e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2007
OR
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o |
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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 0-23837
SurModics, Inc.
(Exact name of registrant as specified in its Charter)
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MINNESOTA
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41-1356149 |
(State of incorporation)
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(I.R.S. Employer Identification No.) |
9924 West 74th Street
Eden Prairie, Minnesota 55344
(Address of principal executive offices)
Registrants telephone number, including area code: (952) 829-2700
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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule
12b-2).
Yes o No þ
The number of shares of the registrants Common Stock, $.05 par value per share, outstanding as of
July 31, 2007 was 17,995,294.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
SURMODICS, INC.
Condensed Balance Sheets
(In thousands, except share data)
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June 30, |
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September 30, |
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2007 |
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2006 |
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(unaudited) |
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ASSETS |
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Current Assets |
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Cash and cash equivalents |
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$ |
3,960 |
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$ |
3,751 |
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Short-term investments |
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42,343 |
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55,062 |
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Accounts receivable, net |
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30,460 |
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14,493 |
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Inventories |
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1,259 |
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952 |
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Deferred tax asset |
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496 |
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435 |
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Income tax receivable |
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483 |
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Prepaids and other |
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1,754 |
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1,403 |
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Total current assets |
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80,755 |
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76,096 |
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Property and equipment, net |
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11,447 |
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11,686 |
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Long-term investments |
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47,785 |
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47,758 |
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Deferred tax asset |
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3,268 |
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4,883 |
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Other assets, net |
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21,603 |
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16,979 |
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Total Assets |
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$ |
164,858 |
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$ |
157,402 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities |
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Accounts payable |
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$ |
1,013 |
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$ |
963 |
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Accrued liabilities |
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1,470 |
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2,880 |
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Accrued income taxes payable |
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1,910 |
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Deferred revenue |
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3,654 |
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2,236 |
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Other current liabilities |
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1,000 |
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1,000 |
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Total current liabilities |
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7,137 |
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8,989 |
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Deferred revenue, less current portion |
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20,175 |
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2,210 |
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Other long-term liabilities |
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1,000 |
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Total Liabilities |
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27,312 |
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12,199 |
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Commitments and contingencies (Note 11) |
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Stockholders Equity |
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Series A Preferred stock-
$.05 par value, 450,000 shares authorized;
no shares issued and outstanding |
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Common stock-
$.05 par value, 45,000,000 shares authorized;
17,979,280 and 18,830,455 shares issued and outstanding |
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899 |
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942 |
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Additional paid-in capital |
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68,728 |
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96,281 |
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Accumulated other comprehensive income (loss) |
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2,393 |
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(293 |
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Retained earnings |
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65,526 |
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48,273 |
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Total Stockholders Equity |
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137,546 |
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145,203 |
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Total Liabilities and Stockholders Equity |
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$ |
164,858 |
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$ |
157,402 |
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The accompanying notes are an integral part of these unaudited condensed financial statements.
2
Item 1. Financial Statements
SURMODICS, INC.
Condensed Statements of Income
(In thousands, except per share data)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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June 30 |
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June 30 |
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2007 |
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2006 |
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2007 |
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2006 |
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Revenue |
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Royalties and license fees |
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$ |
13,416 |
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$ |
13,948 |
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$ |
39,664 |
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$ |
39,514 |
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Product sales |
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2,947 |
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2,659 |
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9,054 |
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7,914 |
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Research and development |
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1,399 |
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1,532 |
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3,147 |
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4,883 |
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Total revenue |
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17,762 |
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18,139 |
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51,865 |
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52,311 |
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Operating costs and expenses |
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Product |
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1,217 |
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891 |
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3,396 |
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2,441 |
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Research and development |
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6,200 |
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5,281 |
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17,124 |
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14,935 |
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Sales and marketing |
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343 |
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348 |
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989 |
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1,052 |
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General and administrative |
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2,484 |
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2,156 |
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6,644 |
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6,887 |
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Total operating costs and expenses |
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10,244 |
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8,676 |
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28,153 |
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25,315 |
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Income from operations |
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7,518 |
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9,463 |
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23,712 |
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26,996 |
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Other income |
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Investment income |
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1,211 |
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1,113 |
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3,731 |
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2,894 |
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Impairment loss |
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(4,651 |
) |
Other loss |
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(10 |
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(11 |
) |
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(29 |
) |
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(112 |
) |
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Other income (loss) |
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1,201 |
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1,102 |
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3,702 |
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(1,869 |
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Income before income taxes |
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8,719 |
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10,565 |
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27,414 |
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25,127 |
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Income tax provision |
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(3,132 |
) |
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(4,207 |
) |
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(10,161 |
) |
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(11,087 |
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Net income |
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$ |
5,587 |
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$ |
6,358 |
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$ |
17,253 |
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$ |
14,040 |
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Basic net income per share |
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$ |
0.31 |
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$ |
0.34 |
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$ |
0.95 |
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$ |
0.76 |
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Diluted net income per share |
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$ |
0.31 |
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$ |
0.34 |
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$ |
0.95 |
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$ |
0.75 |
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Weighted average shares outstanding |
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Basic |
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17,815 |
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18,570 |
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18,116 |
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18,494 |
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Dilutive effect of outstanding stock options |
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153 |
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155 |
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133 |
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187 |
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Diluted |
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17,968 |
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18,725 |
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18,249 |
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18,681 |
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The accompanying notes are an integral part of these unaudited condensed financial statements.
3
SURMODICS, INC.
Condensed Statements of Cash Flows
(In thousands)
(unaudited)
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Nine months ended |
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June 30, |
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2007 |
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2006 |
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Operating Activities |
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Net income |
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$ |
17,253 |
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$ |
14,040 |
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Adjustments to reconcile net income to net cash provided by
operating activities- |
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Depreciation and amortization |
|
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2,923 |
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2,726 |
|
Loss on equity method investment and sales of investments |
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29 |
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|
112 |
|
Amortization of discount on investments |
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(1,354 |
) |
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(941 |
) |
Noncash compensation |
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5,035 |
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4,358 |
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Tax benefit from exercise of stock options |
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(116 |
) |
Impairment loss |
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|
|
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|
4,651 |
|
Deferred taxes |
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|
(106 |
) |
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|
(758 |
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Other |
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24 |
|
Loss on disposals of property and equipment |
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|
370 |
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|
83 |
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Change in operating assets and liabilities: |
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Accounts receivable |
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4,033 |
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(866 |
) |
Inventories |
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(307 |
) |
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(24 |
) |
Accounts payable and accrued liabilities |
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(701 |
) |
|
|
(789 |
) |
Income taxes |
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(2,393 |
) |
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|
4,574 |
|
Deferred revenue |
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(683 |
) |
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(120 |
) |
Prepaids and other |
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(502 |
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120 |
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Net cash provided by operating activities |
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23,597 |
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27,074 |
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Investing Activities |
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Purchases of property and equipment |
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(2,054 |
) |
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(5,300 |
) |
Proceeds from sales of property and equipment |
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36 |
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|
0 |
|
Purchases of available-for-sale investments |
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(131,971 |
) |
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(135,609 |
) |
Sales/maturities of available-for-sale investments |
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146,208 |
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|
110,357 |
|
Purchase of licenses and patents |
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(1,224 |
) |
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(906 |
) |
Purchase of equity in OctoPlus, Novocell and other |
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(2,147 |
) |
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(160 |
) |
Repayment of notes receivable |
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|
395 |
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Net cash provided by (used in) investing activities |
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9,243 |
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(31,618 |
) |
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Financing Activities |
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Tax benefit from exercise of stock options |
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|
116 |
|
Issuance of common stock |
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|
2,399 |
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2,377 |
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Repurchase of common stock |
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(35,030 |
) |
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Net cash (used in) provided by financing activities |
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(32,631 |
) |
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|
2,493 |
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Net change in cash and cash equivalents |
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|
209 |
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(2,051 |
) |
|
|
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Cash and Cash Equivalents |
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|
|
|
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|
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|
Beginning of period |
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|
3,751 |
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|
|
3,921 |
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|
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End of period |
|
$ |
3,960 |
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|
$ |
1,870 |
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|
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|
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Cash paid for income taxes |
|
$ |
12,606 |
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|
$ |
7,365 |
|
Noncash transaction-acquisition of property, plant, and equipment on account |
|
$ |
330 |
|
|
$ |
1,043 |
|
Accrual of deferred Merck license revenue |
|
$ |
20,000 |
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed financial statements.
4
SURMODICS, INC.
Notes to Condensed Financial Statements
Period Ended June 30, 2007
(Unaudited)
(1) Basis of Presentation
In the opinion of management, the accompanying unaudited condensed financial statements have
been prepared in accordance with accounting principles generally accepted in the United States of
America and reflect all adjustments, consisting solely of normal recurring adjustments, needed to
fairly present the financial results for the interim periods presented. These financial statements
include some amounts that are based on managements best estimates and judgments. These estimates
may be adjusted as more information becomes available, and any adjustment could be significant.
The impact of any change in estimates is included in the determination of earnings in the period in
which the change in estimate is identified. The results of operations for the three month period
ended June 30, 2007 are not necessarily indicative of the results that may be expected for the
entire 2007 fiscal year.
In accordance with the rules and regulations of the United States Securities and Exchange
Commission, the Company has omitted footnote disclosures that would substantially duplicate the
disclosures contained in the audited financial statements of the Company. These unaudited
condensed financial statements should be read together with the audited financial statements for
the year ended September 30, 2006, and footnotes thereto included in the Companys Form 10-K as
filed with the United States Securities and Exchange Commission on December 14, 2006.
(2) New Accounting Pronouncements
On July 13, 2006, Financial Accounting Standards Board (FASB) Interpretation (FIN) No. 48,
Accounting for Uncertainty in Income Taxes - an Interpretation of FASB Statement No. 109, was
issued. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an
enterprises financial statements in accordance with FASB Statement No. 109, Accounting for Income
Taxes. FIN 48 also prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to be taken in a tax
return. The new FASB standard also provides guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosure, and transition. The provisions of FIN 48 are
effective for the Company in fiscal 2008. The Company is currently evaluating the effect that the
adoption of FIN 48 will have on its results of operations and financial condition.
In September 2006, FASB issued Statement of Financial Accounting Standards (SFAS) No. 157
(SFAS No. 157), Fair Value Measurements. This statement establishes a consistent framework for
measuring fair value and expands disclosures on fair value measurements. SFAS No. 157 is effective
for the Company starting in fiscal 2008. We have not determined the impact, if any, the adoption
of this statement will have on our consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities (SFAS No. 159). SFAS No. 159 permits entities to choose to measure many
financial assets and financial liabilities at fair value. Unrealized gains and losses on items for
which the fair value option has been elected will be reported in earnings. SFAS No. 159 is
effective for the Company in fiscal 2009. We are currently evaluating the impact of SFAS No. 159 on
our consolidated financial position and results of operations.
5
(3) Other Assets
Other assets consist principally of investments in marketable securities, a note receivable
and acquired patents. The balance in other assets increased primarily as a result of an additional
investment in OctoPlus N.V. and the increased market value of OctoPlus during the year. In October
2006, we made an additional investment of $1.9 million in OctoPlus, a company based in the
Netherlands active in the development of pharmaceutical formulations incorporating novel
biodegradable polymers. Also in October 2006, OctoPlus common stock began trading on an
international exchange following an initial public offering of its common stock. With a readily
determinable fair market value, the Company now treats the investment in OctoPlus as an
available-for-sale investment rather than a cost method investment. Available-for-sale investments
are reported at fair value with unrealized gains and losses excluded from operations and reported
as a separate component of stockholders equity, except for other-than-temporary impairments, which
are reported as a charge to current operations and result in a new cost basis for the investment.
Our investment in OctoPlus represents an ownership interest of less than 20%.
In September 2005, we entered into an agreement to sell a contract manufacturing facility and
27 acres of land located in Bloomington, Minnesota. The terms of the sale agreement included a
$100,000 cash down payment and a note receivable of $6.9 million, which is collateralized by the
property. The terms of the note call for monthly installment payments of principal and interest at
6% with the remaining amount due and payable in September 2010. The $5.3 million balance in other
assets represents the long-term portion due on the note.
On July 10, 2007, we made a $3.5 million equity investment in Paragon Intellectual Properties,
LLC and its wholly owned subsidiary Apollo Therapeutics, LLC. In addition to the equity
investment, we entered into a licensing agreement with Apollo Therapeutics, LLC whereby we will
provide coating technology. See Note 12.
The Company recorded amortization expense of $443,000 and $1.3 million for the three and nine
months ended June 30, 2007, respectively. We expect to incur approximately $1.8 million of
amortization each year in fiscal years 2007 and 2008, $503,000 in fiscal 2009, and $85,000 in
fiscal years 2010 through 2012. Management does not believe an other-than-temporary impairment
existed as of June 30, 2007, with respect to its existing investments. Other assets consisted of
the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
September 30, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
Abbott license |
|
$ |
7,037 |
|
|
$ |
7,037 |
|
Note receivable (long-term portion) |
|
|
5,280 |
|
|
|
5,635 |
|
Investment in Novocell |
|
|
559 |
|
|
|
559 |
|
Investment in OctoPlus |
|
|
10,331 |
|
|
|
4,095 |
|
Investment in ThermopeutiX |
|
|
1,185 |
|
|
|
1,000 |
|
Patents and other |
|
|
2,051 |
|
|
|
2,262 |
|
Less-accumulated amortization |
|
|
(4,840 |
) |
|
|
(3,609 |
) |
|
|
|
|
|
|
|
Other assets, net |
|
$ |
21,603 |
|
|
$ |
16,979 |
|
|
|
|
|
|
|
|
(4) Accounts Receivable
Accounts receivable at June 30, 2007 includes a $20 million up front licensing fee due from
Merck & Co., Inc. (Merck). Merck paid the licensing fee on July 20, 2007. See Note 10.
6
(5) Inventories
Inventories are stated at the lower of cost or market using the specific identification method
and include direct labor, materials and overhead. Inventories consisted of the following
components:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
September 30, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
Raw materials |
|
$ |
642 |
|
|
$ |
512 |
|
Finished goods |
|
|
617 |
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
$ |
1,259 |
|
|
$ |
952 |
|
|
|
|
|
|
|
|
(6) Operating Segments
Operating segments are defined as components of an enterprise about which separate financial
information is available that is evaluated regularly by the chief operating decision maker, or
decision making group, in deciding how to allocate resources and in assessing performance.
SurModics manages its business on the basis of the operating segments noted in the table
below, which are composed of the Companys six business units. The three operating segments are
aggregated into one reportable segment. The Drug Delivery operating segment contains: (1) the
Drug Delivery business unit and (2) the Ophthalmology division. The Hydrophilic and Other
operating segment consists of three business units: (1) Hydrophilic Technologies, (2) Regenerative
Technologies, and (3) Orthopedics. The In Vitro operating segment contains the In Vitro
Technologies (formerly Diagnostics and Drug Discovery) business unit. Each operating segment has
similar economic characteristics, technology, manufacturing processes, customers, regulatory
environments, and shared infrastructures. The Company manages its expenses on a company-wide basis,
as many costs and activities are shared among the business units and a majority of the Companys
employees reside in shared resource units. The focus of the business units is to provide solutions
to customers and maximizing revenue over the long-term. The accounting policies for segment
reporting are the same as for the Company as a whole. The table below presents revenue from the
three operating segments.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Operating segment: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
$ |
5,772 |
|
|
$ |
8,647 |
|
|
$ |
18,607 |
|
|
$ |
25,580 |
|
Hydrophilic and Other |
|
|
6,897 |
|
|
|
5,522 |
|
|
|
18,720 |
|
|
|
15,988 |
|
In Vitro |
|
|
5,093 |
|
|
|
3,970 |
|
|
|
14,538 |
|
|
|
10,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
17,762 |
|
|
$ |
18,139 |
|
|
$ |
51,865 |
|
|
$ |
52,311 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7) Stock-based Compensation
Commencing October 1, 2005, the Company adopted Statement of Financial Accounting Standards
No. 123(R), Share Based Payment (SFAS 123(R)), which requires all share-based payments,
including grants of stock options, to be recognized in the income statement as an operating
expense, based on their fair values, over the requisite service period. The Company recorded $2.2
million and $5.0 million of related compensation expense, before taxes, for the three and nine
months ended June 30, 2007, respectively. The Company recorded $1.6 million and $4.4 million of
related compensation expense, before taxes, for the three and nine months ended June 30, 2006,
respectively.
7
The Company uses the Black-Scholes option pricing model to determine the weighted average fair
value of options. The weighted average fair value of options granted during the three month periods
ended June 30, 2007 and 2006 were $16.41 and $14.37, respectively. The fair market value of each
option is estimated on the date of grant using the Black-Scholes option pricing model with the
following weighted-average assumptions for the three months ended June 30, 2007 and June 30, 2006,
respectively: risk-free interest rates of 4.61% and 5.04%; expected lives of 5.0 years and 4.6
years; and expected volatility of 41% and 42%. The weighted average fair value of options granted
during the nine month periods ended June 30, 2007 and 2006 were $16.55 and $17.55, respectively.
The following weighted-average assumptions were used for the nine months ended June 30, 2007 and
June 30, 2006, respectively: risk-free interest rates of 4.64% and 4.67%; expected lives of 5.7
years and 4.9 years; and expected volatility of 49% and 48%.
The Companys Incentive Stock Options (ISO) are granted at a price of at least 100% of the
fair market value of the Common Stock on the date of the grant or 110% with respect to optionees
who own more than 10% of the total combined voting power of all classes of stock. Options generally
expire in seven years or upon termination of employment and are exercisable at a rate of 20% per
year commencing one year after the date of grant. Nonqualified stock options are also granted at
fair market value on the date of grant. Options generally expire in 3 to 10 years and are
exercisable at rates of 20% per year from the date of grant or 20% to 33% per year commencing one
year after the date of grant.
Restricted Stock Awards
The Company has entered into restricted stock agreements with certain key employees, covering
the issuance of Common Stock (Restricted Stock). The Restricted Stock will be released to the key
employees if they are employed by the Company at the end of the vesting period. Compensation has
been recognized for the estimated fair value of the 148,664 unvested common shares and is being
charged to income over the vesting term. Stock compensation expense recognized related to these
awards totaled $292,000 and $324,000 during the three month periods ended June 30, 2007 and 2006,
respectively. Stock compensation expense recognized related to these awards totaled $848,000 and
$648,000 during the nine month periods ended June 30, 2007 and 2006, respectively.
Performance Share Awards
The Company has entered into Performance Share agreements with certain key employees, covering
the issuance of Common Stock (Performance Shares). The Performance Shares will vest upon the
achievement of all or a portion of certain performance objectives which must be achieved during the
performance period. Stock compensation expense related to the Performance Share awards expected to
vest totaled $667,000 and $183,000 during the three month periods ended June 30, 2007 and 2006,
respectively. Stock compensation expense related to these awards totaled $805,000 and $540,000
during the nine month periods ended June 30, 2007 and 2006, respectively.
1999 Employee Stock Purchase Plan
Under the 1999 Employee Stock Purchase Plan (Stock Purchase Plan) the Company is authorized
to issue up to 200,000 shares of Common Stock. All full-time and part-time employees can choose to
have up to 10% of their annual compensation withheld to purchase the Companys Common Stock at
purchase prices defined within the provisions of the Stock Purchase Plan. As of June 30, 2007,
there was approximately $184,000 of employee contributions included in accrued liabilities in the
accompanying balance sheets. Stock compensation
8
expense
recognized related to Stock Purchase Plan totaled $38,000 and $40,000 during the three month periods ended June 30, 2007 and 2006,
respectively and totaled $118,000 and $123,000 during the nine month periods ended June 30, 2007
and 2006, respectively.
(8) Comprehensive Income
The components of comprehensive income are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net income |
|
$ |
5,587 |
|
|
$ |
6,358 |
|
|
$ |
17,253 |
|
|
$ |
14,040 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized holding gains (losses) on
available-for-sale securities arising
during the period, net of tax |
|
|
(173 |
) |
|
|
(90 |
) |
|
|
2,668 |
|
|
|
(359 |
) |
Add reclassification adjustment
for realized losses included in net
income, net of tax |
|
|
6 |
|
|
|
7 |
|
|
|
18 |
|
|
|
70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss) |
|
|
(167 |
) |
|
|
(83 |
) |
|
|
2,686 |
|
|
|
(289 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
5,420 |
|
|
$ |
6,275 |
|
|
$ |
19,939 |
|
|
$ |
13,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9) Share Repurchases
In September 2006, the Board of Directors of the Company authorized the repurchase of $35
million and up to 1 million shares of SurModics common stock. In January 2007, the authorization
was amended to provide for repurchases up to an aggregate cost not to exceed $35 million without
restriction as to the number of shares repurchased. During the nine months ended June 30, 2007,
the Company repurchased a total of 1,007,752 shares for $35 million at an average price of $34.76
per share. By the end of second quarter of fiscal 2007, the Company had purchased all the shares
authorized under the repurchase program approved in September 2006 and amended in January 2007.
(10) Arrangement with Merck & Co., Inc.
On June 27, 2007 the Company announced a license and research collaboration agreement with
Merck. The agreement calls for SurModics and Merck to pursue the joint development and
commercialization of SurModics I-vation sustained drug delivery system with TA (Triamcinolone
acetonide) and other products combining certain of Mercks proprietary drug compounds and the
I-vation system for the treatment of serious retinal diseases. Under the terms of the agreement,
Merck will lead and fund development and commercialization activities. SurModics received an up
front licensing fee of $20 million and will be eligible to receive up to an additional $288 million
in fees and development milestones. In addition Merck will reimburse SurModics for its development
activities, and the Company will be responsible for the manufacture and supply of the jointly
developed products. The Company will also receive royalties on product sales. The $20 million up
front license fee was reported in accounts receivable and deferred revenue as of June 30, 2007.
The Company will recognize the revenue from the up-front license fee over the life of the Merck
agreement. SurModics received the $20 million license fee payment on July 20, 2007.
9
(11) Commitments and Contingencies
On May 22, 2007, the former Stockholders of InnoRx (the Plaintiffs) filed a declaratory
judgment action (the Declaratory Judgment) in the U.S. District Court for the Southern District
of Alabama against Michael Cooney, M.D. (Dr. Cooney) of New York, New York. In the litigation,
the Plaintiffs are seeking a determination that Dr. Cooney was not a co-founder of InnoRx, and
further that he was not an inventor of certain patent rights covering technology for delivering
drugs to the eye, including certain patent rights exclusively licensed by the Johns Hopkins
University to InnoRx (collectively, the Patent Rights), and now controlled by the Company as
successor-in-interest to InnoRx pursuant to an agreement of merger between the Company and InnoRx
made effective on January 18, 2005 (the Merger Agreement). The Company is not a party to the
litigation.
On June 8, 2007, the Company was named as a defendant in litigation filed in the U.S. District
Court for the District of Minnesota by Dr. Cooney. JHU and certain former shareholders of InnoRx,
among others, were also named as defendants. The complaint alleges that Dr. Cooney was a
co-founder of InnoRx and an inventor of subject matter claimed in the Patent Rights. The complaint
seeks an order correcting inventorship, and certain unspecified damages (including punitive
damages) based on claims of unjust enrichment, fraud, and breach of fiduciary duties. A trial has
not yet been scheduled. Pursuant to the Merger Agreement, the Company has submitted a demand for
indemnification of losses (including without limitation, damages, expenses and costs) incurred as a
result of the litigation involving Dr. Cooney, including both the Alabama and Minnesota cases
described above.
On June 18, 2007, the Company was named as an involuntary plaintiff in patent litigation between
Abbott Laboratories (Abbott) and Church & Dwight, Inc. (Church & Dwight). In the litigation,
Abbott is alleging that certain of Church & Dwights products utilizing lateral flow technology for
diagnostic purposes infringe certain of the Companys patents that have been exclusively licensed
to Abbott under the terms of a license agreement between the Company and Abbott dated May 30, 1989,
as amended and restated (the License Agreement). The suit was filed in the U.S. District Court
for the Northern District of Illinois seeking a finding of infringement, monetary damages and
injunctive relief. Pursuant to the terms of the License Agreement, Abbott is responsible for
reimbursing the Company for at least a portion of its costs and fees incurred in connection with
the suit. A trial has not yet been scheduled.
(12) Subsequent Events
On July 10, 2007 the Company announced its equity investment in Paragon Intellectual
Properties, LLC (Paragon) and an equity investment in Apollo Therapeutics, LLC (Apollo), a
Paragon subsidiary. The Paragon and Apollo investments totaled $3.5 million. The arrangement
calls for SurModics to invest additional equity totaling $2.5 million upon successful
completion of specified development milestones. The investment in Paragon represents an ownership
interest of less than 20% and the investment in Apollo represents an ownership interest of less
than 20%.
On July 31, 2007 the Company entered into a stock purchase agreement with Southern Research
Institute whereby it acquired 100% of the capital stock of Brookwood Pharmaceuticals, Inc.
(Brookwood) held by Southern Research Institute for $40 million in cash on the closing date and
up to an additional $22 million in cash upon the successful achievement of specified milestones.
Brookwood is a drug delivery company based in Birmingham, Alabama that provides proprietary polymer
based technologies to companies developing pharmaceutical products. The Company is evaluating the
purchase price allocation and expects to write off a portion of the purchase price as purchased research and development in its
fourth quarter of fiscal 2007. Brookwood, a wholly owned subsidiary of SurModics, will operate as
a separate business unit.
10
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
Overview
SurModics is a leading provider of surface modification and drug delivery technologies to the
healthcare industry. The Company is organized into three operating segments composed of six
technology-centered and industry-focused business units. The Drug Delivery operating segment
contains: (1) the Drug Delivery business unit, which is responsible for technologies dedicated to
site-specific delivery of drugs, and (2) the Ophthalmology division, which is dedicated to the
advancement of treatments for eye diseases, such as age-related macular degeneration (AMD) and
diabetic macular edema (DME), two of the leading causes of blindness. The Hydrophilic and Other
operating segment consists of three business units: (1) Hydrophilic Technologies business unit,
which focuses on enhancing medical devices with advanced lubricious coatings that facilitate their
placement and maneuverability in the body; (2) Regenerative Technologies business unit, which is
developing platforms intended to augment or replace tissue/organ function (e.g., cell encapsulation
applications), or to modify medical devices to facilitate tissue/organ recovery through natural
repair mechanisms (e.g., biocompatible or prohealing coatings); and (3) Orthopedics business unit,
which is committed to innovative solutions for orthopedics patients using proven SurModics
technologies, and creating new technology solutions to existing patient care gaps in the
orthopedics field. The In Vitro operating segment contains the In Vitro Technologies (formerly
Diagnostics and Drug Discovery) business unit, which includes our genomics slide technologies, our
stabilization and antigen products for immunoassay diagnostic tests, our in vitro diagnostic format
technology and our synthetic cell culture products.
Revenue in each of our operating segments is derived from three primary sources: (1) royalties
and license fees from licensing our patented surface modification and drug delivery technologies
and in vitro diagnostic formats to customers; the vast majority (typically in excess of 90%) of
revenue in the royalties and license fees category is in the form of royalties; (2) the sale of
reagent chemicals to licensees of our technologies, stabilization products to the diagnostics
industry and coated glass slides to the genomics market; and (3) research and development fees
generated on customer projects. Revenue should be expected to fluctuate from quarter to quarter
depending on, among other factors: our customers success in selling products incorporating our
technologies; the timing of introductions of coated products by customers; the timing of
introductions of products that compete with our customers products; the number and activity level
associated with customer development projects; the number and terms of new license agreements that
are finalized; the value of reagent chemicals and other products sold to licensees; and the timing
of future acquisitions we complete, if any.
For financial accounting and reporting purposes, we treat our three operating segments as one
reportable segment. We made this determination because our operating segments currently share the
same facilities; a significant percentage of our employees provide support services (including
research and development) to each operating segment; technology and products from each operating
segment are marketed to the same or similar customers; each operating segment uses the same sales
and marketing resources; and each operating segment operates in the same regulatory environment.
Critical Accounting Policies
Critical accounting policies are those policies that require the application of managements
most challenging subjective or complex judgment, often as a result of the need to make estimates
about the effect of matters that are inherently uncertain and may change in subsequent periods.
Critical accounting policies involve judgments and uncertainties that are sufficiently sensitive to
result in materially different results under different assumptions and conditions. For a detailed
description of our critical accounting policies, see the notes to the financial statements included
in our Annual Report on Form 10-K for the year ended September 30, 2006.
11
Results of Operations
Three Months Ended June 30, 2007 and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
% Increase/ |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
|
(Decrease) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
$ |
5,772 |
|
|
$ |
8,647 |
|
|
|
($2,875 |
) |
|
|
(33 |
%) |
Hydrophilic and Other |
|
|
6,897 |
|
|
|
5,522 |
|
|
|
1,375 |
|
|
|
25 |
% |
In Vitro |
|
|
5,093 |
|
|
|
3,970 |
|
|
|
1,123 |
|
|
|
28 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
17,762 |
|
|
$ |
18,139 |
|
|
|
($377 |
) |
|
|
(2 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue. Third quarter revenue was $17.8 million, a decrease of $377,000, or 2%, compared
with the same period in fiscal 2006. Substantial growth in our Hydrophilic and Other and In Vitro
operating segments was offset by a 33% decrease in Drug Delivery segment revenue. Results for
each of our three operating segments are detailed in the table above and further explained in the
narrative below.
Drug Delivery. Revenue in the Drug Delivery segment decreased 33% to $5.8 million for the
three-month period ended June 30, 2007, compared with $8.6 million for the prior year period. Nearly all
of the decrease is a result of lower royalties and license fees when compared with the prior year period. Drug Delivery derives a
substantial majority of its revenue through licensing and product sales to Cordis Corporation, a
Johnson & Johnson company, on its CYPHER® Sirolimus-eluting Coronary Stent. CYPHER® is a trademark
of Cordis Corporation. The CYPHER® stent incorporates a proprietary SurModics polymer coating that
delivers a therapeutic drug designed to reduce the occurrence of restenosis in coronary artery
lesions. The decrease in Drug Delivery revenue reflects lower royalty revenue and reagent revenue
(as a result of lower CYPHER® sales) and less research and development work performed for Cordis.
Excluding Cordis activities, research and development revenue decreased 6% compared with the prior
year period as a result of reduced activity with ophthalmology and other drug delivery customers.
The CYPHER® stent, from which we derive a substantial majority of our Drug Delivery revenue,
faces continuing competition from Boston Scientific Corporations Taxus drug-eluting stent, which
is sold within and outside the U.S., and stents from Medtronic, Abbott Vascular, and others sold
outside the U.S. In addition, several drug-eluting stents from others are expected to be approved
in the U.S. over the next two years. These stents (in addition to bare metal stents) compete or
will compete directly with the CYPHER® stent. Further, drug-eluting stent sales have been
adversely affected by recent concerns over stent safety. Therefore, future Drug Delivery royalty
and reagent sales revenue could decrease because of lower CYPHER® stent sales as a result of this
ongoing and expected future competition and overall market contraction. We anticipate that
quarterly royalty revenue from the CYPHER® stent may decrease for the remainder of fiscal 2007
and beyond as the various marketers of drug-eluting stents continue competing in the marketplace
and as others enter the marketplace. Management expects royalties from the CYPHER® stent to
continue to constitute a significant portion of our revenue in fiscal 2007. However, whether and
the extent to which royalties from the CYPHER® stent continue to constitute a significant source of
revenue is subject to a number of risks,
12
including intellectual property litigation generally, and specifically the damages,
settlements and mutual agreements that may result from various infringement suits between Boston
Scientific and Cordis in which each has been found to have violated certain intellectual property
rights of the other.
Hydrophilic and Other. Revenue in the Hydrophilic and Other segment increased 25% to $6.9
million compared with the third quarter of fiscal 2006, primarily as a result of 29% growth in
royalties and license fees and a 50% increase in reagent sales. In contrast to our Drug Delivery
segment, where a significant percentage of revenue is attributable to Cordis, there are several
dozen licensees and an even larger number of coated products generating royalties in our
Hydrophilic and Other segment. Partially offsetting the increase in royalties and license fees and
reagent sales was a 23% decrease in research and development revenue. Much of the research and
development revenue earned in the Hydrophilic and Other segment is related to small-scale interim
coating services we provide to some of our customers as they transition to coating their products
with our technology in their own manufacturing facilities. Some of our customers, who had
contributed significantly to research and development revenue in the prior year period, have
transitioned to in-house coating. Accordingly, we performed less of this service in the third
quarter of fiscal 2007, resulting in the decrease in research and development revenue. For this
same reason, we anticipate research and development revenue within this segment will continue to
decrease when compared to prior year comparable periods for the remainder of fiscal 2007. We
believe royalty and license fee revenue will continue to increase for the remainder of fiscal 2007
when compared to prior year comparable periods, though not necessarily at the same rate experienced
in the third quarter of fiscal 2007. It is unlikely that fourth quarter fiscal 2007 reagent sales,
when compared to prior year comparable periods, will grow at the rate experienced in the third
quarter of fiscal 2007.
In Vitro. Revenue in the In Vitro segment (formerly Diagnostics) increased 28% to $5.1 million
compared with the prior year period. A majority of the increase was attributable to a 44% increase
in royalties and license fees compared with the same period in fiscal 2006. It is unlikely that
fourth quarter fiscal 2007 In Vitro royalties and license fees, when compared with prior year
comparable periods, will grow at the rate experienced in the third quarter of fiscal 2007.
Product sales in the In Vitro segment increased approximately 2% compared with the prior year.
Product sales include genomics slides, stabilization products and recently launched recombinant
autoimmune antigens (both stabilization products and antigens are used by diagnostic kit
manufacturers in immunoassay diagnostic tests). However, when current period sales of antigens are
excluded (prior year results do not include any antigen sales, as distribution of these products began in the fourth quarter of fiscal 2006) product sales decreased approximately 16%. We
expect product sales in the In Vitro segment to be higher on a sequential basis in the final
quarter of fiscal 2007. The In Vitro segment derives a significant percentage of its revenue from
Abbott Laboratories and GE Healthcare. On January 18, 2007, Abbott announced an agreement to sell
its core laboratory diagnostics business to GE. On July 11, 2007, Abbott announced that it and GE
mutually agreed to terminate the sale agreement. We do not expect the termination of this
transaction to have a material impact on future In Vitro operating segment results.
Product costs. Product costs were $1.2 million for the third quarter of fiscal 2007, a
37% increase from $891,000 in the third quarter of fiscal 2006. Overall product margins averaged
59%, compared with 66% for the comparable period last year. The decrease in product margins
reflects the mix of products sold in the period (some of our stabilization and antigen products and
genomics slides carry lower margins than our reagent products) and higher depreciation costs on the
recently-constructed manufacturing space at our Eden Prairie facility. We anticipate that product
margins will continue to be lower on a year-over-year basis throughout fiscal 2007 compared
with prior year results as a result of recent trends in the mix of products sold.
13
Research and development expenses. Research and development expenses were $6.2 million in the
third quarter of fiscal 2007, an increase of 17% compared with the same period in fiscal 2006. The
increase reflects higher personnel costs and an approximate $600,000 increase in stock based
compensation paid to employees as a result of executing the Merck license. In addition,
a $353,000 loss was recorded on the cancellation of a technology license.
Sales and marketing expenses. Sales and marketing expenses were $343,000 for the third
quarter of fiscal 2007, a 1% decrease from the prior year period. We expect sales and marketing
expenses to increase modestly on a year-over-year basis for the remainder of fiscal 2007.
General and administrative expenses. General and administrative expenses were $2.5 million
for the third quarter of fiscal 2007, a 15% increase compared with $2.2 million in same period of
fiscal 2006. The increase reflects increased legal and professional fees. General and
administrative expenses will likely increase modestly in the fourth quarter of fiscal 2007.
Other income, net. Other income was $1.2 million in the third quarter of fiscal 2007, an
increase of 9% compared with $1.1 million in the same period of fiscal 2006, reflecting higher
levels of investable cash and higher yields generated from our investment portfolio.
Income tax expense. The Companys income tax provision was $3.1 million in the third quarter
of fiscal 2007, compared with $4.2 million in the same period of fiscal 2006, resulting in an
effective tax rate of 35.9% for the third quarter of fiscal 2007, compared with 39.8% for the same
period last year. Current period results include a benefit from the release of certain tax
reserves related to expiring statutes of limitations.
Nine Months Ended June 30, 2007 and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
Increase |
|
|
% Increase |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
$ |
18,607 |
|
|
$ |
25,580 |
|
|
|
($6,973 |
) |
|
|
(27 |
%) |
Hydrophilic and Other |
|
|
18,720 |
|
|
|
15,988 |
|
|
|
2,732 |
|
|
|
17 |
% |
In Vitro |
|
|
14,538 |
|
|
|
10,743 |
|
|
|
3,795 |
|
|
|
35 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
51,865 |
|
|
$ |
52,311 |
|
|
|
($447 |
) |
|
|
(1 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue. Total revenue was $51.9 million for the first nine months of fiscal 2007, a decrease
of $447,000, or 1%, compared with the same period of fiscal 2006. A significant decrease in Drug
Delivery segment revenue, primarily as a result of lower CYPHER® stent royalties, offset strong
revenue growth in the Hydrophilic and Other and In Vitro segments.
Drug Delivery. Drug Delivery revenue decreased 27% to $18.6 million through the third quarter
of fiscal 2007, compared with $25.6 million for the same period last year. The decrease reflects
lower revenue in all three revenue sources: royalties and license fees, product sales, and research
and development revenue as a result of lower CYPHER® sales and less research and development work
performed for Cordis as described above.
Hydrophilic and Other. Hydrophilic and Other revenue increased 17% to $18.7 million for the
first nine months of fiscal 2007, driven principally by increased royalties and reagent sales.
Partially offsetting the increase in royalties and reagent sales was a decrease in research and
development revenue as a result of less interim contract coating work performed for certain
customers as previously described.
14
In Vitro. In Vitro revenue increased 35% to $14.5, million compared with $10.7 million for the
same period last year. Approximately $2.8 million of the increase is a result of higher royalties
and license fees, a portion of which was a settlement related to past due royalties. The balance
of the increase reflects the 28% growth in sales of genomics slides, stabilization and antigen
product sales.
Product costs. Product costs were $3.4 million for the nine months ended June 30, 2007, a 39%
increase from $2.4 million last year. Overall product margins averaged 62% compared with 69% for
the comparable period last year. The margin decrease is primarily attributable to a higher mix of
genomics slides, and stabilization and antigen products, which carry lower margins than reagents.
Research and development expenses. Research and development expenses were $17.1 million for
the first nine months of fiscal 2007, an increase of 15% compared with the same period in fiscal
2006. Approximately $600,000 of the increase reflects higher costs associated with the clinical
trial on our I-vation intravitreal implant in our Ophthalmology division. The balance of the
increase is a result of higher compensation and development expenses in all of our business
segments.
Sales and marketing expenses. Sales and marketing expenses were $989,000 for the nine months
ending June 30, 2007, a 6% decrease from the same period of the prior year.
General and administrative expenses. General and administrative expenses were $6.6 million
for the first nine months of fiscal 2007, a 4% decrease compared with the same period in fiscal
2006. The decrease primarily reflects the cost savings realized since we exited our contract
manufacturing facility in Bloomington in April 2006 and reduced professional fees.
Other income, net. Other income was $3.7 million for the first nine months of fiscal 2007,
compared with a loss of $1.9 million in the same period last year. The prior year loss was
primarily a result of the $4.7 million impairment loss recorded on our investment in Novocell in
the second quarter of fiscal 2006. Income from investments was $3.7 million through the third
quarter of fiscal 2007, an increase of $837,000, compared with $2.9 million for the same period of
fiscal 2006, reflecting higher levels of investable cash and higher yields generated from our
investment portfolio.
Income tax expense. The Companys income tax provision was $10.2 million for the first nine
months of fiscal 2007 compared with $11.1 million in the same period of fiscal 2006. The effective
tax rate for the first nine months of fiscal 2007 was 37.1%, compared with 37.2% for the same
period last year (excluding the impact of the $4.7 million impairment loss). Without excluding the impact
of the impairment loss recorded in the first nine months of fiscal 2006, the effective tax rate for such period was 44.1%.
Liquidity and Capital Resources
As of June 30, 2007, the Company had working capital of $73.6 million and cash, cash
equivalents and investments totaling $94.1 million. The Companys investments principally consist
of U.S. government and government agency obligations and investment grade, interest-bearing
corporate debt securities with varying maturity dates, the majority of which are five years or
less. The Companys policy requires that no more than 5% of investments be held in any one credit
issue, excluding U.S. government and government agency obligations. The primary investment
objective of the portfolio is to provide for the safety of principal and appropriate liquidity
while meeting or exceeding a benchmark (Merrill Lynch 1-3 Year Government-Corporate Index) total
rate of return. Management plans to continue to direct its investment advisors to manage the
Companys investments primarily for the safety of principal for the foreseeable future as it
assesses other investment opportunities and uses of its investments. We had positive cash flows
from operating activities of approximately $23.6 million in the first nine months of fiscal 2007,
compared with $27.1 million in the first nine months of fiscal 2006. On July 20, 2007, the Company received the $20 million
up front licensing fee due from Merck. See Note 4 and Note 10.
15
We conduct a significant majority of our operations at our Eden Prairie, Minnesota,
headquarters. In addition to our Eden Prairie location, we lease approximately 3,000 square feet
of commercial office space in Irvine, California, where our Ophthalmology division conducts a
portion of its operations.
In January 2005, we entered into a merger agreement whereby SurModics acquired all of the
assets of InnoRx, Inc. by paying approximately $4.1 million in cash and issuing 600,064 shares of
SurModics common stock to InnoRx stockholders. In July 2005, we issued 60,002 shares of SurModics
common stock to the shareholders of InnoRx upon the successful completion of the first milestone
involving the InnoRx technology acquired in the purchase of InnoRx. In March 2006, we issued an
additional 60,007 shares as a result of completion of the second milestone. The 60,007 shares are
held in escrow pending possible indemnification per the merger agreement. Upon the successful
completion of the remaining development and commercial milestones involving InnoRx technology
acquired in the transaction, we will be required to issue up to approximately 480,060 additional
shares of our common stock to the stockholders of InnoRx.
In September 2004, we made a commitment to purchase for $7 million certain additional
sublicense rights and the accompanying future royalty revenue streams under certain sublicenses
through an amendment to our diagnostic format patent license with Abbott Laboratories. Prior to
such amendment, we were receiving only a portion of the royalties under such sublicenses. The first
$5 million installment was paid in November 2004. We made an additional $1 million installment
payment in June 2007. The remaining $1 million installment is reflected in other current
liabilities at June 30, 2007.
In September 2006, our Board of Directors authorized the repurchase of up to $35 million and
up to 1 million shares of the Companys stock. In November 2006, the Company entered into a Rule
10b5-1 agreement and purchased $17.5 million of the $35 million authorized at an average price of
$32.87 per share. In January 2007, the Board of Directors approved an amendment to the share
repurchase program to authorize the Company to repurchase up to $35 million of the Companys stock
without restriction as to the total number of shares being repurchased. Pursuant to the amended
share repurchase program, the Company entered into a Rule 10b5-1 agreement in January 2007 and
during the second quarter of fiscal 2007 purchased the remaining $17.5 million of the $35 million
repurchase authorization at an average price of $36.88 per share. In total, the Company
repurchased 1,007,752 shares for $35.0 million at an average price of $34.76 per share.
On July 10, 2007 we announced the Companys equity investment in Paragon Intellectual
Properties, LLC (Paragon) and an equity investment in Apollo Therapeutics, LLC (Apollo), a
Paragon subsidiary. The Paragon and Apollo investments totaled $3.5 million. The arrangement
calls for the SurModics to invest additional equity totaling $2.5 million upon successful
completion of specified development milestones. Our investment in Paragon represents an ownership
interest of less than 20% and the investment in Apollo represents an ownership interest of less
than 20%. See Note 12.
On July 31, 2007 SurModics entered into a stock purchase agreement with Southern Research
Institute whereby it acquired 100% of the capital stock of Brookwood Pharmaceuticals, Inc.
(Brookwood) for $40 million in cash on the closing date and up to an additional $22 million in
cash upon the successful achievement of specified milestones. Brookwood is a drug delivery company
based in Birmingham, Alabama that provides proprietary polymer based technologies to companies
developing pharmaceutical products. See Note 12.
16
As of June 30, 2007, we had no debt, nor did we have any credit agreements. We believe that
our existing capital resources will be adequate to fund our operations and material commitments
into the foreseeable future.
As of June 30, 2007, the Company did not have any off-balance sheet arrangements with any
unconsolidated entities.
Certain information regarding the effective tax rate in this Quarterly Report on Form 10-Q may
be considered non-GAAP financial information as contemplated by Regulation G. The non-GAAP measure
excluded the impact of an impairment loss recorded in the second quarter of 2006. The Company no
longer provides non-GAAP financial measures for the current period, but believes that providing
this non-GAAP financial measure for the prior period is still useful to investors because it
provides a basis for comparison of the Companys financial condition and results of operations
between quarters, which comparison is not influenced by changes in its effective tax rate.
Management also uses such financial measures internally to monitor performance of the business.
The potential non-GAAP financial measures should be considered in addition to, and not a substitute
for, financial measures in accordance with GAAP.
Forward-Looking Statements
Certain statements contained in this report and other written and oral statements made from
time to time by the Company do not relate strictly to historical or current facts. As such, they
are considered forward-looking statements that provide current expectations or forecasts of
future events. These forward-looking statements are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Such statements can be identified by the use
of terminology such as anticipate, believe, could, estimate, expect, forecast,
intend, may, plan, possible, project, will and similar words or expressions. Any
statement that is not an historical fact, including estimates, projections, future trends and the
outcome of events that have not yet occurred, are forward-looking statements. The Companys
forward-looking statements generally relate to its growth strategy, financial results, product
development programs, sales efforts, sufficiency of capital resources, and the impact of the Cordis
agreement and other significant customer agreements. You should carefully consider forward-looking
statements and understand that such statements involve a variety of risks and uncertainties, known
and unknown, and may be affected by inaccurate assumptions. Consequently, no forward-looking
statement can be guaranteed and actual results may vary materially. The Company undertakes no
obligation to update any forward-looking statement.
Although it is not possible to create a comprehensive list of all factors that may cause
actual results to differ from the Companys forward-looking statements, such factors include, among
others: (i) the Companys significant dependence upon Cordis, which causes our financial results
and stock price to be subject to factors affecting Cordis and its Cypher stent program, including
among others, the rate of market penetration by Cordis, the timing of market introduction of
competing products, product safety or efficacy concerns and intellectual property litigation
generally and specifically the litigation involving Boston Scientific Scimed, Inc. and Cordis in
the U.S. District Court for the District of Delaware in which each was reported in June and July
2005 to have been found to have infringed the patent rights of the other; (ii) frequent
intellectual property litigation in the medical device industry that may directly or indirectly
adversely affect our customers ability to market their products incorporating our technologies;
(iii) our ability to protect our own intellectual property; (iv) healthcare reform efforts and
reimbursement rates for medical device products that may adversely affect our customers ability to
cost effectively market and sell devices incorporating our technologies; (v) the Companys ability
to attract new licensees and to enter into agreements for additional product
17
applications with existing licensees, the willingness of potential licensees to sign license
agreements under the terms offered by the Company, and the Companys ability to maintain
satisfactory relationships with its licensees; (vi) the Companys ability to increase the number of
market segments and applications that use its coating technologies through its sales and marketing
and research and development efforts; (vii) the Companys ability to facilitate through strategic
investment and research and development support the creation of new medical device market segments
and applications that incorporate its coating technologies; (viii) market acceptance of products
sold by customers incorporating our technologies and the timing of new product introductions by
licensees; (ix) market acceptance of products sold by customers competitors and the timing and
pricing of new product introductions by customers competitors; (x) the difficulties and
uncertainties associated with the lengthy and costly new product development and foreign and
domestic regulatory approval processes, such as delays, difficulties or failures in achieving
acceptable clinical results or obtaining foreign or FDA marketing clearances, which may result in
lost market opportunities or postpone or preclude product commercialization by licensees; (xi)
efficacy or safety concerns with respect to products marketed by us and our licensees, whether
scientifically justified or not, that may lead to product recalls, withdrawals or declining sales;
(xii) the ability to secure raw materials for reagents the Company sells; (xiii) the Companys
ability to manage successfully clinical trials and related foreign and domestic regulatory
processes for the I-vation intravitreal implant or other acquired products from InnoRx
under development by the Companys ophthalmology division, whether delays, difficulties or failures
in achieving acceptable clinical results or obtaining foreign or FDA marketing clearances postpone
or preclude product commercialization of the intravitreal implant or other acquired products, and
whether the intravitreal implant and any other acquired products remain viable commercial
prospects; (xiv) product liability claims not covered by insurance; (xv) the development of new
products or technologies by competitors, technological obsolescence and other changes in
competitive factors; (xvi) the trend of consolidation in the medical device industry, resulting in
more significant, complex and long term contracts than in the past and potentially greater pricing
pressures; (xvii) the Companys ability to identify suitable businesses to acquire or with whom to
form strategic relationships to expand its technology development and commercialization, its
ability to successfully integrate the operations of companies it may acquire from time to time and
its ability to create synergies from acquisitions and other strategic relationships; (xviii) the
Companys ability to successfully internally perform certain product development activities and
governmental and regulatory compliance activities with respect to acquired technology, including
InnoRx technology, which activities the Company has not previously undertaken in any significant
manner; (xix) the Companys ability to successfully perform and earn milestone payments related to
contractual milestone criteria in general and specifically the $288 million in fees and development
milestones in the Merck agreement; (xx) economic and other factors over which the Company has no
control, including changes in inflation and consumer confidence; (xxi) acts of God or terrorism
which impact the Companys personnel or facilities; and (xxii) other factors described in the Risk
Factors and other sections of SurModics Annual Report on Form 10-K, which you are encouraged to
read carefully. Many of these factors are outside the control and knowledge of the Company and
could result in increased volatility in period-to-period results. Investors are advised not to
place undue reliance upon the Companys forward-looking information and to consult any further
disclosures by the Company on this subject in its filings with the Securities and Exchange
Commission.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
The Companys investment policy requires investments with high credit quality issuers and
limits the amount of credit exposure to any one issuer. The Companys investments principally
consist of U.S. government and government agency obligations and investment-grade, interest-bearing
corporate debt securities with varying maturity dates, the majority of which are five years or
less. Because of the credit criteria of the Companys investment policies, the primary market risk
associated with these investments is interest rate risk. SurModics does not use
18
derivative
financial instruments to manage interest rate risk or to speculate on future changes in interest rates. A one
percentage point increase in interest rates would result in an approximate $1.4 million decrease in
the fair value of the Companys available-for-sale securities as of June 30, 2007, but no material
impact on the results of operations or cash flows. Management believes that a reasonable change in
raw material prices would not have a material impact on future earnings or cash flows because the
Companys inventory exposure is not material.
Although we conduct business in foreign countries, our international operations consist
primarily of sales of reagent and stabilization chemicals. Additionally, all sales transactions are
denominated in U.S. dollars. Accordingly, we do not expect to be subject to material foreign
currency risk with respect to future costs or cash flows from our foreign sales. To date, we have
not entered into any foreign currency forward exchange contracts or other derivative financial
instruments to hedge the effects of adverse fluctuations in foreign currency exchange.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this report, the Company conducted an evaluation under
the supervision and with the participation of the Companys management, including the Companys
Chief Executive Officer and Chief Financial Officer regarding the effectiveness of the design and
operation of the Companys disclosure controls and procedures pursuant to Rule 13a-15(b) of the
Securities Exchange Act of 1934 (the Exchange Act). Based upon that evaluation, the Chief
Executive Officer and Chief Financial Officer concluded that the Companys disclosure controls and
procedures are effective to ensure that information that is required to be disclosed by the Company
in reports that it files under the Exchange Act is recorded, processed, summarized and reported
within the time period specified in the rules of the Securities and Exchange Commission.
Changes in Internal Controls
There were no changes in the Companys internal control over financial reporting that occurred
during the period covered by this report that have materially affected, or are reasonably likely to
materially affect, the Companys internal control over financial reporting.
19
PART
II - OTHER INFORMATION
Item 1. Legal Proceedings.
On May 22, 2007, the former Stockholders of InnoRx (the Plaintiffs) filed a declaratory
judgment action (the Declaratory Judgment) in the U.S. District Court for the Southern District
of Alabama against Michael Cooney, M.D. (Dr. Cooney) of New York, New York. In the litigation,
the Plaintiffs are seeking a determination that Dr. Cooney was not a co-founder of InnoRx, and
further that he was not an inventor of certain patent rights covering technology for delivering
drugs to the eye, including certain patent rights exclusively licensed by the Johns Hopkins
University to InnoRx (collectively, the Patent Rights), and now controlled by the Company as
successor-in-interest to InnoRx pursuant to an agreement of merger between the Company and InnoRx
made effective on January 18, 2005 (the Merger Agreement). The Company is not a party to the
litigation.
On June 8, 2007, the Company was named as a defendant in litigation filed in the U.S. District
Court for the District of Minnesota by Dr. Cooney. JHU and certain former shareholders of InnoRx,
among others, were also named as defendants. The complaint alleges that Dr. Cooney was a
co-founder of InnoRx and an inventor of subject matter claimed in the Patent Rights. The complaint
seeks an order correcting inventorship, and certain unspecified damages (including punitive
damages) based on claims of unjust enrichment, fraud, and breach of fiduciary duties. A trial has
not yet been scheduled. Pursuant to the Merger Agreement, the Company has submitted a demand for
indemnification of losses (including without limitation, damages, expenses and costs) incurred as a
result of the litigation involving Dr. Cooney, including both the Alabama and Minnesota cases
described above.
On June 18, 2007, the Company was named as an involuntary plaintiff in patent litigation between
Abbott Laboratories (Abbott) and Church & Dwight, Inc. (Church & Dwight). In the litigation,
Abbott is alleging that certain of Church & Dwights products utilizing lateral flow technology for
diagnostic purposes infringe certain of the Companys patents that have been exclusively licensed
to Abbott under the terms of a license agreement between the Company and Abbott dated May 30, 1989,
as amended and restated (the License Agreement). The suit was filed in the U.S. District Court
for the Northern District of Illinois seeking a finding of infringement, monetary damages and
injunctive relief. Pursuant to the terms of the License Agreement, Abbott is responsible for
reimbursing the Company for at least a portion of its costs and fees incurred in connection with
the suit. A trial has not yet been scheduled.
Item 1A. Risk Factors.
There have been no material changes from risk factors as previously disclosed in the Companys
Form 10-K for the fiscal year ended September 30, 2006 in response to Item 1A to Part I of Form
10-K.
20
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
The following table presents information with respect to purchases of common stock of the
Company made during the three months ended June 30, 2007, by the Company or on behalf of the
Company or any affiliated purchaser of the Company, as defined in Rule 10b-18(a)(3) under the
Exchange Act.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(c) |
|
(d) |
|
|
|
|
|
|
Total Number |
|
Approximate Dollar |
|
|
|
|
|
|
of Shares |
|
Value of |
|
|
|
|
|
|
Purchased |
|
Shares that |
|
|
|
|
|
|
as Part of |
|
May Yet Be |
|
|
(a) |
|
(b) |
|
Publicly |
|
Purchased |
|
|
Total Number |
|
Average |
|
Announced |
|
Under the |
|
|
of Shares |
|
Price Paid |
|
Plans or |
|
Plans or |
Period |
|
Purchased(1) |
|
Per Share |
|
Programs |
|
Programs |
|
4/01/07 - 4/30/07 |
|
1,537 |
|
$39.94 |
|
NA |
|
NA |
5/01/07 - 5/31/07 |
|
0 |
|
NA |
|
NA |
|
NA |
6/01/07 - 6/30/07 |
|
5,296 |
|
$49.42 |
|
NA |
|
NA |
|
Total |
|
6,833 |
|
$47.29 |
|
|
|
|
|
|
|
(1) |
|
All of the Shares were repurchased by the Company to pay the exercise price and/or to
satisfy tax withholding obligations in connection with so-called stock swap exercises of employee
stock options issued to employees. |
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Security Holders.
None
Item 5. Other Information.
None.
Item 6. Exhibits.
Exhibits
|
|
|
10.1+
|
|
Exclusive License and Research Collaboration Agreement with Merck & Co., Inc. dated June 26, 2007 |
|
|
|
10.2+
|
|
Supply Agreement with Merck & Co., Inc. dated June 26, 2007 |
|
|
|
31.1**
|
|
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
31.2**
|
|
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.1**
|
|
Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.2**
|
|
Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
+ |
|
Confidential treatment requested as to portions of the exhibit. Confidential portions omitted and provided separately to the Securities and Exchange Commission. |
|
** |
|
Filed herewith. |
21
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
SurModics, Inc.
|
|
|
|
|
August 9, 2007 |
|
|
|
|
|
|
By: |
/s/ Philip D. Ankeny
|
|
|
|
Philip D. Ankeny |
|
|
|
Chief Financial Officer |
|
|
22
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
EXHIBIT INDEX TO FORM 10-Q
For the Quarter Ended June 30, 2007
SURMODICS, INC.
|
|
|
Exhibit |
|
Description |
|
|
|
10.1+
|
|
Exclusive License and Research Collaboration Agreement with Merck & Co., Inc. dated June 26, 2007 |
|
|
|
10.2+
|
|
Supply Agreement with Merck & Co., Inc. dated June 26, 2007 |
|
|
|
31.1**
|
|
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
31.2**
|
|
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.1**
|
|
Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.2**
|
|
Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
+ |
|
Confidential treatment requested as to portions of the exhibit. Confidential portions omitted and provided separately to the Securities and Exchange Commission. |
|
** |
|
Filed herewith. |
23