Press Releases< /span>
MISSISSAUGA, ON, Oct. 21, 2015 /CNW/ - Cipher Pharmaceutiquired to build its commercial infrastructure in Canada.
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1 Source: IMS Health. Market share calculated based on total isotretinoin prescriptions. |
Product Update
Absorica™/Epuris™ (CIP-ISOTRETINOIN)
Absorica™ was released in the U.S. market in late November 2012. The product has
performed strongly to date, achieving 13.1% market share by June 2013,
based on total isotretinoin prescriptions. In addition, the overall
U.S. isotretinoin market continues to show growth. Prescriptions
increased by 15%2 in the first half of 2013 and by 17%3 in Q2 2013, over the comparable periods in the prior year.
The product was also approved by Health Canada in Q4 2012 under the trade name Epuris™. Cipher launched Epuris™ in June 2013, supported by a field sales force of six fully dedicated representatives.
Lipofen® (CIP-FENOFIBRATE)
In Q2 2013, Lipofen® prescriptions were 6% below Q2 2012 levels, however, Cipher's royalty
increased over the period due to the 3% increase in the royalty rate
compared to prior year. Kowa Pharmaceuticals America, Cipher's U.S.
marketing partner for Lipofen®, plans to continue to promote the product in a second detail position
throughout the remainder of 2013.
ConZip®/Durela® (CIP-TRAMADOL ER)
Cipher's extended-release tramadol is marketed in the U.S. by Vertical
Pharmaceuticals under the trade name ConZip®. In Q1 2013, Vertical expanded its sales force from 60 to 75
representatives, which has contributed to improved performance. In Q2
2013, prescriptions grew 5% compared to Q2 2012. In Canada, Medical
Futures launched the product in March 2012 under the trade name Durela®, with a dedicated sales force comprising 22 representatives. The
product demonstrated steady improvement and market share growth during
Q2 2013.
Cipher is actively pursuing marketing partners for CIP-TRAMADOL ER and CIP-ISOTRETINOIN in other territories, including Latin America. During Q2 2013, Cipher granted the Latin American distribution rights to CIP-TRAMADOL ER to Tecnofarma International Ltd. Tecnofarma, headquartered in Uruguay, operates in 18 Latin American countries and following regulatory approval, plans to launch the product in several jurisdictions, including Brazil and Mexico.
Other Products
In Q3 2012, Cipher obtained exclusive license and distribution rights in
Canada to market the Betesil® Patch, a novel, patent-protected, self-adhesive medicated plaster for
the treatment of inflammatory skin conditions such as plaque psoriasis.
The efficacy and safety of the Betesil® Patch has been established in three successful phase III trials, and the
product is currently marketed in several European countries. Cipher is
working toward completion of a New Drug Submission for the product and
will provide additional detail on expected timelines and plans in the
coming months.
In addition, the Company is seeking other late-stage to commercial-stage product candidates targeting specialty markets to support its commercial marketing and sales presence in Canada.
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2 Source: IMS Health 3 Source: IMS Health |
Notice of Conference Call
Cipher will hold a conference call today, July 31, 2013, 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) is a growing specialty pharmaceutical company with three commercial products and a fourth in development. Our product candidates are typically improved formulations of successful, currently marketed drugs. We in-license a product, manage the required clinical development and regulatory approval process, and either out-license it to a marketing partner, or, in Canada, we may market the product ourselves. Our core capabilities are in clinical and regulatory affairs, product licensing, supply chain management, and marketing and sales. Since the Company was founded in 2000, we have achieved final regulatory approval in the U.S. and Canada for all three of our original products and completed six marketing partnerships, generating growing licensing revenue.
Cipher Pharmaceuticals Inc.
Condensed Interim Financial Statements
For the Three Months Ended June 30, 2013
(Unaudited)
Cipher Pharmaceuticals Inc. | ||||
Balance Sheets | ||||
As at June 30, 2013 and December 31, 2012 | ||||
(in thousands of Canadian dollars - unaudited) | ||||
June 30, | December 31, | |||
2013 | 2012 | |||
$ | $ | |||
ASSETS | ||||
Current assets | ||||
Cash and cash equivalents | 17,775 | 15,843 | ||
Accounts receivable | 8,062 | 3,185 | ||
Inventory | 328 | - | ||
Prepaid expenses and other assets | 70 | 212 | ||
26,235 | 19,240 | |||
Property and equipment, net | 21 | 25 | ||
Intangible assets, net | 2,136 | 2,690 | ||
28,392 | 21,955 | |||
LIABILITIES | ||||
Current liabilities | ||||
Accounts payable and accrued liabilities | 5,520 | 2,808 | ||
Current portion of deferred revenue | 2,400 | 2,392 | ||
7,920 | 5,200 | |||
Deferred revenue | 3,210 | 4,349 | ||
11,130 | 9,549 | |||
SHAREHOLDERS' EQUITY | ||||
Share capital | 9,298 | 50,339 | ||
Contributed surplus | 3,402 | 33,227 | ||
Retained earnings (Deficit) | 4,562 | (71,160) | ||
17,262 | 12,406 | |||
28,392 | 21,955 | |||
Cipher Pharmaceuticals Inc. | ||||||
Statements of Operations and Comprehensive Income | ||||||
Three month periods ended June 30, 2013 and 2012 | ||||||
(in thousands of Canadian dollars, except per share data - unaudited) | ||||||
Three months | Six months | |||||
June 30, | June 30, | June 30, | June 30, | |||
2013 | 2012 | 2013 | 2012 | |||
$ | $ | $ | $ | |||
Revenues | ||||||
Licensing revenue | 5,459 | 1,629 | 8,752 | 3,440 | ||
Product revenue | 88 | - | 88 | - | ||
5,547 | 1,629 | 8,840 | 3,440 | |||
Expenses | ||||||
Cost of product sold | 27 | - | 27 | - | ||
Research and development | 341 | 348 | 649 | 819 | ||
Selling, general and administrative | 1,901 | 861 | 3,163 | 1,877 | ||
Amortization of intangible assets | 277 | 245 | 554 | 470 | ||
Interest income | (60) | (35) | (115) | (61) | ||
2,486 | 1,419 | 4,278 | 3,105 | |||
Income before income taxes | 3,061 | 210 | 4,562 | 335 | ||
Provision for (recovery of) income taxes | ||||||
Current | 811 | 127 | 1,209 | 127 | ||
Deferred | (811) | (127) | (1,209) | (127) | ||
Income and comprehensive income for the period | 3,061 | 210 | 4,562 | 335 | ||
Basic earnings per share | 0.13 | 0.01 | 0.19 | 0.01 | ||
Diluted earnings per share | 0.12 | 0.01 | 0.18 | 0.01 | ||
Cipher Pharmaceuticals Inc. | |||||||
Statements of Changes in Equity | |||||||
Three month periods ended June 30, 2013 and 2012 | |||||||
(in thousands of Canadian dollars - unaudited) | |||||||
Retained | Total | ||||||
Share | Contributed | Earnings | Shareholders' | ||||
Capital | Surplus | (Deficit) | Equity | ||||
$ | $ | $ | $ | ||||
Balance, January 1, 2013 | 50,339 | 33,227 | (71,160) | 12,406 | |||
Income and comprehensive income for the period | - | - | 4,562 | 4,562 | |||
Exercise of stock options | 26 | (14) | - | 12 | |||
Shares issued under the share purchase plan | 93 | - | - | 93 | |||
Share-based compensation - stock option plan | - | 189 | - | 189 | |||
Reduction of stated capital | (41,160) | (30,000) | 71,160 | - | |||
Balance, June 30, 2013 | 9,298 | 3,402 | 4,562 | 17,262 | |||
Balance, January 1, 2012 | 50,172 | 33,032 | (73,704) | 9,500 | |||
Income and comprehensive income for the period | - | - | 335 | 335 | |||
Exercise of stock options | 8 | (8) | - | ||||
Shares issued under the share purchase plan | 74 | - | - | 74 | |||
Share-based compensation - stock option plan | - | 100 | - | 100 | |||
Balance, June 30, 2012 | 50,254 | 33,124 | (73,369) | 10,009 | |||
Cipher Pharmaceuticals Inc. | |||||||||
Statements of Cash Flows | |||||||||
Three month periods ended June 30, 2013 and 2012 | |||||||||
(in thousands of Canadian dollars - unaudited) | |||||||||
Three months | Six months | ||||||||
June 30, | June 30, | June 30, | June 30, | ||||||
2013 | 2012 | 2013 | 2012 | ||||||
$ | $ | $ | $ | ||||||
Cash provided by (used in) | |||||||||
Operating activities | |||||||||
Income for the period | 3,061 | 210 | 4,562 | 335 | |||||
Items not affecting cash: | |||||||||
Depreciation of property and equipment | 4 | 6 | 9 | 13 | |||||
Amortization of intangible assets | 277 | 245 | 554 | 470 | |||||
Share-based compensation - share purchase plan | 9 | 5 | 14 | 11 | |||||
Share-based compensation - stock option plan | 121 | 51 | 189 | 100 | |||||
3,472 | 517 | 5,328 | 929 | ||||||
Changes in non-cash operating items: | |||||||||
Accounts receivable | (2,720) | (403) | (4,877) | (558) | |||||
Inventory | (328) | - | (328) | - | |||||
Prepaid expenses and other assets | 69 | 105 | 142 | 197 | |||||
Accounts payable and accrued liabilities | 1,236 | (197) | 2,712 | 103 | |||||
Deferred revenue | (533) | 4,911 | (1,131) | 4,716 | |||||
Net cash generated from operating activities | 1,196 | 4,933 | 1,846 | 5,387 | |||||
Investing activities | |||||||||
Purchase of property and equipment | - | (2) | (5) | (12) | |||||
Acquisition of intangible rights | - | (671) | - | (671) | |||||
Net cash generated from (used in) investing activities | - | (673) | (5) | (683) | |||||
Financing activities | |||||||||
Proceeds from shares issued under the share purchase plan | 49 | 30 | 79 | 63 | |||||
Proceeds from exercise of stock options | 12 | - | 12 | - | |||||
Net cash generated from financing activities | 61 | 30 | 91 | 63 | |||||
Increase in cash and cash equivalents | 1,257 | 4,290 | 1,932 | 4,767 | |||||
Cash and cash equivalents, beginning of period | 16,518 | 10,113 | 15,843 | 9,636 | |||||
Cash and cash equivalents, end of period | 17,775 | 14,403 | 17,775 | 14,403 | |||||
SOURCE Cipher Pharmaceuticals Inc.
Craig Armitage
Investor Relations
TMX Equicom
(416) 815-0700 ext 278
(416) 815-0080 fax
carmitage@tmxequicom.com
Larry Andrews
President and CEO
Cipher Pharmaceuticals
(905) 602-5840 ext 324
(905) 602-0628 fax
landrews@cipherpharma.com