HESKA CORP - Quarter Report: 2009 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
|
|||
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, 2009
|
|||
OR
|
|||
o |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
|
||
For
the transition period from _________________ to
_______________________
|
|||
Commission
file number: 000-22427
|
|||
HESKA
CORPORATION
|
|||
(Exact
name of registrant as specified in its charter)
|
|||
Delaware
|
77-0192527
|
||
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer Identification Number)
|
||
3760
Rocky Mountain Avenue
Loveland,
Colorado
|
80538
|
||
(Address
of principal executive offices)
|
(Zip
Code)
|
||
Registrant's
telephone number, including area code: (970) 493-7272
|
|||
Indicate
by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for
the past 90 days.
|
|||
Yes
x
No o
|
|||
Indicate
by check mark whether the registrant has submitted electronically 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 (§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
o No
o
|
|||
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company
as defined in Rule 12b-2 of the Exchange Act. See the
definitions of "large accelerated filer," "accelerated filer" and "smaller
reporting company" in Rule 12b-2 of the Exchange Act. (Check
one):
|
|||
Large
accelerated filer o
|
Accelerated
filer x
|
||
Non-accelerated
filer o (Do
not check if a small reporting company)
|
Smaller
reporting company o
|
||
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act).
|
|||
Yes
o No
x
|
|||
The
number of shares of the Registrant's Common Stock outstanding at
October 27, 2009 was 52,122,944.
|
|||
TABLE
OF CONTENTS
Page
|
|||
PART
I - FINANCIAL INFORMATION
|
|||
Item
1.
|
Financial
Statements:
|
||
|
2
|
||
|
3
|
||
|
4
|
||
5
|
|||
Item
2.
|
10
|
||
Item
3.
|
19
|
||
Item
4.
|
20
|
||
PART
II - OTHER INFORMATION
|
|||
Item
1.
|
21
|
||
Item
1A.
|
21
|
||
Item
2.
|
32
|
||
Item
3.
|
32
|
||
Item
4.
|
33
|
||
Item
5.
|
33
|
||
Item
6.
|
33
|
||
34
|
|||
DRI-CHEM
is a registered trademark of FUJIFILM Corporation. i-STAT is a
registered trademark of Abbott Laboratories. SPOTCHEM is a trademark
of Arkray, Inc. TRI-HEART is a registered trademark of
Schering-Plough Animal Health Corporation ("SPAH") in the United States and is a
trademark of Heska Corporation in other countries. HESKA, ALLERCEPT,
AVERT, E.R.D.-HEALTHSCREEN, E-SCREEN, FELINE ULTRANASAL, HEMATRUE,
SOLO STEP, THYROMED and VET/OX are registered trademarks and CBC-DIFF,
G2 DIGITAL and VET/IV are registered trademarks of Heska Corporation in the
United States and/or other countries. This Form 10-Q also refers to
trademarks and trade names of other organizations.
-1-
HESKA
CORPORATION AND SUBSIDIARIES
(dollars
in thousands except per share amounts)
(unaudited)
ASSETS
|
|||||||||
December
31,
2008
|
September
30,
2009
|
||||||||
Current
assets:
|
|||||||||
Cash
and cash equivalents
|
$
|
4,705
|
$
|
5,603
|
|||||
Accounts
receivable, net of allowance for doubtful accounts of
$209 and $163,
respectively
|
9,514
|
9,434
|
|||||||
Inventories,
net
|
15,249
|
12,849
|
|||||||
Deferred
tax asset, current
|
869
|
811
|
|||||||
Other
current assets
|
953
|
833
|
|||||||
Total
current assets
|
31,290
|
29,530
|
|||||||
Property
and equipment, net
|
8,509
|
6,785
|
|||||||
Goodwill
|
890
|
907
|
|||||||
Deferred
tax asset, net of current portion
|
29,749
|
28,770
|
|||||||
Total
assets
|
$
|
70,438
|
$
|
65,992
|
|||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||||
Current
liabilities:
|
|||||||||
Accounts
payable
|
$
|
3,904
|
$
|
3,643
|
|||||
Accrued
liabilities
|
3,128
|
3,565
|
|||||||
Accrued
restructuring
|
578
|
—
|
|||||||
Current
portion of deferred revenue
|
2,806
|
2,595
|
|||||||
Line
of credit
|
11,042
|
5,984
|
|||||||
Current
portion of long-term debt
|
770
|
573
|
|||||||
Total
current liabilities
|
22,228
|
16,360
|
|||||||
Long-term
debt, net of current portion
|
381
|
—
|
|||||||
Deferred
revenue, net of current portion, and other
|
5,306
|
4,995
|
|||||||
Total
liabilities
|
27,915
|
21,355
|
|||||||
Commitments
and contingencies
|
|||||||||
Stockholders'
equity:
|
|||||||||
Preferred
stock, $.001 par value, 25,000,000 shares authorized; none issued or
outstanding
|
—
|
—
|
|||||||
Common
stock, $.001 par value, 75,000,000 shares authorized; 52,010,928 and
52,122,944 shares issued and outstanding, respectively
|
52
|
52
|
|||||||
Additional
paid-in capital
|
216,463
|
216,744
|
|||||||
Accumulated
other comprehensive income
|
46
|
97
|
|||||||
Accumulated
deficit
|
(174,038
|
)
|
(172,256
|
)
|
|||||
Total
stockholders' equity
|
42,523
|
44,637
|
|||||||
Total
liabilities and stockholders' equity
|
$
|
70,438
|
$
|
65,992
|
See
accompanying notes to condensed consolidated financial
statements.
-2-
HESKA
CORPORATION AND SUBSIDIARIES
(in
thousands, except per share amounts)
(unaudited)
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||||
2008
|
2009
|
2008
|
2009
|
|||||||||||
Revenue,
net:
|
||||||||||||||
Core
companion animal health
|
$
|
19,240
|
$
|
16,892
|
$
|
54,473
|
$
|
51,908
|
||||||
Other
vaccines, pharmaceuticals and products
|
2,446
|
2,658
|
11,746
|
6,412
|
||||||||||
Total
revenue, net
|
21,686
|
19,550
|
66,219
|
58,320
|
||||||||||
Cost
of revenue
|
13,490
|
12,130
|
41,716
|
36,496
|
||||||||||
Gross
profit
|
8,196
|
7,420
|
24,503
|
21,824
|
||||||||||
Operating
expenses:
|
||||||||||||||
Selling
and marketing
|
4,458
|
3,695
|
14,024
|
11,075
|
||||||||||
Research
and development
|
506
|
457
|
1,462
|
1,308
|
||||||||||
General
and administrative
|
2,134
|
2,109
|
6,756
|
6,255
|
||||||||||
Total
operating expenses
|
7,098
|
6,261
|
22,242
|
18,638
|
||||||||||
Operating
income
|
1,098
|
1,159
|
2,261
|
3,186
|
||||||||||
Interest
and other (income) expense, net
|
153
|
(13
|
)
|
500
|
193
|
|||||||||
Income
before income taxes
|
945
|
1,172
|
1,761
|
2,993
|
||||||||||
Income
tax expense
|
368
|
429
|
744
|
1,211
|
||||||||||
Net
income
|
$
|
577
|
$
|
743
|
$
|
1,017
|
$
|
1,782
|
||||||
Basic
net income per share
|
$
|
0.01
|
$
|
0.01
|
$
|
0.02
|
$
|
0.03
|
||||||
Diluted
net income per share
|
$
|
0.01
|
$
|
0.01
|
$
|
0.02
|
$
|
0.03
|
||||||
Weighted
average outstanding shares used to compute basic net
income per share
|
51,797
|
52,123
|
51,625
|
52,049
|
||||||||||
Weighted
average outstanding shares used to compute diluted net income per
share
|
52,580
|
52,192
|
53,774
|
52,060
|
See
accompanying notes to condensed consolidated financial
statements.
-3-
HESKA
CORPORATION AND SUBSIDIARIES
(in
thousands)
(unaudited)
Nine
Months Ended
September
30,
|
||||||
2008
|
2009
|
|||||
CASH
FLOWS PROVIDED BY (USED IN) OPERATING ACTIVITIES:
|
||||||
Net
income
|
$
|
1,017
|
$
|
1,782
|
||
Adjustments
to reconcile net income to cash provided by (used in)
operating
activities:
|
||||||
Depreciation
and amortization
|
2,337
|
1,975
|
||||
Deferred
tax expense
|
654
|
1,038
|
||||
Stock-based
compensation
|
302
|
245
|
||||
Unrealized
loss on foreign currency translation
|
38
|
108
|
||||
Changes
in operating assets and liabilities:
|
||||||
Accounts
receivable
|
(55
|
)
|
80
|
|||
Inventories
|
823
|
2,326
|
||||
Other
current assets
|
43
|
106
|
||||
Accounts
payable
|
254
|
(261
|
)
|
|||
Accrued
liabilities
|
559
|
(165
|
)
|
|||
Deferred
revenue and other liabilities
|
(1,686
|
)
|
(498
|
)
|
||
Net
cash provided by (used in) operating activities
|
4,286
|
6,736
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||
Purchase
of property and equipment
|
(528
|
)
|
(177
|
)
|
||
Net
cash provided by (used in) investing activities
|
(528
|
)
|
(177
|
)
|
||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||
Proceeds
from issuance of common stock
|
332
|
36
|
||||
Proceeds
from (repayments of) line of credit borrowings, net
|
(3,594
|
)
|
(5,058
|
)
|
||
Proceeds
from (repayments of) debt and capital lease obligations,
net
|
(582
|
)
|
(578
|
)
|
||
Net
cash provided by (used in) financing activities
|
(3,844
|
)
|
(5,600
|
)
|
||
EFFECT
OF EXCHANGE RATE CHANGES ON CASH
|
(4
|
)
|
(61
|
)
|
||
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(90
|
)
|
898
|
|||
CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
5,524
|
4,705
|
||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
5,434
|
$
|
5,603
|
||
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION:
|
||||||
Cash
paid for interest
|
$
|
528
|
$
|
350
|
||
Non-cash
transfer of inventory to property and equipment
|
$
|
539
|
$
|
71
|
See accompanying notes to condensed
consolidated financial statements.
-4-
HESKA
CORPORATION AND SUBSIDIARIES
September
30, 2009
(UNAUDITED)
1. ORGANIZATION
AND BUSINESS
Heska
Corporation ("Heska" or the "Company") develops, manufactures, markets, sells
and supports veterinary products. Heska's core focus is on the canine
and feline companion animal health markets.
2. SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements are the
responsibility of the Company's management and have been prepared in accordance
with accounting principles generally accepted in the United States of America
for interim financial information and pursuant to the instructions to Form 10-Q
and rules and regulations of the Securities and Exchange Commission (the
"SEC"). The condensed consolidated balance sheet as of September 30,
2009, the condensed consolidated statements of operations for the three months
and nine months ended September 30, 2008 and 2009 and the condensed consolidated
statements of cash flows for the nine months ended September 30, 2008 and 2009
are unaudited, but include, in the opinion of management, all adjustments
(consisting of normal recurring adjustments) which the Company considers
necessary for a fair presentation of its financial position, operating results
and cash flows for the periods presented. All material intercompany
transactions and balances have been eliminated in
consolidation. Although the Company believes that the disclosures in
these financial statements are adequate to make the information presented not
misleading, certain information and footnote disclosures normally included in
complete financial statements prepared in accordance with accounting principles
generally accepted in the United States of America have been condensed or
omitted pursuant to the rules and regulations of the SEC.
Results
for any interim period are not necessarily indicative of results for any future
interim period or for the entire year. The accompanying financial
statements and related disclosures have been prepared with the presumption that
users of the interim financial information have read or have access to the
audited financial statements for the preceding fiscal
year. Accordingly, these financial statements should be read in
conjunction with the audited financial statements and the related notes thereto
for the year ended December 31, 2008, included in the Company's Annual Report on
Form 10-K filed with the SEC on March 16, 2009.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities, the disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amount of revenue and expense during
the reported period. Actual results could differ from those
estimates. Significant estimates are required when establishing the
allowance for doubtful accounts and the provision for excess/obsolete inventory,
in determining the period over which the Company's obligations are fulfilled
under agreements to license product rights and/or technology rights, and in
determining the need for, and the amount of, a valuation allowance on certain
deferred tax assets.
-5-
Reclassifications
Certain
prior year numbers have been reclassified to be consistent with the current year
presentation. These reclassifications include revenue previously
reflected as Research, Development and Other Revenue which is now included in
revenue by segment and costs previously reflected as Cost of Research,
Development and Other Revenue which are now included in Cost of
Revenue.
Inventories
Inventories
are stated at the lower of cost or market using the first-in, first-out
method. Inventory manufactured by the Company includes the cost of
material, labor and overhead. If the cost of inventories exceeds
estimated fair value, provisions are made to reduce the carrying value to
estimated fair value.
Inventories,
net consist of the following (in thousands):
December
31,
2008
|
September
30,
2009
|
|||||
Raw materials
|
$
|
6,893
|
$
|
5,989
|
||
Work in process
|
2,957
|
2,903
|
||||
Finished
goods
|
6,370
|
4,838
|
||||
Allowance for excess or obsolete inventory
|
(971
|
)
|
(881
|
)
|
||
$
|
15,249
|
$
|
12,849
|
Basic
and Diluted Net Income (Loss) Per Share
Basic net
income (loss) per common share is computed using the weighted average number of
common shares outstanding during the period. Diluted net income
(loss) per share is computed using the sum of the weighted average number of
shares of common stock outstanding, and, if not anti-dilutive, the effect of
outstanding common stock equivalents (such as stock options and warrants)
determined using the treasury stock method. For the three and nine
months ended September 30, 2009 and September 30, 2008, the Company reported net
income and therefore, dilutive common stock equivalent securities, as computed
using the treasury stock method, were added to basic weighted average shares
outstanding for the period to derive the weighted average shares for the diluted
earnings per share calculation. Common stock equivalent securities
that were anti-dilutive for the nine months ended September 30, 2009 and
September 30, 2008, and therefore excluded, were outstanding options to purchase
12,028,952 and 4,547,890 shares of common stock, respectively. Common
stock equivalent securities that were anti-dilutive for the three months ended
September 30, 2009 and September 30, 2008, and therefore excluded, were
outstanding options to purchase 12,015,652 and 7,978,742 shares of common stock,
respectively. These securities are anti-dilutive primarily due to
exercise prices greater than the average value of the Company's common stock
during the three and nine months ended September 30, 2009 and
2008. Should the Company's stock price increase, the number of common
stock equivalents considered to be dilutive will increase.
Subsequent
Events
The
Company has evaluated known subsequent events through the close of business on
October 27, 2009. The Company has not evaluated known subsequent
events occurring after the close of business on October 27, 2009 in preparing
the accompanying unaudited condensed consolidated financial
statements.
-6-
3. CAPITAL
STOCK
The fair
value of each option grant was estimated on the date of grant using the
Black-Scholes option-pricing model, with the following weighted average
assumptions for options granted in the three and nine months ended September 30,
2008 and 2009.
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2008
|
2009
|
2008
|
2009
|
||||||||||
Risk-free
interest rate
|
2.14%
|
1.48%
|
2.61%
|
1.43%
|
|||||||||
Expected
lives
|
3.0
years
|
3.0
years
|
2.9
years
|
2.9
years
|
|||||||||
Expected
volatility
|
50%
|
69%
|
51%
|
67%
|
|||||||||
Expected dividend yield
|
0%
|
0%
|
0%
|
0%
|
A summary
of the Company's stock option plans is as follows:
Year
Ended
December
31, 2008
|
Nine
Months Ended
September
30, 2009
|
||||||||||||
Options
|
Weighted
Average
Exercise
Price
|
Options
|
Weighted
Average
Exercise
Price
|
||||||||||
Outstanding
at beginning of period
|
12,118,417
|
$
|
1.3979
|
12,835,269
|
$
|
1.2836
|
|||||||
Granted
at market
|
1,575,268
|
$
|
0.7694
|
325,000
|
$
|
0.4597
|
|||||||
Cancelled
|
(573,898
|
)
|
$
|
2.5005
|
(801,321
|
)
|
$
|
1.6242
|
|||||
Exercised
|
(284,518
|
)
|
$
|
0.8526
|
—
|
$
|
0.0000
|
||||||
Outstanding
at end of period
|
12,835,269
|
$
|
1.2836
|
12,358,948
|
$
|
1.2398
|
|||||||
Exercisable
at end of period
|
11,042,716
|
$
|
1.3360
|
11,046,705
|
$
|
1.2793
|
The
estimated fair value of stock options granted during the nine months ended
September 30, 2009 and 2008 was computed to be approximately $66 thousand and
$264 thousand, respectively. The amount is amortized ratably over the
vesting period of the options. The per share weighted average
estimated fair value of options granted during the nine months ended September
30, 2009 and 2008 was computed to be approximately $0.20 and $0.56,
respectively. The total intrinsic value of options exercised during
the nine months ended September 30, 2009 and 2008 was $0 and $136 thousand,
respectively. The cash proceeds from options exercised during the
nine months ended September 30, 2009 and 2008 were $0 and $241 thousand,
respectively.
The
following table summarizes information about stock options outstanding and
exercisable at September 30, 2009:
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||||
Exercise
Prices
|
Number
of
Options
Outstanding
at
September
30,
2009
|
Weighted
Average
Remaining
Contractual
Life
in Years
|
Weighted
Average
Exercise
Price
|
Number
of
Options
Exercisable
at
September
30,
2009
|
Weighted
Average
Exercise
Price
|
|||||||||||||
$0.27
- $0.70
|
2,829,923
|
5.93
|
$
|
0.5344
|
1,975,173
|
$
|
0.5744
|
|||||||||||
$0.71
- $1.06
|
2,884,867
|
4.36
|
$
|
0.9279
|
2,869,867
|
$
|
0.9279
|
|||||||||||
$1.07
- $1.25
|
2,353,175
|
4.54
|
$
|
1.2156
|
2,353,175
|
$
|
1.2156
|
|||||||||||
$1.26
- $1.82
|
2,069,150
|
5.86
|
$
|
1.5873
|
2,043,108
|
$
|
1.5891
|
|||||||||||
$1.83
- $4.12
|
2,221,833
|
5.12
|
$
|
2.2455
|
1,805,382
|
$
|
2.3413
|
|||||||||||
$0.27
- $4.12
|
12,358,948
|
5.14
|
$
|
1.2398
|
11,046,705
|
$
|
1.2793
|
-7-
As of
September 30, 2009, there was approximately $513 thousand of total unrecognized
compensation expense related to outstanding stock options. That
expense is expected to be recognized over a weighted average period of 2.0
years, with approximately $64 thousand to be recognized in the three months
ending December 31, 2009 and all the cost to be recognized as of September 2013,
assuming all options vest according to the vesting schedules in place at
September 30, 2009. As of September 30, 2009, the aggregate intrinsic
value of outstanding options was approximately $34 thousand and the aggregate
intrinsic value of exercisable options was approximately
$33 thousand.
4. SEGMENT
REPORTING
The
Company is comprised of two reportable segments, Core Companion Animal Health
("CCA") and Other Vaccines, Pharmaceuticals and Products ("OVP"). The
Core Companion Animal Health segment includes diagnostic instruments and
supplies, as well as single use diagnostic and other tests, pharmaceuticals and
vaccines, primarily for canine and feline use. These products are
sold directly by the Company as well as through independent third-party
distributors and other distribution relationships. CCA segment
products manufactured at the Des Moines, Iowa production facility included in
our OVP segment's assets are transferred at cost and are not recorded as revenue
for our OVP segment. The Other Vaccines, Pharmaceuticals and Products
segment includes private label vaccine and pharmaceutical production, primarily
for cattle, but also for other animals including small mammals and
fish. All OVP products are sold by third parties under third-party
labels.
Summarized
financial information concerning the Company's reportable segments is shown in
the following table (in thousands):
Core
Companion
Animal
Health
|
Other
Vaccines,
Pharmaceuticals
and
Products
|
Total
|
||||||||||
Nine
Months Ended
September
30, 2008:
|
||||||||||||
Total
revenue
|
$
|
54,473
|
$
|
11,746
|
$
|
66,219
|
||||||
Operating
income (loss)
|
(12
|
)
|
2,273
|
2,261
|
||||||||
Interest
expense
|
381
|
127
|
508
|
|||||||||
Total
assets
|
61,421
|
10,759
|
72,180
|
|||||||||
Net
assets
|
39,450
|
5,142
|
44,592
|
|||||||||
Capital
expenditures
|
192
|
336
|
528
|
|||||||||
Depreciation
and amortization
|
1,648
|
689
|
2,337
|
|||||||||
Nine
Months Ended
September
30, 2009:
|
||||||||||||
Total
revenue
|
$
|
51,908
|
$
|
6,412
|
$
|
58,320
|
||||||
Operating
income
|
3,126
|
60
|
3,186
|
|||||||||
Interest
expense
|
287
|
65
|
352
|
|||||||||
Total
assets
|
54,665
|
11,327
|
65,992
|
|||||||||
Net
assets
|
37,747
|
6,890
|
44,637
|
|||||||||
Capital
expenditures
|
170
|
7
|
177
|
|||||||||
Depreciation
and amortization
|
1,273
|
702
|
1,975
|
-8-
Core
Companion
Animal
Health
|
Other
Vaccines,
Pharmaceuticals
and
Products
|
Total
|
||||||||||
Three
Months Ended
September
30, 2008:
|
||||||||||||
Total
revenue
|
$
|
19,240
|
$
|
2,446
|
$
|
21,686
|
||||||
Operating
income
|
1,082
|
16
|
1,098
|
|||||||||
Interest
expense
|
93
|
33
|
126
|
|||||||||
Total
assets
|
61,421
|
10,759
|
72,180
|
|||||||||
Net
assets
|
39,450
|
5,142
|
44,592
|
|||||||||
Capital
expenditures
|
66
|
25
|
91
|
|||||||||
Depreciation
and amortization
|
521
|
230
|
751
|
|||||||||
Three
Months Ended
September
30, 2009:
|
||||||||||||
Total
revenue
|
$
|
16,892
|
$
|
2,658
|
$
|
19,550
|
||||||
Operating
income
|
774
|
385
|
1,159
|
|||||||||
Interest
expense
|
58
|
24
|
82
|
|||||||||
Total
assets
|
54,665
|
11,327
|
65,992
|
|||||||||
Net
assets
|
37,747
|
6,890
|
44,637
|
|||||||||
Capital
expenditures
|
49
|
2
|
51
|
|||||||||
Depreciation
and amortization
|
418
|
233
|
651
|
5.
|
COMPREHENSIVE
INCOME
|
Comprehensive
income includes net income plus the results of certain stockholders' equity
changes not reflected in the Condensed Consolidated Statements of
Operations. Such changes primarily include foreign currency
translation items. Total comprehensive income for the nine months
ended September 30, 2009 and 2008 was $1.8 million and $1.1 million,
respectively. Total comprehensive income for the three months ended
September 30, 2009 and 2008 was $873 thousand and $378 thousand,
respectively.
-9-
Item
2.
OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of our financial condition and results of
operations should be read in conjunction with "Selected Consolidated Financial
Data" and the Unaudited Condensed Consolidated Financial Statements and related
Notes included in Part I Item 1 of this Form 10-Q.
This
discussion contains forward-looking statements that involve risks and
uncertainties. Such statements, which include statements concerning
future revenue sources and concentration, gross profit margins, selling and
marketing expenses, general and administrative expenses, research and
development expenses, capital resources, capital expenditures and additional
financings or borrowings, are subject to risks and uncertainties, including, but
not limited to, those discussed below and elsewhere in this Form 10-Q,
particularly in Part II Item 1A. "Risk Factors," that could cause actual results
to differ materially from those projected. The forward-looking
statements set forth in this Form 10-Q are as of October 27, 2009, and we do not
intend to update this forward-looking information.
Overview
We
develop, manufacture, market, sell and support veterinary
products. Our business is comprised of two reportable segments, Core
Companion Animal Health, which represented 89% of our revenue for the twelve
months ended September 30, 2009 and Other Vaccines, Pharmaceuticals and
Products, which represented 11% of our revenue for the twelve months ended
September 30, 2009.
The Core
Companion Animal Health ("CCA") segment includes diagnostic instruments and
supplies as well as single use diagnostic and other tests, pharmaceuticals and
vaccines, primarily for canine and feline use.
Diagnostic
instruments and supplies represented approximately 50% of our revenue for the
twelve months ended September 30, 2009. Many products in this area
involve placing an instrument in the field and generating future revenue from
consumables, including items such as supplies and service, as that instrument is
used. Approximately 38% of our revenue for the twelve months ended
September 30, 2009 resulted from the sale of such consumables to an installed
base of instruments and approximately 13% of our revenue was from new hardware
sales. A loss of or disruption in supply of consumables we are
selling to an installed base of instruments could substantially harm our
business. For example, the supplier of our handheld blood analysis
instruments has informed us of the cancellation of our contractual agreement as
of November 1, 2009 and that they will not supply us with any instruments or
consumables after that date. We have established a large installed
base of handheld blood analysis instruments and sales of instruments and
consumables in this area represented 18% of our revenue in the twelve months
ended September 30, 2009, the largest percentage of any of our product
areas. We anticipate a significant decline in revenue and gross
margin related to our handheld blood analysis instruments following the
termination of supply of these products. All diagnostic instruments
and supplies are supplied by third parties, who typically own the product rights
and supply the product to us under marketing and/or distribution
agreements. In many cases, we have collaborated with a third party to
adapt a human instrument for veterinary use. Major products in this
area include our handheld blood analysis instruments, our chemistry instruments
and our hematology instruments and their affiliated operating
consumables. Revenue from products in these three areas, including
revenues from consumables, represented approximately 46% of our revenue for the
twelve months ended September 30, 2009.
Other CCA
revenue, including single use diagnostic and other tests, pharmaceuticals and
vaccines as well as research and development, licensing and royalty revenue,
represented approximately 39% of our revenue for the twelve months ended
September 30, 2009. Since items in this area are often single use by
their nature, our typical aim is to build customer satisfaction and loyalty for
each product, generate repeat annual sales from existing customers and expand
our customer base in the future. Products in this area are both
supplied by third
-10-
parties
and provided by us. Major products in this area include our heartworm
diagnostic tests, our heartworm preventive, our allergy test kits, our allergy
immunotherapy and our allergy diagnostic tests. Combined revenue from
heartworm-related products and allergy-related products represented
approximately 34% of our revenue for the twelve months ended September 30,
2009.
We
consider the CCA segment to be our core business and devote most of our
management time and other resources to improving the prospects for this
segment. Maintaining a continuing, reliable and economic supply of
products we currently obtain from third parties is critical to our success in
this area. Virtually all of our sales and marketing expenses occur in
the CCA segment. The majority of our research and development
spending is dedicated to this segment, as well. We strive to provide
high value products and advance the state of veterinary medicine.
All our
CCA products are ultimately sold to or through veterinarians. In many
cases, veterinarians will mark up their costs to the end user. The
acceptance of our products by veterinarians is critical to our
success. CCA products are sold directly by us as well as through
independent third-party distributors and other relationships, such as corporate
agreements. Revenue from direct sales, independent third-party
distributors and other relationships represented approximately 51%, 27% and 22%,
respectively, of CCA revenue for the twelve months ended September 30,
2009.
Independent
third-party distributors may be effective in increasing sales of our products to
veterinarians, although we would expect a corresponding lower gross margin as
such distributors typically buy products from us at a discount to end user
prices. For us to be effective when working with an independent
third-party distributor, the distributor must agree to market and/or sell our
products and we must provide proper economic incentives to the distributor as
well as contend effectively for the distributor's time and focus given other
products the distributor may be carrying, potentially including those of our
competitors. We believe that one of our largest competitors, IDEXX
Laboratories, Inc. ("IDEXX"), in effect prohibits its distributors from selling
competitive products, including our diagnostic instruments and heartworm
diagnostic tests. We believe the IDEXX restrictions limit our ability
to engage national distributors to sell our full distribution line of
products.
We intend
to sustain profitability over the long term through a combination of revenue
growth, gross margin improvement and expense control. Accordingly, we
closely monitor revenue growth trends in our CCA segment. Revenue in
this segment declined 9% for the twelve months ended September 30, 2009 as
compared to the twelve months ended September 30, 2008. We believe
poor economic conditions over the past year have impacted our revenue growth as,
for example, veterinarians have delayed or deferred capital expenditures on new
diagnostic instrumentation.
The Other
Vaccines, Pharmaceuticals and Products segment ("OVP") includes our 168,000
square foot USDA- and FDA-licensed production facility in Des Moines,
Iowa. We view this facility as a strategic asset which will allow us
to control our cost of goods on any vaccines and pharmaceuticals that we may
commercialize in the future. We are increasingly integrating this
facility with our operations elsewhere. For example, virtually all
our U.S. inventory is now stored at this facility and fulfillment logistics are
managed there. CCA segment products manufactured at this facility are
transferred at cost and are not recorded as revenue for our OVP
segment. We view OVP reported revenue as revenue primarily to cover
the overhead costs of the facility and to generate incremental cash flow to fund
our CCA segment.
Our OVP
segment includes private label vaccine and pharmaceutical production, primarily
for cattle but also for other animals such as small mammals. All OVP
products are sold by third parties under third-party labels.
We have developed our own
line of bovine vaccines that are licensed by the USDA. We have a
long-term agreement with a distributor, Agri Laboratories, Ltd., ("AgriLabs"),
for the marketing and sale of certain of these vaccines which are sold primarily
under the Titanium® and
MasterGuard®
brands which are registered trademarks of AgriLabs. This agreement
generates a significant portion of our OVP segment's revenue. Subject
-11-
to
certain purchase minimums, under our long-term agreement, AgriLabs has the
exclusive right to sell the aforementioned bovine vaccines in the United States,
Africa and Mexico until December 2009. Our OVP segment also produces
vaccines and pharmaceuticals for other third parties.
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations is
based upon the consolidated financial statements, which have been prepared in
accordance with U.S. generally accepted accounting principles
("GAAP"). The preparation of financial statements in conformity with
GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities, the disclosure of contingent assets
and liabilities as of the date of the financial statements, and the reported
amounts of revenue and expense during the periods. These estimates
are based on historical experience and various other assumptions that we believe
to be reasonable under the circumstances. We have identified those
critical accounting policies used in reporting our financial position and
results of operations based upon a consideration of those accounting policies
that involve the most complex or subjective decisions or
assessment. We consider the following to be our critical
policies.
Revenue Recognition
We
generate our revenue through the sale of products, as well as through licensing
of technology product rights, royalties and sponsored research and
development. Our policy is to recognize revenue when the applicable
revenue recognition criteria have been met, which generally include the
following:
·
|
Persuasive
evidence of an arrangement exists;
|
·
|
Delivery
has occurred or services rendered;
|
·
|
Price
is fixed or determinable; and
|
·
|
Collectability
is reasonably assured.
|
Revenue
from the sale of products is recognized after both the goods are shipped to the
customer and acceptance has been received, if required, with an appropriate
provision for estimated returns and allowances. We do not permit
general returns of products sold. Certain of our products have
expiration dates. Our policy is to exchange certain outdated, expired
product with the same product. We record an accrual for the estimated
cost of replacing the expired product expected to be returned in the future,
based on our historical experience, adjusted for any known factors that
reasonably could be expected to change historical patterns, such as regulatory
actions which allow us to extend the shelf lives of our
products. Revenue from both direct sales to veterinarians and sales
to independent third-party distributors are generally recognized when goods are
shipped. Our products are shipped complete and ready to use by the
customer. The terms of the customer arrangements generally pass title
and risk of ownership to the customer at the time of
shipment. Certain customer arrangements provide for acceptance
provisions. Revenue for these arrangements is not recognized until
the acceptance has been received or the acceptance period has
lapsed. We reduce our revenue by the estimated cost of any rebates,
allowances or similar programs, which are used as promotional
programs.
Recording
revenue from the sale of products involves the use of estimates and management
judgment. We must make a determination at the time of sale whether
the customer has the ability to make payments in accordance with
arrangements. While we do utilize past payment history, and, to the
extent available for new customers, public credit information in making our
assessment, the determination of whether collectability is reasonably assured is
ultimately a judgment decision that must be made by management. We
must also make estimates regarding our future obligation relating to returns,
rebates, allowances and similar other programs.
-12-
License
revenue under arrangements to sell or license product rights or technology
rights is recognized as obligations under the agreement are satisfied, which
generally occurs over a period of time. Generally, licensing revenue
is deferred and recognized over the estimated life of the related agreements,
products, patents or technology. Nonrefundable licensing fees,
marketing rights and milestone payments received under contractual arrangements
are deferred and recognized over the remaining contractual term using the
straight-line method.
Recording
revenue from license arrangements involves the use of estimates. The
primary estimate made by management is determining the useful life of the
related agreement, product, patent or technology. We evaluate all of
our licensing arrangements by estimating the useful life of either the product
or the technology, the length of the agreement or the legal patent life and
defer the revenue for recognition over the appropriate period.
Occasionally
we enter into arrangements that include multiple elements. Such
arrangements may include the licensing of technology and manufacturing of
product. In these situations we must determine whether the various
elements meet the criteria to be accounted for as separate
elements. If the elements cannot be separated, revenue is recognized
once revenue recognition criteria for the entire arrangement have been met or
over the period that the Company's obligations to the customer are fulfilled, as
appropriate. If the elements are determined to be separable, the
revenue is allocated to the separate elements based on relative fair value and
recognized separately for each element when the applicable revenue recognition
criteria have been met. In accounting for these multiple element
arrangements, we must make determinations about whether elements can be
accounted for separately and make estimates regarding their relative fair
values.
Allowance
for Doubtful Accounts
We
maintain an allowance for doubtful accounts receivable based on client-specific
allowances, as well as a general allowance. Specific allowances are
maintained for clients which are determined to have a high degree of
collectability risk based on such factors, among others, as: (i) the aging of
the accounts receivable balance; (ii) the client's past payment experience;
(iii) a deterioration in the client's financial condition, evidenced by weak
financial condition and/or continued poor operating results, reduced credit
ratings, and/or a bankruptcy filing. In addition to the specific
allowance, the Company maintains a general allowance for credit risk in its
accounts receivable which is not covered by a specific allowance. The
general allowance is established based on such factors, among others, as: (i)
the total balance of the outstanding accounts receivable, including
considerations of the aging categories of those accounts receivable; (ii) past
history of uncollectable accounts receivable write-offs; and (iii) the overall
creditworthiness of the client base. A considerable amount of
judgment is required in assessing the realizability of accounts
receivable. Should any of the factors considered in determining the
adequacy of the overall allowance change, an adjustment to the provision for
doubtful accounts receivable may be necessary.
Inventories
Inventories
are stated at the lower of cost or market, cost being determined on the
first-in, first-out method. Inventories are written down if the
estimated net realizable value of an inventory item is less than its recorded
value. We review the carrying cost of our inventories by product each
quarter to determine the adequacy of our reserves for
obsolescence. In accounting for inventories we must make estimates
regarding the estimated net realizable value of our inventory. This
estimate is based, in part, on our forecasts of future sales and shelf life of
product.
-13-
Deferred
Tax Assets – Valuation Allowance
Our
deferred tax assets, such as an NOL, are reduced by an offsetting valuation
allowance based on judgmental assessment of available evidence if we are unable
to conclude that it is more likely than not that some or all of the related
deferred tax assets will be realized. If we are able to conclude it
is more likely than not that we will realize a future benefit from a deferred
tax asset, we will reduce the related valuation allowance by an amount equal to
the estimated quantity of income taxes we would pay in cash if we were not to
utilize the deferred tax asset in the future. The first time this
occurs in a given jurisdiction, it will result in a net deferred tax asset on
our balance sheet and an income tax benefit of equal magnitude in our statement
of operations in the period we make the determination. In future
periods, we will then recognize as income tax expense the estimated quantity of
income taxes we would have paid in cash had we not utilized the related deferred
tax asset. The corresponding journal entry will be a reduction of our
deferred tax asset. If there is a change regarding our tax position
in the future, we will make a corresponding adjustment to the related valuation
allowance.
Results
of Operations
Revenue
Total
revenue decreased 12% to $58.3 million for the nine months ended September 30,
2009 as compared to $66.2 million for the corresponding period in
2008. Total revenue decreased 10% to $19.6 million for the three
months ended September 30, 2009 as compared to $21.7 million for the
corresponding period in 2008.
Revenue
from our CCA segment was $51.9 million for the nine months ended September 30,
2009, a 5% decrease as compared to $54.5 million for the corresponding period in
2008. Key factors in the decline were lower sales of our chemistry
instruments and consumables for our handheld blood analysis instruments,
somewhat offset by increased consumable sales for our non-handheld
instruments. Revenue from our CCA segment was $16.9 million for
the three months ended September 30, 2009, a decrease of 12% as compared to
$19.2 million for the corresponding period in 2008. Key factors in
the decline were lower sales of our heartworm diagnostic tests, consumables for
our handheld blood analysis instruments, our heartworm preventive, our chemistry
instruments and our IV pumps, somewhat offset by increased consumable sales for
our non-handheld instruments.
Revenue
from our Other Vaccines, Pharmaceuticals and Products segment ("OVP") decreased
by $5.3 million to $6.4 million for the nine months ended September
30, 2009 as compared to $11.7 million in the corresponding period in
2008. The largest factor in this decline was loss of fish vaccine
revenue from AquaHealth, a unit of Novartis, a customer who had previously
informed us that they would be taking their production in-house and accordingly
ordered no product from us in the first nine months of
2009. Lower revenue under our contract with AgriLabs and lower sales
of bulk bovine biologicals also contributed to the year-over-year revenue
decline in this segment. Revenue from our OVP segment increased
by $212 thousand to $2.7 million for the three months ended September 30,
2009 as compared to $2.4 million in the corresponding period in
2008. Increased sales of our cattle vaccines in international
markets, somewhat offset by lower revenue under our contract with AgriLabs, was
a key factor in the increase.
We expect
2009 total revenue to decline as compared with 2008.
Cost
of Revenue
Cost of revenue totaled $36.5 million for the first nine months of 2009, a
13% decrease as compared to $41.7 million for the corresponding period in
2008. Gross profit decreased by $2.7 million to $21.8 million for the
nine months ended September 30, 2009 as compared to $24.5 million in the prior
year corresponding period.
-14-
Gross
Margin, i.e. gross profit divided by total revenue, increased to 37.4% for the
nine months ended September 30, 2009 as compared to 37.0% in the
corresponding period in 2008. Lower costs on sponsored research and
development projects in the 2009 period were a factor in the
increase.
Cost of
revenue totaled $12.1 million for the three months ended September 30,
2009, a decrease of $1.4 million as compared to $13.5 million for the
corresponding period in 2008. Gross profit decreased by
$776 thousand to $7.4 million for the three months ended September 30,
2009 as compared to $8.2 million in the prior year period. Gross
Margin, i.e. gross profit divided by total revenue, increased to 38.0% for the
three months ended September 30, 2009 from 37.8% in the prior year
period. Lower costs on sponsored research and development projects in
the 2009 period were a factor in the increase.
We expect
Gross Margin to increase for 2009 as compared to 2008.
Operating
Expenses
Total
operating expenses decreased 16% to $18.6 million in the nine months ended
September 30, 2009 from $22.2 million in the prior year period. Total
operating expenses decreased 12% to $6.3 million in the three months ended
September 30, 2009 from $7.1 million in the prior year period.
Selling
and marketing expenses decreased 21% to $11.1 million in the nine months ended
September 30, 2009 as compared to $14.0 million in the corresponding period in
2008. Key factors in the decline were lower expenses related to
product launches and lower commissions. Selling and marketing
expenses decreased 17% to $3.7 million in the three months ended September
30, 2009 as compared to $4.5 million in the corresponding period in
2008. Lower commissions and lower spending on market research were
key factors in the decline.
Research
and development expenses were $1.3 million for the nine months ended September
30, 2009, an 11% decline as compared to $1.5 million in the corresponding period
in 2008. Research and development expenses were $457 thousand for the
three months ended September 30, 2009, a 10% decline as compared to
$506 thousand in the corresponding period in 2008. In both
cases, a key factor in the decline was lower spending on research and
development resources, such as laboratory supplies.
General
and administrative expenses were $6.3 million in the nine months ended September
30, 2009, down 7% from $6.8 million in the prior year period. General
and administrative expenses were $2.1 million in the three months ended
September 30, 2009, down 1% from the prior year period. In both
cases, a factor in the change was savings resulting from our year-end
restructuring.
We expect
2009 operating expenses will be lower than in 2008.
Interest
and Other Expense, Net
Interest and other expense, net was $193 thousand in the nine months ended
September 30, 2009, a decrease of $307 thousand as compared to $500 thousand in
the prior year period. Interest and other (income) expense, net was
($13) thousand in the three months ended September 30, 2009, an increase of
$166 thousand as compared to $153 thousand in the prior year
period. Interest and other expense, net can be broken into two
components: net interest expense and net foreign currency gain (or
loss). Net interest expense was $307 thousand in the nine months
ended September 30, 2009, a decrease of $149 thousand from $456 thousand in
the prior year period. Lower loan balances and lower market interest
rates, somewhat offset by an increased interest rate spread negotiated with
Wells Fargo Bank, National Association ("Wells Fargo") in December, were
responsible for the decline. In the nine months ended September 30,
2009, net foreign currency gain was $113 thousand, a change of
$157 thousand from a net foreign currency loss of $44 thousand in the
prior year period. Net interest expense was $65 thousand in the
three months ended September 30, 2009, a decrease of $46 thousand from
$111 thousand in the prior year period. Lower loan balances and
lower market interest rates, somewhat offset by an increased interest rate
spread negotiated with Wells Fargo in December, were responsible
-15-
for the
decline. In the three months ended September 30, 2009, net foreign
currency gain was $78 thousand, a change of $120 thousand from a net
foreign currency loss of $42 thousand in the prior year
period.
We expect
interest and other expense, net to decrease in 2009 as compared to 2008 based on
lower market interest rates and lower average borrowings, somewhat offset by an
increase in our interest rate spread.
Income
Tax Expense
Income
tax expense was $1.2 million in the nine months ended September 30, 2009, a
$467 thousand increase as compared to a tax expense of $744 thousand
in the prior year period. In both periods, the tax entry was
primarily non-cash and offsetting a decrease in our deferred tax
assets. Tax expense was greater in the 2009 period due to greater
income before income taxes in that period. Income tax expense was
$429 thousand in the three months ended September 30, 2009, a $61 thousand
increase as compared to a tax expense of $368 thousand in the prior year
period. In both periods, the tax entry was primarily non-cash and a
decrease in our deferred tax assets. Tax expense was greater in the
2008 period due to greater income before income taxes in that
period.
In 2009,
we expect to recognize income tax expense as compared to an income tax benefit
in 2008 as we expect to generate income before income taxes as opposed to the
loss before income taxes we experienced in 2008.
Net
Income
Net
income was $1.8 million in the nine months ended September 30, 2009, an increase
of approximately $765 thousand compared to net income of $1.0 million in
the prior year period. Net income was $743 thousand in the three
months ended September 30, 2009, an increase of approximately $166 thousand
compared to net income of $577 thousand in the prior year period. In
both cases, the increase was primarily due to lower expenses somewhat offset by
lower revenue, as discussed above.
In 2009,
we expect to generate net income as opposed to the net loss we reported in 2008,
primarily as a result of lower operating expenses.
Liquidity
and Capital Resources
We have
incurred net cumulative negative cash flow from operations since our inception
in 1988. For the nine months ended September 30, 2009, we had a net
income of $1.8 million. During the nine months ended
September 30, 2009, our operations provided cash of approximately $6.7
million. At September 30, 2009, we had $5.6 million of cash and
cash equivalents, $13.2 million of working capital, $6.0 million of outstanding
borrowings under our revolving line of credit, discussed below, and $573
thousand of other debt.
Net cash
provided by operating activities was approximately $6.7 million for the nine
months ended September 30, 2009 as compared to $4.3 million of cash
provided by operating activities in the prior year period, an improvement of
approximately $2.5 million. Major factors in the change were a $1.5
million increase in cash provided by inventory as we reduced our overall
inventory levels, $1.2 million in deferred revenue and other liabilities due to
lower deferred revenue recognized for cash previously received and an increase
in net income of $765 thousand, somewhat offset by $1.2 million in cash used for
accounts payable and accrued liabilities.
Net cash
flows from investing activities used cash of $177 thousand in the nine months
ended September 30, 2009, a decline of approximately $351 thousand compared
to $528 thousand during the corresponding period in 2008. All
expenditures were for the purchase of property and equipment in both
cases.
Net cash flows used in financing activities were $5.6 million during the nine
months ended September 30, 2009, an increase as compared to $3.8 million
used during the corresponding period in 2008. The primary reason for the
change is a $1.5 million change related to our revolving line of credit with
Wells Fargo, where we
-16-
repaid
$3.6 million in the nine months ended September 30, 2008 and repaid nearly
$5.1 million in the nine months ended September 30,
2009. In addition, proceeds from the issuance of common stock
declined by approximately $296 thousand as a result of option exercises
which occurred in the nine months ended September 30, 2008, but not
2009.
At
September 30, 2009, we had a $15.0 million asset-based revolving line of credit
with Wells Fargo which has a maturity date of June 30, 2011 as part of our
credit and security agreement with Wells Fargo. At September 30,
2009, $6.0 million was outstanding under this line of credit. Our
ability to borrow under this facility varies based upon available cash, eligible
accounts receivable and eligible inventory. On September 30, 2009,
interest was charged at a stated rate of prime plus 2.50% and was payable
monthly. We are required to comply with various financial and
non-financial covenants, and we have made various representations and
warranties. Among the financial covenants is a requirement to
maintain a minimum liquidity (cash plus excess borrowing base) of
$1.5 million. Additional requirements include covenants for
minimum capital monthly and minimum net income quarterly. Failure to
comply with any of the covenants, representations or warranties could result in
our being in default on the loan and could cause all outstanding amounts payable
to Wells Fargo to become immediately due and payable or impact our ability to
borrow under the agreement. We were in compliance with all financial
covenants as of September 30, 2009. At September 30, 2009, we
had $4.5 million borrowing capacity based upon eligible accounts receivable and
eligible inventory under our revolving line of credit.
At
September 30, 2009, we also had outstanding obligations for long-term debt
totaling approximately $573 thousand related to three term loans with Wells
Fargo. One term loan is secured by real estate in Iowa and had an
outstanding balance at September 30, 2009 of approximately $110 thousand due in
monthly installments of $17,658 plus interest. The term loan had a
stated interest rate of prime plus 2.50% on September 30, 2009 and is to be paid
in full in April 2010. The other two term loans are secured by
machinery and equipment at our Des Moines, Iowa and Loveland, Colorado
locations, respectively (the "Equipment Notes"). The Equipment Notes
had an outstanding balance at September 30, 2009 of approximately $463 thousand
with principal payments on the Equipment Notes of $46,296 plus interest due in
monthly installments. The Equipment Notes had a stated interest rate
of prime plus 2.50% as of September 30, 2009 and are to be paid in full in
August 2010.
At
September 30, 2009, we had deferred revenue and other long-term liabilities, net
of current portion, of approximately $5.0 million. Included in
this total is approximately $3.3 million of deferred revenue related to up-front
fees that have been received for certain product rights and technology rights
out-licensed. These deferred amounts are being recognized on a
straight-line basis over the remaining lives of the agreements, products,
patents or technology.
Our
primary short-term need for capital, which is subject to change, is to fund our
operations, which consist of continued sales and marketing, general and
administrative and research and development efforts, working capital associated
with increased product sales and capital expenditures relating to maintaining
and developing our manufacturing operations. Our future liquidity and
capital requirements will depend on numerous factors, including the extent to
which our marketing and selling efforts, as well as those of third parties who
market and sell our products, are successful in increasing revenue, competition,
the impact of the loss of access to our current handheld blood diagnostic
instruments and consumables, the extent to which currently planned products
and/or technologies are successfully developed, launched and sold, any changes
required by regulatory bodies to maintain our operations and other
factors.
Our financial plan for 2009 indicates that our available cash and cash
equivalents, together with cash from operations and borrowings expected to be
available under our revolving line of credit, will be sufficient to fund our
operations through 2009 and into 2010. However, our actual results
may differ from this plan, and we may be required to consider alternative
strategies. We may be required to raise additional capital in the
future. If necessary, we expect to raise these additional funds
through the sale of equity or refinancing loans currently outstanding on assets
with historical appraised values significantly in excess of related
debt. There is no guarantee that additional capital will be available
from these sources on acceptable terms, if at all, and certain of
-17-
these
sources may require approval by existing lenders. If we cannot raise
the additional funds through these options on acceptable terms or with the
necessary timing, management could also reduce discretionary spending to
decrease our cash burn rate through actions such as delaying or canceling
budgeted research activities or marketing plans. These actions would
likely extend the then available cash and cash equivalents, and then available
borrowings to some degree.
Recent
Accounting Pronouncements
None.
-18-
Item
3.
Market
risk represents the risk of loss that may impact the financial position, results
of operations or cash flows due to adverse changes in financial and commodity
market prices and rates. We are exposed to market risk in the areas
of changes in United States and foreign interest rates and changes in foreign
currency exchange rates as measured against the United States dollar and against
other foreign currency exchange rates. These exposures are directly
related to our normal operating and funding activities.
Interest
Rate Risk
The
interest payable on certain of our lines of credit and other borrowings is
variable based on the United States prime rate and, therefore, is affected by
changes in market interest rates. At September 30, 2009,
approximately $6.6 million was outstanding on these lines of credit and other
borrowings with a weighted average interest rate of 5.75%. We also
had approximately $5.6 million of cash and cash equivalents at September 30,
2009, the majority of which was invested in liquid interest bearing
accounts. We had no interest rate hedge transactions in place on
September 30, 2009. We completed an interest rate risk sensitivity
analysis based on the above and an assumed one percentage point
increase/decrease in interest rates. If market rates
increase/decrease by one percentage point, we would experience an
increase/decrease in annual net interest expense of approximately
$10 thousand based on our outstanding balances as of September 30,
2009.
Foreign
Currency Risk
Our
investment in foreign assets consists primarily of our investment in our
European subsidiary. Foreign currency risk may impact our results of
operations. In cases where we purchase inventory in one currency and
sell corresponding products in another, our gross margin percentage is typically
at risk based on foreign currency exchange rates. In addition, in
cases where we may be generating operating income in foreign currencies, the
magnitude of such operating income when translated into U.S. dollars will be at
risk based on foreign currency exchange rates. Our agreements with
customers and suppliers vary significantly in regard to the existence and extent
of currency adjustment and other currency risk sharing provisions. We
had no foreign currency hedge transactions in place on September 30,
2009.
We have a
wholly-owned subsidiary in Switzerland which uses the Swiss Franc as its
functional currency. We purchase inventory in foreign currencies, primarily
Japanese Yen and Euros, and sell corresponding products in U.S.
dollars. We also sell products in foreign currencies, primarily
Japanese Yen and Euros, where our inventory costs are in U.S.
dollars. Based on our results of operations for the most recent
twelve months, if foreign currency exchange rates were to strengthen/weaken by
25% against the dollar, we would expect a resulting pre-tax loss/gain of
approximately $493 thousand.
-19-
Item
4.
(a) Evaluation of Disclosure Controls
and Procedures. Our management, with the participation of our
chief executive officer and our chief financial officer, evaluated the
effectiveness of our disclosure controls and procedures, as defined by Rule
13a-15 of the Exchange Act, as of the end of the period covered by this
Quarterly Report on Form 10-Q. Based on this evaluation, our chief
executive officer and our chief financial officer have concluded that our
disclosure controls and procedures are adequate 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 the SEC's 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.
(b) Changes in Internal Control over
Financial Reporting. There was no change in our internal
control over financial reporting that occurred during our last fiscal quarter
that has materially affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
-20-
PART
II. OTHER INFORMATION
Item
1. Legal
Proceedings
From time
to time, we may be involved in litigation relating to claims arising out of our
operations. As of September 30, 2009, we were not a party to any
legal proceedings that are expected, individually or in the aggregate, to have a
material effect on our business, financial condition or operating
results.
Item
1A. Risk
Factors
Our
future operating results may vary substantially from period to period due to a
number of factors, many of which are beyond our control. The
following discussion highlights some of these factors and the possible impact of
these factors on future results of operations. The risks and
uncertainties described below are not the only ones we
face. Additional risks or uncertainties not presently known to us or
that we deem to be currently immaterial also may impair our business
operations. If any of the following factors actually occur, our
business, financial condition or results of operations could be
harmed. In that case, the price of our common stock could decline and
you could experience losses on your investment.
We
rely substantially on third-party suppliers. The loss of products or
delays in product availability from one or more third-party supplier could
substantially harm our business. We recently received notice that one
of our major third-party suppliers has decided to cancel our agreement and we
expect to lose access to the corresponding product line in November
2009.
To be
successful, we must contract for the supply of, or manufacture ourselves,
current and future products of appropriate quantity, quality and
cost. Such products must be available on a timely basis and be in
compliance with any regulatory requirements. Failure to do so could
substantially harm our business.
We rely
on third-party suppliers to manufacture those products we do not manufacture
ourselves. Proprietary products provided by these suppliers represent
a majority of our revenue. We currently rely on these suppliers for
our veterinary instruments and consumable supplies for these instruments, for
our point-of-care diagnostic and other tests, for the manufacture of our allergy
immunotherapy treatment products as well as for the manufacture of other
products.
Currently,
the largest of these suppliers is Abbott Point of Care Inc. ("APOC"), formerly
known as i-STAT Corporation, a unit of Abbott
Laboratories. Approximately 18% of our revenue for the twelve months
ended September 30, 2009 is related to the proprietary products manufactured by
APOC (the "iSTAT Products"). The iSTAT Products generate slightly
below average Gross Margin as compared to our overall business. On
May 1, 2009, APOC informed us that they were canceling our contractual agreement
as of November 1, 2009. Under our agreement with APOC, our rights
became non-exclusive upon receipt of such notice. We subsequently
learned through an 8-K filing with the SEC that Abaxis, Inc. ("Abaxis"), one of
our major competitors, had signed an agreement with APOC to distribute certain
iSTAT Products into the animal health market and that such rights are to be
exclusive outside of Japan on November 1, 2009. Through November 1,
we may face severe competition to service the customers who purchase iSTAT
Products, including the currently existing base of users and customers who also
purchase our other products, which could significantly lower our revenue and
gross margin and increase our sales and marketing and other
expenses. After November 1, our ability to compete in this area will
be severely hampered as we do not expect to have access to iSTAT Products to
sell to our installed base of customers and anticipate a significant decline in
revenue and gross margin related to iSTAT Products as a result. There
can be no assurance we will be able to find an alternative product to the iSTAT
Products, that any such product could compete effectively against the iSTAT
Products, directly or in a niche, or that any such product will be available in
a timely or economic manner. In addition, under our contract with
APOC, we may only sell inventory for a given period after contract termination,
so that we could face inventory reserves and losses if we do not sell iSTAT
Products as currently expected.
-21-
Other
major suppliers who sell us proprietary products which are responsible for more
than 5% of our revenue for the twelve months ended September 30, 2009 are Arkray
Global Business, Inc., Boule Medical AB, FUJIFILM Corporation and Quidel
Corporation. None of these suppliers sell us proprietary products
which are responsible for more than 15% of our revenue, although the proprietary
products of two suppliers are responsible for more than 10% of our
revenue. We often purchase products from our suppliers under
agreements that are of limited duration or potentially can be terminated on an
annual basis. In the case of our veterinary diagnostic instruments,
we are typically entitled to non-exclusive access to consumable supplies for a
defined period upon expiration of exclusive rights, which could subject us to
competitive pressures in the period of non-exclusive access. Although
we believe we have arrangements to ensure supply of our other major product
offerings other than the iSTAT products in the marketplace through at least the
end of 2009, there can be no assurance that our suppliers will meet their
obligations under any agreements we may have in place with them or that we will
be able to compel them to do so. Risks of relying on suppliers
include:
·
|
The loss of product rights
upon expiration or termination of an existing
agreement. Unless we are able to find an alternate
supply of a similar product, we would not be able to continue to offer our
customers the same breadth of products and our sales and operating results
would likely suffer. In the case of an instrument supplier, we
could also potentially suffer the loss of sales of consumable supplies,
which would be significant in cases where we have built a significant
installed base, further harming our sales prospects and
opportunities. Even if we were able to find an alternate supply
for a product to which we lost rights, we would likely face increased
competition from the product whose rights we lost being marketed by a
third party or the former supplier and it may take us additional time and
expense to gain the necessary approvals and launch an alternative
product.
|
·
|
Loss of
exclusivity. In the case of our veterinary diagnostic
instruments, if we are entitled to non-exclusive access to consumable
supplies for a defined period upon expiration of exclusive rights, we may
face increased competition from a third party with similar non-exclusive
access or our former supplier, which could cause us to lose customers
and/or significantly decrease our margins and could significantly affect
our financial results. In addition, current agreements, or
agreements we may negotiate in the future, with suppliers may require us
to meet minimum annual sales levels to maintain our position as the
exclusive distributor of these products. We may not meet these
minimum sales levels and maintain exclusivity over the distribution and
sale of these products. If we are not the exclusive distributor
of these products, competition may increase significantly, reducing our
revenues and/or decreasing our
margins.
|
·
|
High switching costs.
In our diagnostic instrument products we could face significant
competition and lose all or some of the consumable revenues from the
installed base of those instruments if we were to switch to a competitive
instrument. If we need to change to other commercial
manufacturing contractors for certain of our regulated products,
additional regulatory licenses or approvals must be obtained for these
contractors prior to our use. This would require new testing
and compliance inspections prior to sale thus resulting in potential
delays. Any new manufacturer would have to be educated in, or
develop substantially equivalent processes necessary for the production of
our products. We likely would have to train our sales force,
distribution network employees and customer support organization on the
new product and spend significant funds marketing the new product to our
customer base.
|
·
|
Inability to meet minimum
obligations. Current agreements, or agreements we may
negotiate in the future, may commit us to certain minimum purchase or
other spending obligations. It is possible we will not be able
to create the market demand to meet such obligations, which could create a
drain on our financial resources and liquidity. Some such
agreements may require minimum purchases and/or sales to maintain product
rights and we may be significantly harmed if we are unable to meet such
requirements and lose product
rights.
|
-22-
·
|
The involuntary or voluntary
discontinuation of a product line. Unless we are able to
find an alternate supply of a similar product in this or similar
circumstances with any product, we would not be able to continue to offer
our customers the same breadth of products and our sales would likely
suffer. Even if we are able to identify an alternate supply, it
may take us additional time and expense to gain the necessary approvals
and launch an alternative product, especially if the product is
discontinued unexpectedly. An example of such a situation arose
in 2006 when Dolphin Medical Inc. (a majority-owned subsidiary of OSI
Systems, Inc.) discontinued production of our VET/OX G2 DIGITAL Monitor as
part of an agreement with Masimo Corporation to settle a patent
dispute.
|
·
|
Inconsistent or inadequate
quality control. We may not be able to control or
adequately monitor the quality of products we receive from our
suppliers. Poor quality items could damage our reputation with
our customers.
|
·
|
Limited capacity or ability to
scale capacity. If market demand for our products
increases suddenly, our current suppliers might not be able to fulfill our
commercial needs, which would require us to seek new manufacturing
arrangements and may result in substantial delays in meeting market
demand. If we consistently generate more demand for a product
than a given supplier is capable of handling, it could lead to large
backorders and potentially lost sales to competitive products that are
readily available. This could require us to seek or fund new
sources of supply, which may be difficult to find unless it is under terms
that are less advantageous.
|
·
|
Regulatory
risk. Our manufacturing facility and those of some of
our third-party suppliers are subject to ongoing periodic unannounced
inspection by regulatory authorities, including the FDA, USDA and other
federal, state and foreign agencies for compliance with strictly enforced
Good Manufacturing Practices, regulations and similar foreign standards,
and we do not have control over our suppliers' compliance with these
regulations and standards. Violations could potentially lead to
interruptions in supply that could cause us to lose sales to readily
available competitive products.
|
·
|
Developmental
delays. We may experience delays in the scale-up
quantities needed for product development that could delay regulatory
submissions and commercialization of our products in development, causing
us to miss key opportunities.
|
·
|
Limited intellectual property
rights. We typically do not have intellectual property
rights, or may have to share intellectual property rights, to the products
themselves and any improvements to the manufacturing processes or new
manufacturing processes for our
products.
|
Potential
problems with suppliers such as those discussed above could substantially
decrease sales, lead to higher costs, and/or damage our reputation with our
customers due to factors such as poor quality goods or delays in order
fulfillment, resulting in our being unable to sell our products effectively and
substantially harm our business.
If
the third parties to whom we granted substantial marketing rights for certain of
our existing products or future products under development are not successful in
marketing those products, then our sales and financial position may
suffer.
Our agreements with our corporate marketing partners generally contain no or
small minimum purchase requirements in order for them to maintain their
exclusive or co-exclusive marketing rights. We are party to an
agreement with SPAH which grants exclusive distribution and marketing
rights in the U.S. for our canine heartworm preventive product, TRI-HEART Plus
Chewable Tablets. AgriLabs has the exclusive right to sell certain of
our bovine vaccines in the United States, Africa and Mexico. Novartis
Japan markets and distributes our SOLO STEP CH heartworm test and our E.R.D.
Healthscreen urine test products in Japan under an exclusive
arrangement. One or more of these marketing partners may not devote
sufficient resources to marketing our products. For example, on March
9, 2009, Merck & Co., Inc. ("Merck") and Schering-Plough Corporation
-23-
("SGP") announced plans to
merge. SGP is the parent company of SPAH. Merck and
Sanofi-Aventis each own 50% of Merial Limited ("Merial"), a company which sells
a canine heartworm preventive competitive with ours. On July 30,
2009, Merck and Sanofi-Aventis announced that they had entered into an agreement
under which Merck is to sell its interest in Merial to Sanofi-Aventis and that
Sanofi-Aventis is to receive a call option exercisable after the merger of Merck
and SGP to essentially combine Merial with SPAH in a new joint venture company
equally owned by Sanofi-Aventis and the company created from the merger of Merck
and SGP. If SGP, SPAH or any related entity is required to divest or
cease operations related to our heartworm preventive in order to complete a
merger or other combination, our sales could decline significantly and our
business could be damaged. Similarly, if SPAH personnel are
distracted or experience turmoil as a result of the announced merger between
Merck and SGP, a future combination between SPAH and Merial or for other
reasons, our sales could decline significantly. Furthermore, there
may be nothing to prevent these partners from pursuing alternative technologies
or products that may compete with our products in current or future
agreements. For example, we believe a unit of SPAH has obtained FDA
approval for a canine heartworm preventive product with additional claims
compared with our TRI-HEART Plus Chewable Tablets. Should SPAH decide
to emphasize sales and marketing efforts of this product rather than our
TRI-HEART Plus Chewable Tablets or cancel our agreement regarding canine
heartworm preventive distribution and marketing, our sales could decline
significantly. In the future, third-party marketing assistance may
not be available on reasonable terms, if at all. If any of these
events occur, we may not be able to commercialize our products and our sales
will decline. In addition, our agreement with AgriLabs requires us to
potentially pay penalties if we are unable to supply product over an extended
period of time.
We
may be unable to successfully market and sell our products.
We may
not successfully develop and maintain marketing and/or sales capabilities, and
we may not be able to make arrangements with third parties to perform these
activities on satisfactory terms. If our marketing and sales strategy
is unsuccessful, our ability to sell our products will be negatively impacted
and our revenues will decrease. The loss of distribution rights for
products or failure to gain access to new products may cause damage to our
reputation and adversely affect our business and future prospects.
We
believe the recent worldwide economic weakness has had a negative effect on our
business, and this may continue in the future. This is particularly
notable in the sale of new instruments, which is a capital expenditure many, if
not most, veterinarians may choose to defer in times of perceived economic
weakness. Even if the overall economy begins to grow in the future,
there may be a lag before veterinarians display confidence such growth will
continue and return to historical capital expenditure purchasing
patterns. As the vast majority of cash flow to veterinarians
ultimately is funded by pet owners without private insurance or government
support, our business may be more susceptible to severe economic downturns than
other health care businesses which rely less on individual
consumers.
The
market for companion animal healthcare products is highly
fragmented. Because our Core Companion Animal Health proprietary
products are generally available only to veterinarians or by prescription and
our medical instruments require technical training to operate, we predominately
sell all our Core Companion Animal Health products to or through veterinarians
ultimately. The acceptance of our products by veterinarians is
critical to our success. Changes in our ability to obtain or maintain
such acceptance or changes in veterinary medical practice could significantly
decrease our anticipated sales.
We
currently market and sell most of our Core Companion Animal Health products in
the United States to veterinarians through an outside field organization of
approximately 36 individuals, an inside sales force of approximately 22
individuals, approximately 10 independent third-party distributors who carry our
full distribution product line and approximately 6 independent third-party
distributors who carry portions of our distribution product line, as well as
through trade shows and print advertising. To be successful in these
endeavors, we will have to effectively market our products and continue to
develop and train our direct sales force as well as the sales personnel of our
independent third-party distributors.
-24-
Independent
third-party distributors may be effective in increasing sales of our products to
veterinarians, although we would expect a corresponding lower gross margin as
such distributors typically buy products from us at a discount to end user
prices. It is possible new or existing independent third-party
distributors could cannibalize our direct sales efforts and lower our total
gross margin. For us to be effective when working with an independent
third-party distributor, the distributor must agree to market and/or sell our
products and we must provide proper economic incentives to the distributor as
well as contend effectively for the distributor's time and focus given other
products the distributor may be carrying, potentially including those of our
competitors. If we fail to be effective with new or existing
independent third-party distributors, our financial performance may
suffer. In addition, most of our independent third-party distributor
agreements can be terminated on 60 days notice and we believe that IDEXX,
one of our largest competitors, in effect prohibits its distributors from
selling competitive products, including our diagnostic instruments and heartworm
diagnostic tests. We believe this restriction limits our ability to
engage national independent third-party distributors to sell our full
distribution line of products and has caused large distributors of our products
in the past to no longer carry our instruments and heartworm diagnostic tests
upon commencing distribution of the IDEXX product line.
The
loss of significant customers could harm our operating results.
Sales to
SPAH accounted for 11% of total revenue for the nine months ended September 30,
2009. Sales to no other single customer accounted for more than 10%
of our consolidated revenue for the nine months ended September 30, 2009.
Sales to no single customer accounted for more than 10% of our consolidated
revenue for the three months ended September 30, 2009. Sales to no
single customer accounted for more than 10% of our consolidated revenue for the
three and nine months ended September 30, 2008. No single customer
accounted for more than 10% of our consolidated accounts receivable at
September 30, 2009. SPAH accounted for 13% of our consolidated
accounts receivable at September 30, 2008. No other customer accounted for
more than 10% of our consolidated accounts receivable at September 30,
2008. The loss of significant customers who, for example, are
historically large purchasers or who are considered leaders in their field could
damage our business and financial results.
Our
common stock is listed on the Nasdaq Capital Market and we may not be able to
maintain that listing, which may make it more difficult for you to sell your
shares.
Our
common stock is listed on the Nasdaq Capital Market. The Nasdaq has
several quantitative and qualitative requirements companies must comply with to
maintain this listing, including a $1.00 minimum bid price. We are
currently not in compliance with the $1.00 minimum bid price and we have
received a communication from Nasdaq so advising us. Nasdaq announced
a temporary suspension of minimum bid price enforcement until August 3, 2009; we
are to have 180 calendar days from August 3, 2009 to regain compliance with
the minimum bid price requirement, which requires our stock to have a minimum
closing bid price of $1.00 for a minimum of 10 consecutive trading
days. If we fail to regain compliance with the minimum bid price
requirement within 180 days, Nasdaq has informed us we will be eligible for an
additional 180 calendar day compliance period if we satisfy the Nasdaq Capital
Market initial listing criteria other than the minimum bid price requirement at
that time. There can be no assurance we will meet these criteria at
that point, that Nasdaq will interpret these criteria in the same manner we do
if we believe we meet the criteria, or that Nasdaq will not change such criteria
to include requirements we do not meet in the future, any of which could cause
us to fail to obtain the additional 180 day compliance period. If we
are delisted from the Nasdaq Capital Market, our common stock may be considered
a penny stock under the regulations of the SEC and would therefore be subject to
rules that impose additional sales practice requirements on broker-dealers who
sell our securities. The additional burdens imposed upon
broker-dealers may discourage broker-dealers from effecting transactions in our
common stock, which could severely limit market liquidity of the common stock
and your ability to sell our securities in the secondary market. This
lack of liquidity would also make it more difficult for us to raise capital in
the future.
-25-
We
operate in a highly competitive industry, which could render our products
obsolete or substantially limit the volume of products that we
sell. This would limit our ability to compete and maintain sustained
profitability.
The
market in which we compete is intensely competitive. Our competitors
include independent animal health companies and major pharmaceutical companies
that have animal health divisions. We also compete with independent,
third-party distributors, including distributors who sell products under their
own private labels. In the point-of-care diagnostic testing market,
our major competitors include IDEXX, Abaxis and Synbiotics
Corporation. The products manufactured by our OVP segment for sale by
third parties compete with similar products offered by a number of other
companies, some of which have substantially greater financial, technical,
research and other resources than us and may have more established marketing,
sales, distribution and service organizations than our OVP segment's
customers. Competitors may have facilities with similar capabilities
to our OVP segment, which they may operate and sell at a lower unit price to
customers than our OVP segment does, which could cause us to lose
customers. Companies with a significant presence in the companion
animal health market, such as Bayer AG, CEVA Santé Animale, Merial Limited (a
company jointly owned by Merck & Co., Inc. and Sanofi-Aventis), Novartis AG,
Pfizer Inc., Schering-Plough Corporation, Vétoquinol S.A. and Virbac S.A., may
be marketing or developing products that compete with our products or would
compete with them if developed. These and other competitors and
potential competitors may have substantially greater financial, technical,
research and other resources and larger, more established marketing, sales and
service organizations than we do. Our competitors may offer broader
product lines and have greater name recognition than we do. Our
competitors may develop or market technologies or products that are more
effective or commercially attractive than our current or future products or that
would render our technologies and products obsolete. Further,
additional competition could come from new entrants to the animal health care
market. Moreover, we may not have the financial resources, technical
expertise or marketing, sales or support capabilities to compete
successfully. We believe that one of our largest competitors, IDEXX,
in effect prohibits its distributors from selling competitive products,
including our diagnostic instruments and heartworm diagnostic
tests. Another of our competitors, Abaxis, recently launched a
stand-alone canine heartworm diagnostic test competitive with ours and a
heartworm diagnostic test conducted as part of a chemistry profile on its
chemistry analyzer. On May 1, 2009, APOC informed us that they were
canceling our contractual agreement as of November 1, 2009. Under our
agreement with APOC, our rights became non-exclusive upon receipt of such
notice. We subsequently learned through an 8-K filing with the SEC
that Abaxis had signed an agreement with APOC to distribute certain iSTAT
Products into the animal health market and that such rights are to be exclusive
outside of Japan on November 1, 2009. Through November 1, we may face
severe competition to service the customers who purchase iSTAT Products,
including the currently existing base of users and customers who also purchase
our other products, which could significantly lower our revenue and gross margin
and increase our sales and marketing and other expenses. After
November 1, our ability to compete in this area will be severely hampered as we
do not expect to have access to iSTAT Products to sell to our installed base of
customers and anticipate a significant decline in revenue and gross margin
related to iSTAT Products as a result. There can be no assurance we
will be able to find an alternative product to the iSTAT Products, that any such
product could compete effectively against the iSTAT Products, directly or in a
niche, or that any such product will be available in a timely or economic
manner.
If we
fail to compete successfully, our ability to achieve sustained profitability
will be limited and sustained profitability, or profitability at all, may not be
possible.
We
often depend on third parties for products we intend to introduce in the
future. If our current relationships and collaborations are not
successful, we may not be able to introduce the products we intend to in the
future.
We are often dependent on third parties and collaborative partners to
successfully and timely perform research and development activities to
successfully develop new products. For example, we jointly developed
point-of-care diagnostic products with Quidel Corporation. In other
cases, we have discussed Heska marketing in the veterinary market an instrument
being developed by a third party for use in the human health care
market. In the future, one or more of these third parties or
collaborative partners may not complete research and
-26-
development
activities in a timely fashion, or at all. Even if these third
parties are successful in their research and development activities, we may not
be able to come to an economic agreement with them. If these third
parties or collaborative partners fail to complete research and development
activities, fail to complete them in a timely fashion, or if we are unable to
negotiate economic agreements with such third parties or collaborative partners,
our ability to introduce new products will be impacted negatively and our
revenues may decline. We are currently collaborating with FUJIFILM on
a line extension of our chemistry instrument offering. We expect to
sell the resulting new instrument prior to year end. If FUJIFILM
fails to complete the anticipated development activities in a timely fashion, we
will not generate any sales of this new instrument prior to year end and our
2009 revenue will likely be lower than our current expectations as a
result.
We
may not be able to continue to achieve sustained profitability or increase
profitability on a quarterly or annual basis.
Prior to
2005, we incurred net losses on an annual basis since our inception in 1988 and,
as of September 30, 2009, we had an accumulated deficit of $172.3
million. We have achieved only one quarter with income before income
taxes greater than $1.5 million. Accordingly, relatively small
differences in our performance metrics may cause us to lose money in future
periods. In addition, we anticipate the loss of access to the iSTAT
Products will put significant financial pressure on us in 2010. Our
ability to continue to be profitable in future periods will depend, in part, on
our ability to increase sales in our Core Companion Animal Health segment,
including maintaining and growing our installed base of instruments and related
consumables, to maintain or increase gross margins and to limit the increase in
our operating expenses to a reasonable level as well as avoid or effectively
manage any unanticipated issues. We may not be able to generate,
sustain or increase profitability on a quarterly or annual basis. If
we cannot achieve or sustain profitability for an extended period, we may not be
able to fund our expected cash needs, including the repayment of debt as it
comes due, or continue our operations.
Our
future revenues depend on successful product development, commercialization
and/or market acceptance, any of which can be slower than we expect or may not
occur.
The
product development and regulatory approval process for many of our potential
products is extensive and may take substantially longer than we
anticipate. Research projects may fail. New products that
we may be developing for the veterinary marketplace may not perform up to our
expectations. Because we have limited resources to devote to product
development and commercialization, any delay in the development of one product
or reallocation of resources to product development efforts that prove
unsuccessful may delay or jeopardize the development of other product
candidates. If we fail to successfully develop new products and bring
them to market in a timely manner, our ability to generate additional revenue
will decrease.
Even if
we are successful in the development of a product or obtain rights to a product
from a third-party supplier, we may experience delays or shortfalls in
commercialization and/or market acceptance of the product. For
example, veterinarians may be slow to adopt a product or there may be delays in
producing large volumes of a product. The former is particularly
likely where there is no comparable product available or historical use of such
a product. For example, while we believe our E.R.D.-HEALTHSCREEN
urine tests for dogs and cats represent a significant scientific breakthrough in
companion animal annual health examinations, these products have achieved
significantly lower market acceptance than we anticipated. The
ultimate adoption of a new product by veterinarians, the rate of such adoption
and the extent veterinarians choose to integrate such a product into their
practice are all important factors in the economic success of one of our new
products and are factors that we do not control to a large extent. If
our products do not achieve a significant level of market acceptance, demand for
our products will not develop as expected and our revenues will be lower than we
anticipate.
-27-
Many of our
expenses are fixed and if factors beyond our control cause our revenue to
fluctuate, this fluctuation could cause greater than expected losses, cash flow
and liquidity shortfalls.
We
believe that our future operating results will fluctuate on a quarterly basis
due to a variety of factors which are generally beyond our control,
including:
·
|
supply
of products from third-party suppliers or termination, cancellation or
expiration of such relationships, such as the recent decision by APOC to
cancel our contractual agreement as of November 1, 2009;
|
·
|
the
introduction of new products by our competitors or by
us;
|
·
|
competition
and pricing pressures from competitive
products;
|
·
|
our
ability to maintain relationships with independent third-party
distributors;
|
·
|
large
customers failing to purchase at historical levels, including changes in
independent third-party distributor purchasing patterns and inventory
levels;
|
·
|
fundamental
shifts in market demand;
|
·
|
manufacturing
delays;
|
·
|
shipment
problems;
|
·
|
information
technology problems, which may prevent us from conducting our business
effectively, or at all, and may also raise our
costs;
|
·
|
regulatory
and other delays in product
development;
|
·
|
product
recalls or other issues which may raise our
costs;
|
·
|
changes
in our reputation and/or market acceptance of our current or new products;
and
|
·
|
changes
in the mix of products sold.
|
We have
high operating expenses, including those related to personnel. Many
of these expenses are fixed in the short term. If any of the factors
listed above cause our revenues to decline, our operating results could be
substantially harmed.
We
have historically not consistently generated positive cash flow from operations,
may need additional capital and any required capital may not be available on
reasonable terms or at all.
If our
actual performance deviates from our operating plan, we may be required to raise
additional capital in the future. If necessary, we expect to raise
these additional funds by the sale of equity securities or refinancing
loans currently outstanding on assets with historical appraised values in excess
of related debt. There is no guarantee that additional capital will
be available from these sources on reasonable terms, if at all, and certain of
these sources may require approval by existing lenders. The public
markets may be unreceptive to equity financings and we may not be able to obtain
additional private equity or debt financing. Any equity financing
would likely be dilutive to stockholders and additional debt financing, if
available, may include restrictive covenants and increased interest rates that
would limit our currently planned operations and
strategies. Additionally, funds we expect to be available under our
existing revolving line of credit may not be available and other lenders could
refuse to provide us with additional debt financing. We believe the
credit markets are particularly restrictive and difficult to obtain funding in
versus recent history. Furthermore, even if additional capital is
available, it may not be of the magnitude required to meet our needs under these
or other scenarios. If additional funds are required and are not
available, it would likely have a material adverse effect on our business,
financial condition and our ability to continue as a going concern.
-28-
We
may face costly legal disputes, including related to our intellectual property
or technology or that of our suppliers or collaborators.
We may
face legal disputes related to our business. Even if meritless, these
disputes may require significant expenditures on our part and could entail a
significant distraction to members of our management team or other key
employees. A legal dispute leading to an unfavorable ruling or
settlement could have significant material adverse consequences on our
business.
We may
become subject to additional patent infringement claims and litigation in the
United States or other countries or interference proceedings conducted in the
United States Patent and Trademark Office, or USPTO, to determine the priority
of inventions. The defense and prosecution of intellectual property
suits, USPTO interference proceedings and related legal and administrative
proceedings are likely to be costly, time-consuming and
distracting. As is typical in our industry, from time to time we and
our collaborators and suppliers have received, and may in the future receive,
notices from third parties claiming infringement and invitations to take
licenses under third-party patents. Any legal action against us or
our collaborators or suppliers may require us or our collaborators or suppliers
to obtain one or more licenses in order to market or manufacture affected
products or services. However, we or our collaborators or suppliers
may not be able to obtain licenses for technology patented by others on
commercially reasonable terms, or at all, may not be able to develop alternative
approaches if unable to obtain licenses or current and future licenses may not
be adequate, any of which could substantially harm our business. An
example of such a situation arose in 2006 when Dolphin Medical Inc. (a
majority-owned subsidiary of OSI Systems, Inc.) discontinued production of our
VET/OX G2 DIGITAL Monitor as part of an agreement with Masimo Corporation to
settle a patent dispute.
We may
also need to pursue litigation to enforce any patents issued to us or our
collaborative partners, to protect trade secrets or know-how owned by us or our
collaborative partners, or to determine the enforceability, scope and validity
of the proprietary rights of others. Any litigation or interference
proceeding will likely result in substantial expense to us and significant
diversion of the efforts of our technical and management
personnel. Any adverse determination in litigation or interference
proceedings could subject us to significant liabilities to third
parties. Further, as a result of litigation or other proceedings, we
may be required to seek licenses from third parties which may not be available
on commercially reasonable terms, if at all.
Our
stock price has historically experienced high volatility, which may increase in
the future, and which could affect our ability to raise capital in the future or
make it difficult for investors to sell their shares.
The
securities markets have experienced significant price and volume fluctuations
and the market prices of securities of many microcap and smallcap companies have
in the past been, and can in the future be expected to be, especially
volatile. During the twelve months ended September 30, 2009, our
closing stock price has ranged from a low of $0.17 to a high of
$0.61. Fluctuations in the trading price or liquidity of our common
stock may adversely affect our ability to raise capital through future equity
financings. Factors that may have a significant impact on the market
price and marketability of our common stock include:
·
|
stock
sales by large stockholders or by
insiders;
|
·
|
changes
in the outlook for our business, including any changes in our earnings
guidance;
|
·
|
our
quarterly operating results, including as compared to our revenue,
earnings or other guidance and in comparison to historical
results;
|
·
|
termination,
cancellation or expiration of our third-party supplier
relationships;
|
·
|
announcements
of technological innovations or new products by our competitors or by
us;
|
·
|
litigation;
|
·
|
regulatory
developments, including delays in product
introductions;
|
-29-
·
|
developments
or disputes concerning patents or proprietary
rights;
|
·
|
availability
of our revolving line of credit and compliance with debt
covenants;
|
·
|
releases
of reports by securities analysts;
|
·
|
changes
in regulatory policies;
|
·
|
economic
and other external factors; and
|
·
|
general
market conditions.
|
In the
past, following periods of volatility in the market price of a company's
securities, securities class action litigation has often been
instituted. If a securities class action suit is filed against us, it
is likely we would incur substantial legal fees and our management's attention
and resources would be diverted from operating our business in order to respond
to the litigation.
If
we are unable to maintain various financial and other covenants required by our
credit facility agreement we will be unable to borrow any funds under the
agreement and fund our operations.
Under our
credit and security agreement with Wells Fargo we are required to comply with
various financial and non-financial covenants in order to borrow under the
agreement. The availability of borrowings under this agreement is
essential to continue to fund our operations. Among the financial
covenants is a requirement to maintain minimum liquidity (cash plus excess
borrowing base) of $1.5 million. Additional requirements include covenants
for minimum capital monthly and minimum net income quarterly. Although we
believe we will be able to maintain compliance with all these covenants and any
covenants we may negotiate in the future, there can be no assurance
thereof. We have not always been able to maintain compliance with all
covenants under our credit and security agreement in the past. Although
Wells Fargo granted us a waiver of non-compliance in each case, there can be no
assurance we will be able to obtain similar waivers or other modifications if
needed in the future on economic terms, if at all. Failure to comply
with any of the covenants, representations or warranties, or failure to modify
them to allow future compliance, could result in our being in default and could
cause all outstanding borrowings under our credit and security agreement to
become immediately due and payable, or impact our ability to borrow under the
agreement. In addition, Wells Fargo has discretion in setting the advance
rates which we may borrow against eligible assets. We intend to rely
on available borrowings under the credit and security agreement to fund our
operations in the future. If we are unable to borrow funds under this
agreement, we will need to raise additional capital from other sources to
continue our operations, which capital may not be available on acceptable terms,
or at all.
Obtaining
and maintaining regulatory approvals in order to market our regulated products
may be costly and delay the marketing and sales of our products.
Many of
the products we develop, market or manufacture may subject us to extensive
regulation by one or more of the USDA, the FDA, the EPA and foreign and other
regulatory authorities. These regulations govern, among other things,
the development, testing, manufacturing, labeling, storage, pre-market approval,
advertising, promotion and sale of some of our products. Satisfaction
of these requirements can take several years and time needed to satisfy them may
vary substantially, based on the type, complexity and novelty of the
product.
The
effect of government regulation may be to delay or to prevent marketing of our
products for a considerable period of time and to impose costly procedures upon
our activities. We have experienced in the past, and may experience
in the future, difficulties that could delay or prevent us from obtaining the
regulatory approval or license necessary to introduce or market our
products. Such delays in approval may cause us to forego a
significant portion of a new product's sales in its first year due to
seasonality and advanced booking periods associated with certain
products. Regulatory approval of our products may also impose
limitations on the indicated or intended uses for which our products may be
marketed.
-30-
Among the
conditions for certain regulatory approvals is the requirement that our
facilities and/or the facilities of our third-party manufacturers conform to
current Good Manufacturing Practices and other requirements. If any
regulatory authority determines that our manufacturing facilities or those of
our third-party manufacturers do not conform to appropriate manufacturing
requirements, we or the manufacturers of our products may be subject to
sanctions, including, but not limited to, warning letters, manufacturing
suspensions, product recalls or seizures, injunctions, refusal to permit
products to be imported into or exported out of the United States, refusals of
regulatory authorities to grant approval or to allow us to enter into government
supply contracts, withdrawals of previously approved marketing applications,
civil fines and criminal prosecutions. In addition, certain of our
agreements require us to pay penalties if we are unable to supply products,
including for failure to maintain regulatory approvals. Any of these
events, alone or in unison, could damage our business.
Interpretation
of existing legislation, regulations and rules or implementation of future
legislation, regulations and rules could cause our costs to increase or could
harm us in other ways.
The
Sarbanes-Oxley Act of 2002 ("Sarbanes-Oxley") has increased our required
administrative actions and expenses as a public
company. The general and administrative costs of complying with
Sarbanes-Oxley will depend on how it is interpreted over time. Of
particular concern are the level of standards for internal control evaluation
and reporting adopted under Section 404 of Sarbanes-Oxley. If our
regulators and/or auditors adopt or interpret more stringent standards than we
anticipate, we and/or our auditors may be unable to conclude that our internal
controls over financial reporting are designed and operating effectively, which
could adversely affect investor confidence in our financial
statements. Even if we and our auditors are able to conclude that our
internal controls over financial reporting are designed and operating
effectively in such a circumstance, our general and administrative costs are
likely to increase. In addition, actions by other entities, such as
enhanced rules to maintain our listing on the Nasdaq Capital Market, could also
increase our general and administrative costs or have other adverse effects on
us, as could further legislative, regulatory or rule-making action or more
stringent interpretations of existing legislation, regulations and
rules.
We
depend on key personnel for our future success. If we lose our key
personnel or are unable to attract and retain additional personnel, we may be
unable to achieve our goals.
Our
future success is substantially dependent on the efforts of our senior
management and other key personnel. The loss of the services of
members of our senior management or other key personnel may significantly delay
or prevent the achievement of our business objectives. Although we
have an employment agreement with many of these individuals, all are at-will
employees, which means that either the employee or Heska may terminate
employment at any time without prior notice. If we lose the services
of, or fail to recruit, key personnel, the growth of our business could be
substantially impaired. We do not maintain key person life insurance
for any of our senior management or key personnel.
Changes
to financial accounting standards may affect our results of operations and cause
us to change our business practices.
We
prepare our financial statements in conformance with United States generally
accepted accounting principles, or GAAP. These accounting principles
are established by and are subject to interpretation by the SEC, the Financial
Accounting Standards Board, the American Institute of Certified Public
Accountants, and others who interpret and create accounting
policies. A change in those policies can have a significant effect on
our reported results and may affect our reporting of transactions completed
before a change is made effective. Such changes may adversely affect
our reported financial results or the way we conduct our business.
-31-
We
may face product returns and product liability litigation in excess of or not
covered by our insurance coverage or indemnities and/or warranties from our
suppliers. If we become subject to product liability claims resulting
from defects in our products, we may fail to achieve market acceptance of our
products and our sales could substantially decline.
The
testing, manufacturing and marketing of our current products as well as those
currently under development entail an inherent risk of product liability claims
and associated adverse publicity. Following the introduction of a
product, adverse side effects may be discovered. Adverse publicity
regarding such effects could affect sales of our other products for an
indeterminate time period. To date, we have not experienced any
material product liability claims, but any claim arising in the future could
substantially harm our business. Potential product liability claims
may exceed the amount of our insurance coverage or may be excluded from coverage
under the terms of the policy. We may not be able to continue to
obtain adequate insurance at a reasonable cost, if at all. In the
event that we are held liable for a claim against which we are not indemnified
or for damages exceeding the $10 million limit of our insurance coverage or
which results in significant adverse publicity against us, we may lose revenue,
be required to make substantial payments which could exceed our financial
capacity and/or lose or fail to achieve market acceptance.
We
may be held liable for the release of hazardous materials, which could result in
extensive clean up costs or otherwise harm our business.
Certain
of our products and development programs produced at our Des Moines, Iowa
facility involve the controlled use of hazardous and biohazardous materials,
including chemicals and infectious disease agents. Although we
believe that our safety procedures for handling and disposing of such materials
comply with the standards prescribed by applicable local, state and federal
regulations, we cannot eliminate the risk of accidental contamination or injury
from these materials. In the event of such an accident, we could be
held liable for any fines, penalties, remediation costs or other damages that
result. Our liability for the release of hazardous materials could
exceed our resources, which could lead to a shutdown of our operations,
significant remediation costs and potential legal liability. In
addition, we may incur substantial costs to comply with environmental
regulations if we choose to expand our manufacturing capacity.
None.
Item
3. Defaults upon Senior Securities
None.
-32-
None.
Item
5. Other
Information
None.
Item
6. Exhibits
(a)
|
Exhibits
|
Number
Notes Description
|
31.1
|
Certification
of Chief Executive Officer Pursuant to Rule 13a-14(a) and Rule 15d-14(a)
of the Securities Exchange Act, as
amended.
|
|
31.2
|
Certification of Chief Financial
Officer Pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities
Exchange Act, as amended.
|
|
32.1
|
Certification
of Chief Executive Officer and Chief Financial Officer Pursuant to 18
U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.
|
-33-
HESKA
CORPORATION
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.
HESKA
CORPORATION
Date:
|
October
28, 2009
|
By
|
/s/ Robert B.
Grieve
|
ROBERT
B. GRIEVE
|
|||
Chairman
of the Board and Chief Executive Officer
(on
behalf of the Registrant and as the Registrant's Principal Executive
Officer)
|
|||
Date:
|
October
28, 2009
|
By
|
/s/ Jason A.
Napolitano
|
JASON
A. NAPOLITANO
|
|||
Executive
Vice President and Chief Financial Officer
(on
behalf of the Registrant and as the Registrant's Principal Financial
Officer)
|
-34-