Press Releases
Cipher reports third quarter fiscal 2007 results
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Nov. 7 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND)
today announced its financial and operational results for the three and
nine months ended September 30, 2007.Q3 2007 Summary
---------------
- Entered into a licensing and distribution agreement with ProEthic
Pharmaceuticals under which ProEthic was granted the exclusive right
to market, sell and distribute CIP-FENOFIBRATE (approved and marketed
in U.S. under the label Lipofen(TM))
- Successfully completed commercial scale-up and delivery of finished
packaged product to ProEthic on schedule
- Lipofen launched in U.S. market toward the end of the third quarter
- Continued dialogue and correspondence with the U.S. Food and Drug
Administration (FDA) on CIP-ISOTRETINOIN and CIP-TRAMADOL ER
- Recorded commercial revenue of $149,000
- Cash and cash equivalents of $12.1 million at quarter end"We reached important company milestones in the third quarter with the
signing of our first commercial distribution agreement in the U.S. market and,
toward the end of the quarter, the launch of Lipofen in the large and growing
U.S. fenofibrate market," said Larry Andrews, President and CEO of Cipher.
"These successes validate our core business strategy and our transition to a
commercial, specialty pharmaceutical company. During the quarter, we also
continued our dialogue and correspondence with the FDA on CIP-ISOTRETINOIN and
CIP-TRAMADOL ER as we work diligently to advance these two products through
the remaining milestones on the path to final approval."
Financial Review
----------------
In the third quarter of 2007, the Company recorded total revenue of
$149,000, compared with nil in the same period last year. Revenue for the
third quarter of 2007 includes an amortized portion of the US$2 million
up-front licensing fee from ProEthic. Cipher received the initial payment of
US$1 million in the third quarter of 2007 and expects to receive the second
payment of US$1 million in March 2008. Revenue is presented on a net basis and
reflects the elements of the ProEthic licensing and distribution agreement, as
well as direct product-related expenses and amounts due to Galephar, the
Company's technology partner.
Research and development (R&D) expenses for the third quarter of 2007
were $0.2 million, compared with $1.4 million in the third quarter of 2006.
The decrease in R&D spending reflects the advanced stage of development of the
Company's current products. Operating, general and administrative (OG&A)
expenses for the third quarter of 2007 were $1.1 million, compared with
$0.9 million in the same period last year. The increase in OG&A is due to
higher compensation expense resulting from an increase in personnel to support
current growth plans, as well as stock-based compensation expense. Net loss
for the three months ended September 30, 2007 was $1.1 million ($0.04 per
basic and diluted share), compared with a net loss of $2.0 million ($0.08 per
basic and diluted share) in the same period last year.
As at September 30, 2007, Cipher had cash and cash equivalents of
$12.1 million, compared with $12.1 million as at June 30, 2007 and
$15.1 million as at December 31, 2006.
Product Update
--------------
In July 2007, Cipher entered into a licensing and distribution agreement
with ProEthic Pharmaceuticals under which ProEthic was granted the exclusive
right to market, sell and distribute Lipofen in the United States. The
agreement with ProEthic is for a period of ten years and they have the right
to extend the term for additional two-year periods. In late September 2007,
ProEthic launched Lipofen 150 mg and 50 mg capsules in the U.S. market with
the full effort of its sales and marketing teams. Lipofen is the lead product
for ProEthic as it seeks to build its presence in the important primary care
space.
During the second quarter of 2007, Cipher received a second approvable
letter from the FDA pertaining to its CIP-ISOTRETINOIN NDA. In the letter, the
FDA indicated that Cipher's application is approvable subject to the
resolution of two remaining issues. In addition to one question related to
chemistry, manufacturing and controls, which the Company has responded to, the
FDA has requested that Cipher provide additional clinical safety data. The
Company appealed the position taken by the FDA in its approvable letter using
the formal dispute resolution process. Cipher submitted its appeal and met
with the FDA on July 11, 2007. In August 2007, the Company received a response
from the FDA to its request for formal dispute resolution. In the letter to
Cipher, the representative from the FDA agreed with the Division of
Dermatology and Dental Product's view that a clinical study is needed to
further demonstrate the safety of CIP-ISOTRETINOIN. Subsequently, Cipher has
had further discussions with the FDA on the issues raised in its response
letter. Cipher continues to believe that the clinical questions raised by the
FDA have been addressed in the NDA submission. The appeal process is ongoing.
During the second quarter of 2007, Cipher received an approvable letter
from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's
once-daily formulation of tramadol. In its letter, the FDA indicated that
Cipher's application is approvable subject to the resolution of certain
issues, including a request for an additional adequate clinical trial to
provide further efficacy data. In subsequent discussions with the FDA, Cipher
has obtained clarification on the question of efficacy. The FDA has indicated
that the statistical methods used to analyze data from Cipher's clinical
trials did not adequately address missing data relating to subjects who
dropped out of the trials. The Company has a meeting scheduled with the FDA in
November 2007 to further discuss the issues raised in the action letter. The
Company will determine the most appropriate path forward to achieve final
regulatory approval based in part on the outcome of these discussions with the
FDA. Cipher continues to believe its submission includes sufficient efficacy
data to support regulatory approval.
Notice of Conference Call
-------------------------
Cipher will hold a conference call today, November 7, 2007, at 8:30 a.m.
(ET) to discuss its financial results and other corporate developments. To
access the conference call by telephone, dial 416-644-3424 or 1-800-732-1073.
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 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, CIP-FENOFIBRATE, received final approval from the U.S. Food and
Drug Administration and Health Canada in the first quarter of 2006. The
product is being marketed in the United States by ProEthic Pharmaceuticals
under the label Lipofen(TM). In addition, Cipher is developing formulations of
the pain reliever tramadol and the acne treatment isotretinoin.
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. Some forward-looking statements may be
identified by words like "may", "will", "anticipate", "estimate", "expect",
"intend", or "continue" or the negative thereof or similar variations. 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. The Company does not undertake to update any
forward-looking statements; such statements speak only as of the date made.Cipher Pharmaceuticals Inc.
Unaudited Consolidated Balance Sheets
(in thousands of dollars)
As at
September 30, December 31,
2007 2006
ASSETS
Current assets
Cash and cash equivalents $ 12,056 $ 15,077
Accounts receivable (note 4) 1,377 -
Other receivables 97 160
Income taxes receivable 98 95
Other current assets 83 32
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13,711 15,364
Property and equipment 210 99
Intangible assets (note 4) 4,708 5,058
Loan receivable (note 3) 1,331 1,986
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$ 19,960 $ 22,507
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LIABILITIES
Current liabilities
Accounts payable and accrued liabilities $ 905 $ 921
Deferred revenue 601 -
Due to related party (note 5) - 123
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1,506 1,044
Deferred revenue 1,341 -
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2,847 1,044
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SHAREHOLDERS' EQUITY
Share capital (note 6) 49,948 49,891
Contributed surplus 30,846 30,430
Deficit (63,681) (58,858)
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17,113 21,463
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$ 19,960 $ 22,507
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The accompanying notes are an integral part of these unaudited
consolidated financial statements
Cipher Pharmaceuticals Inc.
Unaudited Consolidated Statements of Operations and Comprehensive Loss
(in thousands of dollars, except per share amounts)
For the nine For the three
months ended months ended
September 30 September 30
2007 2006 2007 2006
Revenues
Licensing revenue $ 149 $ - $ 149 $ -
Product sales 227 - - -
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376 - 149 -
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Expenses
Cost of goods sold 177 - - -
Research and
development 1,535 8,111 231 1,370
Operating, general
and administrative 3,739 2,648 1,102 897
Amortization of
property and
equipment 32 17 16 5
Amortization of
intangible assets 350 - 117 -
Interest income (634) (695) (267) (240)
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5,199 10,081 1,199 2,032
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Loss and
comprehensive loss
for the period $ (4,823) $ (10,081) $ (1,050) $ (2,032)
-------------------------------------------------------------------------
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Basic and diluted
loss per share
(note 7) $ (0.20) $ (0.43) $ (0.04) $ (0.08)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Cipher Pharmaceuticals Inc.
Unaudited Consolidated Statements of Deficit
(in thousands of dollars)
For the nine For the three
months ended months ended
September 30 September 30
2007 2006 2007 2006
Deficit, beginning
of period $ (58,858) $ (46,795) $ (62,631) $ (54,844)
Loss for the period (4,823) (10,081) (1,050) (2,032)
-------------------------------------------------------------------------
Deficit, end of
period $ (63,681) $ (56,876) $ (63,681) $ (56,876)
-------------------------------------------------------------------------
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The accompanying notes are an integral part of these unaudited
consolidated financial statements
Cipher Pharmaceuticals Inc.
Unaudited Consolidated Statements of Cash Flows
(in thousands of dollars)
For the nine For the three
months ended months ended
September 30 September 30
2007 2006 2007 2006
Cash provided by
(used in)
Operating activities
Loss for the
period $ (4,823) $ (10,081) $ (1,050) $ (2,032)
Items not affecting
cash
Amortization of
property and
equipment 32 17 16 5
Amortization of
intangible
assets 350 - 117 -
Stock-based
compensation
expense 473 292 170 136
Imputed interest
(note 3) (145) (207) (45) (82)
---------------------------------------------- --------------------------
(4,113) (9,979) (792) (1,973)
Net change in non-
cash operating items 435 (1,780) 709 (339)
Drawdown of loan
receivable (note 3) 800 800 - 98
Exercise of stock
options settled
in cash - (286) - -
---------------------------------------------- --------------------------
(2,878) (11,245) (83) (2,214)
---------------------------------------------- --------------------------
Investing activities
Purchase of property
and equipment (143) (28) (10) (17)
Increase in
intangible assets - (277) - (277)
Proceeds from
loan receivable - 800 - -
---------------------------------------------- --------------------------
(143) 495 (10) (294)
---------------------------------------------- --------------------------
Financing activities
Issuance of
share capital - 10,907 - -
Proceeds from
exercise of
stock options - 201 - -
---------------------------------------------- --------------------------
- 11,108 - -
---------------------------------------------- --------------------------
Increase (decrease)
in cash and cash
equivalents (3,021) 358 (93) (2,508)
Cash and cash
equivalents,
beginning of period 15,077 16,616 12,149 19,482
---------------------------------------------- --------------------------
---------------------------------------------- --------------------------
Cash and cash
equivalents,
end of period $ 12,056 $ 16,974 $ 12,056 $ 16,974
---------------------------------------------- --------------------------
---------------------------------------------- --------------------------
The accompanying notes are an integral part of these unaudited
consolidated financial statements
Cipher Pharmaceuticals Inc.
Notes to Unaudited Consolidated Financial Statements
September 30, 2007
(in thousands of dollars, except per share amounts)
1 Summary of significant accounting policies
Basis of presentation
The accompanying unaudited interim consolidated financial statements
of the Company have been prepared in accordance with accounting
principles generally accepted in Canada for interim reporting.
Accordingly, these financial statements do not include all of the
disclosures required by generally accepted accounting principles for
annual financial statements and should be read in conjunction with
the annual financial statements of the Company. In the opinion of
management, all adjustments considered necessary for fair
presentation have been included. All such adjustments are of a normal
recurring nature. Operating results for the nine months ended
September 30, 2007 are not necessarily indicative of the results that
may be expected for the fiscal year ending December 31, 2007.
There have been no changes to the accounting policies as described in
Note 1 to the consolidated financial statements for the year ended
December 31, 2006, except as explained in the following paragraph and
in Note 2 below.
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, revenue is
deferred and recognized on a straight line basis during the estimated
term over which the Company maintains substantive contractual
obligations. Milestone payments are recognized as revenue when the
underlying condition is met, the milestone is not a condition to
future deliverables and collectibility is reasonably assured.
Otherwise, 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. Revenue from licensing and distribution
agreements is presented on a net basis.
2 Changes in accounting policies
Effective January 1, 2007 the Company adopted the CICA Handbook
Section 1530, "Comprehensive income" and CICA Handbook section 3855,
"Financial instruments - recognition and measurement".
Comprehensive income
Comprehensive income introduces a new requirement to present, among
other things, certain unrealized gains and losses outside of net
income or loss. Section 1530 defines comprehensive income as a change
in net assets arising from transactions and other events and
circumstances from non-owner sources. The new standard requires
presentation of a statement of comprehensive income (loss), which has
been combined with the former statement of operations.
Financial instruments
The new standard for financial instruments prescribes when a
financial instrument is to be recognized on the balance sheet and at
what amount. It also specifies how gains and losses on financial
instruments are to be presented. Upon adoption of this new standard,
the Company has classified its cash and cash equivalents as held-for-
trading financial assets, other receivables and loan receivable as
loans and receivables; accounts payable and accrued liabilities and
due to related party as other financial liabilities.
The adoption of these standards had no substantive impact on the
Company's interim consolidated financial statements.
3 Loan receivable
On February 28, 2005, the Company completed the sale of its wholly-
owned pharmaceutical research services business, Pharma Medica
Research Inc. (Pharma Medica). Consideration consisted of a cash
payment of $14,000 and a deferred payment of $4,000.
The deferred payment is non-interest bearing and is repayable in
annual instalments of $800 over a five year period. As the deferred
payment is non-interest bearing, it was recorded at its fair value of
$3,112 based on a discount rate of 9%. Imputed interest of $145 has
been recorded on this deferred payment during the nine months ended
September 30, 2007 ($207 during the nine months ended September 30,
2006). The first instalment of $800 related to this deferred payment
was collected on January 30, 2006. In accordance with the terms of
the deferred payment agreement, $800 of clinical services purchased
from Pharma Medica during the year ended December 31, 2006 were
offset against the annual payment that was due on January 30, 2007.
During the nine months ended September 30, 2007, $800 of clinical
services purchased from Pharma Medica were offset against the next
annual payment, which would have been due on January 30, 2008.
4 Intangible Assets
During fiscal 2001, the Company 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 Company may be required to pay
additional amounts to Galephar in respect of the CIP-ISOTRETINOIN and
CIP-TRAMADOL intangible rights of up to $1,494 (US $1,500) if certain
future milestones are achieved as defined in the agreements. These
additional payments will be made in the form of additional 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.
Upon receipt of FDA approval in January 2006, the Company began
amortizing the intangible rights related to CIP-FENOFIBRATE.
Currently, no other products have received FDA approval.
A summary of 2007 developments related to the products currently
under development/commercialization follows:
CIP-FENOFIBRATE
In April 2007, the Company completed its first sale of CIP-
FENOFIBRATE in Canada under an agreement with Oryx Pharmaceuticals
Inc.
In July 2007, the Company entered into a licensing and
distribution agreement with ProEthic Pharmaceuticals Inc.
("ProEthic") under which ProEthic was granted the exclusive right
to market, sell and distribute Lipofen in the United States. Under
the terms of the agreement, the Company receives an up-front
licensing fee of US $2 million, US $1 million of which was
received on signing. The balance will be received 180 days after
the first commercial sale of the product, which occurred on
September 11, 2007 and is included in accounts receivable at the
end of the third quarter. In addition, under the terms of the
agreement, the Company could receive additional milestone payments
of up to US $20 million based on the achievement of certain net
sales targets and will also receive a royalty based on a
percentage of net sales. These elements are reflected in net
revenue, which also incorporates direct product-related expenses
and amounts due to Galephar, the Company's technology partner.
After direct product-related expenses are deducted, including
payments to Galephar, the Company anticipates that it will retain
approximately 50% of total revenue under the agreement. In late
September 2007, ProEthic launched Lipofen in the U.S. market.
The Company's US $2 million investment in Galephar preferred
shares will be repaid by Galephar in US $350 quarterly payments,
beginning in the fourth quarter of 2007. These payments will be
included in net revenue based on the remaining amortization period
of the related intangible asset.
CIP-ISOTRETINOIN
On April 27, 2007, the Company received a second approvable letter
from the U.S. Food and Drug Administration ("FDA") pertaining to
its New Drug Application ("NDA") for CIP-ISOTRETINOIN. The FDA
indicated that the Company's application is approvable subject to
the resolution of two remaining issues. In addition to one
question related to chemistry, manufacturing and controls, the FDA
has requested that the Company provide additional safety data. The
Company believes that the clinical question raised has been
adequately addressed in the NDA submission and has appealed the
position taken by the FDA in its approvable letter using the
formal dispute resolution process. The appeal is ongoing.
CIP-TRAMADOL
On May 3, 2007, the Company received an approvable letter from the
FDA pertaining to its NDA for CIP-TRAMADOL. The FDA indicated that
the Company's application is approvable subject to the resolution
of certain issues, including a request for an additional adequate
clinical trial to provide further efficacy data.
In subsequent discussions with the FDA, the Company has obtained
clarification on the question of efficacy. The FDA has indicated
that the statistical methods used to analyze data from the
Company's clinical trials did not adequately address missing data
relating to subjects who dropped out of the trials. The Company
believes its submission includes sufficient efficacy data to
support regulatory approval.
The Company has a meeting scheduled with the FDA in November 2007
to obtain further clarification on the issues raised in the action
letter. The outcome of these discussions will help the Company
determine the most appropriate path forward to achieve final
regulatory approval in the U.S. market.
5 Due to related party
The Company and a related party have in common a majority of their
respective boards. There is no balance owing to the related party at
September 30, 2007. At December 31, 2006 the amount due was $123, for
management and payroll services.
6 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
December 31, 2005 to September 30, 2007:
Number of
common shares Amount
(in thousands) $
Balance outstanding - December 31, 2005 21,336 38,783
Options exercised during 2006 200 201
March 14, 2006 public offering(a) 2,500 10,907
---------------------------
Balance outstanding - December 31, 2006 24,036 49,891
---------------------------
Options exercised during the
three months ended June 30, 2007(b) 19 57
---------------------------
Balance outstanding - September 30, 2007 24,055 49,948
---------------------------
(a) On March 14, 2006, the Company issued 2.5 million common shares
pursuant to the completion of a public offering. Net proceeds
from the offering after considering share issuance costs of
$1,093 amounted to $10,907.
(b) During the three months ended June 30, 2007, 19,277 shares were
issued as a result of the exercise of 37,500 options. The
Company's stock option plan provides that an option holder may
elect to receive an amount of shares equivalent to the growth
value of vested options, which is the difference between the
market price and the exercise price of the options. There is no
cash consideration for the shares issued when this election is
chosen by an option holder.
Stock option plan
The following is a summary of the changes in the stock options
outstanding from December 31, 2005 to September 30, 2007:
Weighted
average
Number of exercise
options price
(in thousands) $
Balance outstanding - December 31, 2005 725 1.67
Options granted during 2006 489 3.91
Options exercised in exchange for
common shares during 2006 (200) 1.00
Options exercised in exchange for
cash consideration during 2006(a) (125) 2.35
--------------
Balance outstanding - December 31, 2006 889 2.96
Options granted during the
three months ended March 31, 2007(b) 274 3.90
Options exercised during the
three months ended June 30, 2007(c) (38) 1.90
Options cancelled during the
three months ended June 30, 2007(c) (112) 1.90
Options cancelled during the
three months ended September 30, 2007(d) (15) 4.12
--------------
Balance outstanding - September 30, 2007 998 3.36
--------------
--------------
At September 30, 2007, 309,741 options were fully vested and
exercisable.
(a) During 2006, 125,000 stock options were exercised in exchange
for cash consideration of $286 representing the difference
between the exercise price of the options and the market value
of the related common shares on the exercise date. The cash
consideration of $286 represents stock option compensation
expense of which $48 was expensed during 2006 and $238 was
expensed in prior years. Subsequent to March 31, 2006, the
Company no longer intends to make cash payments on the exercise
of stock options.
(b) During the three months ended March 31, 2007, the Company
issued 274,000 stock options under the employee and director
stock option plan, which have an exercise price of $3.90, 25%
of which vest on March 9 of each year, commencing in 2008, and
expire in 2017. Total compensation cost for these stock options
is estimated to be $921. This cost will be recognized over the
vesting period of the stock options.
The stock options issued during the three months ended
March 31, 2007 were valued using the Black-Scholes option
pricing model with the following assumptions:
Risk-free interest rate 3.96%
Expected life 10 years
Expected volatility 87%
Expected dividend Nil
(c) During the three months ended June 30, 2007, 37,500 stock
options were exercised in exchange for 19,277 common shares.
The Company's stock option plan provides that an option holder
may elect to receive an amount of shares equivalent to the
growth value of vested options, which is the difference between
the market price and the exercise price of the options. As a
result of the departure of an employee during the three months
ended June 30, 2007, 112,500 options were cancelled.
(d) During the three months ended September 30, 2007, 15,000 stock
options were cancelled as a result of the death of a Board
member.
7 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 nine and three month periods ended
September 30, 2007 was 24,047,252 and 24,054,878 respectively (for
the nine and three month periods ended September 30, 2006
respectively 23,304,649 and 24,035,601).
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.%SEDAR: 00020415E
For further information:
For further information: 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