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Indiana | 001-06351 | 35-0470950 | ||
(State or Other Jurisdiction | (Commission | (I.R.S. Employer | ||
of Incorporation) | File Number) | Identification No.) | ||
Lilly Corporate Center | 46285 | |||
Indianapolis, Indiana | (Zip Code) | |||
(Address of Principal | ||||
Executive Offices) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure | ||||||||
Item 8.01. Other Events. | ||||||||
Item 9.01. Financial Statements and Exhibits | ||||||||
SIGNATURE | ||||||||
EXHIBIT INDEX | ||||||||
EX-10.1 | ||||||||
EX-99.1 |
Item 7.01. | Regulation FD Disclosure. |
Item 8.01. | Other Events. |
Item 9.01. | Financial Statements and Exhibits. |
Exhibit Number | Description | |
10.1
|
Form of Performance Award with two-year award period | |
99.1
|
Press release dated December 11, 2008 |
2
ELI LILLY AND COMPANY (Registrant) |
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By: | /s/ James B. Lootens | |||
Name: | James B. Lootens | |||
Title: | Secretary and Deputy General Counsel | |||
3
Exhibit Number | Exhibit | |
10.1
|
Form of Performance Award with two-year award period | |
99.1
|
Press release dated December 11, 2008 |
4
Box 1 | Box 2 | Box 3 | Box 4 | Box 5 | Box 6 | Box 7 | Box 8 | |||||||||||||||||||||||||
$ | X | $ | X | $ | X | $ | X | $ | X | $ | X | |||||||||||||||||||||
Aggregate EPS |
< $X | | | | | | | > $X | ||||||||||||||||||||||||
$ | X | $ | X | $ | X | $ | X | $ | X | $ | X | |||||||||||||||||||||
% of
Target |
0 | % | 50 | % | 75 | % | 100 | % | 125 | % | 150 | % | 175 | % | 200 | % |
Answers That Matter. |
A. Recitals |
3 | |||
B. Performance Award |
3 | |||
Section 1. Statement of Award Period |
3 | |||
Section 2. Number of Shares |
3 | |||
Section 3. Computation of EPS |
4 | |||
Section 4. Determination and Announcement of Award |
4 | |||
Section 5. Committee Election to Pay Cash |
4 | |||
Section 6. Issuance or Transfer of Performance Shares and Payment of Cash Award |
4 | |||
Section 7. Restricted Stock Units |
5 | |||
Section 8. Consideration for Continued Employment Requirement |
5 | |||
Section 9. Adjustments for Certain Employment Status Changes |
5 | |||
Section 10. Compensation Recovery |
6 | |||
Section 11. Notices, Payments and Electronic Delivery and Participation |
6 | |||
Section 12. Waiver |
7 | |||
Section 13. Revocation or Modification |
7 | |||
Section 14. Withholding Tax |
7 | |||
Section 15. No Compensation Deferrals |
8 | |||
Section 16. Non-Transfer of Performance Award |
8 | |||
Section 17. Severability and Section Headings |
9 | |||
Section 18. Determinations by Committee |
9 | |||
Section 19. Change in Control |
9 | |||
Section 20. Nature of 2002 Plan and Performance Award |
9 | |||
Section 21. Data Privacy Notice and Consent |
11 | |||
Section 22. Effective Date |
12 | |||
Section 23. Governing Law |
12 | |||
Section 24. Language |
12 | |||
Section 25. Appendix |
13 |
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Answers That Matter. |
A. | Recitals | |
Under the 2002 LILLY STOCK PLAN (2002 Plan), the Compensation Committee (Committee) has determined the form of this Performance Award and selected the Grantee, an Eligible Employee of the Company, to receive a Performance Award for the Award Period January 1, 2009, through December 31, 2010. The applicable terms of the 2002 Plan are incorporated in this Performance Award by reference, including the definitions of terms contained in the 2002 Plan. | ||
B. | Performance Award | |
Lilly grants to the Grantee the right to acquire Lilly Stock by issuance or transfer to the Grantee of the Performance Shares to which he or she is entitled under this Performance Award upon the following terms and conditions, including any special terms and conditions set forth in the appendix for the Grantees country of residence, if any, as provided in Section 23: |
The Award Period shall begin January 1, 2009 and end December 31, 2010. |
The target number of Performance Shares for the Award Period shall be the Performance Share value as approved by the Grantees supervisor, divided by the grant date price of $x rounded to the nearest full share. Target shares are set in box 4. The remaining columns of the table on the first page of this Performance Award are multiples of the target shares as set forth in the % Target row and correspond to the applicable level of earnings per share (EPS), subject to adjustment as provided below in this Section or in Section 8. Grantees may view their Performance Award by logging on to the Merrill Lynch website at http://benefits.ml.com after March 31 of each grant year. |
The number of Performance Shares for the Award Period and the EPS ranges on the first page of this Performance Award will be adjusted by the Committee under Section 4(b) of the 2002 Plan upon the occurrence, prior to the effective date of issuance or transfer of shares for payment, of any subdivision or combination of shares of Lilly Stock, or a stock dividend, capital reorganization, recapitalization, or consolidation or merger with Lilly as the surviving corporation, or if additional shares or new or different shares or other securities of Lilly or any other issuer are distributed with respect to the shares of Lilly Stock through a spin-off, exchange offer, or other extraordinary distribution occurring prior to the effective date of issuance or transfer of shares for payment. A fractional share resulting from such adjustment shall in the discretion of the Committee either be paid in cash or rounded. |
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Answers That Matter. |
The EPS for the Award Period shall be computed in accordance with Section 18 and using the following procedures: |
a. | A determination of adjusted consolidated net income ascertained from the Companys audited consolidated financial statements shall be made for each fiscal year in the Award Period in accordance with generally accepted accounting principles, adjusted to the extent deemed appropriate by the Committee for any unusual items deemed significant by the Committee. | ||
b. | The number of shares of outstanding Lilly Stock used to compute consolidated earnings per share shall be determined as of the end of each fiscal year in the Award Period on a diluted basis or its equivalent in accordance with generally accepted accounting principles. | ||
c. | To calculate consolidated earnings per share for each fiscal year in the Award Period, the adjusted consolidated net income shall be divided by the number of shares of outstanding Lilly Stock as computed in accordance with subsection (b) above and the quotient rounded to the nearest cent. | ||
d. | To determine the EPS for the Award Period, the EPS amounts for each fiscal year as determined above shall be added. |
After the EPS for the Award Period is computed, the EPS and the resulting number of Performance Shares for Grantee (determined in accordance with Sections 2 and 8), together with the Committees election between cash and shares of Lilly Stock under Section 5, shall be communicated to Grantee. |
At any time until the determination of EPS and the resulting number of Performance Shares, the Committee may, if it so elects, determine to pay part or all of any Performance Award in cash in lieu of issuing or transferring Performance Shares. The amount of cash shall be based upon the fair market value of Lilly Stock on a valuation date to be determined by the Committee. |
Subject to the condition relating to withholding tax stated in Section 14, Lilly shall issue or transfer to the Grantee any Performance Shares to be issued or transferred under Section 4 and pay to the Grantee any cash determined to be payable under that section within a sixty day period starting the day after the Award Period expiration (as stated in Section 1) and ending on the sixtieth day after the Award Period expiration, but not later than December 31 of the year after the Award Period expires. Grantee shall have no rights as a shareholder of Lilly with respect to the shares of Lilly Stock until the shares are issued or transferred on the books of Lilly. |
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Answers That Matter. |
Any shares issued or transferred under this grant shall be in the form of restricted stock units that will be governed by the provisions of Section 10 of the 2002 Plan and the restricted stock unit grant document to be provided to the Grantee. The Restriction Period shall be approximately one year from the date of valuation, as specified in the restricted stock unit grant document. The restrictions shall lapse upon the earliest of (a) the expiration of the Restriction Period if all conditions related to the Restriction Period have been met; (b) the date of Grantees death, disability or retirement as a retiree (as defined in Section 9(c)); or (c) a change in control as provided under Section 12(a)(iii) of the 2002 Plan, unless the Committee specifies in the restricted stock unit grant document that Section 12 (a)(iii) shall not apply. |
If the status of the Grantee as an Eligible Employee, as defined in the 2002 Plan, terminates before the end of the Award Period except as outlined in Section 9 (c), then all rights of the Grantee under this Performance Award shall terminate with respect to the Award Period. The Company shall incur no liability to Grantee under this Performance Award by terminating Grantees status as an Eligible Employee whether by action with respect to Grantee individually, either with or without cause, or by dissolution or liquidation of Lilly or merger or consolidation of Lilly with a corporation in which Lilly is not the surviving corporation, or otherwise. |
The number of Performance Shares described in Section 2 is based on the assumption that the Grantee is an employee in good standing throughout the entire Award Period. Unless otherwise required by law, the number of Performance Shares shall be adjusted for changes in employment status during the Award Period as follows: |
a. | Leaves of Absence. The number of Performance Shares shall be reduced proportionally for any portion of the total days in the Award Period during which the Grantee is on an approved unpaid leave of absence longer than ninety (90) days. | ||
b. | Demotions and Disciplinary Actions. The Committee may, at its discretion, reduce the number of Performance Shares, prorated according to time, for any portion of the Award Period during which the Grantee has been (i) demoted to a job classification below those considered by the Committee to be eligible for Performance Awards, or (ii) subject to disciplinary action by the Company. In the case of disciplinary action during the Award Period, the senior most vice president responsible for human resources may also, in his or her discretion, withhold payment of this Performance Award entirely. | ||
c. | Retirement, death, disability or termination due to a plant closing or reduction in workforce. In the event the Grantees employment is terminated due to retirement as a retiree, death, disability, plant closing or reduction in workforce (as defined below), the number of Performance Shares shall be reduced proportionally for the portion of the total days during the Award Period in which the Grantee was not an active employee. Any payment of Performance Shares that have been reduced by operation of this Section 8.c. shall be paid following the Award Period expiration as described in Section 6. A retiree is |
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Answers That Matter. |
a person who is (i) a retired employee under the Lilly Retirement Plan; (ii) a retired employee under the retirement plan or program of a Lilly subsidiary; or (iii) a retired employee under a retirement program specifically approved by the Committee. Plant closing means the closing of a plant site or other corporate location that directly results in termination of employment. Reduction in workforce means the elimination of a work group, functional or business unit or other broadly applicable reduction in job positions that directly results in termination of employment. The senior most vice president over human resources of Lilly will be responsible for approving, in his or her discretion, what is classified as disability, a plant closing, or a reduction in workforce. |
The Company reserves the right to and, in appropriate cases, will, seek restitution of all or part of any performance shares or cash paid under this Performance Award if: |
a. | the amount of the payment was based upon the achievement of earnings per share (EPS) that were subsequently the subject of restatement of all or a portion of the Companys financial statements; | ||
b. | the Grantee engaged in intentional misconduct that caused or partially caused the need for such a restatement; and | ||
c. | the amount of the payment that would have been made to the Grantee had the financial results been properly reported would have been lower than the amount actually paid. |
In the event that the Company determines to seek restitution under this section at a time when the Performance Shares are still subject to the restrictions set forth in Section 7, then, notwithstanding any contrary language in the restricted stock unit grant, the conditions of the restriction shall be deemed to have been breached by the Grantee, and all interest of the grantee in the restricted performance shares shall immediately terminate and be forfeited. |
This section is not intended to limit the Companys power to take such action as it deems necessary to remedy the misconduct, prevent its reoccurrence and, if appropriate, based on all relevant facts and circumstances, punish the wrongdoer in a manner it deems appropriate. |
Any notice to be given by the Grantee or Successor Grantee shall be in writing, and any notice or payment shall be deemed to have been given or made only upon receipt thereof by the Treasurer of Lilly at Lilly Corporate Center, Indianapolis, Indiana 46285, U.S.A. Any notice or communication by Lilly in writing shall be deemed to have been given in the case of the Grantee if mailed or delivered to the Grantee at any address specified in writing to Lilly by the Grantee and, in the case of any Successor Grantee, at the address specified in writing to Lilly by the Successor Grantee. In addition, Lilly may, in its sole discretion, decide to deliver any documents related to the Performance Award grant or future awards under the 2002 Plan by electronic means or request the Grantees consent to participate in the 2002 Plan by electronic means. By accepting this Performance Award, the Grantee hereby consents to receive such documents by electronic delivery and agrees to participate in the |
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Answers That Matter. |
2002 Plan through an on-line or electronic system established and maintained by Lilly or another third party designated by Lilly. |
The waiver by Lilly of any provision of this instrument at any time or for any purpose shall not operate as or be construed to be a waiver of that provision or any other provision of this instrument at any subsequent time or for any other purpose. |
This Performance Award shall be irrevocable except that Lilly shall have the right to revoke or modify this Performance Award under Section 13(e) of the 2002 Plan. |
Regardless of any action Lilly and/or the Grantees employer (the Employer) takes with respect to any or all income tax (including federal, state, local and non-U.S. tax), social insurance, payroll tax, payment on account or other tax-related withholding (Tax Related Items), the Grantee acknowledges that the ultimate liability for all Tax Related Items legally due by the Grantee is and remains the Grantees responsibility and that Lilly and the Employer (a) make no representations or undertakings regarding the treatment of any Tax Related Items in connection with any aspect of the Performance Award, including the grant of the Performance Award, the expiration of the Award Period, the transfer and issuance of any Performance Shares or the receipt of any cash payment pursuant to this Performance Award, the receipt of any dividends and the sale of any Performance Shares acquired pursuant to this Performance Award; and (b) do not commit to structure the terms of the grant or any aspect of the Performance Award to reduce or eliminate the Grantees liability for Tax Related Items. |
Prior to the applicable tax event, the Grantee shall pay, or make adequate arrangements satisfactory to Lilly and/or the Employer to satisfy all Tax Related Items. In this regard, the Grantee authorizes Lilly and/or the Employer to withhold all applicable Tax Related Items legally payable by the Grantee from the Grantees wages or other cash compensation payable to the Grantee by Lilly and/or the Employer or from any cash payment received upon expiration of the Award Period in accordance with Section 6. Alternatively, or in addition, if permissible under local law, the Grantee authorizes Lilly and/or the Employer, at their discretion, to (i) withhold from the proceeds of the sale of Performance Shares acquired pursuant to this Performance Award, (ii) arrange for the sale of Performance Shares to be issued upon the expiration of the Award Period (at the Grantees behalf and at the Grantees direction pursuant to this authorization), and/or (iii) withhold in Performance Shares otherwise issuable to the Grantee pursuant to this Performance Award, provided that Lilly and/or the Employer shall withhold only the number of Performance Shares necessary to satisfy the minimum withholding amount (or such other amount that, as determined by Lilly, will not trigger unfavorable accounting). If the obligation for Tax Related Items is satisfied by withholding Performance Shares as described in (iii) herein, the Grantee will be deemed to have been issued the full number of Performance Shares to which he or she is entitled pursuant to this Performance Award, notwithstanding that a number of Performance Shares are withheld to satisfy the obligation for Tax Related Items. The Grantee shall pay to Lilly and/or the Employer any amount of Tax Related |
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Answers That Matter. |
Items that Lilly and/or the Employer may be required to withhold as a result of any aspect of this Performance Award that cannot be satisfied by the means previously described. Lilly may refuse to deliver Performance Shares or any cash payment to the Grantee if the Grantee fails to comply with the Grantees obligation in connection with the Tax Related Items as described herein. |
To the extent applicable, it is intended that this Performance Award comply with the requirements of Section 409A of the U.S. Internal Revenue Code of 1986, as amended and the Treasury Regulations and other guidance issued thereunder (Section 409A), and this Performance Award shall be interpreted and applied by the Committee in a manner consistent with this intent in order to avoid the imposition of any additional tax under Section 409A. This Performance Award is subject to Section 13(k) of the 2002 Plan concerning Section 409A. |
No right in or under this Performance Award is transferable except by operation of law to a duly appointed guardian of the estate of Grantee or upon the death of the Grantee by will or the applicable laws of descent and distribution and then only subject to the provisions of Sections 8 and 9. |
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Answers That Matter. |
If one or more of the provisions of this instrument shall be held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby and the invalid, illegal or unenforceable provisions shall be deemed null and void; however, to the extent permissible by law, any provisions which could be deemed null and void shall first be construed, interpreted or revised retroactively to permit this instrument to be construed so as to foster the intent of this Performance Award and the 2002 Plan. |
The section headings in this instrument are for convenience of reference only and shall not be deemed a part of, or germane to, the interpretation or construction of this instrument. |
Determinations by the Committee pursuant to any provision of the 2002 Plan, pursuant to rules, regulations and procedures adopted by the Committee or pursuant to this instrument, including without limitation the determination of the amount and method of computation of EPS, whether to make an exception to the rule of Section 8, or adjustments under Section 2 or Section 3, shall be final and binding on the Grantee and any Successor Grantee. |
The provisions of Section 12(a)(iii) of the 2002 Plan apply to this Performance Award with the following modifications: |
a. | The only Change in Control event that shall result in a payment under Section 12(a)(iii) of the 2002 Plan shall be consummation of a change in ownership of the Company as defined in Section 12(b)(i) of the 2002 Plan (a Transaction). | ||
b. | On the date of the consummation of such Transaction, the Grantee will be paid an amount equal to the product of (a) the Grantees award opportunity for the Performance Award based on the Companys expected results for the Award Period (as determined by the companys last approved forecast prior to the consummation of the Transaction, not considering the impact of the Transaction) and (b) a fraction, the numerator of which is the number of days that have elapsed since the beginning of the Award Period to the date of the consummation of the Transaction and the denominator of which is the total number of days in the Award Period. The payment will be deemed to have been made immediately prior to the consummation of the Transaction in order to allow the Performance Shares paid to be deemed outstanding and eligible to receive the consideration being paid to Lilly shareholders in the Transaction. |
In accepting this Performance Award, the Grantee acknowledges that: |
a. | the 2002 Plan is established voluntarily by Lilly, it is discretionary in nature and may be modified, amended, suspended or terminated by Lilly at any time, as provided in the 2002 Plan; |
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Answers That Matter. |
b. | the Performance Award is voluntary and occasional and does not create any contractual or other right to receive future Performance Awards, or benefits in lieu of Performance Awards even if Performance Awards have been granted repeatedly in the past; | ||
c. | all decisions with respect to future grants of Performance Awards, if any, will be at the sole discretion of Lilly; | ||
d. | the Grantees participation in the 2002 Plan is voluntary; | ||
e. | the Performance Award is an extraordinary item that does not constitute compensation of any kind for services of any kind rendered to Lilly or the Employer and which is outside the scope of the Grantees employment contract, if any; | ||
f. | the Performance Award is not part of normal or expected compensation or salary for any purposes, including, but not limited to, calculation of any severance, resignation, termination, redundancy, end of service payments, bonuses, long-service awards, pension or welfare or retirement benefits or similar payments and in no event should be considered as compensation for, or relating in any way to, past services for Lilly or the Employer; | ||
g. | neither the Performance Award nor any provision of this instrument, the 2002 Plan or the policies adopted pursuant to the 2002 Plan confer upon the Grantee any right with respect to employment or continuation of current employment, and in the event that the Grantee is not an employee of Lilly or any subsidiary of Lilly, the Performance Award shall not be interpreted to form an employment contract or relationship with Lilly or any subsidiary of Lilly; | ||
h. | the future value of the underlying Performance Shares is unknown and cannot be predicted with certainty; | ||
i. | the value of any Performance Shares acquired upon expiration of the Award Period may increase or decrease in value, even below the tax valuation price; | ||
j. | no claim or entitlement to compensation or damages shall arise from termination of the Performance Award or from any diminution in value of the Performance Award or Performance Shares acquired upon expiration of the Award Period resulting from termination of the Grantees employment by Lilly or the Employer (for any reason whatsoever and whether or not in breach of local labor laws) and the Grantee irrevocably releases Lilly and the Employer from any such claim that may arise; if, notwithstanding the foregoing, any such claim is found by a court of competent jurisdiction to have arisen, then, by accepting this Performance Award, the Grantee shall be deemed irrevocably to have waived his or her entitlement to pursue such claim; |
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Answers That Matter. |
k. | in the event of termination of the Grantees employment (whether or not in breach of local labor laws), the Grantees right to receive Performance Shares upon expiration of the Award Period will terminate effective as of the date the Grantee is no longer actively employed (unless one of the adjustments in Section 8 applies) and will not be extended by any notice period mandated under local law (e.g., active employment would not include a period of garden leave or similar period pursuant to local law); the Committee shall have the exclusive discretion to determine when the Grantee is no longer actively employed for purposes of the Performance Award; | ||
l. | Lilly is not providing any tax, legal or financial advice, nor is Lilly making any recommendations regarding the Grantees participation in the 2002 Plan or the Grantees acquisition or sale of the underlying Performance Shares; and | ||
m. | the Grantee is hereby advised to consult with his or her own personal tax, legal and financial advisors regarding the Grantees participation in the 2002 Plan before taking any action related to the 2002 Plan. |
The Grantee hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic or other form, of the Grantees personal data as described in this Performance Award by and among, as applicable, the Employer, Lilly, its subsidiaries and its affiliates for the exclusive purpose of implementing, administering and managing the Grantees participation in the 2002 Plan. |
The Grantee understands that Lilly may hold certain personal information about the Grantee, including, but not limited to, the Grantees name, home address and telephone number, date of birth, social insurance number or other identification number, salary, nationality, job title, any shares of stock or directorships held in Lilly, details of all Performance Awards or any other entitlement to shares awarded, canceled, vested, unvested or outstanding in the Grantees favor, for the purpose of implementing, administering and managing the 2002 Plan (Data). The Grantee understands that Data may be transferred to any third parties assisting in the implementation, administration and management of the 2002 Plan, that these recipients may be located in the Grantees country, or elsewhere, and that the recipients country may have different data privacy laws and protections than the Grantees country. The Grantee authorizes the recipients to receive, possess, use, retain and transfer the Data, in electronic or other form, for the purposes of implementing, administering and managing the Grantees participation in the 2002 Plan, including any requisite transfer of such Data as may be required to a broker, escrow agent or other third party with whom any shares received upon expiration of the Award Period may be deposited. The Grantee understands that Data will be held only as long as is necessary to implement, administer and manage the Grantees participation in the 2002 Plan. The Grantee understands that the Grantee may, at any time, request an equity award transaction statement, request any necessary amendments to Data or refuse or withdraw the consents herein, in any case without cost, by contacting in writing the Grantees local human resources representative. The Grantee understands that refusal or withdrawal of consent may affect the Grantees ability to participate in the 2002 Plan. For more information on the consequences of |
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the Grantees refusal to consent or withdrawal of consent, the Grantee understands that the Grantee may contact the Grantees local human resources representative. |
The effective date of this instrument shall be the date of grant. |
The validity and construction of this Performance Award shall be governed by the laws of the State of Indiana, U.S.A. without regard to laws that might cause other law to govern under applicable principles of conflict of laws. For purposes of litigating any dispute that arises under this Performance Award, the parties hereby submit to and consent to the jurisdiction of the State of Indiana, and agree that such litigation shall be conducted in the courts of Marion County, Indiana, or the federal courts for the United States for the Southern District of Indiana, and no other courts, where this Performance Award is granted and/or to be performed. |
If the Grantee has received this instrument or any other document related to the 2002 Plan translated into a language other than English and if the translated version is different than the English version, the English version will control. |
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If the Grantee is a non-U.S. resident, his or her participation in the 2002 Plan and this Performance Award will be subject to the special terms and conditions set forth in the appendix for the Grantees country of residence, if any (Appendix). The Appendix constitutes part of this instrument. |
ELI LILLY AND COMPANY |
||||
By: | /s/ John Lechleiter | |||
John Lechleiter | ||||
Chairman of the Board and Chief Executive Officer | ||||
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Answers That Matter. |
Eli Lilly and Company | ||
Lilly Corporate Center | ||
Indianapolis, Indiana 46285 | ||
U.S.A. |
Refer to: | (317) 354-7045 Mark Taylor (on-site in New York) (317) 332-1593 Angela Sekston (on-site in New York) |
| Innovation and Patient-Centered Approach Expected to Drive Future Success | ||
| Lilly Climbs into Top 10 Pharmaceutical Companies in Worldwide Sales and Is Fastest Growing in U.S. | ||
| FIPNet Strategy Expands Global Reach and Improves R&D Productivity | ||
| Company Aims to Reduce Cost of Bringing New Medicine to Market from $1.2 Billion to $800 Million by 2010. | ||
| R&D Pipeline Boasts Unprecedented 59 Molecules in Clinical Development | ||
| Investment in Biotechnology Capabilities Results in Expanded Large Molecule Portfolio | ||
| ImClone Acquisition Creates Leading Oncology Franchise | ||
| 2009 EPS Guidance Set at $4.00 to $4.25, Including $.30 to $.35 of ImClone Dilution | ||
| Excluding ImClone Dilution, 2009 EPS Expected to be $4.35 to $4.55 |
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| Prasugrel The company continues to invest heavily in the ongoing development of prasugrel. Prasugrel, which Lilly is developing with its partner Daiichi Sankyo, continues to be under review with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) for treatment of acute coronary syndrome (ACS) in patients undergoing percutaneous coronary intervention (PCI). Lilly remains in active dialogue with both regulatory agencies. In addition, prasugrel is also being studied in the TRILOGY trial in medically-managed ACS patients. TRILOGY will include approximately 10,000 patients at more than 800 hospitals in 35 countries and is structured as a superiority trial against clopidogrel. Since December, 2007, several follow-on data analyses of the TRITON TIMI-38 study have been published and presented regarding secondary endpoint data and data on relevant patient subpopulations. These include analyses of stent thrombosis, recurrent cardiovascular events and prasugrels use in patients with either diabetes or STEMI (ST-Segment Elevation Myocardial Infarction). | ||
| Arzoxifene A five-year Phase III study, GENERATIONS, that enrolled more than 9,000 patients is expected to be completed in 2010. Two additional Phase III trials, FOUNDATION and NEXT, have already completed. The company expects to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2009. The submission will seek approval for three indications in postmenopausal women treatment of osteoporosis, prevention of osteoporosis and reduction of risk of invasive breast cancer. | ||
| Exenatide once weekly The company continues to develop exenatide once weekly with its partners, Amylin Pharmaceuticals, Inc. and Alkermes, Inc. During 2008, the |
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partners made significant progress toward commercialization of the molecule. A pre-NDA meeting was held with the FDA, commercial-scale production was begun at Amylins Ohio facility, and the FDA has agreed to accept data from the DURATION-1 trial as an appropriate way to demonstrate comparability between clinical trial scale and commercial scale material from the Ohio facility. The companies anticipate regulatory submission to the FDA by the end of the first half of 2009. European regulatory submission is expected in late 2009. | |||
| Olanzapine long-acting injection The European Commission recently approved ZypadheraTM, the companys long-acting injectable formulation of Zyprexa®. Zypadhera is approved in Europe for maintenance treatment of adult patients with schizophrenia who are sufficiently stabilized during acute treatment with oral Zyprexa. In the U.S., the company has submitted a complete response to the FDAs not approvable letter and is currently awaiting the FDAs final review. | ||
| Gamma Secretase Inhibitor In March 2008, the company began its first pivotal trial in Alzheimers disease for the gamma secretase inhibitor, a small molecule designed to reduce the levels of the amyloid beta peptide in the brain. The trial, called IDENTITY, is actively enrolling and is ahead of schedule. A second pivotal trial, IDENTITY 2, was started in September 2008 and is also enrolling at a better-than-expected rate. Approximately 400 subjects have now been randomized in the two studies. | ||
| A-beta Antibody A monoclonal antibody, the companys A-beta antibody offers the potential for slowing down the progression of Alzheimers disease. It is expected to enter Phase III in 2009. | ||
| Enzastaurin A Phase III clinical trial is currently under way for the use of enzastaurin as a maintenance therapy for diffuse large B-cell lymphoma. Because events are occurring at a slower rate than projected, the company is considering expanding enrollment and extending the trial. The company now expects U.S. regulatory submission to occur in mid-2013. | ||
| Teplizumab The company continues to collaborate with its partner, MacroGenics Inc., on teplizumab, which is currently being studied in a pivotal Phase II/III clinical trial for Type 1 diabetes. | ||
| Dirucotide (MBP8298) Along with its partner, BioMS, the company is studying dirucotide for the treatment of several types of multiple sclerosis (MS). There are two Phase III clinical trials ongoing targeting secondary progressive MS, one in Europe and |
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Canada, and the other in the U.S. There is also a Phase II clinical trial underway in Europe for relapsing remitting MS. | |||
| Tasisulam (ASAP) Currently in Phase II, tasisulam has exhibited properties resembling a targeted agent as well as a cytotoxic. The company is testing the anti-tumor activity of tasisulam in several ongoing Phase II studies. Potential registration studies could begin in 2009. | ||
| GLP-Fc A Phase II/III adaptive, seamless trial was initiated in early 2008 for the companys leading proprietary GLP-1 asset, a novel Fc-fusion protein GLP-1 analog, or GLP-Fc. Two other Phase II studies of GLP-Fc are also underway in over 400 patients. The company expects safety and efficacy data from the first of these two studies to become available in 2009. | ||
| Inflammation The company has made a strong commitment to research in inflammation, as evidenced by four leading internal antibody candidates. IL-17 is progressing into larger Phase II clinical trials in the near future, while IL-23 entered Phase I in 2008. The company also anticipates initiating larger Phase II clinical trials for its BAFF antagonist antibody and IL-1beta in the near future. |
| ERBITUX® In addition to its approved indications, Erbitux is also being studied in numerous cancer types, including colorectal, head and neck, non-small cell lung, gastric and esophageal. | ||
| IMC-1121B is a fully-human monoclonal antibody that targets the vascular endothelial growth factor (VEGF) receptor. Phase II studies are underway for metastatic melanoma, renal, liver, ovarian, prostate and non-small cell lung cancers. Metastatic breast cancer is in Phase III testing, while Phase III testing in gastric cancer is expected to begin in 2009. | ||
| IMC-A12 is a fully-human monoclonal antibody that targets the insulin-like growth factor-1 receptor (IGF-1R). Phase II testing is underway in breast, prostate, pancreatic, colorectal, liver and head and neck cancers, as well as sarcoma, with Phase III trials planned in 2009. IMC-A12 has the potential to work with a variety of other targeted agents. |
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| IMC-11F8 is a potent, fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFR). It is currently in Phase II studies for metastatic colorectal cancer with one or more Phase III trials planned in 2009. |
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2008 | 2007 | |||||||||||
Expectations | Results | % Growth | ||||||||||
Earnings (Loss) per share (reported) |
($1.56) to ($2.06 | ) | $ | 2.71 | ||||||||
Estimated financial impact of ImClone
acquisition, including in-process research
and development and other charges |
4.05 to 4.50 | | ||||||||||
Charges related to Zyprexa investigations |
1.33 | | ||||||||||
Asset impairments and restructuring charges
(included in asset impairments,
restructuring and other special charges) |
.25 | .15 | ||||||||||
Asset impairments (included in cost of sales) |
.04 | | ||||||||||
In-process research and development charges
associated with SGX acquisition (2008),
ICOS, Hypnion, and Ivy acquisitions (2007)
and in-licensing transactions with BioMS and
TransPharma (2008) and OSI, MacroGenics and
Glenmark (2007) |
.10 | .63 | ||||||||||
Benefit from resolution of IRS audit |
(.19 | ) | | |||||||||
Charge for a reduction in expected insurance
recoveries |
| .06 | ||||||||||
Pro forma as if the ICOS acquisition was
completed on January 1, 2007 |
| (.01 | ) | |||||||||
Earnings per share (pro forma non-GAAP) |
$ | 3.97 to $4.02 | $ | 3.54 | 12% to 14% | |||||||
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2009 | 2008 | |||||||
Expectations | Expectations | % Growth | ||||||
Earnings (Loss) per share (reported) |
$4.00 to $4.25 | $(1.56) to $(2.06) | ||||||
Estimated financial impact of ImClone
acquisition, including in-process research
and development and other charges |
| 4.05 to 4.50 | ||||||
Charges related to Zyprexa investigations |
| 1.33 | ||||||
Asset impairments and restructuring charges
(included in asset impairments,
restructuring and other special charges) |
| .25 | ||||||
Asset impairments (included in cost of sales) |
| .04 | ||||||
In-process research and development charges
associated with SGX acquisition and
in-licensing transactions with BioMS and
TransPharma |
| .10 | ||||||
Benefit from resolution of IRS audit |
| (.19) | ||||||
Earnings per share (non-GAAP) |
$4.00 to $4.25 | $3.97 to $4.02 | 0% to 7% | |||||
2009 ImClone dilution impact |
.30 to .35 | | ||||||
Earnings per share (non-GAAP excl 2009
ImClone dilution impact) |
$4.35 to $4.55 | $3.97 to $4.02 | 8% to 15% | |||||
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