations.
- 30 -
ITEM 1A. RISK FACTORS
Investing in our common stock involves a high degree of risk.
Current investors and potential investors should consider carefully
the risks and uncertainties described below and in our Annual
Report, together with all other information contained in this Form
10-Q and our Annual Report, including our financial statements, the
related notes and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations,” before
making investment decisions with respect to our common stock. If
any of the following risks actually occur, our business, financial
condition, results of operations and future growth prospects would
likely be materially and adversely affected. Under these
circumstances, the trading price and value of our common stock
could decline, and you may lose all or part of your investment. The
risks and uncertainties described in this Form 10-Q and in our
Annual Report are not the only ones facing our Company. Additional
risks and uncertainties of which we are not presently aware, or
that we currently consider immaterial, may also impair our business
operations. The risk factors set forth below that are marked with
an asterisk (*) contain changes to the similarly titled risk
factors included in Part I, Item 1A of our Annual
Report.
Risks Related to our Company and our Business
*We have a history of operating losses, may need additional
financing to meet our future long-term capital requirements and may
be unable to raise sufficient capital on favorable terms or at
all.
We have
recorded a net loss of approximately $2,556,000 for the nine months
ended September 30, 2017, 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 $2,928,000,
$2,771,000 and $5,388,000 for the years ended December 31, 2016,
January 2, 2016 and January 3, 2015, respectively. As of September
30, 2017, our accumulated deficit was approximately $47.8 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 September 30, 2017, the Company entered into a
securities purchase agreement for the sale of approximately $23.0
million of its common stock in a private placement, in return for
which the purchaser will receive approximately 5.6 million shares
at a per share price of $4.10. The private placement is expected to
close on or about November 17, 2017, subject to the satisfaction of
customary closing conditions.
While
we anticipate that our current cash, cash equivalents, cash to be
generated from operations and cash to be received from the private
placement described above will be sufficient to meet our projected
operating plans into 2019, we may require additional funds, either
through additional equity or debt financings or collaborative
agreements or from other sources. We have no commitments to obtain
such additional financing, and we may not be able to obtain any
such additional financing on terms favorable to us, or at all. If
adequate financing is not available, the Company will further
delay, postpone or terminate product and service expansion and
curtail certain selling, general and administrative operations. The
inability to raise additional financing may have a material adverse
effect on the future performance of the Company.
*Our capital requirements will depend on many factors.
Our
capital requirements will depend on many factors,
including:
●
the
revenues generated by sales of our products;
●
the
costs associated with expanding our sales and marketing efforts,
including efforts to hire independent agents and sales
representatives and obtain required regulatory approvals and
clearances;
●
the
expenses we incur in developing and commercializing our products,
including the cost of obtaining and maintaining regulatory
approvals; and
●
unanticipated
general and administrative expenses, including expenses involved
with our ongoing litigation with Elysium.
- 31 -
As a
result of these factors, we may seek to raise additional capital
prior to November 2018 both to meet our projected operating plans
after November 2018 and to fund our longer term strategic
objectives. Additional capital may come from public and private
equity or debt offerings, borrowings under lines of credit or other
sources. These additional funds may not be available on favorable
terms, or at all. There can be no assurance we will be successful
in raising these additional funds. Furthermore, if we issue equity
or debt securities to raise additional funds, our existing
stockholders may experience dilution and the new equity or debt
securities we issue may have rights, preferences and privileges
senior to those of our existing stockholders. In addition, if we
raise additional funds through collaboration, licensing or other
similar arrangements, it may be necessary to relinquish valuable
rights to our products or proprietary technologies, or grant
licenses on terms that are not favorable to us. If we cannot raise
funds on acceptable terms, we may not be able to develop or enhance
our products, obtain the required regulatory clearances or
approvals, execute our business plan, take advantage of future
opportunities, or respond to competitive pressures or unanticipated
customer requirements. Any of these events could adversely affect
our ability to achieve our development and commercialization goals,
which could have a material and adverse effect on our business,
results of operations and financial condition.
*We are currently engaged in substantial and
complex litigation with Elysium, the oucome of which could
materially harm our business and financial
results.
We are currently engaged in litigation with Elysium, a customer
that represented 19% of our net sales for the year
ended December 31, 2016. Elysium has made no purchases
from us since August 9, 2016. The litigation includes multiple
complaints and counterclaims by us and Elysium in venues in
California and New York, as well as a petition by Elysium with the
U.S. Patent and Trademark Office for inter partes review of two
patents to which we are the exclusive licensee. For further details
on this litigation, please refer to Part II, Item 1 of this
Quarterly Report on Form 10-Q.
The litigation is substantial and complex, and it has and
could continue to cause us to incur significant costs, as well as
distract our management over an extended period of time. The
litigation may substantially disrupt our business and we cannot
assure you that we will be able to resolve the litigation on terms
favorable to us. If we are
unsuccessful in resolving the litigation on favorable terms to us,
we may be forced to pay compensatory and punitive damages and
restitution for any royalty payments that we received from Elysium,
which payments could materially harm our business, or be subject to
other remedies, including injunctive relief. Further, if we are
unsuccessful in resolving the Patent Claim on favorable terms, or
if the U.S. Patent and Trademark Office invalidates the two patents
subject to the inter partes review, we may lose the competitive
advantage that is provided by the subject intellectual property
rights, which would have a material adverse effect on our business.
In addition, Elysium has not paid us approximately $2.7 million for
previous purchase orders. We may not collect the full amount owed
to us by Elysium, and as a result, we may have to write off a large
portion of that amount as uncollectible expense. We cannot predict
the outcome of our litigation with Elysium, which could have any of
the results described above or other results that could materially
harm our business.
*Interruptions in our relationships or declines in
our business with major customers could materially ham our business
and financial results.
Two of our customers accounted for approximately 50% of our sales
during the three months ended September 30, 2017. Any interruption
in our relationship or decline in our business with these customers
or other customers upon whom we become highly dependent could cause
harm to our business. Factors that could influence our relationship
with our customers upon whom we may become highly dependent
include:
●
our
ability to maintain our products at prices that are competitive
with those of our competitors;
●
our
ability to maintain quality levels for our products sufficient to
meet the expectations of our customers;
●
our
ability to produce, ship and deliver a sufficient quantity of our
products in a timely manner to meet the needs of our
customers;
●
our
ability to continue to develop and launch new products that our
customers feel meet their needs and requirements, with respect to
cost, timeliness, features, performance and other
factors;
●
our
ability to provide timely, responsive and accurate customer support
to our customers; and
●
the
ability of our customers to effectively deliver, market and
increase sales of their own products based on ours.
* In an effort to promote and
better market our consumer products, we have made a strategic
decision to not ship NIAGEN® to certain ingredient segment
customers, which could potentially harm our overall
sales.
By
developing and selling TRU NIAGEN®, our own consumer standalone
NIAGEN® supplement product, we are in direct competition with
some of our current ingredients segment customers that use
NIAGEN® in the products that are sold to consumers. In an
effort to promote and better market our consumer product, we have
made a strategic decision to not ship NIAGEN® to certain
ingredient segment customers, which will have a negative effect on
our ingredient segment sales. For example, sales for our
ingredients segment for the nine-month period ended September 30,
2017 decreased 45% compared to the same period in 2016.
Additionally, as our own consumer product becomes more prominent
and widely adopted by consumers, the competition with our consumer
product could potentially further harm the sales of our ingredients
segment business, and our sales of NIAGEN® for our ingredients
segment may further decrease. The sales of our consumer product may
not outweigh the decrease in sales of our ingredients segment,
which would lead to an overall decrease in our sales. Sales for our
ingredients segment represented approximately 63% of the
Company’s revenue for 2016, and sales of NIAGEN®
accounted for approximately 71% of our ingredient segment’s
total sales in 2016, or 45% of our overall revenue, so any harm to
our NIAGEN® ingredient sales, if not compensated for by sales
of our consumer product, may materially and negatively affect our
business.
- 32 -
Decline in the state of the global
economy and financial market conditions could adversely affect our
ability to conduct business and our results of
operations.
Global
economic and financial market conditions, including disruptions in
the credit markets and the impact of the global economic
deterioration may materially impact our customers and other parties
with whom we do business. These conditions could negatively affect
our future sales of our ingredient lines as many consumers consider
the purchase of nutritional products discretionary. Decline in
general economic and financial market conditions could materially
adversely affect our financial condition and results of operations.
Specifically, the impact of these volatile and negative conditions
may include decreased demand for our products and services, a
decrease in our ability to accurately forecast future product
trends and demand, and a negative impact on our ability to timely
collect receivables from our customers. The foregoing economic
conditions may lead to increased levels of bankruptcies,
restructurings and liquidations for our customers, scaling back of
research and development expenditures, delays in planned projects
and shifts in business strategies for many of our customers. Such
events could, in turn, adversely affect our business through loss
of sales.
We may need to increase the size of our organization, and we can
provide no assurance that we will successfully expand operations or
manage growth effectively.
Our
significant increase in the scope and the scale of our product
launches, including the hiring of additional personnel, has
resulted in significantly higher operating expenses. As a result,
we anticipate that our operating expenses will continue to
increase. Expansion of our operations may also cause a significant
demand on our management, finances and other resources. Our ability
to manage the anticipated future growth, should it occur, will
depend upon a significant expansion of our accounting and other
internal management systems and the implementation and subsequent
improvement of a variety of systems, procedures and controls. There
can be no assurance that significant problems in these areas will
not occur. Any failure to expand these areas and implement and
improve such systems, procedures and controls in an efficient
manner at a pace consistent with our business could have a material
adverse effect on our business, financial condition and results of
operations. There can be no assurance that our attempts to expand
our marketing, sales, manufacturing and customer support efforts
will be successful or will result in additional sales or
profitability in any future period. As a result of the expansion of
our operations and the anticipated increase in our operating
expenses, as well as the difficulty in forecasting revenue levels,
we expect to continue to experience significant fluctuations in our
results of operations.
*Changes in our business strategy, including entering the consumer
product market, or restructuring of our businesses may increase our
costs or otherwise affect the profitability of our
businesses.
As
changes in our business environment occur we may adjust our
business strategies to meet these changes or we may otherwise
decide to restructure our operations or particular businesses or
assets. In addition, external events including changing technology,
changing consumer patterns and changes in macroeconomic conditions
may impair the value of our assets. When these changes or events
occur, we may incur costs to change our business strategy and may
need to write down the value of assets. In any of these events, our
costs may increase, we may have significant charges associated with
the write-down of assets or returns on new investments may be lower
than prior to the change in strategy or restructuring. For example,
if we are not successful in developing our consumer product
business, our sales may decrease and our costs may
increase.
*The success of our ingredient and consumer product 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.
- 33 -
*Our future growth and profitability of our consumer product
business will depend in large part upon the effectiveness and
efficiency of our marketing expenditures and our ability to select
effective markets and media in which to advertise.
Our consumer products business success depends on our ability to
attract and retain customers, which significantly depends on our
marketing practices. Our future growth and profitability will
depend in large part upon the effectiveness and efficiency of our
marketing expenditures, including our ability to:
●
create greater awareness of our brand;
●
identify the most effective and efficient levels of spending in
each market, media and specific media vehicle;
●
determine the appropriate creative messages and media mix for
advertising, marketing and promotional expenditures;
●
effectively manage marketing costs (including creative and media)
in order to maintain acceptable customer acquisition
costs;
●
acquire cost-effective television advertising;
●
select the most effective markets, media and specific media
vehicles in which to advertise; and
●
convert consumer inquiries into actual orders.
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 and consumer product supplier we market and
manufacture products designed for human and animal consumption, we
are subject to product liability claims if the use of our products
is alleged to have resulted in injury. Our products consist of
vitamins, minerals, herbs and other ingredients that are classified
as foods, dietary supplements, or natural health products, and, in
most cases, are not necessarily subject to pre-market regulatory
approval in the United States. Some of our products contain
innovative ingredients that do not have long histories of human
consumption. Previously unknown adverse reactions resulting from
human consumption of these ingredients could occur. In addition,
the products we sell are produced by third-party manufacturers. As
a marketer of products manufactured by third parties, we also may
be liable for various product liability claims for products we do
not manufacture. We may, in the future, be subject to various
product liability claims, including, among others, that our
products include inadequate instructions for use or inadequate
warnings concerning possible side effects and interactions with
other substances. A product liability claim against us could result
in increased costs and could adversely affect our reputation with
our customers, which, in turn, could have a materially adverse
effect on our business, results of operations, financial condition
and cash flows.
- 34 -
We acquire a significant amount of
key ingredients for our products from foreign suppliers, and may be
negatively affected by the risks associated with international
trade and importation issues.
We
acquire a significant amount of key ingredients for a number of our
products from suppliers outside of the United States, particularly
India and China. Accordingly, the acquisition of these
ingredients is subject to the risks generally associated with
importing raw materials, including, among other factors, delays in
shipments, changes in economic and political conditions, quality
assurance, nonconformity to specifications or laws and regulations,
tariffs, trade disputes and foreign currency fluctuations. While we
have a supplier certification program and audit and inspect our
suppliers’ facilities as necessary both in the United States
and internationally, we cannot assure you that raw materials
received from suppliers outside of the United States will conform
to all specifications, laws and regulations. There have
in the past been quality and safety issues in our industry with
certain items imported from overseas. We may incur
additional expenses and experience shipment delays due to
preventative measures adopted by the Indian and U.S. governments,
our suppliers and our company.
The insurance industry has become
more selective in offering some types of coverage and we may not be
able to obtain insurance coverage in the
future.
The
insurance industry has become more selective in offering some types
of insurance, such as product liability, product recall, property
and directors’ and officers’ liability insurance. Our
current insurance program is consistent with both our past level of
coverage and our risk management policies. However, we cannot
assure you that we will be able to obtain comparable insurance
coverage on favorable terms, or at all, in the
future. Certain of our customers as well as prospective
customers require that we maintain minimum levels of coverage for
our products. Lack of coverage or coverage below these minimum
required levels could cause these customers to materially change
business terms or to cease doing business with us
entirely.
*If we experience product recalls, we may incur significant and
unexpected costs, and our business reputation could be adversely
affected.
We may be exposed to product recalls and adverse public relations
if our products are mislabeled or alleged to cause injury or
illness, or if we are alleged to have violated governmental
regulations. A product recall could result in substantial and
unexpected expenditures, which would reduce operating profit and
cash flow. In addition, a product recall may require significant
management attention. Product recalls may hurt the value of our
brands and lead to decreased demand for our products. Product
recalls also may lead to increased scrutiny by federal, state or
international regulatory agencies of our operations and increased
litigation and could have a material adverse effect on our
business, results of operations, financial condition and cash
flows.
*We depend on key personnel, the
loss of any of which could negatively affect our
business.
We
depend greatly on Frank L. Jaksch Jr., Kevin M. Farr, Troy A.
Rhonemus and Robert N. Fried who are our Chief Executive Officer,
Chief Financial Officer, Chief Operating Officer, and President and
Chief Strategy 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.
- 35 -
*Our operating results may fluctuate significantly as a result of a
variety of factors, many of which are outside of our
control.
We are
subject to the following factors, among others, that may negatively
affect our operating results:
●
the
announcement or introduction of new products by our
competitors;
●
our
ability to upgrade and develop our systems and infrastructure to
accommodate growth;
●
the
decision by significant customers to reduce purchases;
●
disputes and
litigation with competitors;
●
our
ability to attract and retain key personnel in a timely and
cost-effective manner;
●
technical
difficulties;
●
the
amount and timing of operating costs and capital expenditures
relating to the expansion of our business, operations and
infrastructure;
●
regulation by
federal, state or local governments; and
●
general economic
conditions as well as economic conditions specific to the
healthcare industry.
As a
result of our limited operating history and the nature of the
markets in which we compete, it is extremely difficult for us to
make accurate forecasts. We have based our current and future
expense levels largely on our investment plans and estimates of
future events although certain of our expense levels are, to a
large extent, fixed. Assuming our products reach the market, we may
be unable to adjust spending in a timely manner to compensate for
any unexpected revenue shortfall. Accordingly, any significant
shortfall in revenues relative to our planned expenditures would
have an immediate adverse effect on our business, results of
operations and financial condition. Further, as a strategic
response to changes in the competitive environment, we may from
time to time make certain pricing, service or marketing decisions
that could have a material and adverse effect on our business,
results of operations and financial condition. Due to the foregoing
factors, our revenues and operating results are and will remain
difficult to forecast.
We face significant competition, including changes in
pricing.
The
markets for our products and services are both competitive and
price sensitive. Many of our competitors have significant
financial, operations, sales and marketing resources and experience
in research and development. Competitors could develop new
technologies that compete with our products and services or even
render our products obsolete. If a competitor develops superior
technology or cost-effective alternatives to our products and
services, our business could be seriously harmed.
The
markets for some of our products are also subject to specific
competitive risks because these markets are highly price
competitive. Our competitors have competed in the past by lowering
prices on certain products. If they do so again, we may be forced
to respond by lowering our prices. This would reduce sales revenues
and increase losses. Failure to anticipate and respond to price
competition may also impact sales and aggravate
losses.
We
believe that customers in our markets display a significant amount
of loyalty to their supplier of a particular product. To the extent
we are not the first to develop, offer and/or supply new products,
customers may buy from our competitors or make materials
themselves, causing our competitive position to
suffer.
Many of our competitors are larger and have greater financial and
other resources than we do.
Our
products compete and will compete with other similar products
produced by our competitors. These competitive products could be
marketed by well-established, successful companies that possess
greater financial, marketing, distributional, personnel and other
resources than we possess. Using these resources, these companies
can implement extensive advertising and promotional campaigns, both
generally and in response to specific marketing efforts by
competitors, and enter into new markets more rapidly to introduce
new products. In certain instances, competitors with greater
financial resources also may be able to enter a market in direct
competition with us, offering attractive marketing tools to
encourage the sale of products that compete with our products or
present cost features that consumers may find
attractive.
- 36 -
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.
- 37 -
*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.
As further described in Part II, Item 1 of this Quarterly Report on
Form 10-Q, we are currently involved in patent litigation, as
Elysium is claiming that we misused certain patent rights, and has
filed a petition with the U.S. Patent and Trademark Office for
inter partes review of two patents to which we are the exclusive
licensee. If we are unsuccessful in resolving the patent misuse
claim on favorable terms, or if the U.S. Patent and Trademark
Office invalidates the two patents subject to the inter partes
review, we may lose the competitive advantage that is provided by
the subject intellectual property rights, which could have a
material adverse effect on our business. We may not have sufficient
resources to enforce our intellectual property rights or to defend
our patents rights against a challenge. The failure to obtain
patents and/or protect our intellectual property rights could have
a material and adverse effect on our business, results of
operations and financial condition.
*Our patents and licenses may be subject to challenge on validity
grounds, and our patent applications may be rejected.
We rely
on our patents, patent applications, licenses and other
intellectual property rights to give us a competitive advantage.
Whether a patent is valid, or whether a patent application should
be granted, is a complex matter of science and law, and therefore
we cannot be certain that, if challenged, our patents, patent
applications and/or other intellectual property rights would be
upheld. If one or more of those patents, patent applications,
licenses and other intellectual property rights are invalidated,
rejected or found unenforceable, that could reduce or eliminate any
competitive advantage we might otherwise have had. For example, as
further described in Part II, Item 1 of this Quarterly Report on
Form 10-Q, we are currently involved in patent litigation, as
Elysium is claiming that we misused certain patent rights, and has
filed a petition with the U.S. Patent and Trademark Office for
inter partes review of two patents to which we are the exclusive
licensee. If we are unsuccessful in resolving the patent misuse
claim on favorable terms, or if the U.S. Patent and Trademark
Office invalidates the two patents subject to the inter partes
review, we may lose the competitive advantage that is provided by
the subject intellectual property rights, which could have a
material adverse effect on our business.
- 38 -
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
products may not be successful and our business would be harmed if
the patents were infringed on or misappropriated without action by
such third parties.
We have
obtained licenses from third parties for patents and patent
application rights related to the products we are developing,
allowing us to use intellectual property rights owned by or
licensed to these third parties. We do not control the maintenance,
prosecution, enforcement or strategy for many of these patents or
patent application rights and as such are dependent in part on the
owners of the intellectual property rights to maintain their
viability. Without access to these technologies or suitable
design-around or alternative technology options, our ability to
conduct our business could be impaired significantly. As further
described in Part II, Item 1 of this Quarterly Report on Form 10-Q,
Elysium has filed a petition with the U.S. Patent and Trademark
Office for inter partes review of two patents to which we are the
exclusive licensee. Pursuant to the exclusive license agreement
with the Trustees of Dartmouth College (“Dartmouth”),
Dartmouth controls all future preparation, filing, prosecution and
maintenance of the two patents subject to such inter partes
review.
We may be subject to damages resulting from claims that we, our
employees, or our independent contractors have wrongfully used or
disclosed alleged trade secrets of others.
Some of
our employees were previously employed at other dietary supplement,
nutraceutical, food and beverage, functional food, analytical
laboratories, pharmaceutical and cosmetic companies. We may also
hire additional employees who are currently employed at other such
companies, including our competitors. Additionally, consultants or
other independent agents with which we may contract may be or have
been in a contractual arrangement with one or more of our
competitors. We may be subject to claims that these employees or
independent contractors have used or disclosed such other
party’s trade secrets or other proprietary information.
Litigation may be necessary to defend against these claims. Even if
we are successful in defending against 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.
- 39 -
*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. As further described in Part
II, Item 1 of this Quarterly Report on Form 10-Q, we are currently
involved in substantial and complex litigation with Elysium.
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.
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
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.
- 40 -
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 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 write-downs
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.
If we experience a significant disruption in our information
technology systems or if we fail to implement new systems and
software successfully, our business could be adversely
affected.
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.
*Our cash flows and capital resources may be
insufficient to make required payments on future
indebtedness.
On
November 4, 2016, we entered into entered into a business financing
agreement (the “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. 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. 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.
- 41 -
As of
September 30, 2017 and November 8, 2017, we did not have any
indebtedness under the Financing Agreement. However, we may incur
indebtedness in the future and such indebtedness could have
important consequences to you. For example, it could:
●
make
it difficult for us to satisfy our other debt
obligations;
●
make
us more vulnerable to general adverse economic and industry
conditions;
●
limit
our ability to obtain additional financing for working capital,
capital expenditures, acquisitions and other general corporate
requirements;
●
expose
us to interest rate fluctuations because the interest rate on the
debt under the Financing Agreement is variable;
●
require us to
dedicate a portion of our cash flow from operations to payments on
our debt, thereby reducing the availability of our cash flow for
operations and other purposes;
●
limit
our flexibility in planning for, or reacting to, changes in our
business and the industry in which we operate; and
●
place
us at a competitive disadvantage compared to competitors that may
have proportionately less debt and greater financial
resources.
In
addition, our ability to make payments or refinance our obligations
depends on our successful financial and operating performance, cash
flows and capital resources, which in turn depend upon prevailing
economic conditions and certain financial, business and other
factors, many of which are beyond our control. These factors
include, among others:
●
economic and
demand factors affecting our industry;
●
pricing
pressures;
●
increased
operating costs;
●
competitive
conditions; and
●
other
operating difficulties.
If our
cash flows and capital resources are insufficient to fund our debt
service obligations, we may be forced to reduce or delay capital
expenditures, sell material assets or operations, obtain additional
capital or restructure our debt. In the event that we are required
to dispose of material assets or operations to meet our debt
service and other obligations, the value realized on such assets or
operations will depend on market conditions and the availability of
buyers. Accordingly, any such sale may not, among other things, be
for a sufficient dollar amount. Our obligations pursuant to the
Financing Agreement are secured by a security interest in all of
our assets, exclusive of intellectual property. The foregoing
encumbrances may limit our ability to dispose of material assets or
operations. We also may not be able to restructure our indebtedness
on favorable economic terms, if at all.
We may
incur additional indebtedness in the future. Our incurrence of
additional indebtedness would intensify the risks described
above.
- 42 -
The Financing Agreement contains various covenants limiting
the discretion of our management in operating our
business.
The
Financing Agreement contains various restrictive covenants that
limit our management's discretion in operating our business. In
particular, these instruments limit our ability to, among other
things:
●
incur
additional debt;
●
grant
liens on assets;
●
make
investments, including capital expenditures;
●
sell
or acquire assets outside the ordinary course of business;
and
●
make
fundamental business changes.
If we
fail to comply with the restrictions in the Financing Agreement, a
default may allow the creditors under the relevant instruments to
accelerate the related debt and to exercise their remedies under
these agreements, which will typically include the right to declare
the principal amount of that debt, together with accrued and unpaid
interest and other related amounts, immediately due and payable, to
exercise any remedies the creditors may have to foreclose on assets
that are subject to liens securing that debt and to terminate any
commitments they had made to supply further funds.
If we are unable to maintain sales, marketing and distribution
capabilities or 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 our
product lines and/or technologies at favorable prices. In addition
to being expensive, maintaining such a sales force is
time-consuming. Qualified direct sales personnel with experience in
the natural products 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.
- 43 -
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 customers’ 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 in the United States,
strictly regulate the pharmaceutical, dietary supplement, food and
cosmetic 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.
- 44 -
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;
●
acceptance of and
demand for our products by consumers;
●
media coverage
regarding our industry or us;
●
litigation;
●
disputes with or
our inability to collect from significant customers;
●
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.
- 45 -
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.
*We may become involved in securities class action litigation that
could divert management’s attention and harm our
business.
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. 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
September 30, 2017, we had outstanding options exercisable for an
aggregate of 5,922,288 shares of common stock at a weighted
average exercise price of $3.41 per share and outstanding warrants
exercisable for an aggregate of 470,444 shares of common stock at a
weighted average exercise price of $4.15 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.
- 46 -
ITEM
2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
On
April 26, 2017, the Company entered into a Securities Purchase
Agreement with certain purchasers named therein (the
“Purchasers”), pursuant to which the Company agreed to
sell and issue up to $25.0 million of its common stock at a
purchase price of $2.60 per share in three tranches of
approximately $3.5 million, $16.4 million and $5.1 million,
respectively. The first tranche closed on April 27, 2017, pursuant
to which the Company issued 1,346,154 shares of its common stock.
The second tranche closed on May 24, 2017, pursuant to which the
Company issued 6,303,814 shares of its common stock. The third
tranche closed on August 18, 2017, pursuant to which the Company
issued 1,965,417 shares of its common stock.
The
shares of the Company’s common stock sold pursuant to the
Securities Purchase Agreement were not registered under the
Securities Act, or any state securities laws. The Company had
relied on the exemption from the registration requirements of the
Securities Act by virtue of Section 4(a)(2) thereof and Rule 506 of
Regulation D thereunder. In connection with the Purchasers’
execution of the Securities Purchase Agreement, the
Purchasers’ represented to the Company that they are each an
“accredited investor” as defined in Regulation D of the
Securities Act and that the securities purchased by them were
acquired solely for their own account and for investment purposes
and not with a view to the future sale or
distribution.
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4.
MINE SAFETY
DISCLOSURES
Not
applicable.
ITEM 5.
OTHER INFORMATION
As
previously disclosed in our Current Report on Form 8-K filed on
June 12, 2017, on June 9, 2017, ChromaPharma, Inc., entered into a
License Agreement (the "License Agreement") and a Research Funding
Agreement with the Scripps Research Institute, a California
nonprofit public benefit corporation ("TSRI").
Under
the terms of the License Agreement, TSRI granted to the Company a
worldwide, exclusive, royalty-bearing right and license to use
certain patent rights relating to methods and compositions for
enhancing cancer therapy. As consideration for the license granted,
the Company made a cash payment of $50,000 to TSRI. Additionally,
the Company will pay TRSI (i) annual cash fees that range from
$50,000 to $100,000 which will be credited against running
royalties due, (ii) product development milestone payments that
range from the low-six digit dollar figure to the low-eight digit
dollar figure and that in the aggregate may total up to $32.2
million if all product development milestones are achieved, (iii)
royalties on net sales of licensed products in the mid-single digit
percentage figure range, and (iv) a percentage of sublicense
revenues in the 10% to 30% range, based on the achievement of
certain product development milestones on the date of the agreement
with the sublicensee. The Company will also reimburse TSRI for
certain costs incurred in connection with the preparation, filing
and/or maintenance of applications for patent
protection.
- 47 -
ITEM 6.
EXHIBITS
Exhibit No. |
|
Description of Exhibits
|
|
|
|
|
|
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)
|
|
Asset
Purchase Agreement, dated as of August 21, 2017, by and among
Covance Laboratories Inc., ChromaDex, Inc., ChromaDex Analytics,
Inc., and ChromaDex Corporation ❖(1)(2)
|
|
|
Amendment
to Asset Purchase Agreement, dated as of September 5, 2017, by and
among Covance Laboratories Inc., ChromaDex, Inc., ChromaDex
Analytics, Inc., and ChromaDex Corporation ❖
|
|
|
Amended
and Restated Certificate of Incorporation of the Registrant
(incorporated by reference to, and filed as Exhibit 3.1 to the
Registrant’s Annual Report on Form 10-K filed with the
Commission on March 16, 2017)
|
|
|
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)
|
|
|
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)
|
|
|
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)
|
|
|
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)
|
|
|
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)
|
|
|
|
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)
|
|
|
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)
|
|
|
Fourth
Business Financing Modification Agreement, dated as of July 13,
2017, by and among Western Alliance Bank, ChromaDex Corporation,
ChromaDex, Inc., ChromaDex Analytics, Inc. and Healthspan Research,
LLC (incorporated by reference to, and filed as Exhibit 10.7 to the
Registrant’s Quarterly Report on Form 10-Q filed with the
Commission on August 10, 2017)
|
|
Fifth
Business Financing Modification Agreement, dated as of August 21,
2017, by and among Western Alliance Bank, ChromaDex Corporation,
ChromaDex, Inc., ChromaDex Analytics, Inc. and Healthspan Research,
LLC❖
|
|
|
Certification of the Chief Executive Officer pursuant to Rule
13a-14(A) of the Securities Exchange Act of 1934, as
amended❖
|
|
|
Certification of the Chief Financial Officer pursuant to Rule
13a-14(A) of the Securities Exchange Act of 1934, as
amended❖
|
|
|
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
|
❖
Filed
herewith.
(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.
(2)
Schedules have been
omitted pursuant to Item 601(b)(2) of Regulation S-K. ChromaDex
Corporation undertakes to furnish supplemental copies of any of the
omitted schedules upon request by the Securities and Exchange
Commission; provided, however, that ChromaDex Corporation may
request confidential treatment pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended, for any schedule so
furnished.
- 48 -
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
Date:
November 9, 2017
|
CHROMADEX
CORPORATION
/s/ KEVIN M.
FARR
Kevin
M. Farr
Chief
Financial Officer
(principal financial and accounting
officer
and
duly authorized on behalf of
the registrant)
|
-
49 -