|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
20-5300780
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
(I.R.S. Employer
Identification No.)
|
|
|
12400 High Bluff Drive, Suite 650
San Diego, California
|
92130
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Large accelerated filer
|
|
¨
|
Accelerated filer
|
|
x
|
|
|
|
|
||
Non-accelerated filer
|
|
¨
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
|
¨
|
|
|
Page
|
|
|
||
|
|
|
Item 1
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
Item 2
|
||
|
|
|
Item 3
|
||
|
|
|
Item 4
|
||
|
|
|
|
||
|
|
|
Item 1
|
||
|
|
|
Item 1A
|
||
|
|
|
Item 2
|
||
|
|
|
Item 3
|
||
|
|
|
Item 4
|
||
|
|
|
Item 5
|
||
|
|
|
Item 6
|
|
June 30,
2013 |
|
December 31,
2012 |
||||
|
(Unaudited)
|
|
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
16,121
|
|
|
$
|
41,228
|
|
Trade accounts receivable, net
|
4,138
|
|
|
5,643
|
|
||
Inventory, net
|
13,185
|
|
|
12,886
|
|
||
Prepaid expenses and other current assets
|
2,044
|
|
|
2,254
|
|
||
Total current assets
|
35,488
|
|
|
62,011
|
|
||
Property and equipment, net
|
13,414
|
|
|
13,561
|
|
||
Other assets
|
4,496
|
|
|
5,114
|
|
||
Total assets
|
$
|
53,398
|
|
|
$
|
80,686
|
|
Liabilities and stockholders’ equity (deficit)
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
6,337
|
|
|
$
|
4,592
|
|
Accrued expenses
|
12,052
|
|
|
14,343
|
|
||
Common stock warrant liabilities
|
12,488
|
|
|
9,493
|
|
||
Accrued compensation
|
2,518
|
|
|
4,226
|
|
||
Total current liabilities
|
33,395
|
|
|
32,654
|
|
||
Long-term debt, less current portion
|
28,638
|
|
|
28,481
|
|
||
Other long-term liabilities
|
7,452
|
|
|
5,078
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders’ equity (deficit):
|
|
|
|
||||
Common stock
|
101
|
|
|
101
|
|
||
Additional paid-in capital
|
347,592
|
|
|
343,763
|
|
||
Accumulated deficit
|
(363,780
|
)
|
|
(329,391
|
)
|
||
Total stockholders’ equity (deficit)
|
(16,087
|
)
|
|
14,473
|
|
||
Total liabilities and stockholders’ equity (deficit)
|
$
|
53,398
|
|
|
$
|
80,686
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Net product revenue
|
$
|
8,942
|
|
|
$
|
8,030
|
|
|
$
|
15,924
|
|
|
$
|
17,915
|
|
Contract revenue
|
—
|
|
|
—
|
|
|
—
|
|
|
8,462
|
|
||||
Total revenue
|
8,942
|
|
|
8,030
|
|
|
15,924
|
|
|
26,377
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of sales
|
4,630
|
|
|
4,167
|
|
|
8,789
|
|
|
9,229
|
|
||||
Royalty expense
|
338
|
|
|
315
|
|
|
620
|
|
|
672
|
|
||||
Research and development
|
3,577
|
|
|
6,381
|
|
|
6,814
|
|
|
12,345
|
|
||||
Selling, general and administrative
|
12,000
|
|
|
12,068
|
|
|
26,482
|
|
|
26,717
|
|
||||
Restructuring
|
876
|
|
|
—
|
|
|
876
|
|
|
—
|
|
||||
Total operating expenses
|
21,421
|
|
|
22,931
|
|
|
43,581
|
|
|
48,963
|
|
||||
Loss from operations
|
(12,479
|
)
|
|
(14,901
|
)
|
|
(27,657
|
)
|
|
(22,586
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Interest income
|
3
|
|
|
10
|
|
|
11
|
|
|
29
|
|
||||
Interest expense
|
(1,595
|
)
|
|
(2,589
|
)
|
|
(3,208
|
)
|
|
(5,267
|
)
|
||||
Change in fair value of warrant liabilities
|
1,264
|
|
|
(91
|
)
|
|
(2,995
|
)
|
|
(42
|
)
|
||||
Change in fair value of embedded derivatives
|
(480
|
)
|
|
330
|
|
|
(562
|
)
|
|
368
|
|
||||
Other income (expense)
|
(45
|
)
|
|
72
|
|
|
22
|
|
|
42
|
|
||||
Total other income (expense)
|
(853
|
)
|
|
(2,268
|
)
|
|
(6,732
|
)
|
|
(4,870
|
)
|
||||
Net loss before income taxes
|
(13,332
|
)
|
|
(17,169
|
)
|
|
(34,389
|
)
|
|
(27,456
|
)
|
||||
Provision for income taxes
|
—
|
|
|
—
|
|
|
—
|
|
|
(5
|
)
|
||||
Net loss
|
$
|
(13,332
|
)
|
|
$
|
(17,169
|
)
|
|
$
|
(34,389
|
)
|
|
$
|
(27,461
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.13
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.42
|
)
|
Weighted average shares outstanding, basic and diluted
|
100,876
|
|
|
65,449
|
|
|
100,843
|
|
|
65,409
|
|
||||
Comprehensive loss
|
$
|
(13,332
|
)
|
|
$
|
(17,169
|
)
|
|
$
|
(34,389
|
)
|
|
$
|
(27,461
|
)
|
|
Six Months Ended June 30,
|
||||||
|
2013
|
|
2012
|
||||
Operating activities:
|
|
|
|
||||
Net loss
|
$
|
(34,389
|
)
|
|
$
|
(27,461
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Stock-based compensation
|
3,364
|
|
|
2,794
|
|
||
Stock-based compensation, restructuring
|
201
|
|
|
—
|
|
||
Depreciation and amortization
|
945
|
|
|
790
|
|
||
Amortization of debt issuance costs and non-cash interest
|
276
|
|
|
797
|
|
||
Change in fair value of warrant liabilities
|
2,995
|
|
|
42
|
|
||
Change in fair value of embedded derivatives
|
562
|
|
|
(368
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Trade accounts receivable
|
1,505
|
|
|
19
|
|
||
Inventory, net
|
(299
|
)
|
|
1,237
|
|
||
Prepaid expenses and other current assets
|
210
|
|
|
(260
|
)
|
||
Other assets
|
498
|
|
|
(426
|
)
|
||
Accounts payable and accrued expenses
|
(584
|
)
|
|
1,832
|
|
||
Restructuring liabilities
|
146
|
|
|
—
|
|
||
Deferred revenue
|
—
|
|
|
(8,462
|
)
|
||
Net cash used in operating activities
|
(24,570
|
)
|
|
(29,466
|
)
|
||
Investing activities:
|
|
|
|
||||
Purchases of property and equipment
|
(798
|
)
|
|
(291
|
)
|
||
Net cash used in investing activities
|
(798
|
)
|
|
(291
|
)
|
||
Financing activities:
|
|
|
|
||||
Proceeds from revolving credit facility
|
—
|
|
|
9,899
|
|
||
Payments on borrowings of debt
|
—
|
|
|
(15,040
|
)
|
||
Proceeds from exercise of common stock options
|
—
|
|
|
2
|
|
||
Proceeds from issuance of common stock and common stock warrants
|
261
|
|
|
345
|
|
||
Net cash provided by (used in) financing activities
|
261
|
|
|
(4,794
|
)
|
||
Net decrease in cash and cash equivalents
|
(25,107
|
)
|
|
(34,551
|
)
|
||
Cash and cash equivalents at beginning of period
|
41,228
|
|
|
56,525
|
|
||
Cash and cash equivalents at end of period
|
$
|
16,121
|
|
|
$
|
21,974
|
|
1.
|
Organization and Basis of Presentation
|
2.
|
Summary of Significant Accounting Policies
|
Level 1:
|
Observable inputs such as quoted prices in active markets;
|
Level 2:
|
Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
|
Level 3:
|
Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||
|
Quoted
Prices in
Active
Markets
for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
|
||||||
At June 30, 2013
|
|
|
|
|
|
|
|
||||||
Assets
|
|
|
|
|
|
|
|
||||||
Cash equivalents
(1)
|
$
|
13,415
|
|
|
—
|
|
|
—
|
|
|
$
|
13,415
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||
Common stock warrant liabilities
(2)
|
$
|
—
|
|
|
—
|
|
|
12,488
|
|
|
$
|
12,488
|
|
Embedded derivative liabilities
(3)
|
$
|
—
|
|
|
—
|
|
|
1,554
|
|
|
$
|
1,554
|
|
At December 31, 2012
|
|
|
|
|
|
|
|
||||||
Assets
|
|
|
|
|
|
|
|
||||||
Cash equivalents
(1)
|
$
|
37,605
|
|
|
—
|
|
|
—
|
|
|
$
|
37,605
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||
Common stock warrant liabilities
(2)
|
$
|
—
|
|
|
—
|
|
|
9,493
|
|
|
$
|
9,493
|
|
Embedded derivative liabilities
(3)
|
$
|
—
|
|
|
—
|
|
|
992
|
|
|
$
|
992
|
|
(1)
|
Cash equivalents are comprised of money market fund shares and are included as a component of cash and cash equivalents on the consolidated balance sheets.
|
(2)
|
Common stock warrant liabilities include liabilities associated with warrants issued in connection with the Company's July 2012 public offering of common stock and warrants (see Note 6) and warrants issued in connection with the Healthcare Royalty financing agreement (see Note 4), which are measured at fair value using the Black-Scholes option pricing valuation model. The assumptions used in the Black-Scholes option pricing valuation model for both common stock warrant liabilities were: (a) a risk-free interest rate based on the rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the remaining contractual term of the warrants; (b) an assumed dividend yield of zero based on the Company’s expectation that it will not pay dividends in the foreseeable future; (c) an expected term based on the remaining contractual term of the warrants; and (d) given the Company’s lack of relevant historical data due to the Company’s limited historical experience, an expected volatility based upon the Company's historical volatility, supplemented with historical volatility of comparable companies whose share prices have been publicly available for a sufficient period of time. The significant unobservable input used in measuring the fair value of the common stock warrant liabilities associated with the Healthcare Royalty financing agreement is the expected volatility. Significant increases in volatility would result in a higher fair value measurement. The following additional assumptions were used in the Black-Scholes option pricing valuation model to measure the fair value of the warrants sold in the July 2012 public offering: (a) management’s projections regarding the probability of the occurrence of an extraordinary event that would require cash settlement of the warrants; and for the valuation scenario in which an extraordinary event occurs, (b) a volatility rate equal to the lesser of
40%
and the 180-day volatility rate obtained from the HVT function on Bloomberg as of the trading day immediately following the public announcement of an extraordinary transaction. The significant unobservable input used in measuring the fair value of the common stock warrant liabilities associated with the July 2012 public offering is the expected volatility and probability of the occurrence of an extraordinary event. Significant increases in volatility would result in a higher fair value measurement and significant increases in the probability of an extraordinary event occurring would result in a significantly lower fair value measurement.
|
(3)
|
Embedded derivative liabilities measured at fair value using various discounted cash flow valuation models are included as a component of other long-term liabilities on the consolidated balance sheets. The assumptions used in the discounted cash flow valuation models include: (a) management’s revenue projections and a revenue sensitivity analysis based on possible future outcomes; (b) probability weighted net cash flows based on the likelihood of Healthcare Royalty receiving revenue interest payments over the term of the financing agreement; (c) probability of bankruptcy; (d) weighted average cost of capital that included the addition of a company specific risk premium to account for uncertainty associated with the Company achieving future cash flows; (e) the probability of a change in control occurring during the term of the Healthcare Royalty financing agreement; and (f) the probability of an exercise of the embedded derivative instruments. The significant unobservable inputs used in measuring the fair value of the embedded derivatives are management’s revenue projections. Significant decreases in these significant inputs would result in a higher fair value measurement.
|
|
Common
Stock
Warrant
Liabilities
|
|
Embedded
Derivative
Liabilities
|
||||
Balance at December 31, 2012
|
$
|
9,493
|
|
|
$
|
992
|
|
Changes in fair value
|
2,995
|
|
|
562
|
|
||
Balance at June 30, 2013
|
$
|
12,488
|
|
|
$
|
1,554
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
||||||||||||
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Numerator
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(13,332
|
)
|
|
$
|
(17,169
|
)
|
|
$
|
(34,389
|
)
|
|
$
|
(27,461
|
)
|
Denominator
|
|
|
|
|
|
|
|
||||||||
Weighted average common shares outstanding, basic and diluted
|
100,876
|
|
|
65,449
|
|
|
100,843
|
|
|
65,409
|
|
||||
Basic and diluted net loss per share
|
$
|
(0.13
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.42
|
)
|
|
Three and Six Months Ended
June 30,
|
||||
|
2013
|
|
2012
|
||
Common stock options and restricted stock units
|
1,710
|
|
|
6,171
|
|
|
1,710
|
|
|
6,171
|
|
3.
|
Inventory, net (in thousands)
|
|
June 30, 2013
|
|
December 31, 2012
|
||||
Raw materials
|
$
|
3,517
|
|
|
$
|
4,867
|
|
Work in process
|
6,606
|
|
|
6,134
|
|
||
Finished goods
|
3,062
|
|
|
1,885
|
|
||
|
$
|
13,185
|
|
|
$
|
12,886
|
|
4.
|
Collaboration and Financing Agreements
|
•
|
5%
to
5.75%
of the first
$75,000,000
of Revenue Interest recorded (in the case of net product sales) or received (in the case of co-promotion revenues and license fees) by the Company in a calendar year (initially
5%
and then
5.75%
after the co-promotion agreement with Astellas terminated on March 31, 2012);
|
•
|
2.5%
of the next
$75,000,000
of Revenue Interest recorded (in the case of net product sales) or received (in the case of co-promotion revenues and license fees) by the Company in a calendar year; and
|
•
|
0.5%
of Revenue Interest over and above
$150,000,000
recorded (in the case of net product sales) or received (in the case of co-promotion revenues and license fees) by the Company in a calendar year.
|
5.
|
Restructuring
|
|
Three and Six Months Ended June 30, 2013
|
||||||||||
|
Accruals
|
|
Non-cash items
|
|
Total
|
||||||
Employee-related charges
|
$
|
663
|
|
|
$
|
201
|
|
|
$
|
864
|
|
Other restructuring charges
|
12
|
|
|
—
|
|
|
12
|
|
|||
|
675
|
|
|
201
|
|
|
$
|
876
|
|
|
Employee severance costs
|
|
Other restructuring charges
|
|
Total
|
|||||||
Balance at December 31, 2012
|
$
|
—
|
|
—
|
|
$
|
—
|
|
|
$
|
—
|
|
Accruals
|
663
|
|
|
12
|
|
|
675
|
|
||||
Payments
|
(519
|
)
|
|
(10
|
)
|
|
(529
|
)
|
||||
Balance at June 30, 2013
|
144
|
|
|
2
|
|
|
$
|
146
|
|
6.
|
Common Stock Warrants
|
7.
|
Stock-Based Compensation
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||
Risk free interest rate
|
1.2%
|
|
|
0.7% to 1.0%
|
|
|
0.8% to 1.2%
|
|
|
0.2% to 1.2%
|
|
Expected term
|
5.1 to 6.0 years
|
|
|
5.0 to 6.1 years
|
|
|
5.0 to 6.1 years
|
|
|
5.0 to 6.1 years
|
|
Expected volatility
|
84.5% to 85.6%
|
|
|
81.5% to 82.8%
|
|
|
84.5% to 87.9%
|
|
|
80.6% to 82.8%
|
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Cost of sales
|
$
|
63
|
|
|
$
|
47
|
|
|
$
|
108
|
|
|
$
|
76
|
|
Research and development
|
250
|
|
|
236
|
|
|
466
|
|
|
431
|
|
||||
Selling, general and administrative
|
1,465
|
|
|
1,255
|
|
|
2,790
|
|
|
2,287
|
|
||||
Restructuring
|
201
|
|
|
—
|
|
|
201
|
|
|
—
|
|
||||
Total
|
$
|
1,979
|
|
|
$
|
1,538
|
|
|
$
|
3,565
|
|
|
$
|
2,794
|
|
•
|
our ability to maintain and increase market demand for, and sales of, Sumavel DosePro;
|
•
|
our ability to successfully execute our sales and marketing strategy for the commercialization of Sumavel DosePro;
|
•
|
the progress and timing of clinical trials for Relday and our other product candidates;
|
•
|
the potential for the FDA to approve the NDA for Zohydro ER despite the advisory committee's recommendation against approval;
|
•
|
the timing of submissions to, and decisions made by, the FDA and other regulatory agencies, including foreign regulatory agencies, and demonstrating the safety and efficacy of Zohydro ER or any other product candidates to the satisfaction of the FDA and such other agencies;
|
•
|
adverse side effects or inadequate therapeutic efficacy of Sumavel DosePro that could result in product recalls, market withdrawals or product liability claims;
|
•
|
the safety and efficacy of Zohydro ER and our other product candidates;
|
•
|
the market potential for migraine treatments, and our ability to compete within that market;
|
•
|
the goals of our development activities and estimates of the potential markets for our product candidates, and our ability to compete within those markets;
|
•
|
estimates of the capacity of manufacturing and other facilities to support our product and product candidates;
|
•
|
our ability to ensure adequate and continued supply of Sumavel DosePro to successfully meet anticipated market demand;
|
•
|
our and our licensors ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of our products and product candidates and the ability to operate our business without infringing the intellectual property rights of others;
|
•
|
our ability to obtain and maintain adequate levels of coverage and reimbursement from third-party payors for Sumavel DosePro or any of our other product candidates that may be approved for sale, the extent of such coverage and reimbursement and the willingness of third-party payors to pay for our products versus less expensive therapies;
|
•
|
the impact of healthcare reform legislation; and
|
•
|
projected cash needs and our expected future revenues, operations and expenditures.
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Research and development expenses (in thousands):
|
|
|
|
|
|
|
|
||||||||
Zohydro
|
$
|
1,422
|
|
|
$
|
4,081
|
|
|
$
|
2,015
|
|
|
$
|
7,127
|
|
Relday
|
524
|
|
|
751
|
|
|
1,279
|
|
|
2,081
|
|
||||
Sumavel DosePro
|
253
|
|
|
204
|
|
|
491
|
|
|
346
|
|
||||
Other
(1)
|
1,378
|
|
|
1,345
|
|
|
3,029
|
|
|
2,791
|
|
||||
Total
|
$
|
3,577
|
|
|
$
|
6,381
|
|
|
$
|
6,814
|
|
|
$
|
12,345
|
|
•
|
The decrease in sales and marketing expenses is primarily the result of a $0.7 million decrease in salary and bonus expense, offset by an increase in other marketing and promotional activities.
|
•
|
The increase in general and administrative expenses is primarily the result of an increase in public relations costs and an increase in professional service related costs, such as legal and accounting and advisory services.
|
•
|
The decrease in sales and marketing expenses is primarily the result of a $1.8 million decrease in co-promote service fees resulting from the termination of the Astellas co-promotion agreement on March 31, 2012, offset by an increase in other marketing and promotional activities.
|
•
|
The increase in general and administrative expenses is primarily the result of an increase in public relations costs and an increase in professional service related costs, such as legal and accounting and advisory services.
|
•
|
our $30.0 million financing agreement, or the Healthcare Royalty financing agreement, with Healthcare Royalty Partners (formerly Cowen Healthcare Royalty Partners II, LP), or Healthcare Royalty;
|
•
|
our $10.0 million revolving credit facility with Oxford Finance Corporation, or Oxford, and Silicon Valley Bank, or SVB (terminated in July 2012);
|
•
|
our $25.0 million loan and security agreement with Oxford and SVB, or the amended Oxford/SVB loan agreement (terminated in July 2012); and
|
•
|
imputed interest from the two annual tail payments to Astellas.
|
|
Six Months Ended June 30,
|
||||||
|
2013
|
|
2012
|
||||
|
(In Thousands)
|
||||||
Statement of Cash Flows Data
|
|
|
|
||||
Total cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
(24,570
|
)
|
|
$
|
(29,466
|
)
|
Investing activities
|
(798
|
)
|
|
(291
|
)
|
||
Financing activities
|
261
|
|
|
(4,794
|
)
|
||
Decrease in cash and cash equivalents
|
$
|
(25,107
|
)
|
|
$
|
(34,551
|
)
|
•
|
maintain our sales and marketing activities for Sumavel DosePro;
|
•
|
qualify secondary sources for the manufacturing of Sumavel DosePro;
|
•
|
fund our operations, fund further development of Zohydro ER, if required, Relday and any other product candidate to support potential regulatory approval of marketing applications; and
|
•
|
commercialize Zohydro ER or any of our product candidates or any products or product candidates that we may develop, in-license or otherwise acquire, if any of these product candidates receive regulatory approval.
|
•
|
the commercial success of Sumavel DosePro;
|
•
|
the timing of regulatory approval, if granted, of Zohydro ER or any other product candidates and the commercial success of any approved products;
|
•
|
the rate of progress and cost of our clinical trials and other product development programs for Relday and our other product candidates and any other product candidates that we may develop, in-license or acquire;
|
•
|
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with Sumavel DosePro, Zohydro ER, Relday and any of our other product candidates;
|
•
|
the costs and timing of completion of outsourced commercial manufacturing supply arrangements for any product candidate;
|
•
|
the costs of maintaining and expanding our sales and marketing infrastructure or establishing distribution capabilities;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the terms and timing of any additional collaborative, licensing, co-promotion or other arrangements that we may establish.
|
•
|
Mallinckrodt could unsuccessfully devote sufficient resources to the promotion of Sumavel DosePro, including by failing to develop, deploy or expand its sales force as necessary;
|
•
|
Mallinckrodt could unsuccessfully comply with applicable regulatory guidelines with respect to the promotion of Sumavel DosePro, which could result in administrative or judicially imposed sanctions, including warning letters, civil and criminal penalties, and injunctions; and
|
•
|
disputes regarding the co-promotion agreement that negatively impact or terminate the commercialization efforts of Mallinckrodt may negatively impact or prevent the generation of sufficient revenue or result in significant litigation or arbitration.
|
•
|
reliance on the third parties for regulatory compliance and quality assurance;
|
•
|
the possible breach of the manufacturing agreements by the third parties because of factors beyond our control or the insolvency of any of these third parties or other financial difficulties, labor unrest, natural disasters or other factors adversely affecting their ability to conduct their business; and
|
•
|
the possibility of termination or non-renewal of the agreements by the third parties, at a time that is costly or inconvenient for us, because of our breach of the manufacturing agreement or based on their own business priorities.
|
•
|
the FDA may not deem a product candidate safe and effective;
|
•
|
the FDA may not find the data from pre-clinical studies and clinical trials sufficient to support approval;
|
•
|
the FDA may require additional pre-clinical studies or clinical trials;
|
•
|
the FDA may not approve of our third-party manufacturers' processes and facilities; or
|
•
|
the FDA may change its approval policies or adopt new regulations.
|
•
|
obtaining regulatory authorization to commence a clinical trial;
|
•
|
reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, clinical investigators and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs, clinical investigators and trial sites;
|
•
|
manufacturing or obtaining sufficient quantities of a product candidate for use in clinical trials;
|
•
|
obtaining institutional review board, or IRB, approval to initiate and conduct a clinical trial at a prospective site;
|
•
|
identifying, recruiting and training suitable clinical investigators;
|
•
|
identifying, recruiting and enrolling subjects to participate in clinical trials for a variety of reasons, including competition from other clinical trial programs for the treatment of pain, migraine or similar indications;
|
•
|
retaining patients who have initiated a clinical trial but may be prone to withdraw due to side effects from the therapy, lack of efficacy, personal issues, or for any other reason they choose, or who are lost to further follow-up;
|
•
|
uncertainty regarding proper dosing; and
|
•
|
scheduling conflicts with participating clinicians and clinical institutions.
|
•
|
failure to design appropriate clinical trial protocols;
|
•
|
failure by us, our employees, our CROs or their employees to conduct the clinical trial in accordance with all applicable FDA, DEA or other regulatory requirements or our clinical protocols;
|
•
|
inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
|
•
|
discovery of serious or unexpected toxicities or side effects experienced by study participants or other unforeseen safety issues;
|
•
|
lack of adequate funding to continue the clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties;
|
•
|
lack of effectiveness of any product candidate during clinical trials;
|
•
|
slower than expected rates of subject recruitment and enrollment rates in clinical trials;
|
•
|
failure of our CROs or other third-party contractors to comply with all contractual requirements or to perform their services in a timely or acceptable manner;
|
•
|
inability or unwillingness of medical investigators to follow our clinical protocols; and
|
•
|
unfavorable results from on-going clinical trials and pre-clinical studies.
|
•
|
manage our internal and external commercialization efforts for Sumavel DosePro effectively while carrying out our contractual obligations to third parties and complying with all applicable laws, rules and regulations;
|
•
|
manage our internal development efforts for Zohydro ER, Relday and our other product candidates effectively while carrying out our contractual obligations to licensors, collaborators and other third parties and complying with all applicable laws, rules and regulations;
|
•
|
continue to improve our operational, financial and management controls, reporting systems and procedures; and
|
•
|
attract and retain sufficient numbers of talented employees.
|
•
|
heightening our vulnerability to downturns in our business or our industry or the general economy and restricting us from making improvements or acquisitions, or exploring business opportunities;
|
•
|
requiring a significant amount of interest payments and fixed payments on our indebtedness, therefore reducing our ability to use our available cash to fund our operations, capital expenditures and future business opportunities;
|
•
|
limiting our ability to obtain additional financing for working capital, capital expenditures, debt service requirements, acquisitions and general corporate or other purposes;
|
•
|
limiting our ability to adjust to changing market conditions and placing us at a competitive disadvantage compared to our competitors who have greater capital resources; and
|
•
|
subjecting us to financial and other restrictive covenants in our debt instruments, the failure with which to comply could result in an event of default under the applicable debt instrument that allows the lender to demand immediate repayment of the related debt.
|
•
|
others may be able to make or use compounds that are similar to the pharmaceutical compounds used in Sumavel DosePro and our product candidates but that are not covered by the claims of our patents;
|
•
|
the APIs in Sumavel DosePro and our current product candidates are, or will soon become, commercially available in generic drug products, and no patent protection will be available without regard to formulation or method of use;
|
•
|
we or our licensors, as the case may be, may not be able to detect infringement against our in-licensed patents, which may be especially difficult for manufacturing processes or formulation patents;
|
•
|
we or our licensors, as the case may be, might not have been the first to make the inventions covered by our owned or in-licensed issued patents or pending patent applications;
|
•
|
we or our licensors, as the case may be, might not have been the first to file patent applications for these inventions;
|
•
|
others may independently develop similar or alternative technologies or duplicate any of our technologies;
|
•
|
it is possible that our pending patent applications will not result in issued patents;
|
•
|
it is possible that there are dominating patents to Sumavel DosePro or our product candidates of which we are not aware;
|
•
|
it is possible that there are prior public disclosures that could invalidate our or our licensors' inventions, as the case may be, or parts of our or their inventions of which we or they are not aware;
|
•
|
it is possible that others may circumvent our owned or in-licensed patents;
|
•
|
it is possible that there are unpublished applications or patent applications maintained in secrecy that may later issue with claims covering our products or technology similar to ours;
|
•
|
the laws of foreign countries may not protect our or our licensors', as the case may be, proprietary rights to the same extent as the laws of the United States;
|
•
|
the claims of our owned or in-licensed issued patents or patent applications, if and when issued, may not cover our device or product candidates;
|
•
|
our owned or in-licensed issued patents may not provide us with any competitive advantages, or may be narrowed in scope, be held invalid or unenforceable as a result of legal challenges by third parties;
|
•
|
we may not develop additional proprietary technologies for which we can obtain patent protection; or
|
•
|
the patents of others may have an adverse effect on our business.
|
•
|
announcements concerning our and Mallinckrodt's commercial progress in promoting and selling Sumavel DosePro, including sales and revenue trends;
|
•
|
announcements concerning our NDA for Zohydro ER;
|
•
|
FDA or international regulatory actions, including results and announcements from FDA advisory committee meetings convened with respect to
hydrocodone
and whether and when we receive regulatory approval for Zohydro ER or any of our other product candidates;
|
•
|
the development status of Relday or any of our other product candidates, including the results from our clinical trials;
|
•
|
other regulatory developments, including the FDA's potential grant of regulatory exclusivity to a competitor who receives FDA approval before us for an extended-release
hydrocodone
product, which could significantly delay our ability to receive approval for Zohydro ER;
|
•
|
announcements of the introduction of new products by us or our competitors;
|
•
|
announcements concerning product development results or intellectual property rights of others;
|
•
|
announcements relating to litigation, intellectual property or our business, and the public's response to press releases or other public announcements by us or third parties;
|
•
|
variations in the level of expenses related to Zohydro ER, Relday or any of our other product candidates or clinical development programs, including relating to the timing of invoices from, and other billing practices of, our CROs and clinical trial sites;
|
•
|
market conditions or trends in the pharmaceutical sector or the economy as a whole;
|
•
|
changes in operating performance and stock market valuations of other pharmaceutical companies and price and volume fluctuations in the overall stock market;
|
•
|
litigation or public concern about the safety of Sumavel DosePro or our product candidates;
|
•
|
actual and anticipated fluctuations in our quarterly operating results;
|
•
|
the financial projections we may provide to the public, any changes in these projections or our inability to meet these projections;
|
•
|
deviations from securities analysts' estimates or the impact of other analyst comments;
|
•
|
ratings downgrades by any securities analysts who follow our common stock;
|
•
|
additions or departures of key personnel;
|
•
|
third-party payor coverage and reimbursement policies;
|
•
|
developments concerning current or future strategic collaborations, and the timing of payments we may make or receive under these arrangements;
|
•
|
developments affecting our contract manufacturers, component fabricators and service providers;
|
•
|
the development and sustainability of an active trading market for our common stock;
|
•
|
future sales of our common stock by our officers, directors and significant stockholders;
|
•
|
other events or factors, including those resulting from war, incidents of terrorism, natural disasters, security breaches, system failures or responses to these events;
|
•
|
changes in accounting principles; and
|
•
|
discussion of us or our stock price by the financial and scientific press and in online investor communities.
|
Exhibit
Number
|
|
Description
|
3.1(2)
|
|
Fifth Amended and Restated Certificate of Incorporation of the Registrant
|
|
|
|
3.2
|
|
Certificate of Amendment of Fifth Amended and Restated Certificate of Incorporation of the Registrant
|
|
|
|
3.3(2)
|
|
Amended and Restated Bylaws of the Registrant
|
|
|
|
4.1(3)
|
|
Form of the Registrant’s Common Stock Certificate
|
|
|
|
4.2(1)
|
|
Third Amended and Restated Investors’ Rights Agreement dated December 2, 2009
|
|
|
|
4.3(1)
|
|
Amendment to Third Amended and Restated Investors’ Rights Agreement dated as of July 1, 2010
|
|
|
|
4.4(4)
|
|
Second Amendment to Third Amended and Restated Investors’ Rights Agreement dated June 30, 2011
|
|
|
|
4.5(1)
|
|
Warrant dated March 5, 2007 issued by the Registrant to General Electric Capital Corporation
|
|
|
|
4.6(1)
|
|
Warrant dated June 30, 2008 issued by the Registrant to Oxford Finance Corporation
|
|
|
|
4.7(1)
|
|
Warrant dated June 30, 2008 issued by the Registrant to CIT Healthcare LLC (subsequently transferred to The CIT Group/Equity Investments, Inc.)
|
|
|
|
4.8(1)
|
|
Transfer of Warrant dated March 24, 2009 from CIT Healthcare LLC to The CIT Group/Equity Investments, Inc.
|
|
|
|
4.9(1)
|
|
Warrant dated July 1, 2010 issued by the Registrant to Oxford Finance Corporation
|
|
|
|
4.10(1)
|
|
Warrant dated July 1, 2010 issued by the Registrant to Silicon Valley Bank
|
|
|
|
4.11(4)
|
|
Warrant dated June 30, 2011 issued by the Registrant to Oxford Finance LLC
|
|
|
|
4.12(4)
|
|
Warrant dated June 30, 2011 issued by the Registrant to Silicon Valley Bank
|
|
|
|
4.13(4)
|
|
Warrant dated July 18, 2011 issued by the Registrant to Healthcare Royalty Partners (formerly Cowen Healthcare Royalty Partners II, L.P.)
|
|
|
|
10.1
|
|
Form of Restricted Stock Unit Award Agreement under the 2012 Equity Incentive Award Plan
|
|
|
|
10.2†
|
|
Co-promotion Agreement dated June 27, 2013, by and between the Registrant and Valeant Pharmaceuticals North America LLC
|
|
|
|
10.3
|
|
Agreement to Termination of Agreements dated August 5, 2013, by and between the Registrant and Desitin Arzneimittel GmbH
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Section 302 of the Public Company Accounting Reform and Investor Protection Act of 2002 (18 U.S.C. §1350, as adopted)
|
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Section 302 of the Public Company Accounting Reform and Investor Protection Act of 2002 (18 U.S.C. §1350, as adopted)
|
|
|
|
32.1*
|
|
Certification of Chief Executive Officer pursuant to Section 906 of the Public Company Accounting Reform and Investor Protection Act of 2002 (18 U.S.C. §1350, as adopted)
|
|
|
|
32.2*
|
|
Certification of Chief Financial Officer pursuant to Section 906 of the Public Company Accounting Reform and Investor Protection Act of 2002 (18 U.S.C. §1350, as adopted)
|
|
|
|
101
|
|
The following financial statements from the Registrant’s Quarterly Report on form 10-Q for the period ended June 30, 2013, formatted in XBRL: (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations and Comprehensive Loss, (iii) Consolidated Statements of Cash Flows, and (iv) the Notes to Consolidated Financial Statements.
|
(1)
|
Filed with the Registrant’s Registration Statement on Form S-1 on September 3, 2010.
|
(2)
|
Filed with Amendment No. 2 to Registrant’s Registration Statement on Form S-1 on October 27, 2010.
|
(3)
|
Filed with Amendment No. 3 to the Registrant’s Registration Statement on Form S-1 on November 4, 2010.
|
(4)
|
Filed with the Registrant’s Quarterly Report on Form 10-Q on August 11, 2011.
|
*
|
These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not subject to the liability of that section. These certifications are not to be incorporated by reference into any filing of Zogenix, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.
|
|
|
|
|
|
ZOGENIX, INC.
|
|
|
|
Date: August 8, 2013
|
By:
|
/s/ Roger L. Hawley
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
Date: August 8, 2013
|
By:
|
/s/ Ann D. Rhoads
|
|
|
Executive Vice President, Chief Financial Officer, Treasurer and Secretary
|
|
|
(Principal Financial and Accounting Officer)
|
Participant:
|
|
Grant Date:
|
June 18, 2013
|
Total Number of RSUs:
|
|
Distribution Schedule:
|
Subject to the terms of the Restricted Stock Unit Agreement, the RSUs shall be distributable in accordance with Section 2.1 of the Restricted Stock Unit Agreement.
|
Vesting Schedule:
|
Subject to the terms of the Restricted Stock Unit Agreement, the Award shall vest on June 1, 2014, subject to Participant’s continued status as an Employee of or Consultant to the Company or any Subsidiary on the applicable vesting date. In addition, the RSUs shall vest upon the occurrence of a Change in Control.
|
|
|
1.
|
Definitions.
|
2.
|
Grants and Obligations
.
|
3.
|
Joint Commercialization Committee
.
|
5.
|
Compensation
.
|
6.
|
Regulatory Affairs
.
|
7.
|
Supply and Distribution
.
|
8.
|
Representations and Warranties
.
|
9.
|
Intellectual Property Matters
.
|
10.
|
Indemnification and Insurance
.
|
11.
|
Confidentiality; Publicity
.
|
12.
|
Maintenance of Books and Records; Audits.
|
13.
|
Term and Termination
.
|
7.
|
Notices
.
|
8.
|
Miscellaneous
.
|
ZOGENIX, INC.
By: /s/ Roger L. Hawley
Name: Roger L. Hawley
Title: Chief Executive Officer
|
VALEANT PHARMACEUTICALS NORTH AMERICA LLC
By:
/s/ Hemanth Varghese
Name: Hemanth Varghese
Title: Sr. Vice President Corporate Development
|
Profit Share Calc
|
Month A
|
Defined Terms
|
TRx-Unit Conversion Rate
|
[***]
|
|
|
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
Total
|
[***]
|
[***]
|
|
|
|
Baseline
|
[***]
|
Baseline Forecast (Or Adjusted Baseline Forecast)
|
Above baseline
|
[***]
|
|
Threshold
|
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
|
|
|
|
|
Valeant Net Sales
|
$
[***]
|
Net Sales
|
[***]
|
[***]
|
Units
|
[***]
|
$
[***]
|
[***]
|
|
|
|
Applicable Net Sales
|
$
[***]
|
Zogenix Net Sales
|
Zogenix
|
$ [***]
|
Zogenix Service Fee
|
[***]
|
$
[***]
|
[***]
|
[***]
|
$
[***]
|
[***]
|
|
|
|
Valeant
|
$
[***]
|
|
[***]
|
|
|
|
|
[***]
|
[***]
|
|
|
|
Product
|
Form
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
-
|
The Parties have entered into a Licensing and Distribution Agreement (the “
License Agreement
”) signed on March 14, 2008 covering the development and commercialization of the
Product
in the
Territory
.
|
-
|
The Parties have entered into a Manufacturing Agreement (the “
Manufacturing Agreement
”) signed on January 21, 2011 covering the manufacturing and supply of the
Product
for commercialization in the
Territory
.
|
-
|
DESITIN holds Marketing Authorisations for the
Product
in Germany, Denmark, UK, France, Norway and Sweden.
|
-
|
DESITIN commercializes the
Product
in Germany and Denmark (as Sumavel® DosePro®). The
Product
has never been launched in UK, France, Norway and Sweden.
|
-
|
DESITIN will stop commercialization of the
Product
in Germany and Denmark on September 30, 2013.
|
1.
|
The
License Agreement
between the Parties will terminate, effective October 1, 2013.
|
2.
|
Following termination of the License Agreement, DESITIN will maintain each then-existing Marketing Authorisations of the
Product
in good standing until the earlier of the expiration of such Marketing Authorisation(s) or March 31, 2014. ZOGENIX acknowledges that the Marketing Authorisations for the United Kingdom and Sweden are expected to expire in December 2013, and for France and Norway in February 2014 unless the
Product
is commercialized by ZOGENIX (or a ZOGENIX
Affiliate
) or a Third Party prior to their expiry. All costs related for maintaining the Marketing Authorizations in 2014 will be borne by ZOGENIX.
|
3.
|
Upon written request by ZOGENIX, DESITIN will transfer one or more of the Marketing Authorisations of the
Product
to ZOGENIX, a ZOGENIX
Affiliate
or a Third Party qualified to hold Marketing Authorizations in Europe as indicated by ZOGENIX.
|
4.
|
If no company or other legal entity is indicated by ZOGENIX for transfer of a Marketing Authorisation, DESITIN will renounce the applicable Marketing Authorisation of the
Product
on March 31, 2014. DESITIN will promptly provide ZOGENIX with a copy of any documentation filed with the Regulatory Authorities in connection with any renouncing of the Marketing Authorisations.
|
5.
|
Notwithstanding clause 6.1 of the
Manufacturing Agreement
, the
Manufacturing Agreement
between the Parties will terminate on October 1, 2013.
|
6.
|
The agreement on pharmacovigilance (Drug Safety Agreement) between the Parties will be amended in order to reflect the termination of commercialization and transfer/renouncement of Marketing Authorisations.
|
7.
|
For the avoidance of doubt, the “Consequences of Termination” described in clause
21 of the
License Agreement
and the “Effect of Expiration and Termination” described in clause 6.2 of the
Manufacturing Agreement
will remain effective (including without limitation, DESITIN’s agreement to refrain from using the trademarks associated with the Product following termination of the License Agreement).
|
8.
|
The Quality Agreement will terminate on December 31, 2014, which corresponds to the expiry date of the drug product batches recently released to the market in the territories by Desitin plus one additional year.
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Zogenix, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Roger L. Hawley
|
Roger L. Hawley
|
Chief Executive Officer
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Zogenix, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
/s/ Ann D. Rhoads
|
Ann D. Rhoads
|
Chief Financial Officer
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Roger L. Hawley
|
Roger L. Hawley
|
Chief Executive Officer
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Ann D. Rhoads
|
Ann D. Rhoads
|
Chief Financial Officer
|