e10vqza
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 10-Q/A
(AMENDMENT NO. 1)
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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 March 31, 2005
OR
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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.
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of
the Exchange Act).
The number of shares of the registrants Common Stock, $.05 par value per share, outstanding as of
April 29, 2005 was 18,290,359.
SURMODICS, INC.
EXPLANATORY NOTE
This Amendment No. 1 on Form 10-Q/A (Form 10-Q/A) to the Companys Quarterly Report on Form
10-Q for the quarterly period ended March 31, 2005, originally filed with the Securities and
Exchange Commission (the SEC) on May 10, 2005 (the Original Filing), is being filed to reflect
a restatement of its condensed balance sheet as of March 31, 2005, as discussed in Note 8 to the
financial statements included at Item 1.
In connection with the Companys preparation of the Original Filing, the Company recorded an
$8,090,000 liability for a contingent stock payment obligation reflecting an event arising when the
Company acquired InnoRx, Inc. in January 2005. The Company consulted with outside accounting, tax
and valuation advisors regarding such treatment. In connection with the preparation of the
Companys Quarterly Report on Form 10-Q for the period ended June 30, 2005, the Company reassessed
its accounting for the contingent stock payment obligation. On August 5, 2005, the Company
determined that the initial fair value of the contingent stock payment obligation should have been
recorded as permanent equity rather than as a liability. As a result, in this Form 10-Q/A, the
Company is restating its condensed balance sheet as of March 31, 2005 to reduce its previously
reported other long-term liabilities by $8,090,000 and to increase its previously reported
additional paid-in capital by $8,090,000. The restatement does not have an impact on the results
of operations for the three-month and six-month periods ended March 31, 2005. Also, as a result of
this change in the manner in which the obligation to issue the additional shares of the Company is
now recorded, this obligation will not have any impact on future results of operations.
Although this Form 10-Q/A sets forth the Original Filing in its entirety, this Form 10-Q/A
only amends and restates Items 1, 2 and 4 of Part I solely as a result of, and to reflect, the
restatement, and no other information in the Original Filing is amended hereby. The foregoing
items have not been updated to reflect other events occurring after the Original Filing or to
modify or update those disclosures affected by subsequent events. In addition, pursuant to the
rules of the SEC, Item 6 of Part II of the Original Filing has been amended to contain
currently-dated certifications from our Chief Executive Officer and Chief Financial Officer, as
required by Sections 302 and 906 of the Sarbanes-Oxley Act of 2002. The certifications of our Chief
Executive Officer and Chief Financial Officer are attached to this Form 10-Q/A as Exhibits 31.1,
31.2, 32.1 and 32.2, respectively.
On July 20, 2005, the Company issued a press release announcing its preliminary results of
operations for the three- and nine-month periods ended June 30, 2005 and presenting a preliminary
condensed balance sheet as of June 30, 2005. The information in such preliminary condensed balance
sheet does not reflect the restatement, and accordingly liabilities will be decreased and
stockholders equity will be correspondingly increased in the Companys condensed balance sheet to
be included in the Companys Form 10-Q filed for such period.
2
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
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Item 1. Financial Statements
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SURMODICS, INC.
Condensed Balance Sheets
(In thousands, except share data)
(unaudited)
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March 31, |
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September 30, |
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2005 |
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2004 |
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(As Restated See Note 1) |
ASSETS |
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Current Assets |
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Cash and cash equivalents |
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$ |
974 |
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$ |
2,709 |
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Short-term investments |
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7,869 |
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16,506 |
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Accounts receivable, net |
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11,277 |
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8,130 |
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Inventories |
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992 |
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1,040 |
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Deferred tax asset |
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379 |
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379 |
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Prepaids and other |
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1,060 |
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805 |
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Total current assets |
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22,551 |
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29,569 |
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Property and equipment, net |
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15,155 |
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15,738 |
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Long-term investments |
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47,832 |
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44,088 |
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Deferred tax asset |
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8,205 |
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5,579 |
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Other assets, net |
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15,744 |
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14,613 |
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$ |
109,487 |
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$ |
109,587 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities |
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Accounts payable |
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$ |
464 |
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$ |
683 |
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Accrued liabilities |
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1,433 |
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6,751 |
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Accrued income taxes payable |
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2,096 |
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3,827 |
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Deferred revenue |
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577 |
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528 |
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Total current liabilities |
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4,570 |
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11,789 |
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Deferred revenue, less current portion |
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1,433 |
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1,488 |
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Other long-term liabilities |
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2,000 |
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2,000 |
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Total liabilities |
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8,003 |
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15,277 |
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Commitments
and contingencies |
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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-
$.05 par value, 45,000,000 shares authorized;
18,289,319 and 17,536,656 shares issued and outstanding |
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914 |
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877 |
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Additional paid-in capital |
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86,097 |
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57,849 |
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Unearned compensation |
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(2,239 |
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(632 |
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Accumulated other comprehensive income (loss) |
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(314 |
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56 |
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Retained earnings |
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17,026 |
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36,160 |
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Total stockholders equity |
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101,484 |
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94,310 |
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$ |
109,487 |
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$ |
109,587 |
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The accompanying notes are an integral part of these unaudited condensed financial statements.
3
SURMODICS, INC.
Condensed Statements of Operations
(In thousands, except per share data)
(unaudited)
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Three Months Ended |
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Six Months Ended |
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March 31, |
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March 31, |
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2005 |
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2004 |
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2005 |
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2004 |
Revenue |
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Royalties and license fees |
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$ |
12,268 |
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$ |
8,944 |
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$ |
22,359 |
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$ |
17,572 |
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Product sales |
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2,321 |
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2,803 |
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4,321 |
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5,403 |
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Research and development |
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1,116 |
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991 |
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3,094 |
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1,850 |
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Total revenue |
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15,705 |
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12,738 |
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29,774 |
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24,825 |
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Operating costs and expenses |
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Product |
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730 |
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752 |
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1,349 |
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1,488 |
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Research and development |
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3,890 |
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3,140 |
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7,246 |
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6,411 |
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Sales and marketing |
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307 |
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588 |
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569 |
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1,006 |
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General and administrative |
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1,649 |
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1,580 |
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2,843 |
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2,955 |
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Purchased in-process research & development |
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30,277 |
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30,277 |
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Total operating costs and expenses |
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36,853 |
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6,060 |
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42,284 |
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11,860 |
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Income (loss) from operations |
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(21,148 |
) |
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6,678 |
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(12,510 |
) |
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12,965 |
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Other income |
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Investment income |
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434 |
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269 |
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|
851 |
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|
546 |
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Gain (loss) on sales of investments |
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(64 |
) |
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1 |
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(64 |
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20 |
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Loss on equity method investment in InnoRx |
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(55 |
) |
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(67 |
) |
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(500 |
) |
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(67 |
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Other income |
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315 |
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|
203 |
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|
287 |
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|
499 |
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|
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Income (loss) before income taxes |
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(20,833 |
) |
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6,881 |
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(12,223 |
) |
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13,464 |
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Income tax provision |
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(3,538 |
) |
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(2,576 |
) |
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(6,911 |
) |
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(5,048 |
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Net income (loss) |
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($ |
24,371 |
) |
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$ |
4,305 |
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($ |
19,134 |
) |
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$ |
8,416 |
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Basic net income (loss) per share |
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($ |
1.34 |
) |
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$ |
0.25 |
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($ |
1.07 |
) |
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$ |
0.48 |
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Diluted net income (loss) per share |
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($ |
1.34 |
) |
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$ |
0.24 |
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($ |
1.07 |
) |
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$ |
0.47 |
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Weighted average shares outstanding |
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Basic |
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18,135 |
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|
17,483 |
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|
17,851 |
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|
17,468 |
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Dilutive effect of outstanding stock options |
|
|
|
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|
|
292 |
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|
|
|
|
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|
306 |
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|
|
|
|
|
|
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|
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|
|
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Diluted |
|
|
18,135 |
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|
|
17,775 |
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|
17,851 |
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|
17,774 |
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The accompanying notes are an integral part of these unaudited condensed financial statements.
4
SURMODICS, INC.
Condensed Statements of Cash Flows
(In thousands)
(unaudited)
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Six months ended |
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March 31, |
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2005 |
|
2004 |
Operating Activities |
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Net income (loss) |
|
($ |
19,134 |
) |
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$ |
8,416 |
|
Adjustments
to reconcile net income (loss) to net cash provided by
operating activities- |
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Depreciation and amortization |
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1,934 |
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|
1,770 |
|
Loss on
InnoRx equity method investment and sales of investments |
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|
564 |
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|
47 |
|
Noncash compensation |
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|
244 |
|
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|
107 |
|
Purchased in-process research & development |
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|
30,277 |
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|
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Deferred taxes |
|
|
(219 |
) |
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|
48 |
|
Gain on disposals of property and equipment |
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(193 |
) |
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Change in operating assets and liabilities: |
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Accounts receivable |
|
|
(3,147 |
) |
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|
(630 |
) |
Inventories |
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|
48 |
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(181 |
) |
Accounts payable and accrued liabilities |
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(569 |
) |
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|
(5,368 |
) |
Income taxes |
|
|
(1,732 |
) |
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|
(49 |
) |
Deferred revenue |
|
|
(6 |
) |
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|
111 |
|
Prepaids and other |
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|
(255 |
) |
|
|
(298 |
) |
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Net cash provided by operating activities |
|
|
7,812 |
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|
|
3,973 |
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Investing Activities |
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Purchases of property and equipment |
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(224 |
) |
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|
(780 |
) |
Purchases of available-for-sale investments |
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|
(58,610 |
) |
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|
(20,692 |
) |
Sales/maturities of available-for-sale investments |
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|
62,569 |
|
|
|
20,088 |
|
Investments
in OctoPlus and other |
|
|
(3,910 |
) |
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|
(287 |
) |
Purchase of licenses |
|
|
(5,223 |
) |
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|
Investment in and acquisition costs for InnoRx, net of cash acquired |
|
|
(5,180 |
) |
|
|
(2,157 |
) |
Payments received on note receivable |
|
|
|
|
|
|
1,869 |
|
|
|
|
|
|
|
|
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|
Net cash used in investing activities |
|
|
(10,578 |
) |
|
|
(1,959 |
) |
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
Financing Activities |
|
|
|
|
|
|
|
|
Issuance of common stock |
|
|
1,031 |
|
|
|
471 |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
1,031 |
|
|
|
471 |
|
|
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
(1,735 |
) |
|
|
2,485 |
|
|
|
|
|
|
|
|
|
|
Cash and Cash Equivalents |
|
|
|
|
|
|
|
|
Beginning of period |
|
|
2,709 |
|
|
|
4,007 |
|
|
|
|
|
|
|
|
|
|
End of period |
|
$ |
974 |
|
|
$ |
6,492 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid
for income taxes |
|
$ |
8,655 |
|
|
$ |
5,092 |
|
The accompanying notes are an integral part of these unaudited condensed financial statements.
5
SURMODICS, INC.
Notes to Condensed Financial Statements
(Unaudited)
(1) Basis
of Presentation and Restatement
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 and
reflect all adjustments, consisting solely of normal recurring adjustments, needed to fairly
present the financial results for these interim periods. 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 and six month
periods ended March 31, 2005, are not necessarily indicative of the results that may be expected
for the entire 2005 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 financial statements for the year
ended September 30, 2004, and footnotes thereto included in the Companys Form 10-K as filed with
the United States Securities and Exchange Commission on December 14, 2004.
In the three-month period ended March 31, 2005, the Company originally recorded its contingent
stock payment obligation described in Note 8 as a liability in its condensed balance sheet.
Subsequent to the issuance of its condensed financial statements the Company determined that under
generally accepted accounting principles this contingent stock payment obligation should have been
recorded as permanent equity rather than as a liability. As a result, the accompanying condensed
balance sheet as of March 31, 2005 has been restated to reduce long-term liabilities by $8,090,000
and to increase additional paid-in capital by $8,090,000.
(2) New Accounting Pronouncements
In
December 2004,
the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 123 (SFAS No.
123(R)), Share-Based Payment
(revised 2004). The revision requires all
entities to recognize compensation expense in an amount equal to the fair value of share-based
payments granted to employees. The statement eliminates the alternative method of accounting for
employee share-based payments previously available under Accounting Principles Board Opinion No.
25. The Statement is effective for the Company beginning in the first quarter of fiscal 2006. The
Company has not completed the process of evaluating the impact that will result from adopting SFAS
123(R).
In March 2004, the FASB issued EITF Issue No. 03-1 (EITF 03-1), The Meaning of Other-Than
Temporary Impairment and its Application to Certain Investments. EITF 03-1 includes new guidance
for evaluating and recording impairment losses on certain debt and equity investments when the fair
value of the investment security is less than its carrying value. The provisions of this rule are
required to be applied prospectively to all current and future investments accounted for in
accordance with FAS No. 115, Accounting for Certain Investments in Debt and Equity Securities,
and other cost method investments beginning in the third quarter of 2004. In September 2004, the
FASB delayed the effective date for the measurement and recognition provisions until the issuance
of additional implementation guidance. The Company is currently evaluating the impact of this new
accounting standard on its process for determining other-than-temporary impairments of applicable
debt and equity securities, but does not expect the impact to be material.
In December 2004, the FASB staff issued FSP FASB 109-1 that provides guidance on the
application of FASB Statement No. 109, Accounting for Income Taxes, to the provision within the
American Jobs Creations Act of 2004 that provides a tax deduction on qualified production
activities. This FSP is effective upon issuance. The adoption of this FSP did not have a material
impact on our results of operations or financial position for Fiscal 2005. The Company has not
determined the impact for Fiscal 2006.
(3) Other assets
Other assets consist principally of investments and acquired intellectual property. The
balance in other assets increased primarily as a result of the Companys $3.9 million investment in
OctoPlus in the second quarter of fiscal 2005, less accumulated amortization on patents and other
intangibles and the
6
retroactive
adjustments of our investment in InnoRx, Inc. as a result of
our acquisition of all of the assets of InnoRx, Inc. in January 2005. See Note 8 for additional
information.
(4) 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 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
September 30, |
|
|
2005 |
|
2004 |
Raw materials |
|
$ |
517 |
|
|
$ |
634 |
|
Finished goods |
|
|
475 |
|
|
|
406 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
992 |
|
|
$ |
1,040 |
|
|
|
|
|
|
|
|
|
|
(5) 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 comprised of the Companys six business units. The three operating segments are
aggregated into one reportable segment. The Drug Delivery operating segment contains the Drug
Delivery business unit and the Ophthalmology business unit. The Hydrophilic and Other operating
segment consists of three business units: (1) Hydrophilic Technologies, (2) Regenerative
Technologies, and (3) SurModics New Ventures. The Diagnostics operating segment contains the
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 providing 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
March 31, |
|
March 31, |
(in thousands) |
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Operating segment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
$ |
7,266 |
|
|
$ |
7,318 |
|
|
$ |
14,387 |
|
|
$ |
14,217 |
|
Hydrophilic and Other |
|
|
4,761 |
|
|
|
3,389 |
|
|
|
8,994 |
|
|
|
6,575 |
|
Diagnostics |
|
|
3,678 |
|
|
|
2,031 |
|
|
|
6,393 |
|
|
|
4,033 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
15,705 |
|
|
$ |
12,738 |
|
|
$ |
29,774 |
|
|
$ |
24,825 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6) Stock-based Compensation
The Company accounts for stock options under the intrinsic value method as described in APB
Opinion No. 25, Accounting for Stock Issued to Employees, under which no compensation expense has
been recognized. Had compensation expense for the options been determined using the fair value
method described in SFAS No. 123, Accounting for Stock-Based Compensation, as amended by
7
SFAS No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, the
Companys net income and earnings per share would have changed to the following pro forma amounts
for the three and six months ended March 31, 2005 and 2004 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
March 31, |
|
March 31, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Net income (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported |
|
($ |
24,371 |
) |
|
$ |
4,305 |
|
|
($ |
19,134 |
) |
|
$ |
8,416 |
|
Fair value compensation expense |
|
|
(759 |
) |
|
|
(488 |
) |
|
|
(1,343 |
) |
|
|
(947 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma |
|
($ |
25,130 |
) |
|
$ |
3,817 |
|
|
($ |
20,477 |
) |
|
$ |
7,469 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported |
|
($ |
1.34 |
) |
|
$ |
0.25 |
|
|
($ |
1.07 |
) |
|
$ |
0.48 |
|
Fair value compensation expense |
|
|
(.04 |
) |
|
|
(.03 |
) |
|
|
(.08 |
) |
|
|
(.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma |
|
($ |
1.38 |
) |
|
$ |
0.22 |
|
|
($ |
1.15 |
) |
|
$ |
0.42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported |
|
($ |
1.34 |
) |
|
$ |
0.24 |
|
|
($ |
1.07 |
) |
|
$ |
0.47 |
|
Fair value compensation expense |
|
|
(.04 |
) |
|
|
(.03 |
) |
|
|
(.08 |
) |
|
|
(.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma |
|
($ |
1.38 |
) |
|
$ |
0.21 |
|
|
($ |
1.15 |
) |
|
$ |
0.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
March 31, 2005 and March 31, 2004, respectively: risk-free interest rates of 3.71% and 3.11%;
expected lives of 7 years and 7 years; and expected volatility of 64% and 68%. The weighted-average
assumptions for the six months ended March 31, 2005 and March 31, 2004, respectively: risk-free
interest rates of 3.70% and 3.21%; expected lives of 7 years and 7 years; and expected volatility
of 64% and 68%.
As described in Note 2, in December 2004 the Financial Accounting Standards Board issued a
revision to Statement of Financial Accounting Standards 123 (SFAS 123(R)), Share-Based Payment.
The Statement is effective for the Company beginning in the first quarter of fiscal 2006. The
Company has not completed the process of evaluating the impact that will result from adopting SFAS
123(R).
During the quarter ended March 31, 2005, SurModics awarded 2,500 shares of restricted stock.
During the six month period ended March 31, 2005, SurModics awarded an aggregate of 59,500 shares
of restricted stock, at a weighted average price of $29.87, which increased the balance of unearned compensation by approximately $1.6
million. Each restricted stock award will fully vest after five years.
8
(7) Comprehensive Income
The components of comprehensive income for the three-month and six-month periods are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
March 31, |
|
March 31, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Net income (loss) |
|
($ |
24,371 |
) |
|
$ |
4,305 |
|
|
($ |
19,134 |
) |
|
$ |
8,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized holding gains (losses) on
available-for-sale securities arising
during the period, net of tax |
|
|
(282 |
) |
|
|
222 |
|
|
|
(410 |
) |
|
|
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less reclassification adjustment
for realized gains included in net
income, net of tax |
|
|
40 |
|
|
|
(1 |
) |
|
|
40 |
|
|
|
(13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss) |
|
|
(242 |
) |
|
|
221 |
|
|
|
(370 |
) |
|
|
93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
($ |
24,613 |
) |
|
$ |
4,526 |
|
|
($ |
19,504 |
) |
|
$ |
8,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8) InnoRx, Inc. Acquisition
On January 18, 2005, SurModics 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. Upon the successful completion of all
development and commercial milestones involving InnoRx technology acquired in the transaction,
SurModics will be required to issue up to a maximum of 600,064 additional shares of its common
stock to the former InnoRx stockholders. As the transaction was accounted for as a purchase of
assets, SurModics was required to determine the fair value of the assets acquired and the total
consideration given. The fair value was determined by an outside valuation consultant.
Prior to the acquisition, SurModics held an ownership interest in InnoRx of less than 20% and
accounted for the investment under the cost method. Upon completion of the InnoRx acquisition,
the Company retroactively adjusted its previously reported results to show the impact of accounting for InnoRx under the
equity
9
method. The net impact was an approximate $67,000 reduction in net income for the three
months and six months ended March 31, 2004 from previously reported results. The assets of InnoRx
acquired consisted almost exclusively of in-process research and development. In the
three-month period ended March 31, 2005, the Company recorded a charge of $30.3 million to write-off the
value of the acquired in-process research and development at the date of
acquisition. SurModics purchased InnoRx primarily to
acquire all of InnoRxs rights to a sustained-release intravitreal implant. The implant is
designed to deliver drugs to the eye to treat retinal diseases, such as age-related macular
degeneration and diabetic macular edema. Management expects to begin Phase I clinical trials in
connection with the intravitreal implant in our third fiscal quarter. Assuming successful
completion of clinical trials, and assuming the implant continues to be a viable opportunity,
SurModics believes it could commence commercial sale of the implant in 2010.
(9) Income Taxes
The charge for purchased in-process research and development (IPR&D) described in Note 8 is
not deductible for income tax purposes. Excluding the IPR&D charge, SurModics would have reported
income for the periods ended March 31, 2005. As a result, SurModics recorded an income tax
provision for the period ended March 31, 2005. Excluding the effect of the IPR&D charge,
SurModics effective tax rate was 38.3 % for the six month period ended March 31, 2005.
10
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The Accompanying Managements discussion and analysis of financial condition and results of
operations have been updated for the effects of the revisions
discussed in Note 1 to the financial
statements included in this report.
Overview
SurModics is a leading provider of surface modification and drug delivery technologies to the
healthcare industry. The Company is organized into six technology-centered business units. The
Drug Delivery operating segment contains the Drug Delivery business unit, which is responsible
for technologies dedicated to site specific delivery of drugs, and the Ophthalmology business unit,
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 unit which focuses on enhancing medical devices with advanced lubricious coatings that
facilitate their placement and maneuverability in the body; (2) Regenerative Technologies unit
which encompasses the Companys hemocompatibility, tissue engineering and cell encapsulation
technologies; and (3) SurModics New Ventures unit which is dedicated to the identification,
research and development of new technologies outside the research conducted in the other business
units. The Diagnostics operating segment contains the Diagnostics and Drug Discovery business
unit which includes the Companys genomics slide technologies, the Companys stabilization products
for immunoassay diagnostics tests, and its in vitro diagnostic format technology.
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 to
customers; (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 commercial 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 size of development projects that are entered into; the number of new license agreements
that are finalized; the value of reagent chemicals and other products sold to licensees; and the
timing of future acquisitions completed by the Company, if any.
For financial accounting and reporting purposes, we treat our three operating segments as one
reportable segment. We made this determination because each of our operating segments uses 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.
On January 18, 2005, we acquired all of the assets of InnoRx, Inc. by paying cash and issuing
shares of SurModics common stock to InnoRx stockholders. InnoRx was an early-stage company
developing drug delivery devices and therapies for the ophthalmology market. The assets we
acquired were folded into our newly created Ophthalmology business unit.
11
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, 2004.
There have been no changes in critical accounting policies subsequent to September 30, 2004.
Recently Issued Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board issued a revision to Statement of
Financial Accounting Standards 123 (SFAS 123(R)), Share-Based Payment. The revision requires all
entities to recognize compensation expense in an amount equal to the fair value of share-based
payments granted to employees. The statement eliminates the alternative method of accounting for
employee share-based payments previously available under Accounting Principles Board Opinion No.
25. The Statement is effective for the Company beginning in the first quarter of fiscal 2006. The
Company has not completed the process of evaluating the impact that will result from adopting SFAS
123(R).
In March 2004, the FASB issued EITF Issue No. 03-1 (EITF 03-1), The Meaning of Other-Than
Temporary Impairment and its Application to Certain Investments. EITF 03-1 includes new guidance
for evaluating and recording impairment losses on certain debt and equity investments when the fair
value of the investment security is less than its carrying value. The provisions of this rule are
required to be applied prospectively to all current and future investments accounted for in
accordance with SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities,
and other cost method investments beginning in the third quarter of 2004. In September 2004, the
FASB delayed the effective date for the measurement and recognition provisions until the issuance
of additional implementation guidance. The Company is currently evaluating the impact of this new
accounting standard on its process for determining other-than-temporary impairments of applicable
debt and equity securities, but does not expect the impact to be material.
In December 2004, the FASB staff issued FSP FASB 109-1 that provides guidance on the application of
FASB Statement No. 109, Accounting for Income Taxes, to the provision within the American Jobs
Creations Act of 2004 that provides a tax deduction on qualified production activities. This FSP is
effective upon issuance. The adoption of this FSP did not have a material impact on our results of
operations or financial position for fiscal 2005. The Company has not determined the impact for
fiscal 2006.
Results of Operations
Three Months Ended March 31, 2005 and 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase |
|
% Increase |
|
|
Fiscal 2005 |
|
Fiscal 2004 |
|
(Decrease) |
|
(Decrease) |
|
|
(Dollars in thousands) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
$ |
7,266 |
|
|
$ |
7,318 |
|
|
($ |
52 |
) |
|
|
(1 |
%) |
Hydrophilic and Other |
|
|
4,761 |
|
|
|
3,389 |
|
|
|
1,372 |
|
|
|
40 |
% |
Diagnostics |
|
|
3,678 |
|
|
|
2,031 |
|
|
|
1,647 |
|
|
|
81 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
15,705 |
|
|
$ |
12,738 |
|
|
$ |
2,967 |
|
|
|
23 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue. Second quarter revenue was $15.7 million, an increase of $3.0 million or 23% from
fiscal 2004. Growth was concentrated in two of our operating segments as detailed in the table
above. We provide a narrative of revenue for each of our three operating segments in the paragraphs
that follow.
Drug Delivery. Drug Delivery revenue decreased less than 1% to $7.3 million for the period
ending March 31, 2005. Growth in royalties and license fees was offset slightly by a decrease in
sales of reagent chemicals (chemicals that we manufacture and sell to licensees for coating their
medical devices) and a decrease in research and development revenue. Drug Delivery derives a
substantial majority of its revenue from royalties and license fees and product sales attributable
to Cordis Corporation, a Johnson & Johnson company, on its Cypher Sirolimus-eluting Coronary Stent.
The Cypher stent incorporates a proprietary SurModics coating that delivers a therapeutic drug
designed to reduce the occurrence of restenosis in coronary artery lesions. Revenue from sales of
reagents to Cordis decreased because of volume and unit price decreases. Research and development
revenue from Cordis also declined compared to the same period a year ago. In addition, prior to
January 18, 2005, a portion of our research and development revenue was attributable to InnoRx.
Following our acquisition of InnoRx on January 18, 2005, we no longer record revenue for research
and development activities in connection with the InnoRx technology.
We expect the significant decrease in reagent chemical sales to Cordis to continue for the
balance of fiscal 2005 when compared to prior year periods resulting from a contractual reduction
in reagent pricing and as Cordis continues to become more efficient in its manufacturing. In
addition, sequential quarterly royalty revenue could decrease because of possibly lower Cypher
sales as a result of continuing competition from Boston Scientific Corporations Taxus drug-eluting
stent.
Boston Scientific was granted approval by the FDA to begin marketing in the U.S. its Taxus
drug-eluting stent in our second fiscal quarter of 2004. The Taxus stent competes directly with
the Cypher stent and has gained market share leadership. We anticipate that while the overall
market for drug-eluting stents will continue to grow, quarterly royalty revenue from the current
generation Cypher stent will be volatile as the two sole U.S. marketers of drug-eluting stents
compete in the marketplace.
12
Management expects royalties from the Cypher stent to constitute a significant portion of our
revenue throughout fiscal 2005.
Hydrophilic and Other. Hydrophilic and Other revenue increased 40% to $4.8 million, driven by
growth in all three revenue sources, particularly increased royalties and license fees from many of
our several dozen licensees in this operating segment. Second quarter 2005 revenue also includes
$275,000 in back royalties recorded as a result of a settlement with Spectrantics, Inc. Excluding
the impact of the settlement, revenue increased 32% from the prior year period. Management expects
continued growth in Hydrophilic and Other when compared with prior year periods, but growth for the
remainder of fiscal 2005 is unlikely to be as strong as it was in the current three-month period.
Diagnostics. Diagnostics revenue increased 81% to $3.7 million. A substantial majority of the
growth resulted from increased royalty revenue under certain sublicenses, whose royalty streams we
purchased from Abbott. Prior to the purchase, the Company had been receiving only a portion of the
royalty revenue from the sublicenses. Diagnostics derives a significant percentage of its revenue
from GE Healthcare and Abbott Laboratories.
Effective February 1, 2005, the Company terminated its distribution agreement with SeraCare.
SurModics began distributing its line of stabilization products in the U.S. through SeraCare in
last years second quarter. Management believes product sales will increase when compared to prior
year results for the balance of fiscal 2005 because of the impact of selling directly to the U.S.
diagnostics industry, rather than through a distributor.
Product costs. Product costs were $730,000 for the second quarter, a 3% decrease from $752,000
last year. Overall product margins averaged 69% compared with 73% for the comparable period last
year. The margin decrease was primarily attributable to the contractual reduction in reagent
pricing with Cordis discussed above.
Research and development expenses. Research and development expenses were $3.9 million, an
increase of 24% compared with the same period in fiscal 2004. A majority of the increase reflects
the amortization cost associated with the sublicense royalty stream we purchased in the fourth
quarter of fiscal 2004, discussed above in Diagnostics, and additional costs associated with
preparing for the upcoming clinical trial of the intravitreal implant we acquired as part of the
InnoRx transaction. Management believes research and development expense will increase on a
sequential basis for the balance of fiscal 2005 due to anticipated expenses for development
activities and clinical trials associated with the recent acquisition of InnoRx.
Sales and marketing expenses. Sales and marketing expenses were $307,000 for the second
quarter of fiscal 2005, a 48% decrease from the prior year period. A substantial portion of the
decrease resulted from lower payroll costs associated with a reduction in marketing personnel in
connection with a company-wide reorganization in last years second quarter. Management
anticipates sales and marketing expense will increase sequentially for the remainder of fiscal 2005
as the Company expands its sales force.
General and administrative expenses. General and administrative expenses were $1.6 million
for the second quarter of fiscal 2005, a 4% increase compared with the same period in fiscal 2004
reflecting increased compensation cost. Management anticipates general and administrative expense
will increase modestly on a sequential basis for the balance of fiscal 2005.
Purchased in-process research and development. On January 18, 2005, the Company acquired all
of the assets of InnoRx, Inc. by paying cash and issuing shares of SurModics common stock to InnoRx
stockholders. Results in the second quarter of fiscal 2005 include a non-cash in-
13
process research and development charge of $30.3 million. The fair value of the in-process
research and development was determined by an outside valuation consultant.
Other income, net. Other income was $315,000 for the second quarter of fiscal 2005, an
increase of $112,000, or 55%, compared with the same period of fiscal 2004. The increase reflects
increased levels of investable cash and higher yields generated from our investment portfolio.
Previously reported fiscal 2004 results have been retroactively
adjusted to show the impact of accounting for
InnoRx under the equity method. Prior to completing the acquisition of InnoRx in January 2005, we
accounted for our investment in InnoRx under the cost method. See Note 8 to the financial
statements included in this report.
Income tax expense. The Companys income tax provision was $3.5 million for the second quarter
of fiscal 2005 compared with $2.6 million in the same period of fiscal 2004. Excluding the impact
of the $30.3 million in-process research and development charge, which is not tax deductible, the
effective tax rate was 37.5% for the second quarter of fiscal 2005, compared with 37.4% for the
second quarter of fiscal 2004. See Note 9 to the financial statements included in this report.
Six Months Ended March 31, 2005 and 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase |
|
% Increase |
|
|
Fiscal 2005 |
|
Fiscal 2004 |
|
(Decrease) |
|
(Decrease) |
|
|
(Dollars in thousands) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
$ |
14,387 |
|
|
$ |
14,217 |
|
|
$ |
170 |
|
|
|
1 |
% |
Hydrophilic and Other |
|
|
8,994 |
|
|
|
6,575 |
|
|
|
2,419 |
|
|
|
37 |
% |
Diagnostics |
|
|
6,393 |
|
|
|
4,033 |
|
|
|
2,360 |
|
|
|
59 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
29,774 |
|
|
$ |
24,825 |
|
|
$ |
4,949 |
|
|
|
20 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue. The Companys revenue was $29.8 million for the first six months of fiscal 2005, an
increase of $5.0 million, or 20%, compared with the same period of fiscal 2004. We provide a
narrative of revenue for each of our three operating segments in the paragraphs that follow.
Drug Delivery. Drug Delivery revenue increased 1% to $14.4 million for the first half of
fiscal 2005 compared with $14.2 million for the same period last year. Growth in royalties and
license fees as well as increased research and development revenue offset a decrease in reagent
sales. A portion of the growth in research and development revenue was attributable to revenue
from InnoRx prior to our acquisition of all of InnoRxs assets on January 18, 2005. Research and
development revenue is expected to decrease sequentially in future quarters partially as a result
of the InnoRx acquisition. In addition, we expect the significant decrease in reagent chemical
sales to Cordis to continue for the balance of fiscal 2005 when compared to prior year periods
resulting from a contractual reduction in reagent pricing and as Cordis continues to become more
efficient in its manufacturing. Finally, sequential quarterly royalty revenue could decrease due
to possibly lower Cypher sales as a result of continuing competition from Boston Scientific
Corporations Taxus drug-eluting stent.
Hydrophilic and Other. Hydrophilic and Other revenue increased 37% to $9.0 million for the
first six months of fiscal 2005, driven primarily by increased royalties and research and
development revenue. Second quarter 2005 revenue also includes $275,000 in back royalties recorded
as a result of a settlement with Spectrantics, Inc. Management expects continued growth in
Hydrophilic and Other when compared with prior year periods, but growth for the remainder of fiscal
2005 is unlikely to be as strong as it was in the first half of fiscal 2005.
14
Diagnostics. Diagnostics revenue increased 59% to $6.4 million. A substantial majority of the
growth resulted from increased royalty revenue under sublicenses, whose royalty streams we
purchased from Abbott. Prior to the purchase, the Company had been recording only a portion of the
royalty revenue from the sublicenses. Management expects continued growth in this royalty stream
compared with prior periods throughout the remainder of fiscal 2005. However, growth in the second
half of the year may not be as strong as it was in the first six months of 2005.
Product costs. Product costs were $1.3 million for the six months ended March 31, 2005, a 9%
decrease from the $1.5 million last year. Overall product margins averaged 69% compared with 72%
for the comparable period last year. The margin decrease is primarily attributable to a contractual
reduction in reagent pricing from Cordis. We expect the significant decrease in reagent chemical
sales to Cordis to continue for the balance of fiscal 2005, compared to prior year periods,
resulting from the contractual reduction in reagent pricing.
Research and development expenses. Research and development expenses were $7.2 million for
the first six months of fiscal 2005, an increase of 13% compared with the same period in fiscal
2004. The increase principally reflects increased patent related legal costs and the amortization
cost associated with the purchase from Abbott of the sublicense royalty stream discussed above in
Diagnostics and additional costs associated with preparing for the upcoming clinical trial on the
intravitreal implant we acquired from InnoRx.
Sales and marketing expenses. Sales and marketing expenses were $569,000 for the six months
ended March 31, 2005, a 43% decrease from prior year period. A substantial portion of the decrease
resulted from lower payroll costs related to a reduction in marketing personnel in connection with
a company-wide reorganization.
General and administrative expenses. General and administrative expenses were $2.8 million
for the first six months of fiscal 2005, a 4% decrease compared with the same period in fiscal
2004.
Purchased in-process research and development. On January 18, 2005, the Company acquired all
of the assets of InnoRx, Inc. by paying cash and issuing shares of SurModics common stock to InnoRx
stockholders. Results for the first six months of fiscal 2005 include a non-cash in-process
research and development charge of $30.3 million. The fair value of the in-process research and
development was determined by an outside valuation consultant.
Other income, net. Other income was $287,000 for the first six months of fiscal 2005, a
decrease of $212,000, or 42%, compared with the same period of fiscal 2004. The decrease was
attributable to investment losses, the bulk of which were related to the impact in the first
quarter of 2005 related to the change to equity method treatment of our investment in InnoRx. See
Note 8 to the financial statements included in this report.
Income tax expense. The Companys income tax provision was $6.9 million for the first six
months of fiscal 2005 compared with $5.0 million in the same period of fiscal 2004. Excluding the
impact of the $30.3 million in-process research and development charge, which is not tax
deductible, the effective tax rate was 38.3% for the first six months of fiscal 2005, compared with
37.5% for the same period last year. See Note 9 to the financial statements included in this
report.
Liquidity and Capital Resources
As of March 31, 2005, the Company had working capital of $18.0 million and cash, cash
equivalents and investments totaling $56.7 million. The Companys investments principally consist
of U.S. government and government agency obligations and investment grade, interest-bearing
corporate
15
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 generating
an above benchmark (Lehman Brothers 1-3 Year Government Index) total rate of return. Management
plans to continue to direct its investment advisor 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. The Company had positive cash flows from operating
activities of approximately $7.8 million in the first six months of fiscal 2005, compared with $4.0
million in the first six months of fiscal 2004.
SurModics conducts a significant majority of its operations at its Eden Prairie, Minnesota
headquarters. In addition, the Company owns a facility in Bloomington, Minnesota. Management
believes the Company has adequate office space and manufacturing capacity in its Eden Prairie
headquarters to support its business and strategic plan. As such, the Company is seeking to sell or
lease the Bloomington facility and plans to consolidate operations in Eden Prairie. Management is
currently evaluating plans for up to $8 million in capital improvements to increase the research
and development capabilities at its Eden Prairie location. Once plans are finalized, we expect to
begin construction during our fiscal third quarter.
In February 2004, the Company invested $2.1 million in InnoRx, Inc., an Alabama-based,
early-stage company developing drug delivery devices and therapies for the ophthalmology market.
SurModics made an additional investment of approximately $1.6 million in the first quarter of
fiscal 2005. On January 18, 2005, SurModics acquired all of InnoRxs assets through a merger of
InnoRx into SurModics by paying approximately $4.1 million in cash and issuing 600,064 shares of
SurModics common stock to InnoRx stockholders. Upon the successful completion of all development
and commercial milestones involving InnoRx technology acquired by SurModics, SurModics will be
required to issue up to a maximum of an additional 600,064 shares of its common stock to the
stockholders of InnoRx.
In January 2005, the Company made an equity investment of approximately $3.9 million in
OctoPlus, a privately owned company based in the Netherlands active in the development of
pharmaceutical formulations incorporating novel biodegradable polymers. The $3.9 million
investment, which is accounted for under the cost method, represents an ownership interest of less
than 20%.
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. The remaining installments are reflected
in Other long-term liabilities.
SurModics has invested a total of $5.2 million in Novocell, Inc., a privately-held Irvine,
California-based biotech firm that is developing a unique treatment for diabetes. Working with
Novocell, the Companys researchers have created a coating that encapsulates pancreatic islet
cells, the cells that produce insulin in the human body. If successful, this treatment using coated
islet cells could dramatically change the treatment of diabetes. While the Company anticipates that
its investment in Novocell will help facilitate the commercialization of its technology and result
in revenue for the Company in the future, there can be no assurance that this will occur.
Novocells primary technology is in its development stage, and we anticipate that it will be years
before commercialization may be realized. The $5.2 million investment, which is accounted for under
the cost method, is included in Other assets and represents an ownership interest of less than 5%.
16
Risks and uncertainties surrounding a development-stage companys ability to obtain on a
timely and frequent basis financing needed to continue its development activities currently affect,
and will continually affect, the prospects of the Companys investments in Novocell and OctoPlus
and the revenue they may ultimately generate. There is no assurance that Novocells current efforts
to meet its immediate financing needs will be successful or that future financing needs of Novocell
or OctoPlus will be met when required. If adverse results occur in Novocells or OctoPlus
development of its respective technology, or if their respective financing needs are not
continually met, the viability of such companies and their ability to be future sources of revenue
for the Company will be in jeopardy and the Companys investment in such companies would likely be
considered impaired and charged against the Companys earnings at such time.
As of March 31, 2005, the Company had no debt, nor did it have any credit agreements. The
Company believes that its existing capital resources will be adequate to fund SurModics operations
into the foreseeable future. The restatement reflected in this Form 10-Q/A to the Companys
condensed balance sheet does not affect the Companys liquidity or capital resources as the
contingent stock payment obligation does not, as originally recorded or as restated, require the
use of cash or other financial resources of the Company.
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, estimate, expect, intend, may, could,
possible, plan, project, will, forecast and similar words or expressions. Any statement
that is not a 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, and the impact of the Cordis agreement. One must 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 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; (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 SurModics 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
SurModics technologies; (v) the Companys significant dependence upon Cordis, which causes our
financial results and stock price to be subject indirectly to factors affecting Cordis and its
Cypher stent program, including among others, the rate of market penetration and product supply by
Cordis, the timing and impact 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 currently pending in U.S. District Court for
the District of Delaware (and scheduled for trial in June 2005) in which each alleges its patent
rights are being infringed by the others drug-eluting stent, (vi) the Companys ability to attract
new licensees in the Companys current
17
market segments and to enter into agreements for additional product 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; (vii) 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; (viii) the Companys ability to facilitate through strategic investment and research and
development the creation of new medical device market segments and applications that use its
coating technologies; (ix) market acceptance of products sold by customers incorporating SurModics
technologies and the timing of new product introductions by licensees; (x) market acceptance of
products sold by customers competitors and the timing and pricing of new product introductions by
customers competitors; (xi) 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; (xii) efficacy or safety concerns with respect to products
marketed by SurModics and its licensees, whether scientifically justified or not, that may lead to
product recalls, withdrawals or declining sales; (xiii) the Companys ability to manage
successfully clinical trials and related foreign and domestic regulatory processes for the
intravitreal implant or other products in development acquired from InnoRx, 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) economic and other factors over which the Company has no
control, including changes in inflation and consumer confidence; (xvii) acts of God or terrorism
which impact the Companys personnel or facilities; (xviii) any delays or quality problems in the
supply of raw materials used by the Company to manufacture its products, including some raw
materials that currently are being purchased only from single sources; (xix) the timing and success
of acquisitions made by the Company from time to time, including in particular with respect to the
Companys January 2005 acquisition of InnoRxs assets, and (xx) other factors described in the
Risk Factors and other sections of SurModics filings with the Securities and Exchange Commission
which are incorporated herein by reference. 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.
Because of its historical strategy, SurModics has not maintained significant manufacturing
operations, managed significant marketing, sales or product branding efforts or developed
significant expertise with respect to applying for and receiving governmental and regulatory
clearances for marketing products. SurModics may increasingly internally perform certain product
development activities and governmental and regulatory compliance activities with respect to
technology acquired from InnoRx, but there can be no assurance that SurModics efforts will be
effective in these areas.
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 derivative
financial instruments to manage interest rate risk or to speculate on future changes in interest
rates. A one percentage point
18
increase in interest rates would result in an approximate $835,000 decrease in the fair value
of the Companys available-for-sale securities as of March 31, 2005, 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
(a) 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 originally concluded that the Companys disclosure controls and procedures were 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 Exchange Commission.
In connection with the Companys preparation of the Form 10-Q for the period ended March 31,
2005 to which this Form 10-Q/A relates, the Company recorded an $8,090,000 liability for a
contingent stock payment obligation reflecting an event arising when the Company acquired InnoRx,
Inc. in January 2005. On August 5, 2005, in connection with the preparation of the Companys Form
10-Q for the period ended June 30, 2005, the Company determined that the initial fair value of the
contingent stock payment obligation should have been recorded as permanent equity rather than as a
liability . As a result, in this Form 10-Q/A, the Company is restating its condensed balance sheet
as of March 31, 2005 to reduce its previously reported other long-term liabilities by $8,090,000
and to increase its previously reported additional paid-in capital by $8,090,000.
After evaluating the events that led to the need for the restatement, the Companys Chief
Executive Officer and Chief Financial Officer concluded on August 5, 2005 that the design of the
Companys disclosure controls and procedures was effective but that in this instance a material
weakness occurred in the operation of such controls and procedures for complex non-routine
transactions. As a result, the Companys Chief Executive Officer and Chief Financial Officer
concluded that the disclosure controls and procedures were not effective as of March 31, 2005. The
Company has taken action to improve the operating effectiveness of such controls and procedures in
connection with complex non-routine transactions.
(b) Changes in internal control over financial reporting. There were no changes in our
internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act)
identified in connection with the evaluation described in Item 4(a) above that occurred during the
period covered by this quarterly report on Form 10-Q and that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
19
PART II OTHER INFORMATION
Item 1. Legal Proceedings.
None.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Security Holders.
Information regarding matters submitted to a vote of the Companys security holders during the
period covered by this report was previously reported in the Companys Form 10-Q for the quarterly
period ended December 31, 2004.
Item 5. Other Information.
None.
Item 6. Exhibits.
Exhibits
|
|
|
10.1
|
|
Amendment to the SurModics, Inc. 2003 Equity Incentive Plan* |
|
|
|
10.2
|
|
SurModics, Inc. Board Compensation Policy effective January 31, 2005* |
|
|
|
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 |
|
|
|
* |
|
Included in the original Form 10-Q filing to which this Form 10-Q/A relates, and not refiled herewith. |
20
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 10, 2005
|
|
By:
|
|
/s/ Philip D. Ankeny |
|
|
|
|
|
|
|
|
|
Philip D. Ankeny
Chief Financial Officer |
21
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
EXHIBIT INDEX TO FORM 10-Q/A
For the Quarter Ended March 31, 2005
SURMODICS, INC.
|
|
|
Exhibit |
|
Description |
10.1
|
|
Amendment to the SurModics, Inc. 2003 Equity Incentive Plan* |
|
|
|
10.2
|
|
SurModics, Inc. Board Compensation Policy effective January 31, 2005* |
|
|
|
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 |
|
|
|
* |
|
Included in the original Form 10-Q filing to which this Form 10-Q/A relates, and not refiled
herewith. |
22
exv31w1
EXHIBIT 31.1
CERTIFICATION PURSUANT TO SECTION 302
OF SARBANES-OXLEY ACT OF 2002
I, Bruce J Barclay, certify that:
1. I have reviewed this quarterly report on Form 10-Q/A of SurModics, 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 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 registrants other certifying officer 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)) for the registrant and we 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) Evaluated the effectiveness of the registrants 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
c) Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control over
financial reporting.
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants 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 registrants 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 registrants internal control over financial reporting.
|
|
|
|
|
Dated:
August 10, 2005
|
|
Signature:
|
|
/s/ Bruce J Barclay |
|
|
|
|
|
|
|
|
|
Bruce J Barclay |
|
|
|
|
Chief Executive Officer |
23
exv31w2
EXHIBIT 31.2
CERTIFICATION PURSUANT TO SECTION 302
OF SARBANES-OXLEY ACT OF 2002
I, Philip D. Ankeny, certify that:
1. I have reviewed this quarterly report on Form 10-Q/A of SurModics, 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 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 registrants other certifying officer 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)) for the registrant and we 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) Evaluated the effectiveness of the registrants 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
c) Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control over
financial reporting.
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants 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
registrants 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 registrants internal control over financial reporting.
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Dated:
August 10, 2005
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Signature:
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/s/ Philip D. Ankeny |
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Philip D. Ankeny |
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Chief Financial Officer |
24
exv32w1
EXHIBIT 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of SurModics, Inc. (the Company) on Form 10-Q/A for
the quarter ended March 31, 2005, as filed with the Securities and Exchange Commission (the
Report), I, Bruce J Barclay, Chief Executive Officer of the Company, certify, pursuant to 18
U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
(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.
Dated:
August 10, 2005
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/s/ Bruce J Barclay |
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Bruce J Barclay
Chief Executive Officer |
25
exv32w2
EXHIBIT 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of SurModics, Inc. (the Company) on Form 10-Q/A for
the quarter ended March 31, 2005, as filed with the Securities and Exchange Commission (the
Report), I, Philip D. Ankeny, Chief Financial Officer of the Company, certify, pursuant to 18
U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
(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.
Dated:
August 10, 2005
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/s/ Philip D. Ankeny |
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Philip D. Ankeny
Chief Financial Officer |
26