UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K/A
Amendment No. 3
| | |
[X] | | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For Fiscal Year Ended December 31, 2002
or
| | |
[ ] | | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT 1934 |
From the transition period from to
Commission file number 000-31255
ISTA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| | |
Delaware | | 33-0511729 |
(State or other jurisdiction of | | (I.R.S. Employer |
incorporation or organization) | | Identification No.) |
15279 Alton Parkway, Suite 100, Irvine, California 92618
(Address of principal executive offices)
(949) 788-6000
(Registrant’s telephone number)
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.001 par value
(Title of Class)
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ]
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K [ ]
Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2). Yes [ ] No [X]
As of June 28, 2002, the aggregate market value of the Registrant’s voting and non-voting common equities held by non-affiliates was approximately $11,525,000.
As of February 18, 2003 there were 13,291,017 shares of Common Stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
None.
TABLE OF CONTENTS
EXPLANATORY NOTE
This Amendment No. 3 to the Annual Report on Form 10-K/A for ISTA Pharmaceuticals, Inc. for the fiscal year ended December 31, 2003 (the “Report”) supplements the Report by filing Exhibits 10.37, 10.38, 10.39, 10.42, 10.43, 99.1 and 99.2. No further revisions have been made to the previously filed Report.
i
PART IV
Item 15:Exhibits, Financial Statement Schedules and Reports on Form 8-K
| | | | |
Exhibit Number | | Description |
| |
|
| 3.1 | | | Restated Certificate of Incorporation of registrant (1)
|
| 3.2 | | | Certificate of Correction to Restated Certificate of Incorporation (1)
|
| 3.3 | | | Certificate of Correction to Restated Certificate of Incorporation (2)
|
| 3.3 | | | Bylaws of the registrant, as amended (3)
|
| 3.4 | | | Certificate of Amendment to Bylaws of the registrant (1)
|
| 4.1 | | | Specimen common stock certificate (3)
|
| 4.2 | | | Preferred Stock Rights Agreement, dated as of December 31, 2001, between the registrant and Mellon Investor Services LLC (4)
|
| 4.3 | | | First Amendment to the Preferred Stock Rights Agreement with Mellon Investor Services LLC, dated November 18, 2002 (5)
|
| 10.1 | | | Amended and Restated Investors Rights Agreement dated as of March 29, 2000 (3)
|
| 10.2 | | | 1993 Stock Plan and forms of agreements thereunder (3)
|
| 10.3 | | | 2000 Stock Plan, as amended, and forms of agreements thereunder (3)
|
| 10.4 | | | 2000 Employee Stock Purchase Plan, as amended (3)
|
| 10.5 | | | Form of Indemnification Agreement with executive officers and directors (3)
|
| 10.6 | | | Clinical Development Agreement between Covance, Inc. and the registrant dated as of October 28, 1998, as amended (3)
|
| 10.7 | | | Agreement between CroMedica Global Inc. and the registrant as of September 8, 1998 (3)
|
| 10.8 | | | Agreement between CroMedica Global Inc. and the registrant as of May 19, 1999 (3)
|
| 10.9 | | | Lease between the registrant and Aetna Life Insurance Company dated September 13, 1996 for leased premises located at Suite 100, 15279 Alton Parkway, Irvine, California (3)
|
| 10.10 | | | Distributor Agreement between Laboratorios Sophia S.A. de C.V. and the registrant as of April 23, 1998 (3)
|
| 10.11 | | | Supply Agreement between Biozyme Laboratories, Ltd. and the registrant as of September 23, 1999 (3)
|
| 10.12 | | | License Agreement between Allergan Sales, Inc., Allergan Sales, Ltd. and the registrant as of March 29, 2000 (3),(6)
|
| 10.13 | | | Supply Agreement between Allergan Sales, Inc., Allergan Sales, Ltd. and the registrant as of March 29, 2000 (3),(6)
|
| 10.14 | | | Amendment No. 1 to Contract Clinical Research Agreement with CroMedica Global, Inc., dated May 19, 1999 (7)
|
1
| | | | |
Exhibit Number | | Description |
| |
|
| 10.15 | | | Amendment No. 2 to Contract Clinical Research Agreement with CroMedica Global, Inc., dated May 19, 1999 (7)
|
| 10.16 | | | License Agreement between Otsuka Pharmaceutical Co., Ltd., and the registrant, dated as of December 13, 2001 (6),(8)
|
| 10.17 | | | Supply Agreement between Otsuka Pharmaceutical Co., Ltd., and the registrant, dated as of December 13, 2001 (6),(8)
|
| 10.18 | | | Securities Purchase Agreement between Otsuka Pharmaceutical Co., Ltd., and the registrant, dated as of December 13, 2001 (6),(8)
|
| 10.19 | | | Registration Rights Agreement between Otsuka Pharmaceutical Co., Ltd., and the registrant, dated as of December 13, 2001 (6),(8)
|
| 10.20 | �� | | Amendment No. 3 to Contract Clinical Research Agreement with CroMedica Global, Inc., dated December 5, 2001 (9)
|
| 10.21 | | | Executive Employment Agreement between Vicente Anido, Jr., Ph.D. and the registrant, dated December 21, 2001 (9)
|
| 10.22 | | | Stand-Alone Stock Option Agreement between Vicente Anido, Jr., Ph.D. and the registrant, dated December 21, 2001 (9)
|
| 10.23 | | | Transition and Release Agreement between Edward H. Danse and the registrant, dated January 2, 2002 (9)
|
| 10.24 | | | Facility Lease Amendment No. 1 with Alton Plaza Property, Inc. (9)
|
| 10.25 | | | Facility Lease Amendment No. 2 with Alton Plaza Property, Inc. (9)
|
| 10.26 | | | Asset Purchase and Sale Agreement with AcSentient, Inc., dated May 3, 2002 (10)
|
| 10.27 | | | Master Services Agreement with R.P. Scherer West, Inc. doing business as SP Pharmaceuticals, dated June 7, 2002 (11)
|
| 10.28 | | | Form of Change in Control Severance Agreement with certain officers (12)
|
| 10.29 | | | Form of Change in Control Severance Agreement with (Thomas A. Mitro and Kirk McMullin.) (12)
|
| 10.30 | | | Note and Warrant Purchase Agreement between the registrant and Investors, dated September 19, 2002
|
| 10.31 | | | Form of Senior Secured Convertible Promissory Note issued under the Note and Warrant Purchase Agreement (13)
|
| 10.32 | | | Form of Warrant issued under the Note and Warrant Purchase Agreement (13)
|
| 10.33 | | | Common Stock and Warrant Purchase Agreement between the registrant and Investors, dated September 19, 2002
|
| 10.34 | | | Form of Warrant to be issued under the Common Stock and Warrant Purchase Agreement (13)
|
| 10.35 | | | Individual Non-Qualified Stock Option Agreement between Thomas A. Mitro and the registrant, dated July 1, 2002 (14)
|
| 10.36 | | | Individual Non-Qualified Stock Option Agreement between Kirk McMullin and the registrant, dated August 5, 2002 (14)
|
| 10.37 | | | Bausch & Lomb Pharmaceuticals, Inc. Contract Manufacturing Supply Agreement with registrant, dated November 25, 2002 (6)
|
| 10.38 | | | Bausch & Lomb Pharmaceuticals, Inc. Contract Manufacturing Supply Agreement with registrant, dated February 6, 2003 (6)
|
| 10.39 | | | License Agreement between the Eastern Virginia School of Medicine, and AcSentient, Inc., dated as of January 29, 2002 (6)
|
| 10.40 | | | Addendum between the Eastern Virginia School of Medicine, and AcSentient, Inc., dated as of April 30, 2002 (6), (15)
|
| 10.41 | | | Letter regarding consent to assignment of License Agreement from AcSentient, Inc. to the Eastern Virginia School of Medicine, dated April 26, 2002 (15)
|
2
| | | | |
Exhibit Number | | Description |
| |
|
| 10.42 | | | License Agreement between Senju Pharmaceutical Co., Ltd. and AcSentient, Inc., dated March 7, 2002 (6)
|
| 10.43 | | | Agreement between Senju Pharmaceutical Co., Ltd. and AcSentient, Inc., dated April 17, 2002 (6)
|
| 10.44 | | | Series D Preferred Stock Purchase Agreement between Allergan Pharmaceuticals (Ireland) Ltd., Inc., and registrant, dated as of March 29, 2000 (3)
|
| 10.45 | | | Amendment to Bromfenac License Agreement between Senju Pharmaceutical Co., Ltd., and registrant, dated August 13, 2002 (6), (15)
|
| 10.46 | | | Amendment to Timolol Agreement between Senju Pharmaceutical Co., Ltd., and registrant, dated August 13, 2002 (6), (15)
|
| 21.1 | | | Subsidiaries of the registrant (1)
|
| 99.1 | | | President and Chief Executive Officer’s Certification Pursuant to Section 1350, Chapter 63 of Title 18 of the United States Code, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
| 99.2 | | | Chief Financial Officer and Vice President, Corporate Development’s Certification Pursuant to Section 1350, Chapter 63 of Title 18 of the United States Code, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
(1) | | Incorporated by reference to the registrant’s report on Form 10-K for the year ended December 31, 2002, filed with the Commission on March 7, 2003. |
|
|
|
|
(2) | | Incorporated by reference from the registrant’s report on Form 8-K filed with the Commission on April 9, 2003. |
|
|
|
|
(3) | | Incorporated by reference to the registrant’s Registration Statement on Form S-1 (File No. 333-34120). |
|
|
|
|
(4) | | Incorporated by reference to the registrant’s report on Form 8-A filed with the Commission on January 22, 2002. |
|
|
|
|
(5) | | Incorporated by reference from the registrant’s Registration Statement on Form 8-A12G/A filed with the Commission on November 19, 2002. |
|
|
|
|
(6) | | Confidential treatment requested as to certain portions. |
|
|
|
|
(7) | | Incorporated by reference to the registrant’s report on Form 10-K for the year ended December 31, 2000, filed with the Commission on March 30, 2001. |
|
|
|
|
(8) | | Incorporated by reference from the registrant’s report on Form 8-K filed with the Commission on January 2, 2002. |
|
|
|
|
(9) | | Incorporated by reference from the registrant’s report on Form 10-K for the year ended December 31, 2001, filed with the Commission on April 1, 2002. |
|
|
|
|
(10) | | Incorporated by reference from the registrant’s report on Form 8-K filed with the Commission on May 6, 2002. |
|
|
|
|
(11) | | Incorporated by reference from the registrant’s report on Form 8-K filed with the Commission on July 9, 2002. |
|
|
|
|
(12) | | Incorporated by reference from the registrant’s report on Form 10-Q for the period ended June 30, 2002 filed with the Commission on August 14, 2002. |
|
|
|
|
(13) | | Incorporated by reference from the registrant’s report on Form 8-K filed with the Commission September 25, 2002. |
3
(14) | | Incorporated by reference from the registrant’s Registration Statement on Form S-8 filed with the Commission on February 18, 2003. |
|
|
|
|
(15) | | Incorporated by reference from the registrant’s report on Form 10-K/A for the period ended December 31, 2002 filed with the Commission on April 30, 2003. |
4
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Amendment No. 3 to its Annual Report on Form 10-K/A to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Irvine, State of California, on June 3, 2003.
| | |
By: | | /s/ VICENTE ANIDO, JR. |
|
|
| | Vicente Anido, Jr., Ph.D. |
| | President and Chief Executive Officer |
Pursuant to the requirements of the Securities Exchange Act of 1934, this Form 10-K has been signed by the following persons in the capacities and on the dates indicated.
| | | | |
|
Signature | | Title | | Date |
| |
| |
|
/s/ VICENTE ANIDO, JR. | | | | |
| | President, Chief Executive Officer and Director | | June 3, 2003 |
Vicente Anido, Jr., Ph.D. | | | | |
| | | | |
/s/ LAUREN P. SILVERNAIL | | Chief Financial Officer and Vice President, | | |
| | Corporate Development | | June 3, 2003 |
Lauren P. Silvernail | | | | |
| | | | |
/s/ ROBERT G. MCNEIL * | | | | |
| | Chairman of the Board | | June 3, 2003 |
Robert G. McNeil, Ph.D. | | | | |
| | | | |
/s/ JEFFREY L. EDWARDS * | | | | |
| | Director | | June 3, 2003 |
Jeffrey L. Edwards | | | | |
| | | | |
/s/ BENJAMIN F. MCGRAW III * | | | | |
| | Director | | June 3, 2003 |
Benjamin F. McGraw III | | | | |
| | | | |
/s/ PETER BARTON HUTT * | | | | |
| | Director | | June 3, 2003 |
Peter Barton Hutt | | | | |
| | | | |
/s/ KATHLEEN D. LAPORTE * | | | | |
| | Director | | June 3, 2003 |
Kathleen D. LaPorte | | | | |
| | | | |
/s/ LIZA PAGE NELSON * | | | | |
| | Director | | June 3, 2003 |
Liza Page Nelson | | | | |
| | | | |
/s/ RICHARD C. WILLIAMS * | | | | |
| | Director | | June 3, 2003 |
Richard C. Williams | | | | |
| | | | |
/s/ WAYNE I. ROE * | | | | |
| | | | |
Wayne I. Roe | | Director | | June 3, 2003 |
| |
*By: | /s/ VICENTE ANIDO, JR. |
|
|
| Vicente Anido, Jr. (Attorney-in-fact) |
|
5
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
I, Vicente Anido, Jr., Ph.D., certify that:
1. I have reviewed this annual report on Form 10-K, as amended, of ISTA Pharmaceuticals, Inc.;
2. Based on my knowledge, this annual 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 annual report;
3. Based on my knowledge, the financial statements, and other financial information included in this annual 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 annual report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have:
| | a. designed such disclosure controls and procedures 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 annual report is being prepared; |
|
| | b. evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the “Evaluation Date”); and |
|
| | c. presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the evaluation functions):
| | a. all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and |
|
| | b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and |
6. The registrant’s other certifying officer and I have indicated in this annual report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: June 3, 2003
/s/ VICENTE ANIDO, JR., Ph.D
Vicente Anido, Jr., Ph.D.
President and Chief Executive Officer
6
CERTIFICATION OF CHIEF FINANCIAL OFFICER
I, Lauren P. Silvernail, certify that:
1. I have reviewed this annual report on Form 10-K, as amended, of ISTA Pharmaceuticals, Inc.;
2. Based on my knowledge, this annual 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 annual report;
3. Based on my knowledge, the financial statements, and other financial information included in this annual 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 annual report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have:
| | a. designed such disclosure controls and procedures 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 annual report is being prepared; |
|
| | b. evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the “Evaluation Date”); and |
|
| | c. presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the evaluation functions):
| | a. all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and |
|
| | b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and |
6. The registrant’s other certifying officer and I have indicated in this annual report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: June 3, 2003
/s/ Lauren P. Silvernail
Lauren P. Silvernail
Chief Financial Officer and Vice
President, Corporate Development7