Press Releases< /span>
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Feb. 22, 2012 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced its financial and operational results for the fourth quarter and fiscal year ended December 31, 2011.
Fiscal 2011 Summary
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Completed CIP-ISOTRETINOIN Phase III safety study in Q2 and submitted
New Drug Application (NDA) amendment to the U.S. Food and Drug
Administration (FDA) and New Drug Submission (NDS) to Health Canada in
Q4. The NDA amendment was accepted as a complete response with a goal
date under the U.S. Prescription Drug User Fee Act (PDUFA) of May 29,
2012. Subsequent to year end Health Canada accepted the submission for
filing with a response expected by Q1 2013.
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Entered into a U.S. distribution and supply agreement for CIP-TRAMADOL
ER with Vertical Pharmaceuticals, Inc in Q2. The product was launched
by Vertical in the U.S. in Q3 under the trade name ConZip ™.
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CIP-TRAMADOL ER was approved by Health Canada in Q3; product will be
marketed by the Company's Canadian distributor, Medical Futures, under
the trade name Durela™, with an expected launch in Q1 2012.
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Royalty revenue from Lipofen® increased 8% over 2010.
- Strong balance sheet at year end with no debt and cash of $9.6 million, versus $9.2 million at the end of Q3 2011.
"It was a successful year for Cipher with multiple commercial and regulatory milestones, highlighted by two marketing agreements for our once-daily tramadol, the launch of ConZip™ in the U.S. market, and completion of the comprehensive Phase III study of our high-potential acne product," said Larry Andrews, President and CEO of Cipher. "Moreover, we saw steady growth in royalty revenue from Lipofen® which helped us achieve another sales milestone subsequent to year end. With growing revenues from our two commercial products and an upcoming PDUFA date in May for CIP-ISOTRETINOIN, 2012 is shaping up to be an eventful and exciting year for the Company."
Financial Review
Total net revenue in 2011 was $3.6 million, compared with $5.4 million in 2010. Fiscal 2010 revenue included a one-time $1.0 million sales milestone for Lipofen® and the recognition of revenue on up-front and milestone payments, neither of which occurred during 2011. Excluding revenue recognized on these items, net revenue increased by $1.1 million in 2011, driven by an 8% increase in Lipofen® royalties and $0.8 million in revenue from CIP-TRAMADOL ER, the first year that revenue has been recognized for this product.
Research and Development ("R&D") expenditures for 2011 were $2.2 million, compared with $0.7 million in 2010. Reported R&D expense is shown net of the amounts reimbursed for the CIP-ISOTRETINOIN Phase III clinical study and refundable provincial tax credits. The year-over-year increase relates primarily to expenses for the CIP-ISOTRETINOIN Phase III clinical study, which was completed during 2011, as well as a new product development program.
Operating, General and Administrative ("OG&A") expenses for 2011 were $3.1 million, compared with $3.8 million in 2010. Net loss for the 12 months ended December 31, 2011 was $2.3 million ($0.10 per share), compared with net income of $0.2 million ($0.00 per share) in 2010.
In Q4 2011, Cipher recorded licensing revenue of $1.0 million, compared with $1.2 million in Q4 2010.
R&D expenses in Q4 2011 were $0.6 million, compared with nil in Q4 2010. OG&A expenses for Q4 2011 were $0.7 million versus with $0.9 million in the same period last year. Net loss for the three months ended December 31, 2011 was $0.5 million ($0.02 per share), compared with net income of $0.1 million ($0.00 per share) in the same period last year.
The Company's financial position remained solid at year-end. As at December 31, 2011, Cipher had no debt and cash of $9.6 million, compared with $9.2 million at September 30, 2011 and $10.3 million at December 31, 2010.
Product Update
Lipofen®
During 2011, Cipher saw steady growth in royalty revenue from Lipofen®
as Kowa Pharmaceuticals continued its penetration of primary care
physicians in its targeted regions. Subsequent to year end, the Company
received a US$1.0 million one-time milestone payment, which was based
on sales performance over a trailing 12-month period and reflected a
steady increase in new prescriptions during Q4 2011 and early Q1 2012.
Cipher's 50% share of the milestone will be reflected in its financial
results for Q1 2012.
CIP-ISOTRETINOIN
During Q4 2011, Cipher's revised NDA was submitted to the FDA and
accepted for review. Based on the FDA's acceptance as a complete
response, Cipher received a US$1.0 million milestone payment from its
marketing partner, Ranbaxy Pharmaceuticals Inc. The target action date
under PDUFA is May 29, 2012. Once CIP-ISOTRETINOIN is commercialized
in the U.S., Cipher expects that future revenue from this product has
the potential to significantly exceed the revenue generated from the
Company's other current products. Pre-commercial manufacturing planning
is also underway for a possible U.S. launch in Q4 2012.
In addition, Cipher's New Drug Submission for CIP-ISOTRETINOIN was accepted for review by Health Canada subsequent to year end. A response from Health Canada is expected in Q1 2013 and, once the product is approved, Cipher plans to market it in Canada through its own specialty sales team.
CIP-TRAMADOL ER (ConZip™/Durela™)
ConZip™ was launched by Vertical Pharmaceuticals in September 2011.
Product sales to date have been encouraging, and the Company expects
solid growth in 2012 as U.S. physicians gain more experience with the
product and Vertical expands its coverage.
In Canada, Medical Futures plans to launch Durela™ in Q1 2012 with a dedicated sales force comprising approximately 22 representatives, with plans for further expansion.
New Products and Out-Licensing Activities
Cipher is actively pursuing out-licensing agreements for its current
products in other territories and is also seeking products in
development or approved for the Canadian market to complement its
Canadian commercialization plans for CIP-ISOTRETINOIN.
Notice of Conference Call
Cipher will hold a conference call today, February 22, 2012, 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 (TSX: DND; OTC: CPHMF.PK) is a growing specialty pharmaceutical company that commercializes novel formulations of successful, currently marketed molecules. Cipher's strategy is to in-license clearly differentiated products, advance them through the clinical development and regulatory approval stages, and out-license to international marketing partners. The Company's first product is a fenofibrate formulation marketed in the United States as Lipofen®. Cipher's second product, an extended-release tramadol, is marketed in the United States as ConZip™ and will be marketed in Canada as Durela™. Cipher's New Drug Application for its third product, a novel formulation of the acne treatment isotretinoin, is currently being reviewed by the FDA and Health Canada.
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. These factors include, but are not limited to losses; the applicability of patents and proprietary technology; possible patent litigation; approval of products in the Company's pipeline; marketing of products; meeting projected drug development timelines and goals; product liability and insurance; dependence on strategic partnerships and licensees; concentration of the Company's revenue; substantial competition and rapid technological change in the pharmaceutical industry; the publication of negative results of clinical trials of the Company's products; the ability to access capital; the ability to attract and retain key personnel; changes in government regulation or regulatory approval processes; dependence on contract research organizations; third party reimbursement; the success of the Company's strategic investments; the achievement of development goals and time frames; the possibility of shareholder dilution; market price volatility of securities; and the existence of significant shareholders. 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.
Financial Statements
For the Year Ended December 31, 2011
Cipher Pharmaceuticals Inc. | |||||||
Balance Sheets | |||||||
As at December 31, 2011, December 31, 2010 and January 1, 2010 | |||||||
(in thousands of Canadian dollars) | |||||||
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Note |
December 31, 2011 |
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December 31, 2010 |
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January 1, 2010 |
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$ | $ | $ | |||||
ASSETS | |||||||
Current assets | |||||||
Cash | 9,636 | 10,328 | 9,006 | ||||
Accounts receivable | 1,782 | 1,808 | 967 | ||||
Prepaid expenses and other assets | 272 | 465 | 457 | ||||
Loan receivable | - | - | 800 | ||||
11,690 | 12,601 | 11,230 | |||||
Property and equipment, net | 6 | 25 | 50 | 86 | |||
Intangible assets, net | 7 | 2,944 | 3,522 | 3,507 | |||
14,659 | 16,173 | 14,823 | |||||
LIABILITIES | |||||||
Current liabilities | |||||||
Accounts payable and accrued liabilities | 8 | 1,912 | 2,440 | 1,570 | |||
Current portion of deferred revenue | 917 | 567 | 1,956 | ||||
2,829 | 3,007 | 3,526 | |||||
Deferred revenue | 2,330 | 1,692 | 329 | ||||
5,159 | 4,699 | 3,855 | |||||
SHAREHOLDERS' EQUITY | |||||||
Share capital | 9 | 50,172 | 49,977 | 49,948 | |||
Contributed surplus | 5 | 33,032 | 32,890 | 32,585 | |||
Deficit | 5 | (73,704) | (71,393) | (71,565) | |||
9,500 | 11,474 | 10,968 | |||||
14,659 | 16,173 | 14,823 |
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc. | |||||
Statements of Operations and Comprehensive Income (Loss) | |||||
For the years ended December 31, 2011 and 2010 | |||||
(in thousands of Canadian dollars, except per share data) | |||||
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Note |
December 31, 2011 |
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December 31, 2010 |
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$ | $ | ||||
Revenues | |||||
Licensing revenue | 3,569 | 5,385 | |||
Expenses | |||||
Research and development | 10 | 2,205 | 743 | ||
Operating, general and administrative | 3,186 | 3,832 | |||
Amortization of intangible assets | 578 | 704 | |||
Interest income | (89) | (66) | |||
11 | 5,880 | 5,213 | |||
Income (loss) before income taxes | (2,311) | 172 | |||
Provision for (recovery of) income taxes | 13 | ||||
Current | - | 171 | |||
Deferred | - | (171) | |||
Income (loss) and comprehensive income (loss) for the year |
5 | (2,311) | 172 | ||
Basic and diluted earnings (loss) per share | 14 | (0.10) | 0.00 |
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc. Statements of Changes in Equity |
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For the years ended December 31, 2011 and 2010 (in thousands of Canadian dollars) |
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Share Capital |
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Contributed Surplus |
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Deficit |
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Total Shareholders' Equity |
$ | $ | $ | $ | ||||
Balance, January 1, 2011 | 49,977 | 32,890 | (71,393) | 11,474 | |||
Loss and comprehensive loss for the year | - | - | (2,311) | (2,311) | |||
Exercise of stock options | 90 | (43) | - | 47 | |||
Shares issued under the share purchase plan | 105 | - | - | 105 | |||
Share-based compensation - stock option plan | - | 185 | - | 185 | |||
Balance, December 31, 2011 | 50,172 | 33,032 | (73,704) | 9,500 | |||
Balance, January 1, 2010 | 49,948 | 32,585 | (71,565) | 10,968 | |||
Income and comprehensive income for the year | - | - | 172 | 172 | |||
Exercise of stock options | 29 | (14) | - | 15 | |||
Share-based compensation - stock option plan | - | 319 | - | 319 | |||
Balance, December 31, 2010 | 49,977 | 32,890 | (71,393) | 11,474 | |||
The accompanying notes are an integral part of these financial statements |
Cipher Pharmaceuticals Inc. Statements of Cash Flows |
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For the years ended December 31, 2011 and 2010 (in thousands of Canadian dollars) |
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Note |
December 31, 2011 |
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December 31, 2010 |
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$ | $ | |||||
Cash provided by (used in) | ||||||
Operating activities | ||||||
Income (loss) for the year | (2,311) | 172 | ||||
Items not affecting cash: | ||||||
Depreciation of property and equipment | 37 | 53 | ||||
Amortization of intangible assets | 7 | 578 | 704 | |||
Share-based compensation - share purchase plan | 9 | 16 | - | |||
Share-based compensation - stock option plan | 185 | 319 | ||||
(1,495) | 1,248 | |||||
Changes in non-cash operating items: | ||||||
Accounts receivable | 26 | (841) | ||||
Prepaid expenses and other assets | 193 | (8) | ||||
Accounts payable and accrued liabilities | (528) | 870 | ||||
Deferred revenue | 988 | (26) | ||||
Net cash generated from (used in) operating activities | (816) | 1,243 | ||||
Investing activities | ||||||
Proceeds from loan receivable | - | 800 | ||||
Purchase of property and equipment | (12) | (17) | ||||
Acquisition of intangible rights | - | (719) | ||||
Net cash generated from (used in) investing activities | (12) | 64 | ||||
Financing activities | ||||||
Proceeds from exercise of stock options and from | ||||||
shares issued under the share purchase plan | 136 | 15 | ||||
Increase (Decrease) in cash | (692) | 1,322 | ||||
Cash, beginning of year | 10,328 | 9,006 | ||||
Cash, end of year | 9,636 | 10,328 | ||||
The accompanying notes are an integral part of these financial statements |
Cipher Pharmaceuticals Inc.
Notes to Financial Statements
December 31, 2011
(in thousands of Canadian dollars, except per share amounts)
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 defined 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 ("IFRS"), and to require
publicly accountable enterprises to apply these standards effective for
years beginning on or after January 1, 2011. Accordingly, these are
the Company's first annual financial statements prepared in accordance
with IFRS. In these financial statements, the term "Canadian GAAP"
refers to Canadian GAAP before the adoption of IFRS.
Subject to certain transition elections disclosed in note 5, 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 always been in effect. Note 5
discloses the impact of the transition to IFRS on the Company's
reported financial position, financial performance and 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 prepared under Canadian GAAP.
The policies applied in these financial statements are based on IFRS
issued and outstanding as of December 31, 2011.
3 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The significant accounting policies used in the preparation of these
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 year.
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. The estimates
and judgments that have a significant risk of causing a material
adjustment to the carrying amounts of assets and liabilities within the
next financial year are addressed below.
(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 contractual obligations.
The estimated periods are reviewed at least annually and are updated if
expectations change as a result of licensing partner interactions,
product commercial obsolescence or other 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 deferred income taxes. These estimates are used to determine the
recoverability 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: These 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: These 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: This category includes
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, U.S.
Food and Drug Administration fees, data base subscription fees and
other items paid in advance. Other assets consist of 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. 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. The useful lives of the intangible assets are
reviewed at least once per year
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 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.
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 provides
services and when the costs of fulfilling the Company's contractual
obligations can be measured reliably. Post-commercialization milestone
payments are recognized as revenue when the underlying condition is
met, the milestone is not a condition of 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 estimated service term which the Company
maintains contractual obligations. Royalty revenue is recognized in
the period in which the Company earns the royalty. The gross margin on
sales of finished products to license partners is recognized when the
product is shipped, at which time ownership is transferred. 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.
Investment tax credits
The Company is entitled to provincial investment tax credits, which are
earned as a percentage of eligible research and development
expenditures incurred in each taxation year. Investment tax credits
are accounted for as a reduction of the related expenditure items of a
current nature and a reduction of the related asset cost for items of a
long-term nature, provided that the Company has reasonable assurance
that the tax credits will be realized.
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
IFRS 9, "Financial Instruments", addresses the classification,
measurement and recognition of financial assets and financial
liabilities. IFRS 9 was issued in November 2009 and October 2010. It
replaces the parts of IAS 39 that relate to the classification and
measurement of financial instruments. IFRS 9 requires financial assets
to be classified into two measurement categories: those measured as at
fair value and those measured at amortized cost. The determination is
made at initial recognition. The classification depends on the
entity's business model for managing its financial instruments and the
contractual cash flow characteristics of the instrument. For financial
liabilities, the standard retains most of the IAS 39 requirements. The
main change is that, in cases where the fair value option is taken for
financial liabilities, the part of a fair value change due to an
entity's own credit risk is recorded in other comprehensive income
rather than the income statement, unless this creates an accounting
mismatch. The Company is yet to assess IFRS 9's full impact and
intends to adopt IFRS 9 no later than the accounting period beginning
on or after January 1, 2013.
IFRS 12, "Disclosures of interests in other entities" includes the
disclosure requirements for all forms of interests in other entities,
including joint arrangements, associates, special purpose vehicles and
other off balance sheet vehicles. The Company is yet to assess IFRS
12's full impact and intends to adopt IFRS 12 no later than the
accounting period beginning on or after January 1, 2013.
There are no other IFRS or International Financial Reporting
Interpretations Committee interpretations that are not yet effective
that would be expected to have a material impact on the Company.
4 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 at December 31, 2011 is concentrated between two
distribution partners. One has been a partner of the Company for over
four years, with no defaults in the past and one is a new partner in
the current year. As of December 31, 2011, no accounts receivable were
impaired or past due. The Company's three largest customers comprise
63%, 20% and 15% of licensing revenue (92% for the largest customer in
2010).
(ii) Liquidity risk
The Company has no long term debt. 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 $1,912 as at December 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. Management
forecasts cash flows in order to monitor liquidity requirements and
ensure that the Company has sufficient cash to meet operational needs.
(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 December 31, 2011 includes a total of US$1,602 and accounts
payable and accrued liabilities includes a total of US$1,039. A 10%
change in the US/CDN exchange rate on December 31, 2011 balance would
have had a $56 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.
5 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 and comprehensive
income as previously reported under Canadian GAAP to IFRS
(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. In addition, as
required by IFRS 1, 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 and comprehensive
income 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 | |||
Dec 31, 2010 | Jan 1, 2010 | ||||
As reported under Canadian GAAP | $ | (71,192) | $ | (71,248) | |
Increase in deficit for: | |||||
Share-based compensation expense - IFRS 2 | (201) | (317) | |||
As reported under IFRS | $ | (71,393) | $ | (71,565) | |
Contributed Surplus | As at | As at | |||
Dec 31, 2010 | Jan 1, 2010 | ||||
As reported under Canadian GAAP | $ | 32,689 | $ | 32,268 | |
Increase in contributed surplus for: | |||||
Share-based compensation expense - IFRS 2 | 201 | 317 | |||
As reported under IFRS | $ | 32,890 | $ | 32,585 | |
Comprehensive Income | Year Ended | ||||
Dec 31, 2010 | |||||
As reported under Canadian GAAP | $ | 56 | |||
Increase in comprehensive income for: | |||||
Share-based compensation expense - IFRS 2 | 116 | ||||
As reported under IFRS | $ | 172 | |||
Operating, general and administrative expense | Year Ended | ||||
Dec 31, 2010 | |||||
As reported under Canadian GAAP | $ | 3,895 | |||
Decrease in operating, general and administrative expense for: | |||||
Share-based compensation expense - IFRS 2 | (116) | ||||
As reported under IFRS | $ | 3,779 |
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 as at January 1, 2010. General and
administrative expenses decreased by $116 for the year ended December
31, 2010.
6 PROPERTY AND EQUIPMENT
The following is a summary of property and equipment as at December 31,
2011:
December 31, 2011 | December 31,2010 | ||||||||||
Cost |
Accumulated Depreciation |
Cost |
Accumulated Depreciation |
||||||||
Computer equipment | $ | 132 | $ | 115 | $ | 123 | $ | 106 | |||
Furniture and fixtures | 129 | 127 | 126 | 112 | |||||||
Leasehold improvements | 67 | 61 | 67 | 48 | |||||||
328 | $ | 303 | 316 | $ | 266 | ||||||
Accumulated depreciation | (303) | (266) | |||||||||
$ | 25 | $ | 50 |
7 INTANGIBLE ASSETS
The Company has entered into 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 certain intangible rights. The Company may be
required to pay additional amounts to Galephar for the CIP-ISOTRETINOIN
intangible rights of up to $661 (US$650) if certain future milestones
are achieved as defined in the agreement. The recoverability of these
intangible rights is dependant upon sufficient revenues being generated
from the related products. The Company is currently amortizing the
intangible rights related to CIP-ISOTRETINOIN and CIP-TRAMADOL ER.
In accordance with the above-noted agreements, after certain prescribed
thresholds are achieved, the Company pays Galephar a 50% share of all
amounts received, after deducting product-related expenses under
licensing and distribution agreements.
The following is a summary of intangible assets as at December 31, 2011:
CIP-Fenofibrate | CIP-Isotretinoin |
CIP-Tramadol ER |
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 year ended December 31, 2011 | |||||||||
Opening net book value | $ | - | $ | 1,068 | $ | 2,454 | $ | 3,522 | |
Additions | - | - | - | - | |||||
Amortization | - | (228) | (350) | (578) | |||||
Net book value | $ | - | $ | 840 | $ | 2,104 | $ | 2,944 | |
As at December 31, 2011 | |||||||||
Cost | $ | 2,332 | $ | 1,579 | $ | 2,454 | $ | 6,365 | |
Accumulated amortization | (2,332) | (739) | (350) | (3,421) | |||||
Net book value | $ | - | $ | 840 | $ | 2,104 | $ | 2,944 |
The Company has considered indicators of impairment as of January 1,
2010, December 31, 2010 and December 31, 2011 and no indicators were
identified.
8 ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
The following is a summary of accounts payable and accrued liabilities
as at December 31, 2011 and December 31, 2010:
As at | As at | |||
Dec 31, 2011 | Dec 31, 2010 | |||
Trade accounts payable | $ | 1,234 | $ | 1,861 |
Accrued liabilities | 678 | 579 | ||
$ | 1,912 | $ | 2,440 |
9 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 December 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 | 24,080 | 49,977 | |
Options exercised in 2011 | 104 | 90 | |
Shares issued in 2011 under the share purchase plan | 132 | 105 | |
Balance outstanding - December 31, 2011 | 24,316 | 50,172 |
Share purchase plan - in 2011, the Company implemented an Employee and Director Share Purchase Plan ("ESPP") to allow employees and directors to share in the growth of the Company through share ownership. Through the ESPP, employees and directors may contribute amounts from payroll to be used to purchase shares of the Company at a 15% discount from the prevailing trading price. Plan members must hold their shares for a period of at least six months before they can be sold. The plan was approved by the board of directors on March 8, 2011. The shareholders of the Company approved the ESPP at the annual and special meeting of shareholders held on May 12, 2011. The shares issued under the ESPP are new shares issued from treasury and the maximum number of shares that can be issued under the ESPP is one million. During the year, 131,417 shares were issued under the ESPP. Included in share-based compensation expense is $16 which is the discount on the shares issued under the ESPP during the year.
Stock option plan
The following is a summary of the changes in the stock options
outstanding from January 1, 2010 to December 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 in 2011 | 196 | 1.16 | |||
Exercised in 2011 | (104) | 0.45 | |||
Cancelled in 2011 | (104) | 0.74 | |||
Expired in 2011 | (10) | 1.49 | |||
Balance outstanding - December 31, 2011 | 1,755 | 2.24 |
At December 31, 2011, 1,247,420 options were fully vested and exercisable (1,114,560 at December 31, 2010).
During 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 2011 were valued using the Black-Scholes
option pricing model, at $1.01 per option, 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 |
During 2011, 104,445 stock options were exercised for a total cash consideration of $47. Capital stock increased by $90 representing the cash consideration of $47 and a $43 transfer from contributed surplus. The share price at the time of exercise was $1.11.
The following is a summary of the outstanding options as at December 31,
2011:
Expiry date | Exercise price | Number of options (in thousands) | ||||
$ | Vested | Unvested | Total | |||
January 11, 2012 | 1.09 | 125 | - | 125 | ||
September 17, 2014 | 2.35 | 125 | - | 125 | ||
March 23, 2016 | 4.12 | 200 | - | 200 | ||
June 28, 2016 | 4.00 | 180 | - | 180 | ||
September 13, 2016 | 2.90 | 69 | - | 69 | ||
March 9, 2017 | 3.90 | 224 | - | 224 | ||
February 28, 2018 | 1.05 | 159 | 53 | 212 | ||
December 3, 2018 | 0.50 | 30 | 10 | 40 | ||
February 20, 2019 | 0.61 | 77 | 101 | 178 | ||
November 6, 2019 | 0.55 | 10 | 10 | 20 | ||
February 19, 2020 | 1.60 | 48 | 141 | 189 | ||
March 11, 2021 | 1.16 | - | 193 | 193 | ||
1,247 | 508 | 1,755 |
10 RESEARCH AND DEVELOPMENT
A total of $4,022 of research and development costs were incurred in
2011 ($12,835 in 2010). The research and development expense reflected
in the Statement of Operations is presented net of refundable
provincial tax credits of $100 ($328 in 2010) for qualifying research
and development expenditures and reimbursed R&D expenditures of $1,717
($11,764 in 2010). Under the terms of the CIP-ISOTRETINOIN
distribution and supply agreement, certain research and development
costs incurred for clinical studies required by the FDA to secure
approval for the product are reimbursed to the Company and as a result,
these reimbursed costs are not reflected in reported research and
development expense.
11 EXPENSES BY NATURE
Year Ended | Year Ended | |||
Dec 31, 2011 | Dec 31, 2010 | |||
Employees salaries and other short term benefits | $ | 2,009 | $ | 2,374 |
Directors fees | 291 | 275 | ||
Share-based compensation | 201 | 319 | ||
Amortization of intangible assets | 578 | 704 | ||
Depreciation of property and equipment | 37 | 53 | ||
Professional fees | 921 | 633 | ||
Contract research | 1,162 | - | ||
Other expenses, net of interest income | 681 | 855 | ||
$ | 5,880 | $ | 5,213 |
12 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:
Year Ended | Year Ended | |||
Dec 31, 2011 | Dec 31, 2010 | |||
Salaries and short-term employee benefits, including bonuses | $ | 1,189 | $ | 1,345 |
Directors fees | 291 | 275 | ||
Share-based compensation expense | 180 | 287 | ||
$ | 1,660 | $ | 1,907 |
13 INCOME TAXES
The provision for income taxes differs from the amount computed by
applying the statutory income tax rate to the loss for the year. The
sources and tax effects of the differences are as follows:
Year Ended | Year Ended | |||
Dec 31, 2011 | Dec 31, 2010 | |||
Statutory income tax rate of 28.25% applied to income (loss) | ||||
for the year (2010 - 31%) | $ | (653) | $ | 53 |
Permanent differences | 115 | 118 | ||
Change in enacted income tax rates and other items | (98) | (740) | ||
Change in deferred tax assets not recognized | 636 | 569 | ||
Provision for income taxes | $ | - | $ | - |
The significant components of unrecognized deferred tax assets are
summarized as follows:
As at | As at | |||
Dec 31, 2011 | Dec 31, 2010 | |||
Non-capital losses | $ | 12,296 | $ | 11,290 |
Excess of tax value of property and equipment over book value | 25 | 28 | ||
SR&ED expenditure pool | 4,378 | 4,186 | ||
Excess of tax value of intangible assets over book value | 2,503 | 3,422 | ||
Benefit of investment tax credits | 2,788 | 2,673 | ||
Capital losses | 233 | 217 | ||
Provincial tax credits | 326 | 289 | ||
Other temporary differences | 614 | 422 | ||
$ | 23,163 | $ | 22,527 |
Deferred tax assets are recognized for tax loss carry-forwards to the extent that the realization of the related tax benefit through future taxable profits is probable. The Company did not recognize deferred tax assets of $23,163 (2010 - $22,527) that can be carried forward against future taxable income.
The Company has non-capital loss carry forwards of $49,100 as at December 31, 2011 that expire in varying amounts from 2014 to 2031.
The Company has Scientific Research and Experimental Development ("SR&ED") expenditures of $17,500 which can be carried forward indefinitely to reduce future years' taxable income.
The Company has approximately $3,700 of investment tax credits on SR&ED expenditures that are available to be applied against federal taxes otherwise payable in future years and expire in varying amounts from 2022 to 2031.
14 EARNINGS (LOSS) PER SHARE
Earnings (loss) per share is calculated using the weighted average
number of shares outstanding. The weighted average number of shares
outstanding for the year ended December 31, 2011 was 24,175,720 (for
the year ended December 31, 2010 - 24,071,522).
As the Company had a loss for the year ended December 31, 2011, basic and diluted loss per share are the same because the exercise of all stock options would have an anti-dilutive effect. For the prior year, the dilutive impact on earnings per share is not significant.
15 COMMITMENTS
The Company has entered into an operating lease for its office
facilities with the following minimum annual payments:
2012: $76 | ||
2013: $73 | ||
2014: $73 | ||
2015: $30 |
16 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
Investor Relations
The Equicom Group
(416) 815-0700 ext 278
(416) 815-0080 fax
carmitage@equicomgroup.com
Larry Andrews
President and CEO
Cipher Pharmaceuticals
(905) 602-5840 ext 324
(905) 602-0628 fax
landrews@cipherpharma.com