Cipher Pharmaceuticals - DND.T - Record Financial Results
Posted: Wednesday May 1 11:37:17AM 2013
MISSISSAUGA, ON, Apr 29, 2013, 2013 (Canada NewsWire via COMTEX) --
Toronto Stock Exchange Symbol: DND
Cipher Pharmaceuticals Inc. (TSX: DND; OTC: CPHMF) today announced it has entered into a definitive distribution and supply agreement with Tecnofarma International Ltd. ("Tecnofarma") under which Cipher has granted Tecnofarma the exclusive right to market, sell and distribute CIP-TRAMADOL ER in Latin America. Tecnofarma, headquartered in Uruguay, operates in 18 Latin American countries and will launch the product in certain territories, including Brazil and Mexico.
CIP-TRAMADOL ER is a patent-protected, extended-release formulation of tramadol, which is used for the treatment of moderate to moderately severe chronic pain in adults. The product received approval from the U.S. Food and Drug Administration in 2010.
"Completing this agreement demonstrates progress with our strategy to extend the reach of our currently marketed products and generate additional revenue streams," said Larry Andrews, President and Chief Executive Officer of Cipher Pharmaceuticals. "Tecnofarma is a significant player in the region with deep experience in pain management, which positions them well to introduce our extended-release tramadol product in key Latin American markets."
Under the terms of the agreement, Cipher will receive an upfront payment and is eligible for additional milestones based upon regulatory approval in Brazil and Mexico. Cipher will supply product to Tecnofarma. Product manufacturing will be fulfilled by Cipher"s partner, Galephar Pharmaceutical Research.
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 choose to 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.
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; 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.
SOURCE: Cipher Pharmaceuticals Inc.
To view this news release in HTML formatting, please use the following URL: http://www.newswire.ca/en/releases/archive/April2013/29/c9415.html
SOURCE: Cipher Pharmaceuticals Inc.
Posted: Saturday Aug 10 4:16:05PM 2013
[I'm going to re-post this because this website doesn't seem to be displaying things properly on my computer...]
I have yet to see independent corroboration, but there was a news article put out a couple of days ago stating that Absorica's US
market share is now 15.3%. If it's true, it would be a continuation of the straight line growth experienced since November last year.
This is the flagship drug of Ranbaxy, the company's US licensee. I would imagine a similar ramp up is being experienced in Canada,
but it's a little to early to get meaningful data on that.
Posted: Saturday Aug 10 4:13:17PM 2013
I have yet to see independent corroboration, but there was a news article put out a couple of days ago stating that Absorica's US market share is now 15.3%. If it's true, it would be a continuation of the straight line growth experienced since November last year. This is the flagship drug of Ranbaxy, the company's US licensee. I would imagine a similar ramp up is being experienced in Canada, but it's a little to early to get meaningful data on that.
Posted: Wednesday Aug 7 5:14:34PM 2013
savaria sis on tsx 2.20
has now put together two good quarters in a row of increasing revenue, gross margin and net income. If they make 24 cents a share this year then I think the shares are worth at least $3.60 a share by yer end. The industry they operate in -- accessibility solutions for the elderly, infirm etc is growing with the aging of the population in the US and Canada. The China factory appears to have improved margins.
Company pays a 2 cent dividend per q so 3.5% rate not bad.
Posted: Wednesday Aug 7 3:55:33PM 2013
Just out today, the June 28th US market share for Absorica was 13.7%, up from the overall June figure of 13.1%. The growth continues...
Posted: Friday Aug 2 8:08:19AM 2013
I agree, these were great results. To go from nothing to a 13.1% share of the US acne market in less than 8 months is outstanding
and just goes to show us all just how superior Cipher's medication is.
The US market is growing and will likely turn out to be about $1B in size over the next couple of years. The introduction into Canada
has just begun and that should be exciting too. There are other products as well and other markets to penetrate. And, Cipher thinks it
should acquire the rights to one or more new products by year end. This has been such a lovely growth story so far.
Posted: Thursday Aug 1 9:27:11PM 2013
Amazing numbers out of Cipher
Cipher Pharmaceuticals earns $3.06-million in Q2
2013-07-31 07:28 ET - News Release
Mr. Larry Andrews reports
CIPHER REPORTS RECORD FINANCIAL RESULTS FOR Q2 2013
Cipher Pharmaceuticals Inc. has released its financial and operational results for the three and six months ended June 30, 2013.
Second quarter 2013 highlights
- Net revenue increased to $5.5-million, from $1.6-million in second quarter 2012.
- EBITDA (earnings before interest, taxes, depreciation and amortization) was $3.3-million versus $400,000 in second quarter 2012.
- Net income was $3.1-million, or 13 cents per basic share, compared with net income of $20,000, or one cent per basic share, in second quarter 2012.
- Cash balance increased to $17.8-million at quarter-end, compared with $15.8-million at Dec. 31, 2012, and $16.5-million at March 31, 2013.
- The company out-licensed Latin American distribution rights for CIP-Tramadol ER to Tecnofarma International Ltd.
- Subsequent to quarter-end, the company announced the Canadian launch of Epuris (isotretinoin) capsules.
"The continued strong growth of Absorica drove significant gains in our revenue, earnings and cash for the second quarter," said Larry Andrews, president and chief executive officer of Cipher. "The product was up to 13.1 per cent share of the U.S. isotretinoin market by June, from 7.5 per cent at the end of the first quarter, and the feedback from our marketing partner Ranbaxy has been very positive. We launched the product in Canada in late June with our own sales force and are pursuing out-licensing agreements in other markets. We are also looking at opportunities to expand our product portfolio."
Financial review and outlook
Net revenue for second quarter 2013 was $5.5-million, compared with $1.6-million in second quarter 2012. The year-over-year increase was mainly driven by the success of Absorica, which contributed $4.2-million of net revenue in second quarter 2013 versus $300,000 in second quarter 2012. Net revenue from Lipofen was $800,000 in second quarter 2013, compared with $900,000 in second quarter 2012. Net revenue from the company's extended release tramadol product (ConZip/Durela) increased to $500,000 in second quarter 2013, compared with $400,000 in second quarter 2012.
Research and development expense in second quarter 2013 was $300,000, the same level as incurred in second quarter 2012. Selling, general and administrative (SG&A) expenses for second quarter 2013 increased to $1.9-million, compared with $900,000 in second quarter 2012. The year-over-year increase in SG&A reflects the planned build-out of the company's commercial infrastructure in Canada to support the launch of Epuris and future products. The company incurred approximately $500,000 of one-time costs to support the June, 2013, launch of Epuris.
Net income in second quarter 2013 grew to $3.1-million, or 13 cents per basic share (12 cents per diluted share), compared with net income of $200,000, or one cent per basic and diluted share, in second quarter 2012.
The company's cash position increased at quarter-end. As at June 30, 2013, Cipher had cash and cash equivalents of $17.8-million, compared with $15.8-million at Dec. 31, 2012.
For the second half of fiscal 2013, Cipher expects continued aggregate revenue growth from its currently marketed products and the recent introduction of Epuris in Canada. In particular, the company expects the full-year contribution of Absorica to be a primary revenue driver. In 2013, Cipher will be investing in commercial sales and marketing capabilities in Canada. The company expects an increase in operating expenses of approximately $1-million to $1.5-million during the balance of 2013, compared with the same period in 2012, related to the launch of Epuris in Canada. Cipher expects its revenue growth to continue to offset the additional spending required to build its commercial infrastructure in Canada.
Absorica was released in the U.S. market in late November, 2012. The product has performed strongly to date, achieving 13.1-per-cent 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 per cent in the first half of 2013 and by 17 per cent in second quarter 2013, over the comparable periods in the prior year.
The product was also approved by Health Canada in fourth quarter 2012 under the trade name Epuris. Cipher launched Epuris in June, 2013, supported by a field sales force of six fully dedicated representatives.
In second quarter 2013, Lipofen prescriptions were 6 per cent below second quarter 2012 levels; however, Cipher's royalty increased over the period due to the 3-per-cent 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 first quarter 2013, Vertical expanded its sales force from 60 to 75 representatives, which has contributed to improved performance. In second quarter 2013, prescriptions grew 5 per cent compared with second quarter 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 second quarter 2013.
Cipher is actively pursuing marketing partners for CIP-Tramadol ER and CIP-Isotretinoin in other territories, including Latin America. During second quarter 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.
In third quarte 2012, Cipher obtained exclusive licence 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 have 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.
Notice of conference call
Cipher will hold a conference call today, July 31, 2013, at 8:30 a.m (Eastern Time) 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. The webcast will be archived for 90 days.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (in thousands of dollars, except per share data) Three months ended Six months ended 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 (loss) (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 (loss) (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
We seek Safe Harbor.
Posted: Friday Jul 19 7:37:19AM 2013
Thanks for the link. No wonder the price has jumped again.
I think most of the price action has been based on the Absorica acne medication's rapid US growth. It will be interesting to
see how well the Canadian version (Epuris) will do. The company has built a sales force for the recent Epuris launch.
I would think the same growth (as in the US) is possible because the same existing inferior products are available in both
markets. Over time, it seems to me, Epuris could add $.10 - $.20 in Cdn eps. This company has become a cash cow and the
business model supports the production of a lot more cash over time. Unless they find something big to acquire, a dividend
wouldn't be out of the question.
Posted: Thursday Jul 18 7:24:38PM 2013
Posted: Wednesday Jul 10 12:17:39PM 2013
This stock has ben on fire of late. A couple of fund managers have spoken highly of the company recently. Company's marketing partner sold $11.5 million worth of product in May alone which equates to $1 million net to DND. They currently have a eps run rate of $0.50 pre-tax for the next 12 months and that does not include a limp sum milestone payment that will net them another $0.20 eps pre-tax. That means if there is no further growth this is now trading at about 8 times next years pre-tax eps.
Posted: Wednesday Jul 3 7:51:25PM 2013
David Taylor of Taylor Asset Management on BNN mentions one of his funds has been buying DND.T
Here's the video. Starts around 2:30 into the video.
Posted: Tuesday Jun 25 6:40:50PM 2013
Posted: Monday May 27 9:16:55AM 2013
The price continues to inch up each day and, if its US acne drug continues to gain market share, it should should
easily make the Zack's target price of $6.50. The company's acne drug Absorica is replacing Accutane, which had peak
US revenue of $750M annually. That equated to a 75% market share. Cipher's Absorica April US market
share was 9.4%, which ramped up from nothing in mid-November 2012 when it was introduced. Here are the
market shares - Dec 1.8%, Jan 3.6%, Feb 5.7%, Mar 7.5% and Apr 9.4%. IMHO, DND's current price has a 10%
market share factored into it. Absorica is a superior drug to both Accutane - which is no longer
on the US market - and the generics currently available but hardly promoted at all. Each 10% increase
in market share is worth perhaps $3.50 in fair value to DND. Personally, I think a 30% market share should be
easily doable. The drug is so new it's not in insurance companies' formularies yet (i.e. insurance
companies are not yet reimbursing the cost of it. The company has 2 other drugs being marketed and a third in
the pipe. No debt and lots of cash on hand to make other aquisitions, plus the company has yet to market
its drugs in other jourisdictions for which it holds licenses.
Posted: Monday May 6 6:09:41PM 2013
Zacks analysts Jason Napodano ups DND target price to $6.50
Posted: Monday May 6 6:07:56PM 2013
Posted: Tuesday Mar 19 5:39:16PM 2013
I agree that the recent financials were very good, but there's a lot more to come IMHO. Like RX and PLB, this company's business model is to acquire the rights to late stage medicines, then get them approved and market them - either via third parties or directly themselves. Unlike the many biopharmas out there, Cipher has real revenue and earnings.
They have 3 products currently being marketed and another one in the pipe. Of the three products currently being sold, one (Lipofen) is a cholesterol drug being marketed by third parties in the US. The second one (ConZip/Durela) is a time release pain medication sold via third parties in Canada and the US. The sales of both of these drugs are increasing, but it is the third medication that caught my eye. The company has the rights to a new formulation of isotretinoin (a prescription acne medication) for the Americas and most of the Pacific Rim countries. This clearly superior product (Absorica) was launched in the US by a third party partner in November and by the end of December had garnered a 2% market share. By the end of January, that market share had virtually doubled. The drug will be introduced into Canada (as Epuris) in H2 2013. I think it can garner significant market share in both countries and will eventually be introduced elsewhere.
The company receives revenue in three ways...milestone payments from its third party partners, royalties from those same partners and revenue from the sale of drugs to wholesalers. Generally speaking, they spend very little on drug development itself because some of those milestone payments cover drug approval costs. The balance of those milestone payments cover sales goal achievements.
Here's a link to my detailed posting on the company...
Oh yes, the company has no debt and lots of cash on hand. I can't imagine that equity financing will ever be needed unless they make a gigantic acquisition. No doubt that revenue will be occasionally boosted by large milestone payments, but that's ok by me because this just adds to the large cash balance of the company.
Posted: Tuesday Mar 19 1:49:02PM 2013
Cipher reports record financial results for 2012