UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q/A
(Amendment No. 1)
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2011
or
¨ | 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: 001-32836
MEDIVATION, INC.
(Exact name of registrant as specified in its charter)
Delaware | 13-3863260 | |
(State or other jurisdiction of incorporation or organization) |
(IRS Employer identification No.) |
525 Market Street, 36th floor
San Francisco, California 94105
(Address of principal executive offices) (Zip Code)
(415) 543-3470
(Registrants telephone number, including area code)
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 whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ¨ | Accelerated filer | x | |||
Non-accelerated filer | ¨ (Do not check if a smaller reporting company) | Smaller reporting company | ¨ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
As of August 3, 2011, 34,907,994 shares of the registrants Common Stock, $0.01 par value per share, were outstanding.
EXPLANATORY NOTE
We are filing this Amendment No. 1 to Quarterly Report on Form 10-Q/A (this Amendment) to amend our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2011, as filed with the Securities and Exchange Commission (the SEC) on August 9, 2011 (the Form 10-Q). This Amendment is being filed solely to file Exhibit 10.2 to the Form 10-Q (certain portions of which are omitted pursuant to a confidential treatment request filed with the SEC). In addition, as required by Rule 12b-15 under the Securities Exchange Act of 1934, as amended, new certifications by our principal executive officer and principal financial officer are filed as exhibits hereto.
No attempt has been made in this Amendment to modify or update the other disclosures presented in the Form 10-Q, including the change in our filing status to a large accelerated filer. This Amendment does not reflect events occurring after the filing of the Form 10-Q (i.e., occurring after August 9, 2011) or modify or update those disclosures that may be affected by subsequent events. Such subsequent matters are addressed in subsequent reports filed by the registrant with the SEC. Accordingly, this Amendment should be read in conjunction with the Form 10-Q and the registrants other filings with the Securities and Exchange Commission.
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. 1 to Quarterly Report on Form 10-Q/A to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: March 24, 2014 | MEDIVATION, INC. | |||||
By: | /s/ C. Patrick Machado | |||||
Name: | C. Patrick Machado | |||||
Title: | Chief Business Officer and Chief Financial Officer (Duly Authorized Officer and Principal Financial Officer) |
EXHIBIT INDEX
Exhibit |
Exhibit Description |
Incorporated by Reference | Filed Herewith | |||||||||
Form | File No. | Exhibit | Filing Date | |||||||||
10.2* | Amendment No. 2 to Collaboration Agreement, dated May 13, 2011, by and among Medivation, Inc., Astellas Pharma Inc. and Astellas US LLC. | X | ||||||||||
31.1 | Certification pursuant to Rule 13a-14(a)/15d-14(a). | X | ||||||||||
31.2 | Certification pursuant to Rule 13a-14(a)/15d-14(a). | X |
* | Confidential treatment has been requested with respect to certain portions of this exhibit. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit 10.2
AMENDMENT NO. 2 TO COLLABORATION AGREEMENT
This Amendment No. 2 (this Amendment) is entered into this 13th day of May, 2011 (Amendment Effective Date), by and among MEDIVATION, INC., a Delaware corporation having its principal place of business at 201 Spear Street, 3rd Floor, San Francisco, California 94105, United States, its wholly owned subsidiary MEDIVATION PROSTATE THERAPEUTICS, INC., a Delaware corporation having its principal place of business at the same location (such entities, collectively, Medivation), ASTELLAS PHARMA INC., a Japanese corporation having its principal place of business at 3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 103-8411, Japan (API) and its indirect wholly owned subsidiary Astellas US LLC, a Delaware limited liability company having its principal place of business at Three Parkway North, Deerfield, Illinois 60015, United States (AUS; collectively with API, Astellas) and amends the Collaboration Agreement effective as of October 26, 2009 as previously amended (the Collaboration Agreement). Medivation and Astellas are sometimes referred to herein individually as a Party and collectively as the Parties. Unless otherwise expressly provided in this Amendment, all definitions in the Collaboration Agreement shall be also applicable to this Amendment. All references to Sections Articles and Exhibits refer to sections, articles and exhibits of the Collaboration Agreement.
RECITALS
WHEREAS, in a meeting on March 4, 2010, in accordance with Section 2.3(b)(xii)(C), the JDC determined to recommend to the JSC as the second pivotal Clinical Trial to be initiated under the Collaboration the protocol entitled PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy (the Clinical Trial identified by such protocol shall be referred to as the PREVAIL Trial); and
WHEREAS, on March 6, 2010, in accordance with Section 2.2(c)(iii), the JSC (by phone and e-mail) endorsed the PREVAIL Trial as the second pivotal Clinical Trial to be initiated under the Collaboration; and
WHEREAS, on September 28, 2010, the first patient was dosed in the PREVAIL Trial; and
WHEREAS, on October 27, 2010, Astellas, [ * ] paid Medivation the sum of Ten Million Dollars ($10,000,000.00) as consideration for achieving the first patient dosing in a Phase 3 Clinical Trial to support receipt of a Regulatory Approval for the Chemo-Naïve CRPC Indication, in accordance with Section 9.4(a); and
WHEREAS, the Parties have been in discussions regarding [ * ] with respect to whether the [ * ] has been [ * ] to [ * ] of [ * ] for [ * ] and the [ * ], such that [ * ] should [ * ] under Section [ * ] with respect to the [ * ] in the [ * ] for the [ * ]; and
WHEREAS, the Parties wish to [ * ].
NOW, THEREFORE, in consideration for the foregoing premises and the mutual promises and covenants and conditions in this Amendment, the Parties hereby agree to amend the Collaboration Agreement as follows
1. The HSPC Patient Dosing Milestone.
1.1 Within [ * ] days of the Amendment Effective Date, Astellas shall pay Medivation the sum of Three Million Dollars ($3,000,000.00). Such payment shall constitute a portion of the Ten Million Dollar ($10,000,000.00) milestone payment that is due upon achievement of the first patient dosed in a Phase 3 Clinical Trial with respect to the HSPC Indication under Section 9.4(a) (the HSPC Patient Dosing Milestone).
1.2 The remaining Seven Million Dollars ($7,000,000.00) of the HSPC Patient Dosing Milestone shall be deferred, and shall become payable within [ * ] of the earlier to occur of: (i) the first to occur Regulatory Approval for a Product with a label Encompassing the HSPC Indication obtained in any one of the Shared Territory,
the First Country in EU5 or Japan; or (ii) the first patient dosed in any Phase 3 Clinical Trial other than the PREVAIL Trial initiated under the Collaboration Agreement that is designed specifically to support receipt of Regulatory Approval for the HSPC Indication (it being understood that nothing in this Amendment shall require either Party to Initiate or fund any such other study). If neither of (i) nor (ii) occurs during the Term, Astellas [ * ] pay the [ * ] of the [ * ] Milestone, [ * ] milestone amounts shall be payable for the [ * ] of a [ * ] for the [ * ] or the [ * ] and Medivation shall in any event be permitted to retain the Three Million Dollars ($3,000,000.00) payable pursuant to Section 1.1 of this Amendment. Upon Astellass payment of the [ * ], [ * ] milestone amounts under Section 9.4(a) shall be payable for the [ * ] of a [ * ] for [ * ] or the [ * ].
2. The US HSPC Indication Filing Milestone if Based on [ * ].
2.1 Under Section 9.4(a) of the agreement, a milestone payment of Fifteen Million Dollars ($15,000,000.00) is payable within [ * ] after the first acceptance for filing of an NDA seeking approval of a Product for the HSPC Indication (the US HSPC Indication Filing Milestone). If such [ * ], and if, but only if, the [ * ] in such [ * ] the [ * ] of the [ * ] for the [ * ] is the [ * ], the parties will discuss in good faith and agree within [ * ] after such [ * ] whether [ * ] of the [ * ] should [ * ]. Such discussions and agreement will be governed by Section 5 below.
2.2 If [ * ] of the [ * ] is so [ * ], such [ * ] shall be paid within [ * ] following the earlier to occur of: (i) [ * ] of [ * ] for a [ * ] in the [ * ] with [ * ] the [ * ]; or (ii) the [ * ] in the [ * ] of [ * ] for the [ * ] in which the [ * ] to [ * ] of the [ * ] for the [ * ] is [ * ] the [ * ] (it being understood that nothing in this Amendment shall require either Party to [ * ] or [ * ]). If neither (i) nor (ii) occurs during the Term, Astellas [ * ] pay the [ * ] of the [ * ], [ * ] milestone amounts shall be payable for the [ * ] of [ * ] in the [ * ] for the [ * ], and Medivation shall in any event be permitted to retain [ * ] the [ * ] payable on the applicable Current Payment Date pursuant to Section 5.1 of this Amendment. Upon Astellass payment of the [ * ] of the [ * ], [ * ] milestone amounts under Section 9.4(a) shall be payable for the [ * ] of [ * ] in the [ * ] of [ * ] for the [ * ].
3. The EU HSPC Indication Filing Milestone if Based on [ * ].
3.1 Under Section 9.4(a) of the agreement, a milestone payment of Ten Million Dollars ($10,000,000.00) is payable within [ * ] after the first acceptance for filing of an MAA in the First Country of EU5 seeking approval of a Product for the HSPC Indication (the EU HSPC Indication Filing Milestone). If such [ * ], and if, but only if, the [ * ] in such [ * ] the [ * ] of the [ * ] for the [ * ] is the [ * ], the parties will discuss in good faith and agree within [ * ] after such [ * ] whether [ * ] of the [ * ] should be [ * ]. Such discussions and agreement will be governed by Section 5 below.
3.2 If [ * ] of the [ * ] is so [ * ], such [ * ] shall be paid within [ * ] following the earlier to occur of: (i) [ * ] of [ * ] for [ * ] in the [ * ] with [ * ] the [ * ]; or (ii) the [ * ] in the [ * ] of a [ * ] for the [ * ] in which the [ * ] to [ * ] of the [ * ] for the [ * ] is [ * ] the [ * ] (it being understood that nothing in this Amendment shall require either Party to [ * ] or [ * ]). If neither (i) nor (ii) occurs during the Term, Astellas [ * ] pay the [ * ] of the [ * ], [ * ] milestone amounts shall be payable for the [ * ] of [ * ] in the [ * ] for [ * ], and Medivation shall in any event be permitted to retain [ * ] the [ * ] payable on the applicable Current Payment Date pursuant to Section 5.1 of this Amendment. Upon Astellass payment of the [ * ] of the [ * ], [ * ] milestone amounts under Section 9.4(a) shall be payable for the [ * ] of [ * ] in the [ * ] of [ * ] for the [ * ].
4. The JP HSPC Indication Filing Milestone if Based on [ * ].
4.1 Under Section 9.4(a) of the agreement, a milestone payment of Ten Million Dollars ($10,000,000.00) is payable within [ * ] after the first acceptance for filing of an MAA in Japan seeking approval of a Product for the HSPC Indication (the JP HSPC Indication Filing Milestone). If such [ * ], and if, but only if, the [ * ] in such [ * ] the [ * ] of the [ * ] for the [ * ] is the [ * ], the parties will discuss in good faith and agree within [ * ] after such [ * ] whether [ * ] of the [ * ] should be [ * ]. Such discussions and agreement will be governed by Section 5 below.
4.2 If [ * ] of the [ * ] is so [ * ], such [ * ] shall be paid within [ * ] following the earlier to occur of: (i) [ * ] of [ * ] for [ * ] in [ * ] with [ * ] the [ * ]; or (ii) the [ * ] in [ * ] of a [ * ] for the [ * ] in which the [ * ] to [ * ] of the [ * ] for the [ * ] is [ * ] the [ * ] (it being understood that nothing in this Amendment shall require either Party to [ * ] or [ * ]). If neither (i) nor (ii) occurs during the Term, Astellas [ * ] pay the [ * ] of the [ * ], [ * ]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
milestone amounts shall be payable for the [ * ] of [ * ] in [ * ] for the [ * ], and Medivation shall in any event be permitted to retain [ * ] the [ * ] payable on the applicable Current Payment Date pursuant to Section 5.1 of this Amendment. Upon Astellass payment of the [ * ] of the [ * ], [ * ] milestone amounts under Section 9.4(a) shall be payable for the [ * ] of [ * ] in [ * ] of [ * ] for the [ * ].
5. Good Faith Discussions and Agreement.
5.1 The guiding principle for good faith discussions to be held and agreement to be reached pursuant to Sections 2.1, 3.1 and/or 4.1 of this Amendment will be the [ * ], estimated reasonably and in good faith by the parties, that assuming the applicable [ * ] is [ * ], the [ * ] will [ * ] (the [ * ]). Once the [ * ] is determined by the parties, [ * ] the applicable [ * ] the [ * ] shall be paid within [ * ] following the end of the [ * ] good faith discussion period pursuant to Section 2.1, 3.1 and/or 4.1 (each such date a Current Payment Date), and the [ * ] of the [ * ] shall be [ * ] as provided in Sections 2.2, 3.2 and/or 4.2 of this Amendment, as applicable. The [ * ] will be determined [ * ] with respect to [ * ] and [ * ]. In determining the [ * ], the following rules will apply:
(a) If and after [ * ] or [ * ] for [ * ] is [ * ] the applicable [ * ] and the [ * ] is the [ * ] as the [ * ] the [ * ] of [ * ] in [ * ], then:
(i) If the applicable [ * ] has [ * ] such [ * ] for [ * ] with [ * ] the [ * ], the presumption shall be that the applicable [ * ] shall be [ * ] on the applicable [ * ], and [ * ] shall be [ * ]; provided, however, that this presumption may be rebutted by Astellas based on any [ * ] the [ * ] and/or [ * ] of [ * ] and the [ * ] that can reasonably be expected to have a [ * ] notwithstanding such [ * ]; and
(ii) If the applicable [ * ] has [ * ] such [ * ] for [ * ], or if the applicable [ * ] has [ * ] such [ * ] with [ * ] the [ * ], the presumption shall be that the applicable [ * ] shall be [ * ]; provided, however, that this presumption may be rebutted by Medivation based on any [ * ] the [ * ] and/or [ * ] of [ * ] and the [ * ] that can reasonably be expected to have [ * ] notwithstanding such [ * ].
(b) In all other circumstances, the [ * ] shall be based on the following factors, all as evaluated reasonably and in good faith by the Parties:
(i) the [ * ] of the applicable [ * ] in [ * ];
(ii) the overall [ * ] of the applicable [ * ] as assessed based upon [ * ];
(iii) the similarity and difference between (i) the [ * ] and the [ * ] of the [ * ] and (ii) the [ * ] and [ * ] of [ * ]; and
(iv) [ * ] and any other relevant factors, whether in existence as of the date of this Amendment or arising hereafter, that may reasonably be expected to affect the [ * ].
5.2 For avoidance of confusion:
(a) In this Amendment, a [ * ] for [ * ] with [ * ] shall mean a [ * ], under any applicable laws and regulations, the [ * ] of [ * ] to any [ * ] (subject to [ * ] for [ * ] and [ * ] and the like), even if such [ * ] also [ * ] or [ * ] of [ * ] or [ * ].
(b) This Amendment shall not apply to any other milestones specified in Section 9.4(a) of the Collaboration Agreement, including without limitation the milestones due upon [ * ] of [ * ] for the [ * ].
(c) The [ * ] shall [ * ] to account for [ * ] that the applicable [ * ] will be [ * ] by the applicable [ * ], but only for [ * ] that such [ * ], [ * ], will [ * ].
6. Miscellaneous.
6.1 Section 1 of this Amendment expressly supersedes the [ * ] under Section 9.4(a) and [ * ]. Section 9.4(a) of the Agreement is amended to reflect the provisions of Sections 2, 3, 4 and 5 of this Amendment. Except as specifically amended herein, the Collaboration Agreement remains in full force and effect. Wherever the terms of this Amendment and the Collaboration Agreement conflict, the terms of this Amendment shall govern and control.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
6.2 This Amendment may be executed in counterparts, which together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties have executed this Amendment by their duly authorized officers as of the Amendment Effective Date.
MEDIVATION, INC. | ASTELLAS PHARMA INC. | |||||||
By: | /s/ C. Patrick Machado |
By: | /s/ Yoshihiko Hatanaka | |||||
Name: | C. Patrick Machado | Name: | Yoshihiko Hatanaka | |||||
Title: | CFO / CBO | Title: | Senior Corporate Executive, CFO and Chief Strategy Officer | |||||
MEDIVATION PROSTATE THERAPEUTICS, INC. | ASTELLAS US LLC | |||||||
By: | /s/ C. Patrick Machado |
By: | /s/ Masao Yoshida | |||||
Name: | C. Patrick Machado | Name: | Masao Yoshida | |||||
Title: | CFO / CBO | Title: | President and CEO |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR RULE 15d-14(a)
I, David T. Hung, M.D., certify that:
1. I have reviewed this Form 10-Q/A of Medivation, Inc.; and
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.
Date: March 24, 2014
/s/ David T. Hung, M.D. | ||
Name: | David T. Hung, M.D. | |
Title: | President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR RULE 15d-14(a)
I, C. Patrick Machado, certify that:
1. I have reviewed this Form 10-Q/A of Medivation, Inc.; and
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.
Date: March 24, 2014
/s/ C. Patrick Machado | ||
Name: | C. Patrick Machado | |
Title: | Chief Business Officer and Chief Financial Officer |