Press Releases< /span>
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, May 12 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced its financial and operational results for the three months ended March 31, 2011 ("Q1 2011"). The first quarter of 2011 represents the Company's first reporting period under IFRS.
Q1 2011 Summary
- Lipofen® royalty revenue increased by $0.2 million in Q1 2011 compared to Q1 2010.
- Strong balance sheet at quarter end with cash of $9.1 million and no debt.
- Subsequent to quarter end, completed the CIP-ISOTRETINOIN Phase III study.
"In the first quarter our team continued to make good progress on the CIP-ISOTRETINOIN safety study, which just finished on schedule with more than 900 patients included," said Larry Andrews, President and CEO of Cipher. "Lipofen® continues to provide a steady revenue stream as we prepare to launch our other two products in the U.S. and evaluate additional markets for these products."
Financial Review
Net revenue in Q1 2011 was $0.7 million, compared with $0.9 million in Q1 2010. Revenue from Lipofen® in Q1 2011 totalled $0.6 million, a decrease of $0.2 million compared to Q1 2010. In 2010, the Company was still recognizing quarterly revenue on the original up-front licensing payment (received in 2007) from Kowa Pharmaceuticals America Inc. ("Kowa"), as well as a milestone payment received in 2009, both of which were being amortized over several quarters, ending in 2010. In Q1 2010, non-cash revenue recognized on these items totalled $0.4 million. Excluding these non-cash items, royalty revenue from Lipofen® increased by $0.2 million in Q1 2011 compared to Q1 2010.
Gross Research and Development ("R&D") expenditures for Q1 2011 were $1.7 million, a decrease of $2.4 million compared to Q1 2010. The year-over-year decrease reflects reduced spending on the CIP-ISOTRETINOIN clinical study, which was approaching completion at the end of Q1 2011. The reported R&D amount of $0.5 million for Q1 2011 is net of reimbursed R&D costs related to the CIP-ISOTRETINOIN Phase III clinical study and the impact of R&D refundable tax credits recorded in the quarter, which together totalled $1.2 million. Reported R&D expense in Q1 2010 was $0.3 million. In Q1 2011, the Company reached the contractual cap on the amount of R&D to be 100% reimbursed by its commercial partner for the CIP-ISOTRETINOIN clinical study. Going forward, 50% of the remaining study costs will be borne by Cipher. The Company's share of these additional R&D costs was $0.3 million during Q1 2011. Cipher expects its share of the additional R&D costs for the CIP-ISOTRETINOIN Phase III study will be approximately $1.0 to $1.5 million to complete the trial.
Operating, General and Administrative ("OG&A") expenses for Q1 2011 were $1.2 million, compared to $0.9 million in Q1 2010. The year-over-year change primarily reflects increased business development activity in Q1 2011 related to exploring new product opportunities. Net loss in Q1 2011 was $1.1 million ($0.05 per share), compared with a loss of $0.5 million ($0.02 per share) in Q1 2010.
The Company's financial position remained solid at quarter end. As at March 31, 2011, Cipher had cash of $9.1 million, compared with $10.3 million as at December 31, 2010.
Product Update
Lipofen® monthly prescriptions remained steady in Q1 2011 relative to the prior quarter. The product continues to be actively promoted by Cipher's U.S. distribution partner, Kowa.
During Q1 2011, Cipher entered into the final stages of its Phase III safety trial for CIP-ISOTRETINOIN. Subsequent to quarter end, the trial was completed, with more than 900 patients enrolled. Cipher expects to report top-line results in late Q2 2011 and complete its FDA and Health Canada submissions by Q4 2011. The FDA review of this submission under PDUFA is expected to be six months, and the Company is targeting the second half of 2012 for the U.S. commercial launch of the product.
During Q1 2011, the Company continued with pre-commercial activities for CIP-TRAMADOL ER, including the completion of the manufacturing validation batches and out-licensing discussions with potential U.S. distributors. The Company is hopeful of completing out-licensing negotiations in Q2 2011 and is targeting late Q3 2011 for the commercial launch. In addition, Cipher expects a response from Health Canada concerning regulatory approval in Q3 2011.
Notice of Conference Call
Cipher will hold a conference call today, May 12, 2011, at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. To access the conference call by telephone, dial 647-427-7450 or 1-888-231-8191. A live audio webcast of the call will be available at www.cipherpharma.com. The webcast will be archived for 90 days.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a commercial-stage drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound is being marketed in the United States by Kowa Pharmaceuticals America under the label Lipofen®. Cipher's second product, an extended-release version of the pain reliever tramadol, received FDA approval in May 2010 and the Company's third product, a novel formulation of the acne treatment isotretinoin, is in its final Phase III safety study.
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
Forward-Looking Statements
Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
Cipher Pharmaceuticals Inc. | ||||||
Balance Sheets | ||||||
As at March 31, 2011, December 31, 2010 and January 1, 2010 | ||||||
(in thousands of Canadian dollars - unaudited) | ||||||
March 31, | December 31, | January 1, | ||||
Note | 2011 | 2010 | 2010 | |||
$ | $ | $ | ||||
ASSETS | ||||||
Current assets | ||||||
Cash | 9,147 | 10,328 | 9,006 | |||
Accounts receivable | 1,592 | 1,808 | 967 | |||
Prepaid expenses and other assets | 365 | 465 | 457 | |||
Loan receivable | - | - | 800 | |||
11,104 | 12,601 | 11,230 | ||||
Property and equipment, net | 41 | 50 | 86 | |||
Intangible assets, net | 6 | 3,463 | 3,522 | 3,507 | ||
14,608 | 16,173 | 14,823 | ||||
LIABILITIES | ||||||
Current liabilities | ||||||
Accounts payable and accrued liabilities | 7 | 2,076 | 2,440 | 1,570 | ||
Current portion of deferred revenue | 575 | 567 | 1,956 | |||
2,651 | 3,007 | 3,526 | ||||
Deferred revenue | 1,540 | 1,692 | 329 | |||
4,191 | 4,699 | 3,855 | ||||
SHAREHOLDERS' EQUITY | ||||||
Share capital | 8 | 49,977 | 49,977 | 49,948 | ||
Contributed surplus | 4 | 32,918 | 32,890 | 32,585 | ||
Deficit | 4 | (72,478) | (71,393) | (71,565) | ||
10,417 | 11,474 | 10,968 | ||||
14,608 | 16,173 | 14,823 | ||||
The accompanying notes are an integral part of these unaudited financial statements | ||||||
Cipher Pharmaceuticals Inc. | ||||
Statements of Operations and Comprehensive Loss | ||||
Three month periods ended March 31, 2011 and 2010 | ||||
(in thousands of Canadian dollars, except per share data - unaudited) | ||||
March 31, | March 31, | |||
Note | 2011 | 2010 | ||
$ | $ | |||
Revenues | ||||
Licensing revenue | 675 | 918 | ||
Expenses | ||||
Research and development | 547 | 278 | ||
Operating, general and administrative | 1,164 | 935 | ||
Depreciation of property and equipment | 13 | 14 | ||
Amortization of intangible assets | 59 | 176 | ||
Interest income | (23) | (6) | ||
9 | 1,760 | 1,397 | ||
Loss and comprehensive loss for the period | 4 | (1,085) | (479) | |
Basic and diluted loss per share | 10 | (0.05) | (0.02) | |
The accompanying notes are an integral part of these unaudited financial statements |
Cipher Pharmaceuticals Inc. | |||||||
Statements of Changes in Equity | |||||||
Three month periods ended March 31, 2011 and 2010 | |||||||
(in thousands of Canadian dollars - unaudited) | |||||||
Total | |||||||
Share | Contributed | Shareholders' | |||||
Capital | Surplus | Deficit | Equity | ||||
$ | $ | $ | $ | ||||
Balance as at January 1, 2011 | 49,977 | 32,890 | (71,393) | 11,474 | |||
Loss and comprehensive loss for the period | - | - | (1,085) | (1,085) | |||
Share-based compensation expense | - | 28 | - | 28 | |||
Balance as at March 31, 2011 | 49,977 | 32,918 | (72,478) | 10,417 | |||
Balance as at January 1, 2010 | 49,948 | 32,585 | (71,565) | 10,968 | |||
Loss and comprehensive loss for the period | - | (479) | (479) | ||||
Share-based compensation expense | - | 86 | - | 86 | |||
Balance as at March 31, 2010 | 49,948 | 32,671 | (72,044) | 10,575 | |||
The accompanying notes are an integral part of these unaudited financial statements | |||||||
Cipher Pharmaceuticals Inc. | ||||
Statements of Cash Flows | ||||
Three month periods ended March 31, 2011 and 2010 | ||||
(in thousands of Canadian dollars - unaudited) | ||||
March 31, | March 31, | |||
Note | 2011 | 2010 | ||
$ | $ | |||
Cash provided by (used in) | ||||
Operating activities | ||||
Loss for the period | (1,085) | (479) | ||
Items not affecting cash: | ||||
Depreciation of property and equipment | 13 | 14 | ||
Amortization of intangible assets | 6 | 59 | 176 | |
Share-based compensation expense | 28 | 86 | ||
(985) | (203) | |||
Changes in non-cash operating items: | ||||
Accounts receivable | 216 | (2,434) | ||
Prepaid expenses and other assets | 100 | 119 | ||
Accounts payable and accrued liabilities | (364) | 596 | ||
Deferred revenue | (144) | 1,239 | ||
Net cash generated from (used in) operating activities | (1,177) | (683) | ||
Investing activities | ||||
Proceeds from loan receivable | - | 800 | ||
Purchase of property and equipment | (4) | (1) | ||
Net cash generated from (used in) investing activities | (4) | 799 | ||
Increase (Decrease) in cash | (1,181) | 116 | ||
Cash as at beginning of period | 10,328 | 9,006 | ||
Cash as at end of period | 9,147 | 9,122 | ||
The accompanying notes are an integral part of these unaudited financial statements | ||||
Cipher Pharmaceuticals Inc.
Notes to the Interim Financial Statements
March 31, 2011
(in thousands of Canadian dollars, except per share amounts - unaudited)
1 NATURE OF OPERATIONS
Cipher Pharmaceuticals Inc. ("Cipher" or "the Company") is a commercial
stage drug development company focused on commercializing novel
formulations of successful, currently marketed molecules using advanced
drug delivery technologies. The Company's strategy is to in-license
products that incorporate proven drug delivery technologies and advance
them through the clinical development and regulatory approval stages,
after which the products are out-licensed to international partners.
Cipher is incorporated under the Business Corporations Act of Ontario
and is located at 5650 Tomken Boulevard, Mississauga, Ontario.
2 BASIS OF PREPARATION AND ADOPTION OF IFRS
The Company prepares its financial statements in accordance with
Canadian generally accepted accounting principles as set out in the
Handbook of the Canadian Institute of Chartered Accountants ("CICA
Handbook"). In 2010, the CICA Handbook was revised to incorporate
International Financial Reporting Standards, and requires publicly
accountable enterprises to apply such standards effective for years
beginning on or after January 1, 2011. Accordingly, the Company has
commenced reporting on this basis in these interim financial
statements. In these financial statements, the term "Canadian GAAP"
refers to Canadian GAAP before the adoption of IFRS.
These interim financial statements have been prepared in accordance with
IFRS applicable to the preparation of interim financial statements,
including IAS 34 and IFRS 1. Subject to certain transition elections
disclosed in note 4, the Company has consistently applied the same
accounting policies in its opening IFRS balance sheet at January 1,
2010 and throughout all periods presented, as if these policies had
been in effect. Note 4 discloses the impact of the transition to IFRS
on the Company's balance sheet, statement of operations and
comprehensive loss and statement of cash flows, including the nature
and effect of significant changes in accounting policies from those
used in the Company's financial statements for the year ended December
31, 2010.
The policies applied in these interim financial statements are based on
IFRS issued and outstanding as of May 11, 2011, the date the Board of
Directors approved the statements. Any subsequent changes to IFRS that
are given effect in the Company's annual financial statements for the
year ending December 31, 2011 could result in restatement of these
interim financial statements, including the transition adjustments
recognized on the change-over to IFRS.
These interim financial statements should be read in conjunction with
the Company's Canadian GAAP annual financial statements for the year
ended December 31, 2010. Note 4 discloses IFRS information for the
year ended December 31, 2010 that is material to an understanding of
these interim financial statements.
3 SIGNIFICANT ACCOUNTING POLICIES
The significant accounting policies used in the preparation of these
interim financial statements are described below.
Basis of measurement
The financial statements have been prepared under the historical cost
convention.
Translation of foreign currencies
The financial statements are presented in Canadian dollars, which is the
Company's functional currency. Revenues and expenses denominated in
foreign currencies are translated into Canadian dollars using the
exchange rate in effect at the transaction date. Monetary assets and
liabilities are translated using the rate in effect at the balance
sheet date and non-monetary items are translated at historical exchange
rates. Related exchange gains and losses are included in the
determination of income (loss) for the period.
Critical accounting estimates and judgments
The Company makes estimates and assumptions concerning the future that
will, by definition, seldom equal actual results. The following are
the estimates and judgments applied by management that most
significantly affect the Company's financial statements. These
estimates and judgments have a significant risk of causing a material
adjustment to the carrying amounts of assets and liabilities within the
next financial year.
(i) Estimated useful lives and valuation of intangible assets -
management estimates the useful lives of intangible assets based on the
period during which the assets are expected to be available for use and
also estimates the recoverability to assess if there has been an
impairment. The amounts and timing of recorded expenses for
amortization and impairments of intangible assets for any period are
affected by these estimates. The estimates are reviewed at least
annually and are updated if expectations change as a result of
technical or commercial obsolescence, generic threats and legal or
other limits to use. It is possible that changes in these factors may
cause significant changes in the estimated useful lives of the
Company's intangible assets in the future.
(ii) Revenue recognition - management evaluates the multiple elements
and units of accounting which are included within certain licensing
and distribution agreements. The recognition of revenue on up-front
licensing payments and pre-commercialization amounts are over the
estimated period that the Company maintains substantive contractual
obligations. The estimate periods are reviewed at least annually and
are updated if expectations change as a result of licensing partner
interactions, product commercial obsolescence or other limiting
factors. It is possible that these factors may cause significant
changes in the Company's recognition of revenue in the future.
(iii) Income taxes - management uses estimates when determining current
and future income taxes. These estimates are used to determine the
recovery of tax loss carry forwards, research and development
expenditures and investment tax credits.
Financial instruments
Financial assets and liabilities are recognized when the Company becomes
a party to the contractual provisions of the instrument. Financial
assets are derecognized when the rights to receive cash flows from the
assets have expired or have been transferred and the Company has
transferred substantially all risks and rewards of ownership. Financial
assets and liabilities are offset and the net amount is reported in the
balance sheet when there is a legally enforceable right to offset the
recognized amounts and there is an intention to settle on a net basis,
or realize the asset and settle the liability simultaneously.
At initial recognition, the Company classifies its financial instruments
in the following categories depending on the purpose for which the
instruments were acquired:
(i) Financial assets and liabilities at fair value through profit or
loss: A financial asset or liability is classified in this category if
acquired principally for the purpose of selling or repurchasing in the
short term. The Company does not have any instruments classified in
this category. Financial instruments in this category are recognized
initially and subsequently at fair value. Transaction costs are
expensed in the statement of operations. Gains and losses arising from
changes in fair value are presented in the statement of operations in
the period in which they arise.
(ii) Available-for-sale investments: Available-for-sale investments are
non-derivatives that are either designated in this category or
not classified in any of the other categories. The Company does not
have any instruments classified in this category. Available-for-sale
investments are recognized initially at fair value plus transaction
costs and are subsequently carried at fair value. Gains or losses
arising from changes in fair value are recognized in other
comprehensive income. When an available-for-sale investment is sold or
impaired, the accumulated gains or losses are moved from accumulated
other comprehensive income to the statement of operations and are
included in other gains and losses.
(iii) Loans and receivables: Loans and receivables are non-derivative
financial assets with fixed or determinable payments that are not
quoted in an active market. The Company's loans and receivables
comprise cash, accounts receivable and loan receivable, and are
included in current assets due to their short-term nature. Loans and
receivables are initially recognized at the amount expected to be
received, less, when material, a discount to reduce the loans and
receivables to fair value. Subsequently, loans and receivables are
measured at amortized cost using the effective interest method less a
provision for impairment.
(iv) Financial liabilities at amortized cost: Financial liabilities at
amortized cost include accounts payable and accrued liabilities.
Accounts payable and accrued liabilities are initially recognized at
the amount required to be paid, less, when material, a discount to
reduce the payables to fair value. Subsequently, accounts payable are
measured at amortized cost using the effective interest method.
Financial liabilities are classified as current liabilities if payment
is due within twelve months. Otherwise, they are presented as
non-current liabilities.
Impairment of financial assets
At each reporting date, the Company assesses whether there is objective
evidence that a financial asset is impaired. If such evidence exists,
the Company recognizes an impairment loss. Impairment losses on
financial assets carried at amortized cost are reversed in subsequent
periods if the amount of the loss decreases and the decrease can be
related objectively to an event occurring after the impairment was
recognized.
Cash
Cash includes deposits held with banks.
Accounts receivable
Accounts receivable consist of amounts due from licensing partners for
royalties and product sales in the normal course of business and other
amounts such as interest receivable and tax credits receivable.
Prepaid expenses and other assets
Prepaid expenses consist of amounts paid in advance for items that have
future value to the Company, such as insurance policy payments, FDA
fees, data base subscription fees and other items paid in advance.
Other assets includes the lease and utility deposits.
Property and equipment
Property and equipment are recorded at historical cost less accumulated
depreciation and accumulated impairment losses. The useful lives of
property and equipment are reviewed at least once per year.
Depreciation is computed using the straight-line method, using the
following estimated useful lives of the assets or lease terms:
Computer equipment | 3 years | ||
Furniture and fixtures | 5 years | ||
Leasehold improvements | over the term of the lease |
Intangible assets
Intangible assets consist of marketing and other rights relating to
products and are recorded at cost less accumulated amortization and
accumulated impairment losses. Intangible assets have a finite life
and are amortized using the straight-line method over their estimated
period of useful life. The useful lives of the intangible assets are
reviewed at least once per year. Amortization commences on the earlier
of the date of regulatory (generally, U.S. Food and Drug
Administration) approval for marketing the related product or upon
substantive revenue being generated from the product under a commercial
licensing agreement. The estimated period of useful life has been
determined to be 3.5 years from the date of regulatory approval for
marketing the related product. Should amortization commence as a result
of generating revenue, the amortization period would include the time
prior to regulatory approval.
Impairment of non-financial assets
Non-financial assets, which include property and equipment and
intangible assets, are tested for impairment whenever events or changes
in circumstances indicate that the carrying amount may not be
recoverable. An impairment loss is recognized when the carrying amount
of a non-financial asset exceeds the sum of the estimated present value
of the expected future cash flows from the non-financial asset. The
Company evaluates impairment losses for potential reversals when events
or circumstances warrant such consideration.
Accounts payable and accrued liabilities
Accounts payable are obligations to pay for goods and services that have
been acquired in the ordinary course of business from suppliers and are
classified as current liabilities if payment is due within one year or
less. If not, they are presented as non-current liabilities.
Deferred revenue
Deferred revenue consists of amounts received from licence partners in
advance of revenue recognition. Amounts expected to be recognized
within one year or less are classified as current liabilities with the
balance being classified as non-current liabilities.
Share capital
Common shares are classified as equity. Incremental costs directly
attributable to the issuance of shares are recognized as a deduction
from equity.
Revenue recognition
The Company recognizes revenue from product sales contracts and
licensing and distribution agreements, which may include multiple
elements. The individual elements of each agreement are divided into
separate units of accounting if certain criteria are met. The
applicable revenue recognition approach is then applied to each unit.
Otherwise, the applicable revenue recognition criteria are applied to
combined elements as a single unit of accounting.
Product sales - revenue from product sales contracts is recognized when
the product is shipped to the Company's customers, at which time
ownership is transferred.
Licensing revenues - for up-front licensing payments and
pre-commercialization milestones, revenue is deferred and recognized on
a straight-line basis over the estimated term that the Company
maintains substantive contractual obligations. Post-commercialization
milestone payments are recognized as revenue when the underlying
condition is met, the milestone is not a condition to future
deliverables and collectability is reasonably assured. Otherwise,
these milestone payments are recognized as revenue over the remaining
term of the underlying agreement or the term over which the Company
maintains substantive contractual obligations. Royalty revenue is
recognized in the period in which the Company earns the royalty.
Amounts received in advance of recognition as revenue are included in
deferred revenue.
Research and development
The Company conducts research and development programs and incurs costs
related to these activities, including employee compensation,
materials, professional services and services provided by contract
research organizations. Research and development costs, net of related
tax credits and contractual reimbursements from development partners,
are expensed in the periods in which they are incurred.
Income taxes
Income tax comprises current and deferred tax. Current tax is the
expected tax payable on the taxable income for the year using tax rates
enacted or substantively enacted at the end of the reporting period and
any adjustment to tax payable in respect of previous years. Deferred
tax is recognized in respect of temporary differences arising between
the tax bases of assets and liabilities and their carrying amounts in
the financial statements. Deferred income tax is determined on a
non-discounted basis using tax rates and laws that have been enacted or
substantively enacted at the balance sheet date and are expected to
apply when the deferred tax asset or liability is settled. Deferred tax
assets are recognized to the extent that it is probable that the assets
can be recovered. Tax on income for interim periods is accrued using
the tax rate that would be applicable to expected total annual
earnings.
Share-based compensation
The fair value of options granted to employees and directors is
estimated on the date of the grants using the Black-Scholes option
pricing model. Stock options vest over four years (25% per year),
expire after ten years and can only be settled for shares. Each
tranche in an award is considered as a separate award with its own
vesting period and grant date fair value. Share-based compensation
expense is recognized over the tranche's vesting period based on the
number of awards expected to vest, by increasing contributed surplus.
The number of awards expected to vest is reviewed annually, with any
impact being recognized immediately. Share-based compensation expense
is included in operating, general and administrative expense in the
statements of operations and contributed surplus in the balance
sheets. The consideration received on the exercise of stock options is
credited to share capital at the time of exercise.
Earnings per share
Basic earnings per share ("EPS") is calculated using the treasury stock
method, by dividing the net income (loss) for the period by the
weighted number of common shares outstanding during the period.
Diluted EPS is calculated by adjusting the weighted average number of
common shares outstanding for dilutive instruments.
Accounting standards issued but not yet applied
International Financial Reporting Standard 9, Financial Instruments ("IFRS 9")
IFRS 9 was issued in November 2009 and contained requirements for
financial assets. This standard addresses classification and
measurement of financial assets and replaces the multiple category and
measurement models in IAS 39 for debt instruments with a new mixed
measurement model having only two categories: amortized cost and fair
value through profit or loss. IFRS 9 also replaces the models for
measuring equity instruments, and such instruments are either
recognized at fair value through profit or loss or at fair value
through other comprehensive income. Where such equity instruments are
measured at fair value through other comprehensive income, dividends
are recognized in profit or loss to the extent not clearly representing
a return of investment, are recognized in profit or loss; however,
other gains and losses (including impairments) associated with such
instruments remain in comprehensive income indefinitely.
Requirements for financial liabilities were added in October 2010 and
they largely carried forward existing requirements in IAS 39, Financial Instruments - Recognition and Measurement, except that fair
value changes due to credit risk for liabilities designated at fair
value through profit and loss would generally be recorded in other
comprehensive income.
This standard is required to be applied for accounting periods beginning
on or after January 1, 2013, with earlier adoption permitted. The
Company has not yet assessed the impact of the standard or determined
whether it will adopt the standard early.
4 TRANSITION TO IFRS
The effect of the Company's transition to IFRS, described in note 2, is
summarized in this note as follows:
(i) Transition elections
(ii) Reconciliation of deficit, contributed surplus, comprehensive
loss and cash flow as previously reported under Canadian GAAP to IFRS
(iii) Disclosure of additional IFRS information for the year ended
December 31, 2010
(i) Transition elections:
IFRS 1 - First-time Adoption of International Financial Reporting
Standards - sets forth guidance for the initial adoption of IFRS. Under IFRS 1,
the standards are applied retrospectively at the transitional balance
sheet date with all adjustments to assets and liabilities taken to
retained earnings unless certain exemptions are applied. The Company
has applied the following exemption to its opening balance sheet dated
January 1, 2010:
Share-based payment transactions - the Company has elected not to apply
IFRS 2 to awards that vested prior to January 1, 2010.
With regard to the designation of financial assets and liabilities, the
Company has elected to re-designate cash from the held-for-trading
category to the loans and receivables category and as required by IFRS
1. In addition, estimates made under IFRS at the date of transition
must be consistent with estimates made for the same date under previous
GAAP, unless there is evidence that those estimates were in error.
(ii) Reconciliation of deficit, contributed surplus, comprehensive loss
and cash flow as previously reported under Canadian GAAP to IFRS:
In preparing its financial statements in accordance with IFRS, the
Company has adjusted amounts reported previously in financial
statements prepared in accordance with Canadian GAAP. An explanation
of how the transition from previous Canadian GAAP to IFRS has affected
the Company's financial position, financial performance and cash flow
is set out below.
Deficit | |||||
As at | As at | As at | |||
Dec 31, 2010 | Mar 31, 2010 | Jan 1, 2010 | |||
As reported under Canadian GAAP | $ (71,192) | $ (71,760) | $ (71,248) | ||
Increase in deficit for: | |||||
Share-based compensation expense - IFRS 2 | (201) | (284) | (317) | ||
As reported under IFRS | $ (71,393) | $ (72,044) | $ (71,565) | ||
Contributed Surplus | |||||
As at | As at | As at | |||
Dec 31, 2010 | Mar 31, 2010 | Jan 1, 2010 | |||
As reported under Canadian GAAP | $ 32,689 | $ 32,387 | $ 32,268 | ||
Increase in contributed surplus for: | |||||
Share-based compensation expense - IFRS 2 | 201 | 284 | 317 | ||
As reported under IFRS | $ 32,890 | $ 32,671 | $ 32,585 | ||
Comprehensive Income (loss) | |||||
Year Ended | Three Months | ||||
Dec 31, 2010 | Ended Mar 31, 2010 | ||||
As reported under Canadian GAAP | $ 56 | $ (512) | |||
Increase in comprehensive income for: | |||||
Share-based compensation expense - IFRS 2 | 116 | 33 | |||
As reported under IFRS | $ 172 | $ (479) | |||
Operating, general and administrative expense | |||||
Year Ended | Three Months | ||||
Dec 31, 2010 | Ended Mar 31, 2010 | ||||
As reported under Canadian GAAP | $ 3,895 | $ 968 | |||
Decrease in operating, general and administrative expense for: | |||||
Share-based compensation expense - IFRS 2 | (116) | (33) | |||
As reported under IFRS | $ 3,779 | $ 935 |
Statements of cash flows - the transition to IFRS had no significant
impact on cash flows generated by the Company.
Under IFRS, the Company accrues the cost of employee stock options over
the vesting period using the graded method of amortization rather than
the straight-line method, which was the Company's policy under Canadian
GAAP. As a result of this change, contributed surplus increased by
$317 and deficit increased by $317 at the date of transition to IFRS.
General and administrative expenses decreased by $33 for the three
months ended March 31, 2010 and by $116 for the year ended December 31,
2010.
(iii) Disclosure of additional IFRS information for the year ended
December 31, 2010:
Certain disclosures required in annual IFRS financial statements were
not previously disclosed in the Company's Canadian GAAP annual
financial statements for the year ended December 31, 2010. Certain
note disclosures in these interim financial statements include December
31, 2010 information as if it had been reported under IFRS.
Compensation of key management - key management includes directors and
executives of the Company. The compensation paid or payable to key
management for services is shown below:
Three Months | Three Months | Year Ended | ||||
Ended Mar 31, 2011 | Ended Mar 31, 2010 | Dec 31, 2010 | ||||
Salaries and short-term employee benefits, including bonuses | $ 339 | $ 365 | $ 1,345 | |||
Directors fees | 88 | 77 | 275 | |||
Share-based payments | 25 | 77 | 287 | |||
$ 452 | $ 519 | $ 1,907 | ||||
5 RISK MANAGEMENT
Financial risk management
In the normal course of business, the Company is exposed to a number of
financial risks that can affect its operating performance. These risks
are: credit risk, liquidity risk and market risk. The Company's
overall risk management program and prudent business practices seek to
minimize any potential adverse affects on the Company's financial
performance.
(i) Credit risk
Cash - the Company's cash balance is on deposit with a Canadian
chartered bank that has a DBRS rating of "AA" for deposits and senior
debt. Accounts receivable - the Company licenses its products to
distribution partners in major markets. The credit risk associated
with the accounts receivable pursuant to these agreements is evaluated
during initial negotiations and on an ongoing basis. The accounts
receivable balance is concentrated between two licensing partners.
Both have been partners with the Company for over two years, with no
defaults in the past. As of March 31, 2011, no accounts receivable
balances were impaired or past due.
(ii) Liquidity risk
The Company has no long term debt with specified repayment terms.
Accounts payable and accrued liabilities are settled in the
regular course of business, based on negotiated terms with trade
suppliers. All components of the balance of $2,076 as at March 31,
2011 are expected to be settled in less than one year. The carrying
value of the balances approximate their fair value as the impact of
discounting is not significant.
(iii) Market risk
Currency risk - the majority of the Company's revenue and a portion of
its expenses are denominated in US currency. The accounts receivable
balance at March 31, 2011 includes a total of US$1,120 and accounts
payable and accrued liabilities includes a total of US$1,033. A 10%
change in the US/CDN exchange rate on the net March 31, 2011 balance
would have had a $9 impact on net income.
Capital risk management
Shareholders' equity is managed as the capital of the Company. The
Company's objective when managing capital is to safeguard its ability
to continue as a going concern in order to provide returns for
shareholders and to maintain an optimal capital structure to minimize
the cost of capital. In order to maintain or adjust the capital
structure, the Company may issue new common shares from time to time.
6 INTANGIBLE ASSETS
The Company has entered into certain agreements with Galephar
Pharmaceutical Research Inc. ("Galephar") for the rights to package,
test, obtain regulatory approvals and market certain products in
various countries around the world. In accordance with the terms of
the agreements, the Company has acquired these intangible rights
through an investment in three separate series of preferred shares of
Galephar. The preferred shares are redeemable by the Company from
amounts received under the licensing agreements for the products. The
Company may be required to pay additional amounts to Galephar in
respect of the CIP-ISOTRETINOIN intangible rights of up to $632
(US$650) if certain future milestones are achieved as defined in the
agreement. These additional payments will be made in the form of
Galephar preferred share purchases. The recoverability of these
intangible rights is dependant upon sufficient revenues being generated
from the related products currently under development and
commercialization. The Company is currently amortizing the intangible
rights related to CIP-ISOTRETINOIN. After product-related expenses are
deducted and after the recovery of Cipher's investment in the Galephar
shares, approximately 50% of all milestone and royalty payments
received by the Company under the licensing agreements will be paid to
Galephar.
The following is a summary of intangible assets as at March 31, 2011:
CIP-Fenofibrate | CIP-Isotretinoin | CIP-Tramadol | Total | |||
As at January 1, 2010 | ||||||
Cost | $ 2,332 | $ 1,579 | $ 1,735 | $ 5,646 | ||
Accumulated amortization | (1,865) | (274) | - | (2,139) | ||
Net book value | $ 467 | $ 1,305 | $ 1,735 | $ 3,507 | ||
For the year ended December 31, 2010 | ||||||
Opening net book value | $ 467 | $ 1,305 | $ 1,735 | $ 3,507 | ||
Additions | - | - | 719 | 719 | ||
Amortization | (467) | (237) | - | (704) | ||
Net book value | $ - | $ 1,068 | $ 2,454 | $ 3,522 | ||
As at December 31, 2010 | ||||||
Cost | $ 2,332 | $ 1,579 | $ 2,454 | $ 6,365 | ||
Accumulated amortization | (2,332) | (511) | - | (2,843) | ||
Net book value | $ - | $ 1,068 | $ 2,454 | $ 3,522 | ||
For the period ended March 31, 2011 | ||||||
Opening net book value | $ - | $ 1,068 | $ 2,454 | $ 3,522 | ||
Additions | - | - | - | - | ||
Amortization | - | (59) | - | (59) | ||
Net book value | $ - | $ 1,009 | $ 2,454 | $ 3,463 | ||
As at March 31, 2011 | ||||||
Cost | $ 2,332 | $ 1,579 | $ 2,454 | $ 6,365 | ||
Accumulated amortization | (2,332) | (570) | - | (2,902) | ||
Net book value | $ - | $ 1,009 | $ 2,454 | $ 3,463 | ||
The Company has considered indicators of impairment as of January 1, 2010, December 31, 2010 and March 31, 2011 and no | ||||||
indicators were identified and therefore no impairment test was required. | ||||||
7 | ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | |||||
The following is a summary of accounts payable and accrued liabilities as at March 31, 2011 and December 31, 2010: | ||||||
As at | As at | |||||
Mar 31, 2011 | Dec 31, 2010 | |||||
Trade accounts payable | $ 1,407 | $ 1,580 | ||||
Accrued liabilities | 669 | 860 | ||||
$ 2,076 | $ 2,440 | |||||
8 | SHARE CAPITAL | |||||
Authorized share capital | ||||||
The authorized share capital consists of an unlimited number of preference shares, issuable in series, and an unlimited number of | ||||||
voting common shares. | ||||||
Issued share capital | ||||||
The following is a summary of the changes in share capital from January 1, 2010 to March 31, 2011: |
Number of | |||||
common shares | Amount | ||||
(in thousands) | $ | ||||
Balance outstanding - January 1, 2010 | 24,055 | 49,948 | |||
Options exercised in 2010 | 25 | 29 | |||
Balance outstanding - December 31, 2010 and March 31, 2011 | 24,080 | 49,977 | |||
Stock option plan | |||||
The following is a summary of the changes in the stock options outstanding from January 1, 2010 to March 31, 2011: | |||||
Number of | Weighted average | ||||
options | exercise price | ||||
(in thousands) | $ | ||||
Balance outstanding - January 1, 2010 | 1,580 | 2.22 | |||
Granted in 2010 | 222 | 1.60 | |||
Exercised in 2010 | (25) | 0.61 | |||
Balance outstanding - December 31, 2010 | 1,777 | 2.17 | |||
Granted during the three months ended March 31, 2011 | 196 | 1.16 | |||
Cancelled during the three months ended March 31, 2011 | (100) | 0.72 | |||
Balance outstanding - March 31, 2011 | 1,873 | 2.14 |
At March 31, 2011, 1,345,062 options were fully vested and exercisable
(1,034,560 at March 31, 2010).
During the three months ended March 31, 2011, the Company issued 196,000
stock options under the employee and director stock option plan, with
an exercise price of $1.16, 25% of which vest on March 11 of each year,
commencing in 2012, and expire in 2021. Total compensation cost for
these stock options is estimated to be $198, which will be recognized
on a graded basis over the vesting period of the stock options.
The stock options issued during the three months ended March 31, 2011
were valued using the Black-Scholes option pricing model, with the
following assumptions. Expected volatility is based on the Company's
historical volatility, while estimated forfeitures are not considered
significant.
Risk-free interest rate | 3.27% | |
Expected life | 10 years | |
Expected volatility | 90.7% | |
Expected dividend |
Nil |
9 | EXPENSES BY NATURE | ||
Three Months | Three Months | ||
Ended Mar 31, 2011 | Ended Mar 31, 2010 | ||
Employees salaries and directors fees | $ 534 | $ 502 | |
Share-based compensation | 28 | 86 | |
Depreciation and amortization | 72 | 190 | |
Professional fees | 435 | 191 | |
Contract research | 305 | - | |
Other expenses, net of interest income | 386 | 428 | |
$ 1,760 | $ 1,397 |
10 LOSS PER SHARE
Loss per share is calculated using the weighted average number of shares
outstanding. The weighted average number of shares outstanding for the
three months ended March 31, 2011 was 24,079,878 (for the three months
ended March 31, 2010 - 24,054,878).
As the Company had a loss for each of the periods presented, basic and
diluted loss per share are the same because the exercise of all stock
options would have an anti-dilutive effect.
11 SEGMENTED INFORMATION
The Company's operations are categorized into one industry segment,
being specialty pharmaceuticals. All of the Company's assets,
including capital and intangible assets, are in Canada, while all
licensing revenue is derived from the United States.
Craig Armitage | Larry Andrews |
Investor Relations | President and CEO |
The Equicom Group | Cipher Pharmaceuticals |
(416) 815-0700 ext 278 | (905) 602-5840 ext 324 |
(416) 815-0080 fax | (905) 602-0628 fax |
carmitage@equicomgroup.com | landrews@cipherpharma.com |