UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2011
Commission File Number: 001-34949
Tekmira Pharmaceuticals Corporation
(Translation of Registrants Name Into English)
100-8900 Glenlyon Parkway
Burnaby, British Columbia
Canada, V5J 5J8
(Address of Principal Executive Offices)
(Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.)
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):
EXHIBITS
Exhibit Number |
Description | |
99.1 |
Consolidated Financial Statements for the three months ended March 31, 2011 | |
99.2 |
Managements Discussion and Analysis of Financial Condition and Operations for the three months ended March 31, 2011 | |
99.3 |
Form 52 - 109F2 - Certification of Interim Filings (Chief Executive Officer) | |
99.4 |
Form 52 - 109F2 - Certification of Interim Filings (Chief Financial Officer) | |
99.5 |
Press release dated May 10, 2011 |
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.
TEKMIRA PHARMACEUTICALS CORPORATION (Registrant) | ||||||
Date: May 10, 2011 | By: /s/ Ian C. Mortimer | |||||
Name: | Ian C. Mortimer | |||||
Title: | Executive Vice President, Finance and | |||||
Chief Financial Officer |
Exhibit 99.1
TEKMIRA PHARMACEUTICALS CORPORATION
Unaudited Interim Condensed Consolidated Financial Statements (expressed in Canadian dollars)
(Prepared in accordance with generally accepted accounting principles used in the United States of America (U.S. GAAP))
2011 Q1
Three months ended March 31, 2011
Page 1 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Condensed Consolidated Balance Sheets
(Expressed in Canadian Dollars)
(Prepared in accordance with U.S. GAAP)
March 31 2011 |
December 31 2010 |
|||||||
(Unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 9,228,665 | $ | 12,346,010 | ||||
Accounts receivable (note 3) |
3,320,363 | 3,318,729 | ||||||
Accrued revenue |
202,754 | 817,464 | ||||||
Deferred expenses |
563,157 | 557,256 | ||||||
Investment tax credits receivable |
403,580 | 403,580 | ||||||
Finished goods inventory |
| 150,731 | ||||||
Prepaid expenses and other assets |
270,621 | 315,057 | ||||||
Total current assets |
13,989,140 | 17,908,827 | ||||||
Property and equipment |
18,724,155 | 18,668,897 | ||||||
Less accumulated depreciation and impairment |
(15,794,130 | ) | (15,555,481 | ) | ||||
2,930,025 | 3,113,416 | |||||||
Total assets |
$ | 16,919,165 | $ | 21,022,243 | ||||
Liabilities and stockholders equity |
||||||||
Current liabilities: |
||||||||
Accounts payable and accrued liabilities (note 4) |
$ | 4,692,242 | $ | 6,151,923 | ||||
Deferred revenue current portion (note 2) |
2,388,396 | 1,982,264 | ||||||
Total current liabilities |
7,080,638 | 8,134,187 | ||||||
Deferred revenue, net of current portion (note 2) |
2,113,847 | 2,155,478 | ||||||
Total liabilities |
9,194,485 | 10,289,665 | ||||||
Stockholders equity: |
||||||||
Common shares |
||||||||
Authorized - unlimited number with no par value Issued and outstanding: |
229,515,870 | 229,491,529 | ||||||
Additional paid-in capital |
30,217,280 | 30,151,810 | ||||||
Deficit |
(252,008,470 | ) | (248,910,761 | ) | ||||
Total stockholders equity |
7,724,680 | 10,732,578 | ||||||
Total liabilities and stockholders equity |
$ | 16,919,165 | $ | 21,022,243 | ||||
Basis of presentation and future operations (note 1) |
||||||||
Contingencies (note 5) |
See accompanying notes to the condensed consolidated financial statements.
Page 2 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(Expressed in Canadian Dollars)
(Prepared in accordance with U.S. GAAP)
Three months ended March 31 | ||||||||
2011 | 2010 | |||||||
Revenue (note 2) |
||||||||
Collaborations and contracts |
$ | 4,343,485 | $ | 2,465,935 | ||||
4,343,485 | 2,465,935 | |||||||
Expenses |
||||||||
Research, development, collaborations and contracts |
5,639,575 | 5,456,477 | ||||||
General and administrative |
1,541,599 | 995,272 | ||||||
Depreciation of property and equipment |
238,649 | 237,739 | ||||||
7,419,823 | 6,689,488 | |||||||
Loss from operations |
(3,076,338 | ) | (4,223,553 | ) | ||||
Other income (losses) |
||||||||
Interest income |
33,257 | 21,393 | ||||||
Foreign exchange gains (losses) |
(54,628 | ) | 38,669 | |||||
Net loss and comprehensive loss |
$ | (3,097,709 | ) | $ | (4,163,491 | ) | ||
Loss per common share |
||||||||
Basic and diluted |
$ | (0.30 | ) | $ | (0.40 | ) | ||
Weighted average number of common shares |
||||||||
Basic and diluted |
10,341,259 | 10,328,688 |
See accompanying notes to the condensed consolidated financial statements.
Page 3 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Condensed Consolidated Statements of Stockholders Equity
For the three months ended March 31, 2011 (unaudited)
(Expressed in Canadian Dollars)
(Prepared in accordance with U.S. GAAP)
Number of shares |
Share capital |
Additional paid-in capital |
Deficit | Total stockholders equity |
||||||||||||||||
Balance, December 31, 2010 |
10,338,703 | $ | 229,491,529 | $ | 30,151,810 | $ | (248,910,761 | ) | $ | 10,732,578 | ||||||||||
Stock-based compensation |
| | 88,375 | | 88,375 | |||||||||||||||
Issuance of common shares pursuant to exercise of options |
3,231 | 24,341 | (22,905 | ) | | 1,436 | ||||||||||||||
Net loss |
| | | (3,097,709 | ) | (3,097,709 | ) | |||||||||||||
Balance, March 31, 2011 |
10,341,934 | $ | 229,515,870 | $ | 30,217,280 | $ | (252,008,470 | ) | $ | 7,724,680 | ||||||||||
See accompanying notes to the condensed consolidated financial statements.
Page 4 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Condensed Consolidated Statements of Cash Flow
(Unaudited)
(Expressed in Canadian Dollars)
(Prepared in accordance with U.S. GAAP)
Three months ended March 31 | ||||||||
2011 | 2010 | |||||||
OPERATING ACTIVITIES |
||||||||
Loss for the period |
$ | (3,097,709 | ) | $ | (4,163,491 | ) | ||
Items not involving cash: |
||||||||
Depreciation of property and equipment |
238,649 | 237,739 | ||||||
Stock-based compensation expense |
88,375 | 359,817 | ||||||
Foreign exchange (gains) losses arising on foreign currency cash balances |
4,646 | (2,888 | ) | |||||
Net change in non-cash operating items: |
||||||||
Accounts receivable |
(1,634 | ) | 304,063 | |||||
Accrued revenue |
614,710 | | ||||||
Deferred expenses |
(5,901 | ) | | |||||
Inventory |
150,731 | | ||||||
Prepaid expenses and other assets |
44,436 | 43,702 | ||||||
Accounts payable and accrued liabilities |
(1,459,681 | ) | (2,227,261 | ) | ||||
Deferred revenue |
364,501 | 128,335 | ||||||
(3,058,877 | ) | (5,319,984 | ) | |||||
INVESTING ACTIVITIES |
||||||||
Acquisition of property and equipment |
(55,258 | ) | (552,570 | ) | ||||
(55,258 | ) | (552,570 | ) | |||||
FINANCING ACTIVITIES |
||||||||
Issuance of common shares pursuant to exercise of options |
1,436 | 200 | ||||||
1,436 | 200 | |||||||
Foreign exchange gains (losses) arising on foreign currency cash balances |
(4,646 | ) | 2,888 | |||||
Decrease in cash and cash equivalents |
(3,117,345 | ) | (5,869,466 | ) | ||||
Cash and cash equivalents, beginning of period |
12,346,010 | 24,397,740 | ||||||
Cash and cash equivalents, end of period |
$ | 9,228,665 | $ | 18,528,274 | ||||
See accompanying notes to the condensed consolidated financial statements.
Page 5 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Notes to interim condensed consolidated financial statements (unaudited)
(Expressed in Canadian dollars)
Three months ended March 31, 2011
1. | Summary of significant accounting policies |
Nature of business and future operations
Tekmira Pharmaceuticals Corporation (the Company) is a Canadian biopharmaceutical business focused on advancing novel RNA interference therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners.
The success of the Company is dependent on obtaining the necessary regulatory approvals to bring its products to market and achieve profitable operations. The continuation of the research and development activities and the commercialization of its products are dependent on the Companys ability to successfully complete these activities and to obtain adequate financing through a combination of financing activities and operations. It is not possible to predict either the outcome of future research and development programs or the Companys ability to fund these programs in the future.
Basis of presentation and significant accounting policies
These unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles of the United States of America (U.S. GAAP) for interim financial statements and accordingly, do not include all disclosures required for annual financial statements.
These statements should be read in conjunction with the Companys audited consolidated financial statements and notes thereto for the year ended December 31, 2010 and included in the 2010 Annual Report.
The unaudited interim condensed consolidated financial statements reflect, in the opinion of management, all adjustments and reclassifications necessary to present fairly the financial position, results of operations and cash flows at March 31, 2011 and for all periods presented.
The results of operations for the three months ended March 31, 2011 and March 31, 2010 are not necessarily indicative of the results for the full year.
These financial statements follow the same significant accounting policies as those described in the notes to the audited consolidated financial statements of Tekmira Pharmaceuticals Corporation (the Company) for the year ended December 31, 2010.
These statements include the accounts of the Company and its two wholly-owned subsidiaries, Protiva Biotherapeutics Inc. (Protiva) and Protiva Biotherapeutics (USA), Inc., which were acquired on May 30, 2008. All intercompany transactions and balances have been eliminated on consolidation.
Income or loss per share
Income or loss per share is calculated based on the weighted average number of common shares outstanding. Diluted loss per share does not differ from basic loss per share since the effect of the Companys stock options are anti-dilutive. Diluted income per share is calculated using the treasury stock method which uses the weighted average number of common shares outstanding during the period and also includes the dilutive effect of potentially issuable common shares from outstanding stock options. At March 31, 2011, potential common shares (prior to consideration of the treasury stock method) of 1,428,763 were excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive (March 31, 2010 1,384,907).
Fair value of financial instruments
The Companys financial instruments consist of cash and cash equivalents, accounts receivable, investment tax credits receivable, accounts payable and accrued liabilities and promissory notes.
The carrying values of cash and cash equivalents are recorded at fair value based on quoted prices in active markets. The carrying values of accounts receivable, investment tax credits receivable and accounts payable and accrued liabilities approximate their fair values due to the immediate or short-term maturity of these financial instruments.
Page 6 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Notes to interim condensed consolidated financial statements (unaudited)
(Expressed in Canadian dollars)
Three months ended March 31, 2011
Recent accounting pronouncements
In October 2009, the Financial Accounting Standards Board (FASB) issued EITF 08-01, Revenue Arrangements with Multiple Deliverables (currently within the scope of FASB Accounting Standards Codification (ASC) Subtopic 605-25). This statement provides principles for allocation of consideration among its multiple-elements, allowing more flexibility in identifying and accounting for separate deliverables under an arrangement. The EITF introduces an estimated selling price method for valuing the elements of a bundled arrangement if vendor-specific objective evidence or third-party evidence of selling price is not available, and significantly expands related disclosure requirements. This standard is effective on a prospective basis for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Alternatively, adoption may be on a retrospective basis, and early application is permitted. The Company adopted this pronouncement in the three month period ending March 31, 2011. Adoption of the pronouncement did not have a material impact on the Companys financial statements.
In March 2010, the FASB ratified the EITF final consensus on Issue ASC 2010-17, Milestone Method of Revenue Recognition. The guidance in this consensus allows the milestone method as an acceptable revenue recognition methodology when an arrangement includes substantive milestones. The guidance provides a definition of a substantive milestone and should be applied regardless of whether the arrangement includes single or multiple deliverables or units of accounting. The scope of this consensus is limited to transactions involving milestones relating to research and development deliverables. The guidance includes enhanced disclosure requirements about each arrangement, individual milestones and related contingent consideration, information about substantive milestones and factors considered in the determination. The consensus is effective prospectively to milestones achieved in fiscal years, and interim periods within those years, after June 15, 2010. Early application and retrospective application are permitted. The Company adopted this pronouncement in the three month period ending March 31, 2011. Adoption of the pronouncement did not have a material impact on the Companys financial statements.
In July 2010, the FASB issued ASU 2010-20, Disclosures about the Credit Quality of Financing Receivables and the Allowance for Credit Losses, which amends ASC 310 by requiring more robust and disaggregated disclosures about the credit quality of an entitys financing receivables and its allowance for credit losses. The enhanced disclosure will provide financial statement users with an improved understanding of (1) the nature of an entitys credit risk associated with its financing receivables and (2) the entitys assessment of that risk in estimating its allowance for credit losses as well as changes in the allowance and the reasons for those changes. This standard is effective on a prospective basis for the first interim or annual period beginning after December 15, 2010. The Company adopted this standard in the three month period ending March 31, 2011. Adoption of the standard did not have a material impact on disclosures in the Companys financial statements.
2. | Collaborations, contracts and licensing agreements |
The following tables set forth revenue recognized under collaborations, contracts and licensing agreements:
Three months ended March 31 | ||||||||
2011 | 2010 | |||||||
Collaborations and contracts |
||||||||
Alnylam (a) |
$ | 917,201 | $ | 865,823 | ||||
U.S. Government (b) |
3,381,133 | | ||||||
Roche (c) |
3,520 | 1,265,187 | ||||||
BMS (d) |
41,631 | 227,995 | ||||||
Other RNAi collaborators (e) |
| 106,930 | ||||||
Total research and development collaborations and contracts |
4,343,485 | 2,465,935 | ||||||
Page 7 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Notes to interim condensed consolidated financial statements (unaudited)
(Expressed in Canadian dollars)
Three months ended March 31, 2011
The following table sets forth deferred collaborations and contracts revenue:
March 31, 2011 | December 31, 2010 | |||||||
Alnylam (a) |
$ | 284,739 | $ | | ||||
U.S. Government (b) |
885,837 | 760,924 | ||||||
Roche (c) |
36,712 | 40,232 | ||||||
BMS current portion (d) |
1,181,108 | 1,181,108 | ||||||
Deferred revenue, current portion |
2,388,396 | 1,982,264 | ||||||
BMS long-term portion (d) |
2,113,847 | 2,155,478 | ||||||
Total deferred revenue |
$ | 4,502,243 | $ | 4,137,742 | ||||
(a) | License and collaboration with Alnylam Pharmaceuticals, Inc. (Alnylam) |
License and Collaboration Agreement with Alnylam through Tekmira
On January 8, 2007, the Company entered into a licensing and collaboration agreement with Alnylam (Alnylam License and Collaboration) giving them an exclusive license to certain of the Companys historical lipid nanoparticle intellectual property for the discovery, development, and commercialization of ribonucleic acid interference (RNAi) therapeutics.
Cross-License with Alnylam acquired through Protiva
As a result of the acquisition of Protiva on May 30, 2008, the Company acquired a Cross-License Agreement between Protiva and Alnylam dated August 14, 2007 (the Alnylam Cross-License). Alnylam was granted a non-exclusive license to the Protiva intellectual property.
Research and development collaboration with Alnylam
Under a manufacturing agreement with Alnylam (the Alnylam Manufacturing Agreement) effective January 1, 2009 the Company is the exclusive manufacturer of any products required by Alnylam through to the end of Phase 2 clinical trials that utilize the Companys technology. Alnylam pays the Company for the provision of staff and for external costs incurred. Time charged to Alnylam is at a fixed rate and under the Alnylam Manufacturing Agreement there is a contractual minimum for the provision of staff of $11,200,000 over the three years commencing January 1, 2009.
Licensing fees and milestone payments
Alnylam has provided non-exclusive access to the Companys lipid nanoparticle intellectual property to F. Hoffman-La Roche Ltd (Roche) and Takeda Pharmaceutical Company Limited (Takeda). The Company is eligible to receive up to US$16,000,000 in milestone payments for each RNAi therapeutic advanced by Alnylam or its partners. The Company is also eligible for royalties on product sales. These milestones and royalties will pass through Alnylam.
(b) | Contract with U.S. Government to develop TKM-Ebola |
On July 14, 2010, the Company signed a contract with the United States Government to advance TKM-Ebola, an RNAi therapeutic utilizing the Companys lipid nanoparticle technology to treat Ebola virus infection.
In the initial phase of the contract, which is expected to last approximately three years and is funded as part of the Transformational Medical Technologies program, the Company is eligible to receive up to US$34.7 million. This initial funding is for the development of TKM-Ebola including completion of preclinical development, filing an Investigational New Drug application with the United States Food and Drug Administration (FDA) and completing a Phase 1 human safety clinical trial.
The U.S. Government has the option of extending the contract beyond the initial funding period to support the advancement of TKM-Ebola through to the completion of clinical development and FDA approval. Based on the contracts budget this would provide the Company with up to US$140.0 million in funding for the entire program.
Page 8 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Notes to interim condensed consolidated financial statements (unaudited)
(Expressed in Canadian dollars)
Three months ended March 31, 2011
Under the contract the Company is reimbursed for costs incurred, including an allocation of overhead costs, and is paid an incentive fee. If the contract is not completed as originally budgeted then the incentive fee may be increased or decreased.
(c) | Roche collaboration |
On May 11, 2009 the Company announced a product development agreement with Roche (the Roche Product Development Agreement). Under the Roche Product Development Agreement Roche was to pay the Company up to US$8,800,000 to support the advancement of each Roche RNAi product candidate using the Companys lipid nanoparticle technology through to the filing of an Investigational New Drug (IND) application.
Under the Roche Product Development Agreement Roche was paying the Company for the provision of staff and for external costs incurred. The Company is recognizing revenue in proportion to the services provided up to the reporting date by comparing actual hours spent to estimated total hours for each product under the contract. Revenue from external costs incurred on Roche product candidates is recorded in the period that Roche was invoiced for those costs. The difference between service revenue recognized and cash received is recorded in the Companys balance sheet as deferred revenue.
On November 17, 2010, Roche announced that, as part of a corporate restructuring, they intend to discontinue research and development in the field of RNAi. Following the announcement Roche confirmed that, except for completing some product stability studies, they would be discontinuing product development with the Company. As at March 31, 2011, the Company has retained a deferred revenue balance sufficient to cover the cost of completing those stability studies.
(d) | Bristol-Myers Squibb collaboration |
On May 10, 2010 the Company announced the expansion of its research collaboration with Bristol-Myers Squibb Company (Bristol-Myers Squibb). Under the new agreement, Bristol-Myers Squibb use small interfering RNA (siRNA) molecules formulated by the Company in lipid nanoparticles (LNPs) to silence target genes of interest. Bristol-Myers Squibb are conducting the preclinical work to validate the function of certain genes and share the data with the Company. The Company can use the preclinical data to develop RNAi therapeutic drugs against the therapeutic targets of interest. The Company received $3,233,400 (US$3,000,000) from Bristol-Myers Squibb concurrent with the signing of the agreement and recorded the amount as deferred revenue. The Company is required to provide a pre-determined number of LNP batches over the four-year agreement. Bristol-Myers Squibb have a first right to negotiate a licensing agreement on certain RNAi products developed by the Company that evolve from Bristol-Myers Squibb validated gene targets.
Revenue from the May 10, 2010 agreement with Bristol-Myers Squibb is being recognized as the Company produces the related LNP batches.
(e) | Other RNAi collaborators |
The Company has active research agreements with a number of other RNAi collaborators.
3. | Concentration of credit risk |
Credit risk is defined by the Company as an unexpected loss in cash and earnings if a collaborative partner is unable to pay its obligations in due time. The Companys main source of credit risk is related to its accounts receivable balance which principally represents temporary financing provided to collaborative partners in the normal course of operations. Accounts receivable from the U.S. Government as at March 31, 2011 were $2,698,227 and represent 81% of total accounts receivable as at that date (December 31, 2010 - $2,031,980 and 61%). Accounts receivable from Alnylam as at December 31, 2010 were $352,270 and represent 11% of total accounts receivable as at that date (December 31, 2010 - $836,655 and 20%).
The Company does not currently maintain a provision for bad debts as the majority of accounts receivable are from collaborative partners or government agencies and are considered low risk.
Page 9 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Notes to interim condensed consolidated financial statements (unaudited)
(Expressed in Canadian dollars)
Three months ended March 31, 2011
The carrying amount of financial assets represents the maximum credit exposure. The maximum exposure to credit risk at March 31, 2011 was the accounts receivable balance of $3,320,363 (December 31, 2010 - $3,318,729).
All accounts receivable balances at March 31, 2011 and at December 31, 2010 were current.
4. | Accounts payable and accrued liabilities |
Accounts payable and accrued liabilities is comprised of the following:
March 31 2011 |
December 31 2010 |
|||||||
Trade accounts payable |
$ | 2,635,422 | $ | 3,035,273 | ||||
Research and development accruals |
641,804 | 1,241,630 | ||||||
Professional fee accruals |
663,388 | 1,030,405 | ||||||
Restructuring cost accruals |
34,999 | 34,999 | ||||||
Deferred lease inducements |
308,815 | 346,098 | ||||||
Other accrued liabilities |
407,814 | 463,518 | ||||||
$ | 4,692,242 | $ | 6,151,923 | |||||
5. | Contingencies |
Litigation
On March 16, 2011, the Company announced that it had filed a complaint against Alnylam for misappropriation and misuse of trade secrets, know-how and other confidential information, unfair and deceptive trade practices, unjust enrichment, unfair competition and false advertising. The suit, filed in the Business Litigation Session of the Massachusetts Superior Court, alleges Alnylam exploited its confidential relationship as a collaborator with the Company to engage in inappropriate and harmful conduct concerning the Companys proprietary lipid nanoparticle siRNA delivery technology, resulting in damage to the Companys intellectual property and business interests.
On April 7, 2011 we announced that Alnylam had filed an answer and counterclaim to the Companys complaint against Alnylam. The Company has not recorded an estimated liability associated with Alnylams answer and counterclaim due to the uncertainties related to both the likelihood and the amount of any potential loss.
Product development partnership with the Canadian Government
The Company entered into a Technology Partnerships Canada (TPC) agreement with the Canadian Federal Government on November 12, 1999. Under this agreement, TPC agreed to fund 27% of the costs incurred by the Company, prior to March 31, 2004, in the development of certain oligonucleotide product candidates up to a maximum contribution from TPC of $9,329,912. As at March 31, 2011, a cumulative contribution of $3,701,571 has been received and the Company does not expect any further funding under this agreement. In return for the funding provided by TPC, the Company agreed to pay royalties on the share of future licensing and product revenue, if any, that is received by the Company on certain non-siRNA oligonucleotide product candidates covered by the funding under the agreement. These royalties are payable until a certain cumulative payment amount is achieved or until a pre-specified date. In addition, until a cumulative amount equal to the funding actually received under the agreement has been paid to TPC, the Company agreed to pay royalties of between 0.375% and 5% on the share of future product revenue, if any, for Marqibo that is received by the Company. To March 31, 2011 the Company has not made any royalty payments to TPC.
Page 10 of 11
TEKMIRA PHARMACEUTICALS CORPORATION
Notes to interim condensed consolidated financial statements (unaudited)
(Expressed in Canadian dollars)
Three months ended March 31, 2011
License agreement with Merck & Co., Inc. (Merck) and related contingently payable promissory notes
The Company has a contingent liability of US$12,000,000 in regard to certain promissory notes and has a related, equal and offsetting contingent asset receivable from Merck.
The Company has a non-exclusive royalty-bearing world-wide license, of certain intellectual property acquired by Merck. Under the license, Merck will pay up to US$17,000,000 in milestones for each product it develops using the acquired intellectual property except for the first product for which Merck will pay up to US$15,000,000 in milestones. Merck will also pay royalties on product sales.
Page 11 of 11
Exhibit 99.2
TEKMIRA PHARMACEUTICALS CORPORATION
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND OPERATIONS
May 11, 2011 / This management discussion and analysis (MD&A) for the three month period ended March 31, 2011 should be read in conjunction with our unaudited interim condensed consolidated financial statements and related notes for the same period and the audited consolidated financial statements and related notes for the year ended December 31, 2010. We have prepared this MD&A with reference to National Instrument 51-102 Continuous Disclosure Obligations of the Canadian Securities Administrators. Under the United States/Canada Multijurisdictional Disclosure System, we are permitted to prepare this MD&A in accordance with the disclosure requirements of Canada, which are different from those of the United States. This MD&A and our consolidated financial statements are prepared in accordance with generally accepted accounting principles used in the United States of America (U.S. GAAP). All amounts are expressed in Canadian dollars unless otherwise indicated. Unless the context otherwise requires, all references to Tekmira, the Company, we, us, and our refer to Tekmira Pharmaceuticals Corporation, including all of its subsidiaries. Additional information relating to Tekmira, including the Companys March 30, 2011 Annual Information Form is available at the SEDAR website at www.sedar.com or the EDGAR website at www.sec.gov/edgar.
FORWARD-LOOKING STATEMENTS
This discussion and analysis contains forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, forward-looking statements). Forward-looking statements are generally identifiable by use of the words believes, may, plans, will, anticipates, intends, budgets, could, estimates, expects, forecasts, projects and similar expressions, and the negative of such expressions. Forward-looking statements in this MD&A include statements about Tekmiras strategy, future operations, clinical trials, prospects and the plans of management; RNAi (ribonucleic acid interference) product development programs; estimates of the number of clinical development programs to be undertaken by Tekmira and its product development partners; selection of additional product candidates; timing of release of clinical data; the quantum and timing of potential funding; use of lipid nanoparticle (LNP) technology by Tekmiras licensees; the effects of Tekmiras products on the treatment of elevated low-density lipoprotein (LDL) cholesterol, cancer and infectious disease; Tekmiras expectations with respect to existing and future agreements with third parties; statements about the nature, prospects and anticipated timing to resolve the complaint filed by Tekmira against Alnylam; the nature, scope and quantum of damages sought by Tekmira from Alnylam; measures taken to ensure that Tekmira can pursue the litigation with Alnylam without interruption to Tekmiras core business activities; estimates and scope of Tekmiras financial guidance and expected cash runway in light of the litigation with Alnylam; and estimates of the length of time Tekmiras business will be funded by its anticipated financial resources.
With respect to the forward-looking statements contained in this MD&A, Tekmira has made numerous assumptions regarding, among other things: LNPs status as a leading RNAi delivery technology; the effectiveness of Tekmiras products as a treatment for high LDL cholesterol, cancer and infectious disease; the developmental milestones and approvals required to trigger funding for TKM-Ebola from the Transformational Medical Technologies program; results in non-human primates are indicative of the potential effect in humans; Tekmiras research and development capabilities and resources; FDA approval with respect to commencing clinical trials; the timing and obtaining of regulatory approvals for Tekmiras products; the timing and results of clinical data releases and use of LNP technology by Tekmiras development partners and licensees; the time required to complete research and product development activities; the timing and quantum of payments to be received under contracts with Tekmiras collaborative partners including the U.S. Government and the manufacturing agreement with Alnylam; the nature and prospects of the litigation with Alnylam; based on the conduct of Alnylam, the nature, scope and quantum of damages that Tekmira is entitled to; costs and timing of the litigation with Alnylam and the effects of such on Tekmiras financial position and execution of Tekmiras business strategy; the effect of Alnylams answer and counterclaim on Tekmiras litigation position; the sufficiency of budgeted capital expenditures in carrying out planned activities;
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Tekmiras ability to protect its intellectual property rights and not to infringe on the intellectual property rights of others; the ability to succeed at establishing a successful commercialization program for any of Tekmiras products; and the availability and cost of labour and services. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Tekmiras actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the possibility that other organizations have made advancements in RNAi delivery technology that Tekmira is not aware of; the FDA will not approve the commencement of Tekmiras planned clinical trials or approve the use of Tekmiras products and generally, difficulties or delays in the progress, timing and results of clinical trials; the FDA may determine that the design and planned analysis of Tekmiras clinical trials do not adequately address the trial objectives in support of Tekmiras regulatory submissions; future operating results are uncertain and likely to fluctuate; competition from other pharmaceutical or biotechnology companies; Tekmiras ability to raise additional financing required to fund further research and development, clinical studies, and obtain regulatory approvals, on commercially acceptable terms or at all; economic and capital market conditions; Tekmiras ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; Tekmiras research and development capabilities and resources will not meet current or expected demand; Tekmiras development partners and licensees conducting clinical trial and development programs will not result in expected results on a timely basis, or at all; anticipated payments under contracts with Tekmiras collaborative partners including the U.S. Government and Alnylam will not be received by Tekmira on a timely basis, or at all, or in the quantum expected by Tekmira; pre-clinical trials may not be completed, or clinical trials started, when anticipated or at all; pre-clinical and clinical trials may be more costly or take longer to complete than anticipated; pre-clinical or clinical trials may not generate results that warrant future development of the tested drug candidate; Tekmira may become subject to product liability or other legal claims for which the Company has made no accrual in its financial statements; the reduction in Roche revenue may not be replaced in the quantity anticipated or at all; the final outcome of the litigation with Alnylam is not presently determinable or estimable and may result in an outcome that is unfavorable to Tekmira, including damages and other relief against Tekmira claimed by Alnylam in its counterclaim; there may be no basis for which Tekmira has any rights or entitlement to damages from Alnylam in the quantum anticipated by Tekmira, or at all; legal expenses associated with litigation are uncertain and may exceed current estimates, which may have a material adverse effect on Tekmiras financial position and ongoing business strategy; the uncertainty of litigation, including the time and expenses associated therewith; risks and uncertainties involved in the litigation process, such as discovery of new evidence or acceptance of unanticipated or novel legal theories, changes in interpretation of the law due to decisions in other cases, the inherent difficulty in predicting the decisions of judges and juries and the possibility of appeals; Tekmira has not sufficiently budgeted for capital expenditures necessary to carry out planned activities.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmiras Annual Information Form dated March 30, 2011 and available at www.sedar.com or at www.sec.gov/edgar. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
OVERVIEW
Tekmira is a biopharmaceutical company focused on advancing novel RNA interference therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners.
Technology, product development and licensing agreements
Our therapeutic product pipeline consists of products being developed internally with our research and development resources. We also support the development of our collaboration partners products and are developing an Ebola antiviral product (TKM-Ebola) under a Transformational Medical Technologies (TMT) contract with the U.S. Government. Our focus is on advancing products that utilize our proprietary lipid nanoparticle (LNP) technology for the delivery of small interfering RNA (siRNA). These products are intended to
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treat diseases through a process known as RNA interference which prevents the production of proteins that are associated with various diseases. We have rights under Alnylam Pharmaceuticals, Inc.s (Alnylam) RNAi intellectual property to develop eight RNAi therapeutic products.
Our most advanced internal product candidates are
| TKM-PLK1, for the treatment of cancer; |
| TKM-Ebola, for the treatment of Ebola infection; and |
| TKM-ApoB, for the treatment of high cholesterol. |
In the field of RNAi therapeutics, we have licensed our LNP delivery technology to Alnylam and Merck & Co., Inc. Alnylam has granted non-exclusive access to some of our intellectual property to certain of its partners, including F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), Regulus Therapeutics, Inc. (Regulus) (a joint venture between Alnylam and Isis Pharmaceuticals, Inc.) and Takeda Pharmaceutical Company Limited. In addition, we have ongoing research relationships with Bristol-Myers Squibb Company, the United States National Cancer Institute, the U.S. Government through their TMT program and other undisclosed pharmaceutical and biotechnology companies. Outside the RNAi field, we have legacy licensing agreements with Talon Therapeutics, Inc. (Talon, formerly Hana Biosciences, Inc.) and Aradigm Corporation.
TKM-PLK1
Our lead internal oncology product candidate, TKM-PLK1, has been shown in preclinical animal studies to selectively kill cancer cells, while sparing normal cells in healthy tissue. TKM-PLK1 is targeted against PLK1 (polo-like kinase 1), a protein involved in tumor cell proliferation and a validated oncology target. Inhibition of PLK1 prevents the tumor cell from completing cell division, resulting in cell cycle arrest and death of the cancer cell.
Our preclinical studies have demonstrated that a single, systemic intravenous administration of TKM-PLK1 blocked PLK1 expression in liver tumors causing extensive tumor cell death. After repeat dosing, this result translated into significant inhibition of tumor growth and prolonged survival without evidence of toxicities often associated with oncology drugs. The TKM-PLK1 anti-tumor efficacy results were confirmed to be the result of silencing PLK1 via RNA interference. Furthermore, certain LNP formulations also provided potent anti-tumor efficacy in preclinical models of tumors outside the liver.
On December 22, 2010 we announced the initiation of patient dosing in a Phase 1 human clinical trial for TKM-PLK1. The Phase 1 clinical trial, conducted at three medical centers in the United States, is an open label, multi-dose, dose escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TKM-PLK1 as well as determining the maximum tolerated dose. The trial will enroll up to 52 patients with advanced solid tumors. Secondary objectives of the trial are to measure tumor response as well as the pharmacodynamic effects of TKM-PLK1 in patients providing biopsies.
TKM-Ebola
On May 28, 2010 we announced the publication of a series of studies demonstrating the ability of an RNAi therapeutic utilizing our LNP technology to protect non-human primates from Ebola virus, a highly contagious and lethal human infectious disease.
We conducted the studies in collaboration with leading infectious disease researchers from the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and funded in part by the U.S. Governments Transformational Medical Technologies (TMT) program. The results, which were published in the prominent medical journal, The Lancet, describe antiviral activity of siRNA in LNPs targeting the Ebola virus (TKM-Ebola). When used to treat infected non-human primates, TKM-Ebola resulted in complete protection from an otherwise lethal dose of Zaire Ebola virus. For many years, the Zaire species of Ebola virus (ZEBOV) has been associated with periodic outbreaks of hemorrhagic fever in human populations with mortality rates reaching 90%. There are currently no treatments for Ebola or other hemorrhagic fever viruses.
In the published studies, non-human primates were infected with a lethal dose of ZEBOV and were then treated with seven daily doses of TKM-Ebola. The TKM-Ebola therapeutic delivered three different siRNAs targeting three separate viral gene products thereby inactivating the virus in three different parts of its life cycle. The three siRNAs were encapsulated in our proprietary LNP delivery technology engineered for delivery to the cells where
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the Ebola virus is known to replicate. All of the non-human primates treated with TKM-Ebola survived the infection and were shown to be free of ZEBOV virus infection within 14 days after inoculation with a lethal dose of ZEBOV virus.
On July 14, 2010, we signed a contract with the U.S. Government to advance an RNAi therapeutic utilizing our LNP technology to treat Ebola virus infection. The initial phase of the contract, which is funded under a TMT program, is budgeted at US$34.7 million and is expected to last approximately three years. This initial funding is for the development of TKM-Ebola including completion of preclinical development, filing an IND application with the FDA and completing a Phase 1 human safety clinical trial. We expect to file an IND for TKM-Ebola in the second half of 2011.
The U.S. Government has the option of extending the contract beyond the initial funding period to support the advancement of TKM-Ebola through to the completion of clinical development and FDA approval. Based on the budget for the extended contract this would provide us with up to US$140.0 million in funding for the entire program.
Under the contract we are being reimbursed for costs incurred, including an allocation of overheads, and we are being paid an incentive fee.
Under the TKM-Ebola program we have successfully completed pilot studies scaling up our current manufacturing capabilities from 10 gram batches to one kilogram batches, which will support late clinical development and commercialization of LNP product candidates. Importantly, key LNP specifications are consistent and reproducible with this 100-fold increase in batch size.
In addition, we have successfully completed a pilot project on LNP lyophilization. This will provide a number of platform wide benefits including long-term product stability and reliable transport.
TKM-ApoB
On July 2, 2009 we announced that we had initiated a Phase 1 human clinical trial for TKM-ApoB (formerly known as ApoB SNALP). TKM-ApoB is being developed as a treatment for patients with high levels of low-density lipoprotein (LDL) cholesterol, or bad cholesterol, who are not well served by current therapy. TKM-ApoB is designed to reduce the production of apolipoprotein B 100 (ApoB), a protein produced in the liver that plays a central role in cholesterol metabolism.
On January 7, 2010 we announced the completion of the Phase 1 TKM-ApoB clinical trial. We enrolled a total of 23 subjects in the trial. Of the 23 subjects enrolled, 17 subjects received a single dose of TKM-ApoB at one of seven different dosing levels and six subjects received a placebo.
The primary endpoints of the TKM-ApoB Phase 1 clinical trial were measures of safety and tolerability. TKM-ApoB was well tolerated overall in this study with no evidence of liver toxicity, which was the anticipated dose-limiting toxicity observed in preclinical studies. Of the two subjects treated at the highest dose level, one subject experienced an adverse event comprised of flu-like symptoms, cytokine release and transient hypotension consistent with stimulation of the immune system caused by the ApoB siRNA payload. The other subject treated at the highest dose level experienced no side effects. Based on the potential for the immune stimulation to interfere with further dose escalation, we decided to conclude the trial.
Our more recent research efforts have been focused on developing new LNP formulations employing novel lipids to achieve improvements in potency and tolerability. We have identified several new LNP formulations with improved characteristics that are currently being evaluated for TKM-ApoB development.
Expansion of intellectual property portfolio
We recently announced that the United States Patent & Trademark Office (USPTO) and the European Patent Office (EPO) had issued key patents covering elements of our leading lipid nanoparticle technology.
The EPO and USPTO granted claims covering our proprietary manufacturing process and apparatus for the production of lipid nanoparticles. Our manufacturing process is a proprietary method that is robust, scalable and highly reproducible. This process has been reviewed by multiple international regulatory agencies for the production of LNPs used in several ongoing human clinical trials.
The USPTO granted claims (U.S. Patents No. 7,807,815 and No. 7,915,399) covering the identification and
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modification of siRNA sequence motifs responsible for immune stimulation. This case is the first in a series of patent filings we have made covering methods of mitigating siRNA immune stimulation through chemical modification. This intellectual property is based on research by our scientists on the sequence-dependent stimulation of the innate immune response by nucleic acids, including siRNA.
Alnylam collaboration and license
On January 8, 2007, we entered into a licensing and collaboration agreement with Alnylam giving them an exclusive license to certain historical lipid nanoparticle intellectual property owned by Tekmira for the discovery, development, and commercialization of RNAi therapeutics. This agreement only covered intellectual property owned before Tekmiras business combination with Protiva Biotherapeutics, Inc. (Protiva) on May 30, 2008.
As a result of the business combination with Protiva on May 30, 2008 we acquired a Cross-License Agreement (Alnylam Cross-License) between Protiva and Alnylam, dated August 14, 2007. The Cross-License grants Alnylam non-exclusive access to Protivas intellectual property and required Alnylam to fund a certain level of collaborative research for two years. The research collaboration element of the Alnylam Cross-License expired on August 13, 2009. We are, however, continuing to make LNP research batches for Alnylam under a manufacturing agreement which is discussed below.
On August 21, 2007, under the Alnylam Cross-License, Alnylam made a payment of US$3.0 million that gives Alnylam the right to opt-in to the Tekmira TKM-PLK1 project and contribute 50% of product development costs and share equally in any future product revenues. Alnylam has until the start of a Phase 2 clinical trial of the TKM-PLK1 project to exercise their opt-in right. If Alnylam chooses to opt into the TKM-PLK1 project the US$3.0 million already paid will be credited towards Alnylams 50% share of project costs to date.
We are eligible to receive up to US$16.0 million in milestones from Alnylam for each RNAi therapeutic advanced by Alnylam or its partners that utilizes our intellectual property, and royalties on product sales. The impact of the Alnylam agreements, including contract manufacturing services, on our results of operations is covered further in the Revenue section of this MD&A.
The agreements with Alnylam grant us intellectual property rights to develop our own proprietary RNAi therapeutics. Alnylam has granted us a worldwide license for the discovery, development and commercialization of RNAi products directed to eight gene targets (three exclusive and five non-exclusive licenses). Licenses for three targets, ApoB, PLK1 and Ebola, have already been granted on a non-exclusive basis. Under the RNAi licenses granted to us, we may select five additional gene targets to develop RNAi therapeutic products, provided that the targets are not part of an ongoing or planned development program of Alnylam. In consideration for this license, we have agreed to pay royalties to Alnylam on product sales and have milestone obligations of up to US$8.5 million on the non-exclusive licenses (with the exception of TKM-Ebola, which has no milestone obligations, and TKM-PLK1 if Alnylam optsin to the development program) and no milestone obligations on the three exclusive licenses.
On April 3, 2009 Alnylam announced that they had initiated a Phase 1 human clinical trial for a product candidate that utilizes our LNP technology. The Alnylam product candidate, ALN-VSP, is being developed as a treatment for advanced solid tumors with liver involvement. ALN-VSP comprises siRNA molecules delivered systemically using our LNP technology. We are responsible for manufacturing the ALN-VSP drug product. The initiation of the ALN-VSP Phase 1 clinical trial triggered a milestone payment of $0.6 million (US$0.5 million) which we received in May 2009. Interim ALN-VSP data were presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) in May 2010 and at the Chemotherapy Foundation Symposium in November 2010. Alnylam has now completed enrollment for this trial and expects to report additional clinical data in the second quarter of 2011.
Alnylam are advancing two ALN-TTR formulations, ALN-TTR01 and ALN-TTR02. Both formulations are RNAi therapeutics targeting transthyretin (TTR) for the treatment of TTR amyloidosis, a systemic disease caused by mutations in the TTR gene. ALN-TTR01 and ALN-TTR02 utilize our LNP technology and are being manufactured by us. On July 7, 2010, Alnylam announced the initiation of a Phase 1 human clinical trial for ALN-TTR01 which triggered a US$0.5 million milestone payment to us and Alnylam expects to report data from this trial in the third quarter of 2011.
Alnylam is also developing ALN-PCS, an RNAi therapeutic, to treat hypercholesterolemia, or high levels of cholesterol in the blood. ALN-PCS is manufactured by us and is enabled by our LNP delivery technology.
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Alnylam expects to file an IND for ALN-PCS in the first half of 2011 and to commence a Phase 1 clinical trial later in 2011.
Under a manufacturing agreement (Alnylam Manufacturing Agreement) dated January 2, 2009, we continue to be the exclusive manufacturer of any products required by Alnylam through to the end of Phase 2 clinical trials that utilize our technology. Alnylam are paying for the provision of staff and for external costs incurred. Under the Alnylam Manufacturing Agreement there is a contractual minimum of $11.2 million payable by Alnylam for the three years from 2009 to 2011.
On March 16, 2011, we announced the filing of a complaint against Alnylam for misappropriation and misuse of trade secrets, know-how and other confidential information, unfair and deceptive trade practices, unjust enrichment, unfair competition and false advertising. The suit, filed in the Business Litigation Session of the Massachusetts Superior Court, alleges Alnylam exploited its confidential relationship with us as a collaborator to engage in inappropriate and harmful conduct concerning our proprietary LNP technology, resulting in damage to our intellectual property and business interests. On April 6, 2011, Alnylam filed an answer and counterclaim to our complaint.
Roche product development and research agreements
On May 30, 2008, we signed an initial research agreement with Roche. This initial research agreement expired at the end of 2008 and was replaced by a research agreement (Roche Research Agreement) dated February 11, 2009. Work under the Roche Research Agreement was completed in the first half of 2009.
On May 11, 2009 we announced a product development agreement with Roche (Roche Product Development Agreement) that provides for product development up to the filing of an IND by Roche. The product development activities under this agreement expand the activities that were formerly covered by the Roche Research Agreement. Under the Roche Product Development Agreement Roche is paying for the provision of our staff and for external costs incurred up to US$8.8 million, for us to support the advancement of a Roche RNAi product candidate using our LNP technology through to the filing of an IND application.
On November 17, 2010, Roche announced that, as part of a corporate restructuring, they intend to discontinue research and development in the field of RNAi. Following the announcement, Roche confirmed that, except for completing some product stability studies, they would be discontinuing product development with Tekmira. Recognition of revenue from the Roche Product Development Agreement is covered in the Revenue section of this MD&A.
Merck & Co., Inc. (Merck) license agreement
As a result of the business combination with Protiva we acquired a non-exclusive royalty-bearing world-wide license agreement with Merck. Under the license, Merck will pay up to US$17.0 million in milestones for each product they develop covered by Protivas intellectual property, except for the first product for which Merck will pay up to US$15.0 million in milestones, and will pay royalties on product sales. Merck has also granted a license to the Company to certain of its patents. The license agreement with Merck was entered into as part of the settlement of litigation between Protiva and a Merck subsidiary.
Bristol-Myers Squibb Company (BMS) research agreement
On May 10, 2010 we announced the expansion of our research collaboration with BMS. Under the new agreement, BMS will use siRNA molecules formulated by us in LNPs to silence target genes of interest. BMS will conduct the preclinical work to validate the function of certain genes and share the data with us. We can use the preclinical data to develop RNAi therapeutic drugs against the therapeutic targets of interest. BMS paid us US$3.0 million concurrent with the signing of the agreement. We are required to provide a predetermined number of LNP batches over the four-year agreement. BMS will have a first right to negotiate a licensing agreement on certain RNAi products developed by us that evolve from BMS validated gene targets. Recognition of revenue from agreements with BMS is covered in the Revenue section of this MD&A.
U.S. National Institutes of Health (NIH) grant
On October 13, 2010 we announced that together with collaborators at The University of Texas Medical Branch (UTMB), we were awarded a new NIH grant to support research to develop RNAi therapeutics to treat Ebola and Marburg hemorrhagic fever viral infections using our LNP delivery technology. The grant, worth US$2.4 million, will support work at Tekmira and the UTMB.
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Takeda Pharmaceutical Company Limited (Takeda) research agreement
We have an ongoing research agreement with Takeda signed on December 26, 2008.
In the first quarter of 2010, we expanded our agreement with Takeda to provide additional LNP batches as Takeda continues to evaluate our technology.
Takeda has, through Alnylam, a non-exclusive sublicense to our intellectual property. Under our agreements with Alnylam we are eligible to receive up to US$16.0 million in milestones plus additional royalties on each Takeda product that uses our technology.
Legacy Agreements
Talon Therapeutics, Inc. (Talon, formerly Hana Biosciences, Inc.) license agreement
Talon is developing targeted chemotherapy products under a legacy license agreement entered into in May 2006. Marqibo® (Optisomal Vincristine), AlocrestTM (formerly INX-0125, Optisomal Vinorelbine) and BrakivaTM (formerly INX-0076, Optisomal Topotecan), products originally developed by us, have been exclusively licensed to Talon. Talon has agreed to pay us milestones and royalties and is responsible for all future development and future expenses. In May 2009, the license agreement with Talon was amended to decrease the size of near-term milestone payments and increase the size of long-term milestone payments. On September 20, 2010, the license agreement with Talon was amended a second time such that Talon paid $5.9 million (US$5.75 million) in consideration for reducing certain future payments associated with the product candidates. The payment of $5.9 million (US$5.75 million) from Talon has been paid to certain of our contingent creditors in full settlement of a contingent obligation. We are now eligible to receive milestone payments from Talon of up to US$19.0 million upon achievement of further development and regulatory milestones and we are also eligible to receive single-digit royalties on product sales. The milestone payments can be made in common shares of Talon. If Talon sublicenses any of the product candidates, Tekmira is eligible to receive a percentage of any upfront fees or milestone payments received by Talon.
In December 2009, Talon announced the results of its Phase 2 relapsed ALL clinical trial. Talon intends to submit a New Drug Application for Marqibo in the first half of 2011.
Aradigm Corporation (Aradigm) license agreement
On December 8, 2004, we entered into a licensing agreement with Aradigm under which Aradigm exclusively licensed certain of our liposomal intellectual property. Under this agreement, we are entitled to milestone payments totaling US$4.75 million for each disease indication, to a maximum of two, pursued by Aradigm using our technology. In addition, we are entitled to royalties on any product revenue.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our critical accounting policies and estimates are disclosed in the MD&A and the notes to our audited annual consolidated financial statements contained in our 2010 Annual Report.
RECENT ACCOUNTING PRONOUNCEMENTS
In October 2009, the Financial Accounting Standards Board (FASB) issued EITF 08-01, Revenue Arrangements with Multiple Deliverables (currently within the scope of FASB Accounting Standards Codification (ASC) Subtopic 605-25). This statement provides principles for allocation of consideration among its multiple-elements, allowing more flexibility in identifying and accounting for separate deliverables under an arrangement. The EITF introduces an estimated selling price method for valuing the elements of a bundled arrangement if vendor-specific objective evidence or third-party evidence of selling price is not available, and significantly expands related disclosure requirements. This standard is effective on a prospective basis for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Alternatively, adoption may be on a retrospective basis, and early application is permitted. We adopted this pronouncement in the three month period ending March 31, 2011. Adoption of the pronouncement did not have a material impact on our financial statements.
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In March 2010, the FASB ratified the EITF final consensus on Issue ASC 2010-17, Milestone Method of Revenue Recognition. The guidance in this consensus allows the milestone method as an acceptable revenue recognition methodology when an arrangement includes substantive milestones. The guidance provides a definition of a substantive milestone and should be applied regardless of whether the arrangement includes single or multiple deliverables or units of accounting. The scope of this consensus is limited to transactions involving milestones relating to research and development deliverables. The guidance includes enhanced disclosure requirements about each arrangement, individual milestones and related contingent consideration, information about substantive milestones and factors considered in the determination. The consensus is effective prospectively to milestones achieved in fiscal years, and interim periods within those years, after June 15, 2010. Early application and retrospective application are permitted. We adopted this pronouncement in the three month period ending March 31, 2011. Adoption of the pronouncement did not have a material impact on our financial statements.
In July 2010, the FASB issued ASU 2010-20, Disclosures about the Credit Quality of Financing Receivables and the Allowance for Credit Losses, which amends ASC 310 by requiring more robust and disaggregated disclosures about the credit quality of an entitys financing receivables and its allowance for credit losses. The enhanced disclosure will provide financial statement users with an improved understanding of (1) the nature of an entitys credit risk associated with its financing receivables and (2) the entitys assessment of that risk in estimating its allowance for credit losses as well as changes in the allowance and the reasons for those changes. This standard is effective on a prospective basis for the first interim or annual period beginning after December 15, 2010. We adopted this standard in the three month period ending March 31, 2011. Adoption of the standard did not have a material impact on disclosures in our financial statements.
SUMMARY OF QUARTERLY RESULTS
The following table presents our unaudited quarterly results of operations for each of our last eight quarters. These data have been derived from our unaudited consolidated financial statements, which were prepared on the same basis as our annual audited financial statements and, in our opinion, include all adjustments necessary, consisting solely of normal recurring adjustments, for the fair presentation of such information.
(in millions Cdn$ except per share data) - unaudited
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Q2 2009 |
Q3 2009 |
Q4 2009 |
Q1 2010 |
Q2 2010 |
Q3 2010 |
Q4 2010 |
Q1 2011 |
|||||||||||||||||||||||||
Revenue |
||||||||||||||||||||||||||||||||
Collaborations and contracts: |
||||||||||||||||||||||||||||||||
Alnylam |
$ | 2.2 | $ | 2.2 | $ | 2.0 | $ | 0.9 | $ | 1.4 | $ | 1.8 | $ | 2.1 | $ | 0.9 | ||||||||||||||||
U.S. Government |
| | | | | 1.2 | 2.4 | 3.4 | ||||||||||||||||||||||||
Roche |
1.0 | 1.0 | 2.4 | 1.3 | 0.9 | 0.7 | 1.7 | | ||||||||||||||||||||||||
Other |
| 0.1 | 0.1 | 0.3 | | 0.3 | | | ||||||||||||||||||||||||
3.2 | 3.3 | 4.5 | 2.5 | 2.3 | 3.9 | 6.2 | 4.3 | |||||||||||||||||||||||||
Alnylam licensing fees and milestone payments |
0.6 | | | | | 0.5 | | | ||||||||||||||||||||||||
Talon license amendment payment |
| | | | | 5.9 | | | ||||||||||||||||||||||||
Total revenue |
3.8 | 3.3 | 4.5 | 2.5 | 2.3 | 10.4 | 6.2 | 4.3 | ||||||||||||||||||||||||
Expenses and other income (losses) |
5.8 | 5.9 | 6.9 | 6.7 | 6.3 | 12.8 | 8.1 | 7.4 | ||||||||||||||||||||||||
Net loss |
(2.0 | ) | (2.6 | ) | (2.4 | ) | (4.2 | ) | (4.0 | ) | (2.4 | ) | (1.9 | ) | (3.1 | ) | ||||||||||||||||
Basic and diluted net loss per share |
$ | (0.19 | ) | $ | (0.25 | ) | $ | (0.23 | ) | $ | (0.40 | ) | $ | (0.38 | ) | $ | (0.24 | ) | $ | (0.18 | ) | $ | (0.30 | ) |
Quarterly Trends / Our revenue is derived from research and development collaborations and contracts, licensing fees and milestone payments. Over the past two years, our principal sources of ongoing revenue have been our Alnylam partnership entered into in March 2006, our Roche partnership which was expanded in May 2009 and our contract with the U.S. Government to advance TKM-Ebola which began in July 2010.
We had a collaborative research agreement with Alnylam that was completed in August 2009. In January 2009 we signed a Manufacturing Agreement with Alnylam. Revenue from the Alnylam Manufacturing Agreement was higher than usual in Q3 2009, Q4 2009, Q3 2010 and Q4 2010 when deferred revenue related to minimum FTE payments was recognized based on our estimate of percentage of completion of the annual commitment. In Q1 2010 and Q1 2011 Alnylam revenue was relatively low as fewer batches were requested for manufacture.
In Q3 2010 we signed a contract with the U.S. Government to develop TKM-Ebola and incurred significant program costs such as materials and preclinical studies that have been included in research, development, collaborations and contracts expenses. These third-party costs are being reimbursed by the U.S. Government so are also recorded as revenue. U.S. Government revenue from the TKM-Ebola program also includes labour, overheads and incentive fee charges. Revenues have increased since the programs inception as the level of activity increases.
Revenue from our Roche collaboration increased throughout 2009 to $2.4 million in Q4 2009 when we manufactured a number of drug batches. In November 2010, Roche announced that, as part of a corporate restructuring, they intend to discontinue research and development in the field of RNAi. Following the announcement, Roche confirmed that, except for completing some product stability studies, they would be discontinuing product development with Tekmira. The balance of Roche deferred revenue, except for a provision for the stability study work, was recognized as revenue in Q4 2010.
In Q2 2009 and in Q3 2010 we received US$0.5 million milestone payments from Alnylam following their initiation of phase 1 human clinical trials for two separate products enabled by our LNP delivery technology.
Also in Q3 2010 we received a $5.9 million license amendment payment from Talon. The $5.9 million was then paid to certain of our contingent creditors in full settlement of a contingent obligation so is also included as an other loss in our Q3 2010 income statement.
We expect revenue to continue to fluctuate particularly due to the variability in demand for our manufacturing services, the development stage of the TKM-Ebola contract and the timing of licensing payments and milestone receipts.
Page 9 of 13
Managements Discussion and Analysis (continued) | Tekmira Q1 2011 |
Net losses from Q3 2009 to Q2 2010 generally increased due to increased spending on our TKM-ApoB and TKM-PLK1 programs. In particular, in Q1 and Q2 2010, we were manufacturing materials for preclinical and clinical trials and conducting toxicology studies in preparation for clinical development of both programs.
Net losses in the second half of 2010 are generally lower than the first half of 2010 as revenues increased significantly.
RESULTS OF OPERATIONS
Three months ended March 31, 2011 compared to the three months ended March 31, 2010
For the three months ended March 31, 2011 (Q1 2011), our net loss was $3.1 million ($0.30 per common share) as compared to a net loss of $4.2 million ($0.40 per common share) for the three months ended March 31, 2010 (Q1 2010).
The primary reason for the decrease in losses is an increase in revenue in Q1 2011.
Revenue / Revenue was $4.3 million for Q1 2011 as compared to $2.5 million in Q1 2010.
Revenue is detailed in the following table:
(in millions Cdn$) |
Q1 2011 | Q1 2010 | ||||||
Collaborations and contracts |
||||||||
Alnylam |
$ | 0.9 | $ | 0.9 | ||||
U.S. Government |
3.4 | | ||||||
Roche |
| 1.3 | ||||||
Other RNAi collaborators |
| 0.3 | ||||||
Total collaborations and contracts |
4.3 | 2.5 |
Alnylam revenue / Under the Alnylam Manufacturing Agreement we are the exclusive manufacturer of any products required by Alnylam that utilize our technology through to the end of Phase 2 clinical trials. Under the Alnylam Manufacturing Agreement there is a contractual minimum payment for the provision of staff in each of the three years from 2009 to 2011 and Alnylam is reimbursing us for any external costs incurred. Revenue from external costs related to the Alnylam Manufacturing Agreement is being recorded in the period that Alnylam is invoiced for those costs except where we bear the risk of batch failure in which case revenue is recognized only once Alnylam accepts the batch. The total payment for the provision of staff from 2009 to 2011 is a minimum of $11.2 million.
U.S. Government revenue / On July 14, 2010, we signed a contract with the United States Government to advance an RNAi therapeutic utilizing our LNP technology to treat Ebola virus infection (see Overview for further discussion). The initial phase of the contract, which is funded under a Transformational Medical Technologies program, is budgeted at US$34.7 million and is expected to last approximately three years. This initial funding is for the development of TKM-Ebola including completion of preclinical development, filing an IND application with the FDA and completing a Phase 1 human safety clinical trial.
Under the contract we are being reimbursed for costs incurred, including an allocation of overheads, and we are being paid an incentive fee.
BMS revenue / In May 2010 we signed a formulation agreement with BMS under which BMS paid us $3.2 million (US$3.0 million) to make a certain number of LNP formulations over the next four years. Revenue from this agreement will be recognized as batches are produced. Revenue under the formulation agreement for Q1 2011 was $0.04 million as we began to produce batches of formulations requested by BMS.
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Managements Discussion and Analysis (continued) | Tekmira Q1 2011 |
Roche revenue / Under the Roche Product Development Agreement dated May 2009 Roche were paying us for the provision of staff and for certain external costs incurred. In November 2010, Roche announced that, as part of a corporate restructuring, they intend to discontinue research and development in the field of RNAi. Following the announcement, Roche confirmed that, except for completing some product stability studies, they would be discontinuing product development with Tekmira. As at December 31, 2010, we retained a deferred revenue balance of $0.04 million to cover a small amount of stability study work to be completed for Roche and the balance of Roche deferred revenue was brought into income in 2010. Roche revenue of $0.004 million for Q1 2011 represents stability study work performed under the contract.
Other RNAi collaborators revenue / We have active research agreements with a number of other RNAi collaborators.
Expenses / Research, development, collaborations and contracts / Research, development, collaborations and contracts expenses were $5.6 million in Q1 2011 as compared to $5.5 million in Q1 2010.
In Q3 2010 we signed a contract with the U.S. Government to develop TKM-Ebola and have since been incurring significant program costs such as materials and preclinical studies that have been included in research, development, collaborations and contracts expenses. These costs are being reimbursed by the U.S. Government who is also paying for TKM-Ebola related labour costs and overheads and an incentive fee.
Q1 2011 spending on our internal programs has decreased as compared to Q1 2010. In Q1 2010 we incurred costs on our TKM-ApoB program for toxicology studies and manufacturing of drug product. As discussed in the Overview section of this MD&A, we are currently evaluating new formulations for potential TKM-ApoB development so Q1 2011 program costs are much lower than Q1 2010. In Q1 2011 we incurred clinical trial costs for TKM-PLK1 but these are less than the toxicology study and materials costs that we incurred in Q1 2010.
Research, development, collaborations and contracts compensation expenses are at a similar level in Q1 2011 to Q1 2010. In Q1 2011, salary expenses increased in line with staff number increases but this was offset by a decrease in stock option expense. Our research and development staff numbers have increased to 87 at March 31, 2011 (total staff 98) as compared to 71 (total staff 81) at March 31, 2010. Ordinarily, we issue an annual grant of stock options to all staff and directors at the end of our fiscal year but due to a stock trading black-out our annual grant was delayed until Q1 2010. Our 2010 annual grant of stock options occurred as planned in December 2010. Typically, a portion of our stock options vest immediately so there is a peak in stock option expense in the period when options are granted.
General and administrative / General and administrative expenses were $1.5 million in Q1 2011 as compared to $1.0 million in Q1 2010. The increase in Q1 2011 largely relates to legal fees incurred in respect of our lawsuit against Alnylam (see Overview for further discussion of the lawsuit).
Depreciation of property and equipment / Depreciation of property and equipment was $0.2 million in Q1 2011 and $0.2 million in Q1 2010.
Other income (losses) / Interest income / Interest income was $0.03 million in Q1 2011 and $0.02 million in Q1 2010. The increase is due to increasing interest rates more than offsetting our reduced cash investment balances. In the future, interest income will continue to fluctuate in relation to cash balances and interest yields.
Other income (losses) / Foreign exchange gains (losses) / Foreign exchange losses were $0.05 million in Q1 2011 as compared to gains of $0.04 million in Q1 2010. Our foreign exchange gains and losses relate almost entirely to changes in the US dollar to Canadian dollar exchange rate. We have some US dollar denominated cash and receivables which provide a natural exchange rate hedge against our US dollar denominated payables and we keep our US dollar cash and investment balances to a working capital level to avoid exchange rate risk.
LIQUIDITY AND CAPITAL RESOURCES
Since our incorporation, we have financed our operations through the sales of shares, debt, revenues from research and development collaborations and licenses with corporate partners, interest income on funds available for investment, and government contracts, grants and tax credits.
Page 11 of 13
Managements Discussion and Analysis (continued) | Tekmira Q1 2011 |
At March 31, 2011, we had cash and cash equivalents of approximately $9.2 million as compared to $12.3 million at December 31, 2010.
Operating activities used cash of $3.1 million in Q1 2011 as compared to $5.3 million in Q1 2010. Excluding changes in non-cash operations items, cash used in operating activities in Q1 2011 fell to $2.8 million as compared to $3.6 million in Q1 2010 due, largely, to increasing revenues as discussed earlier. A large part of the changes in non-cash operating items relate to the TKM-Ebola contract for which we are incurring and being reimbursed for some large sub-contract and material purchases.
Investing activities used $0.06 million in cash in Q1 2011 as compared to $0.6 million in Q1 2010. Investing in Q1 2010 relates to facility improvements and manufacturing equipment. Since the start of our TKM-Ebola contract in July 2010 a lot of the equipment we acquire is purchased and owned by the U.S. Government so is not recorded as a Company investment.
In our 2010 Managements Discussion and Analysis we provided guidance that our funds on hand plus expected income would be sufficient to continue our product development into the first quarter of 2012. In Q1 2011 we reduced costs as compared to budget and invoiced certain materials to the U.S. Government that we had expensed in an earlier period. We now believe that our current funds on hand plus expected income, including funds from our collaborative partners and the U.S. Government, will be sufficient to continue our product development into the second quarter of 2012. To further extend our cash runway, we are considering a reduction in expenses associated with non-core activities (see Risks and uncertainties).
Contractual obligations
There have not been any material changes to our contractual obligations from those disclosed in our 2010 Annual Report.
Off-Balance Sheet arrangements
There have not been any material changes to our off-balance sheet arrangements from those disclosed in our 2010 Annual Report.
OUTSTANDING SHARE DATA
As of April 30, 2011, we had 10,341,934 common shares outstanding and we had outstanding options to purchase 1,427,263 common shares.
RISKS AND UNCERTAINTIES
Our risks and uncertainties are discussed in further detail in our Annual Information Form dated March 30, 2011 which can be found at www.sedar.com or at www.sec.gov/edgar.
We believe that our current funds on hand plus expected income including funds from our collaborative partners and the U.S. Government will be sufficient to continue our product development into the second quarter of 2012. Substantial additional funds will be required to continue with the active development of our pipeline products and technologies. In particular, our funding needs may vary depending on a number of factors including:
| legal costs incurred on our lawsuit against Alnylam; |
| revenues earned from our collaborative partnerships, particularly Alnylam; |
| revenues earned from our U.S. Government contract to develop TKM-Ebola; |
| the extent to which we continue the development of our product candidates or form collaborative relationships to advance our products; |
| our decisions to in-license or acquire additional products or technology for development, in particular for our RNAi therapeutics programs; |
| our ability to attract and retain corporate partners, and their effectiveness in carrying out the development and ultimate commercialization of our product candidates; |
Page 12 of 13
Managements Discussion and Analysis (continued) | Tekmira Q1 2011 |
| whether batches of drugs that we manufacture fail to meet specifications resulting in delays and investigational and remanufacturing costs; |
| the decisions, and the timing of decisions, made by health regulatory agencies regarding our technology and products; |
| competing technological and market developments; and |
| prosecuting and enforcing our patent claims and other intellectual property rights. |
We will seek to obtain funding to maintain and advance our business from a variety of sources including public or private equity or debt financing, collaborative arrangements with pharmaceutical companies and government grants and contracts. There can be no assurance that funding will be available at all or on acceptable terms to permit further development of our products especially in light of the current economic downturn. In addition, we have not established bank financing arrangements and there can be no assurance that we will be able to establish such arrangements or that bank financing can be arranged on satisfactory terms.
If adequate funding is not available, we may be required to delay, reduce or eliminate one or more of our research or development programs or reduce expenses associated with non-core activities. We may need to obtain funds through arrangements with collaborators or others that may require us to relinquish most or all of our rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise seek if we were better funded. Insufficient financing may also mean failing to prosecute our patents or relinquishing rights to some of our technologies that we would otherwise develop or commercialize.
In addition, we are exposed to market risk related to changes in interest and foreign currency exchange rates, each of which could adversely affect the value of our assets and liabilities. We invest our cash reserves in high interest saving accounts and bankers acceptances with varying terms to maturity (not exceeding two years) issued by major Canadian banks, selected with regard to the expected timing of expenditures for continuing operations and prevailing interest rates. The fair value of our cash investments as at March 31, 2011 is at least equal to the face value of those investments and the value reported in our Balance Sheet. Due to the relatively short-term nature of the investments that we hold, we do not believe that the results of operations or cash flows would be affected to any significant degree by a sudden change in market interest rates relative to our investment portfolio. We purchase goods and services in both Canadian and U.S. dollars and earn a significant portion of our revenues in U.S. dollars. We manage our U.S. dollar currency risk by using cash received from U.S. dollar revenues to pay U.S. dollar expenses and by limiting holdings of U.S. dollar cash and cash equivalent balances to working capital levels. We have not entered into any agreements or purchased any instruments to hedge possible currency risks at this time.
DISCLOSURE CONTROLS AND PROCEDURES AND INTERNAL CONTROLS OVER FINANCIAL REPORTING
For the three months ended March 31, 2011, no changes were made in our internal controls over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
Page 13 of 13
Exhibit 99.3
Form 52-109F2 - Certification of Interim Filings
I, Mark Murray, President and Chief Executive Officer of Tekmira Pharmaceuticals Corporation, certify that:
1. I have reviewed the interim financial statements and interim MD&A (together, the interim filings) of Tekmira Pharmaceuticals Corporation (the issuer) for the period ended March 31, 2011.
2. Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, for the period covered by the interim filings.
3. Based on my knowledge, having exercised reasonable diligence, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.
4. The issuers other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers Annual and Interim Filings, for the issuer.
5. The issuers other certifying officer and I have, as at the end of the period covered by the interim filings
(a) designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that
(i) material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and
(ii) information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and
(b) designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuers GAAP.
The control framework the issuers other certifying officer and I used to design the issuers ICFR is the Integrated Framework issued by the Committee of Sponsoring Organization of the Treadway Commission (COSO).
6. The issuer has disclosed in its interim MD&A any change in the issuers ICFR that occurred during the period beginning on January 1, 2011 and ended on March 31, 2011 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR.
/s/ Mark J. Murray |
May 10, 2011 | |||||
Signature | Date | |||||
President and CEO | ||||||
|
||||||
Title or Position |
Exhibit 99.4
Form 52-109F2 - Certification of Interim Filings
I, Ian Mortimer, Executive Vice President and Chief Financial Officer of Tekmira Pharmaceuticals Corporation, certify that:
1. I have reviewed the interim financial statements and interim MD&A (together, the interim filings) of Tekmira Pharmaceuticals Corporation (the issuer) for the period ended March 31, 2011.
2. Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, for the period covered by the interim filings.
3. Based on my knowledge, having exercised reasonable diligence, the interim financial statements together with the other financial information included in the interim filings fairly present in all material respects the financial condition, results of operations and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.
4. The issuers other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers Annual and Interim Filings, for the issuer.
5. The issuers other certifying officer and I have, as at the end of the period covered by the interim filings
(a) designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that
(i) material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and
(ii) information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and
(b) designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuers GAAP.
The control framework the issuers other certifying officer and I used to design the issuers ICFR is the Integrated Framework issued by the Committee of Sponsoring Organization of the Treadway Commission (COSO).
6. The issuer has disclosed in its interim MD&A any change in the issuers ICFR that occurred during the period beginning on January 1, 2011 and ended on March 31, 2011 that has materially affected, or is reasonably likely to materially affect, the issuers ICFR.
/s/ Ian C. Mortimer |
May 10, 2011 | |||||
Signature | Date | |||||
EVP and CFO | ||||||
|
||||||
Title or Position |
Exhibit 99.5
Tekmira Provides Corporate Update and Announces First Quarter 2011 Results
Conference Call at 4:30 pm Eastern Time Today
FOR IMMEDIATE RELEASE: | May 10, 2011 |
Vancouver, BC Tekmira Pharmaceuticals Corporation (Nasdaq: TKMR, TSX: TKM), a leading developer of RNA interference (RNAi) therapeutics, announced its financial and operational results for the first quarter ended March 31, 2010.
Tekmiras lipid nanoparticle RNAi delivery technology is enabling multiple clinical candidates from Tekmira and our partners in a variety of disease indications. Looking at the past quarter, we continue to see advancements in our own product pipeline, such as the preclinical data illustrating the potential of TKM-PLK1 to treat a variety of solid tumor cancers, which was presented at the recent American Association for Cancer Research Meeting showing, said Dr. Mark J. Murray, Tekmiras President and CEO.
Our proprietary LNP delivery technology is also enabling the product development efforts of our partners. We expect to see multiple data points throughout 2011 from four different therapeutic products currently in clinical trials that utilize our LNP technology, including Tekmiras PLK-1 and Alnylams ALN-VSP, ALN-TTR and ALN-PCS products. In addition, Tekmira continues to innovate and protect our LNP technology with a focus on improvements to LNP potency and tolerability, active targeting, as well as combining new nucleic acids payloads with LNP delivery, added Dr. Murray.
Corporate Update and First Quarter Highlights
| The Phase 1 human clinical trial for TKM-PLK1 Tekmiras lead oncology product candidate is ongoing. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target. In December 2010, Tekmira initiated the TKM-PLK1 Phase 1 clinical trial, which is being conducted at three medical centers in the United States. The trial is an open label, multi-dose, multi-cycle, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TKM-PLK1 and determine the maximum tolerated dose in patients with advanced solid tumors. |
| Tekmira continues to develop its TKM-Ebola product under a US$140 million contract awarded by the U.S. Governments Transformational Medical Technologies (TMT) Program. The TMT contract will support the development of TKM-Ebola through FDA approval. The TKM-Ebola is on track for an investigational new drug (IND) application to be filed in the second half of 2011. Tekmiras work on the TKM-Ebola program also supports continued lipid nanoparticle (LNP) technology innovations around process development, manufacturing scale-up, and lyophilization. |
Under the TKM-Ebola program, Tekmira has successfully completed pilot studies scaling up current manufacturing capabilities from 10 gram batches to one kilogram batches, which will support late clinical development and commercialization of LNP product candidates. Importantly, key LNP specifications are consistent and reproducible with this 100-fold increase in batch size. In addition, Tekmira has successfully completed a pilot project on LNP lyophilization, which will provide a number of platform wide benefits including long-term product stability and reliable transport.
| Promising preclinical data from Tekmiras collaboration with the National Cancer Institute (NCI) was published in Oncogene, one of the worlds leading cancer journals. The article, entitled Molecular targeting of CSN5 in human hepatocellular carcinoma: a mechanism of therapeutic response, presents encouraging pre-clinical data related to the treatment of liver cancer using small interfering RNA (siRNA) enabled by Tekmiras lipid nanoparticle (LNP) delivery technology. |
| Subsequent to quarter-end, Tekmira presented data at American Association for Cancer Research (AACR) meeting, with results that suggest that TKM-PLK1 administration results in tumor growth inhibition and increased survival benefit of treated animals in preclinical models of human liver cancer and solid tumors outside the liver. In addition, Tekmiras collaborator, the NCI, presented a scientific poster with results indicating that LNP delivery of siRNA targeting the cell cycle kinase WEE1 effectively suppresses tumor growth and increases survival of treated animals in preclinical models of human hepatocellular carcinoma (HCC or liver cancer) in a dose-dependent manner. |
| Subsequent to quarter-end, Tekmira announced that the United States Patent & Trademark Office (USPTO) and the European Patent Office (EPO) had issued key patents covering elements of its leading LNP technology. The EPO and USPTO granted claims covering Tekmiras proprietary manufacturing process and apparatus for the production of lipid nanoparticles. The USPTO granted claims covering the identification and modification of siRNA sequence motifs responsible for immune stimulation. This case is the first in a series of patent filings by Tekmira that cover methods of mitigating siRNA immune stimulation through chemical modification. |
| On March 16, 2011, Tekmira filed a complaint against Alnylam for misappropriation and misuse of trade secrets, know-how and other confidential information On April 6, 2011, Alnylam filed an answer and counterclaim to Tekmiras complaint. Tekmira has taken appropriate steps to ensure that it can pursue this lawsuit without interruption to its core business activities and intends to fulfill all of its manufacturing obligations to Alnylam. |
| Tekmiras LNP technology is enabling the systemic RNAi product pipeline of Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY). Tekmira continues to be the exclusive manufacturer of any LNP based drug products required by Alnylam through to the end of Phase 2 clinical trials, including the products ALN-VSP, ALN-TTR and ALN-PCS. As reported in Alnylams First Quarter 2011 Financial Results: |
| Alnylam disclosed that they have completed enrollment in its Phase I multi-center, open label, dose escalation clinical trial with ALN-VSP. Earlier this year, Alnylam presented new clinical data from this study. Specifically, analysis of human tissue samples showed RNAi-mediated target mRNA cleavage, and thus proof of RNAi in man with the systemically delivered RNAi therapeutic. Alnylam will report additional clinical data from its ALN-VSP program at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3 - 7, 2011. |
| Alnylam disclosed that they have advanced its ALN-TTR01 program in a Phase I study. The clinical trial is a blinded, randomized, placebo-controlled, single dose escalation study in patients with ATTR. Alnylam expects to report human proof-of-concept data from this trial in the third quarter of 2011. |
| Alnylam disclosed that they have continued to advance ALN-PCS. Alnylam expects to file an IND or IND equivalent application for ALN-PCS in the second quarter of 2011, and has a goal of reporting clinical data by the end of 2011. More detail and additional information about Alnylams programs can be found at http://www.alnylam.com. |
Financial results
For Q1 2011 Tekmiras net loss was $3.1 million ($0.30 per common share) as compared to a net loss of $4.2 million ($0.40 per common share) in Q1 2010. The primary reason for the decrease in losses is an increase in revenue in Q1 2011.
Revenue
Revenue was $4.3 million for Q1 2011 as compared to $2.5 million in Q1 2010.
Alnylam revenue was $0.9 million in Q1 2011 and $0.9 million in Q1 2010. Under an Alnylam Manufacturing Agreement there is a contractual minimum payment for the provision of staff in each of the three years from 2009 to 2011 and Alnylam is reimbursing Tekmira for any external costs incurred. The total payment for the provision of staff from 2009 to 2011 is a minimum of $11.2 million.
On July 14, 2010, Tekmira signed a contract with the United States Government to advance an RNAi therapeutic utilizing the Companys LNP technology to treat Ebola virus infection. Under the contract Tekmira is being reimbursed for costs incurred, including an allocation of overheads, and is being paid an incentive fee. Tekmira recorded $3.4 million in revenue from this contract in Q1 2011.
Research, development, collaborations and contracts expenses
Research, development, collaborations and contracts expenses were $5.6 million in Q1 2011 as compared to $5.5 million in Q1 2010.
In Q3 2010 the Company signed a contract with the U.S. Government to develop TKM-Ebola and have since been incurring significant program costs such as materials and preclinical studies that have been included in research, development, collaborations and contracts expenses. These costs are being reimbursed by the U.S. Government who is also paying for TKM-Ebola related labour costs and overheads and an incentive fee.
In Q1 2011 spending on internal programs decreased as compared to Q1 2010. In Q1 2010 Tekmira incurred costs on its TKM-ApoB program for toxicology studies and manufacturing of drug product. In Q1 2011 Tekmira incurred clinical trial costs for TKM-PLK1 but these are less than the toxicology study and materials costs incurred in Q1 2010.
Research, development, collaborations and contracts compensation expenses are at a similar level in Q1 2011 to Q1 2010.
General and administrative
General and administrative expenses were $1.5 million in Q1 2011 as compared to $1.0 million in Q1 2010. The increase in Q1 2011 largely relates to legal fees incurred in respect of Tekmiras lawsuit against Alnylam (discussed earlier).
2011 financial guidance
At March 31, 2011, Tekmira had cash and cash equivalents of approximately $9.2 million as compared to $12.3 million at December 31, 2010. Tekmiras 2010 Management Discussion and Analysis provided guidance that funds on hand plus expected income would be sufficient to continue product development into the first quarter of 2012. In Q1 2011 the Company was able to reduce costs as compared to budget. Tekmira now believes that its current funds on hand plus expected income, including funds from collaborative partners and the U.S. Government, will be sufficient to continue product development into the second quarter of 2012. To further extend our cash runway, the Company is considering a reduction in expenses associated with non-core activities (see Forward-Looking Statements).
Conference Call Information
Tekmira will hold a conference call and webcast on Tuesday, May 10, 2011 at 1:30 pm Pacific Time (4:30 pm Eastern Time) to discuss its first quarter operating results and a summary of corporate highlights. To access the conference call, please dial 914-495-8556 or 1-866-393-1607. The live webcast can be accessed through the Investor section of Tekmiras website at www.tekmirapharm.com.
An archived webcast will be available on the Tekmira website approximately two hours after the event. In addition, a replay of the conference call will be available until May 17, 2011 by calling 706-645-9291 or 1-800-642-1687.
About RNAi and Tekmiras LNP Technology
RNAi therapeutics have the potential to treat a broad number of human diseases by silencing disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as siRNAs, require delivery technology to be effective systemically. LNP technology is one of the most widely used siRNA delivery approaches for systemic administration. Tekmiras LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles which are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models. Tekmiras LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
This news release contains forward-looking statements or forward-looking information within the meaning of applicable securities laws (collectively, forward-looking statements). Forward-looking statements are generally identifiable by use of the words believes, may, plans, will, anticipates, intends, budgets, could, estimates, expects, forecasts, projects, and similar expressions, and the negative of such expressions. Forward-looking statements in this news release include statements about Tekmiras strategy, future operations, clinical trials, prospects and the plans of management; RNAi (ribonucleic acid interference) product development programs; estimates of the number of clinical
development programs to be undertaken by Tekmira and its product development partners; selection of additional product candidates; timing of release of clinical data; the quantum and timing of potential funding; use of lipid nanoparticle (LNP) technology by Tekmiras licensees; the effects of Tekmiras products on the treatment of elevated low-density lipoprotein (LDL) cholesterol, cancer and infectious disease; Tekmiras expectations with respect to existing and future agreements with third parties; statements about the nature, prospects and anticipated timing to resolve the complaint filed by Tekmira against Alnylam; the nature, scope and quantum of damages sought by Tekmira from Alnylam; measures taken to ensure that Tekmira can pursue the litigation with Alnylam without interruption to Tekmiras core business activities; estimates and scope of Tekmiras financial guidance and expected cash runway in light of the litigation with Alnylam; and estimates of the length of time Tekmiras business will be funded by its anticipated financial resources.
With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things: LNPs status as a leading RNAi delivery technology; the effectiveness of Tekmiras products as a treatment for high LDL cholesterol, cancer and infectious disease; the developmental milestones and approvals required to trigger funding for TKM-Ebola from the Transformational Medical Technologies program; results in non-human primates are indicative of the potential effect in humans; Tekmiras research and development capabilities and resources; FDA approval with respect to commencing clinical trials; the timing and obtaining of regulatory approvals for Tekmiras products; the timing and results of clinical data releases and use of LNP technology by Tekmiras development partners and licensees; the time required to complete research and product development activities; the timing and quantum of payments to be received under contracts with Tekmiras collaborative partners including the U.S. Government and the manufacturing agreement with Alnylam; the nature and prospects of the litigation with Alnylam; based on the conduct of Alnylam, the nature, scope and quantum of damages that Tekmira is entitled to; costs and timing of the litigation with Alnylam and the effects of such on Tekmiras financial position and execution of Tekmiras business strategy; the effect of Alnylams answer and counterclaim on Tekmiras litigation position; the sufficiency of budgeted capital expenditures in carrying out planned activities; Tekmiras ability to protect its intellectual property rights and not to infringe on the intellectual property rights of others; the ability to succeed at establishing a successful commercialization program for any of Tekmiras products; and the availability and cost of labour and services. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Tekmiras actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the possibility that other organizations have made advancements in RNAi delivery technology that Tekmira is not aware of; the FDA will not approve the commencement of Tekmiras planned clinical trials or approve the use of Tekmiras products and generally, difficulties or delays in the progress, timing and results of clinical trials; the FDA may determine that the design and planned analysis of Tekmiras clinical trials do not adequately address the trial objectives in support of Tekmiras regulatory submissions; future operating results are uncertain and likely to fluctuate; competition from other pharmaceutical or biotechnology companies; Tekmiras ability to raise additional financing required to fund further research and development, clinical studies, and obtain regulatory approvals, on commercially acceptable terms or at all; economic and capital market conditions; Tekmiras ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; Tekmiras research and development capabilities and resources will not meet current or expected demand; Tekmiras development partners and licensees conducting clinical trial and development programs will not result in expected results on a timely basis, or at all; anticipated payments under contracts with Tekmiras collaborative partners including the U.S. Government and Alnylam will
not be received by Tekmira on a timely basis, or at all, or in the quantum expected by Tekmira; pre-clinical trials may not be completed, or clinical trials started, when anticipated or at all; pre-clinical and clinical trials may be more costly or take longer to complete than anticipated; pre-clinical or clinical trials may not generate results that warrant future development of the tested drug candidate; Tekmira may become subject to product liability or other legal claims for which the Company has made no accrual in its financial statements; the reduction in Roche revenue may not be replaced in the quantity anticipated or at all; the final outcome of the litigation with Alnylam is not presently determinable or estimable and may result in an outcome that is unfavorable to Tekmira, including damages and other relief against Tekmira claimed by Alnylam in its counterclaim; there may be no basis for which Tekmira has any rights or entitlement to damages from Alnylam in the quantum anticipated by Tekmira, or at all; legal expenses associated with litigation are uncertain and may exceed current estimates, which may have a material adverse effect on Tekmiras financial position and ongoing business strategy; the uncertainty of litigation, including the time and expenses associated therewith; risks and uncertainties involved in the litigation process, such as discovery of new evidence or acceptance of unanticipated or novel legal theories, changes in interpretation of the law due to decisions in other cases, the inherent difficulty in predicting the decisions of judges and juries and the possibility of appeals; Tekmira has not sufficiently budgeted for capital expenditures necessary to carry out planned activities.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmiras Annual Information Form dated March 30, 2011 and available at www.sedar.com or at www.sec.gov/edgar. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
Contact Information
Investors
Jodi Regts
Director, Investor Relations
Phone: 604-419-3234
Email: jregts@tekmirapharm.com
Media
David Ryan
Longview Communications Inc.
Phone: 416-669-7906
Email: dryan@longviewcomms.ca