Takeda Begins Sampling Effort of Vitaros® in the United Kingdom
FDA Clears RayVa™ Investigational New Drug Application to Begin Clinical Studies in Patients with Raynaud's Phenomenon
Conference Call and Webcast Today, Monday, May 12, 2014 at 5:00 p.m. ET
SAN DIEGO, May 12, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq: APRI), a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today provided a corporate update and reported financial results for the first quarter 2014.
"Since the beginning of 2014, we have made significant progress towards achieving our annual corporate goals, which included launching Vitaros® and building a diversified pipeline of novel therapeutics," stated Richard W. Pascoe, Chief Executive Officer. "In April 2014, we completed the first shipment of Vitaros to Takeda for product launch in the United Kingdom. Earlier today, Takeda launched a comprehensive Vitaros sampling program throughout their territory directed towards key opinion leaders of erectile dysfunction treatments. We are delighted that Takeda has taken this important step towards making Vitaros available to physicians and patients in advance of the expected commercial launch of Vitaros in the United Kingdom in June. We applaud Takeda's disciplined and thorough approach to being the first Vitaros partner to introduce the only topical, on-demand treatment for erectile dysfunction, and we are confident that their efforts will set the stage for a successful launch of Vitaros in the United Kingdom and by our other commercial partners in Europe and Canada throughout 2014."
Mr. Pascoe continued, "Earlier today, we announced that the FDA has accepted our Investigational New Drug application for our product candidate RayVa, and as such, we intend to initiate a Phase 2a trial this year to assess the safety and efficacy of RayVa in patients suffering from Raynaud's phenomenon secondary to scleroderma. Raynaud's phenomenon secondary to scleroderma is a disorder of the small blood vessels of the extremities. There are an estimated 100,000 adult patients with scleroderma in the US1, of which approximately 90% have secondary Raynaud's phenomenon3. Overall, there are approximately 500,000 adult patients with secondary Raynaud's phenomenon in the United States.2,3 We believe that the initiation of the RayVa development program this year reflects our continued commitment to bringing novel therapeutics to patients and healthcare providers in areas of high unmet medical need, while creating long-term value for our shareholders."
- Takeda launched its Vitaros sampling program in the United Kingdom to key opinion leaders in advance of their full commercial launch anticipated in June;
- Received FDA clearance to begin clinical studies of RayVa, a combination of alprostadil, a vasodilator and Apricus' proprietary permeation enhancer DDAIP.HCl, applied as an on-demand topical cream to affected extremities, which is being developed for Raynaud's phenomenon;
- Signed an exclusive license agreement with Recordati to market Vitaros in Spain, Russia, Turkey and other global territories in a deal valued at up to $51 million;
- Strengthened the Company's leadership with the addition of Wendell Wierenga, Ph.D. to Apricus' Board of Directors and the appointment of Neil Morton as Vice President, Business Development;
- Manufactured and shipped commercial and sample batches of Vitaros to our partner Takeda in the United Kingdom;
- Received National Phase approvals for Vitaros in Belgium, Luxembourg and Spain; and
- Co-sponsored a symposium with Apricus' European commercialization partners on Vitaros titled "A New Paradigm in the Treatment of ED - The Topical Option" during the European Association of Urology (EAU) Congress.
Anticipated 2014 Milestones
- Partner launches of Vitaros in Europe and Canada;
- Complete the development of the Vitaros room temperature device;
- Initiate the RayVa Phase 2a clinical trial in patients with Raynaud's phenomenon secondary to scleroderma, in the second half of 2014; and
- Out-license Femprox® in Europe.
First Quarter 2014 and Full-Year 2013 Financial Results
Net loss for the first quarter ended March 31, 2014 decreased to $3.3 million, or $0.09 per share, compared to a net loss of $8.7 million, or $0.29 per share for the first quarter ended March 31, 2013.
As of March 31, 2014, cash and cash equivalents totaled $22.5 million, compared to $21.4 million as of December 31, 2013. This includes $4.7 million received in cash for up-front license fees related to the recent Vitaros European license agreements.
2014 Financial Outlook
In 2014, Apricus expects to generate cash from the potential out-license of Femprox and late in 2014, expects to begin to realize initial royalty revenues from partner sales of Vitaros. Apricus' expenditures in 2014 will include costs supporting the further development of the Vitaros room temperature device, the commercialization and launch of Vitaros in Europe, and the start of new clinical development programs.
Apricus believes it has an appropriate level of cash now to support the current operating plan into the second quarter of 2015, which includes conducting the RayVa Phase 2a clinical trial.
Conference Call Details
Apricus will host a live conference call and webcast today at 5 p.m. Eastern Time to discuss the Company's financial results and provide a corporate update. To participate by telephone, please dial 877-407-9210 (Domestic) or 201-689-8049 (International). The conference ID number is 13580814. The live audio webcast can be accessed via the following link: http://www.investorcalendar.com/IC/CEPage.asp?ID=172650 or on the Company's website at www.apricusbio.com. A replay of the call will be available by dialing 877-660-6853 (Domestic) or 201-612-7415 (International). The archived webcast will remain available for three months following the live call.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company focused on the development and commercialization of novel therapeutics for men's and women's health. The Company's lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and will be commercialized by Apricus' marketing partners, which include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. The Company's second-generation Vitaros room temperature device is under development and is expected to enhance the product's commercial value. Femprox®, the Company's product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed an approximately 400-subject proof-of-concept study. The Company is currently seeking a strategic partner for Femprox. RayVa™, the Company's product candidate for the treatment of Raynaud's phenomenon, recently received FDA clearance to begin clinical studies. The Company intends to begin a Phase 2a trial with RayVa in the second half of 2014.
For further information on Apricus, visit http://www.apricusbio.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to the timing of planned launches of Vitaros® in various countries by Apricus' commercial partners, particularly the United Kingdom, the planned commencement of a Phase 2a clinical trial for RayVa™ and the planned out-license of Femprox® in Europe; the potential for Vitaros to achieve commercial success generally or in any specific territory; and the Apricus' 2014 financial outlook, including cash projections. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of the Company, including, but not limited to: its ability to further develop its product Vitaros for the treatment of ED, such as the room temperature version of Vitaros, and its product candidate RayVa for the treatment of Raynaud's phenomenon, as well as the timing of such events; Apricus' ability to carry out clinical studies for RayVa, as well as the timing and success of the results of such studies; Apricus' dependence on its commercial partners to carry out the commercial launch of Vitaros in various territories, and the potential for delays in the timing of commercial launch; competition in the ED market and other markets in which Apricus and its partners operate; Apricus' ability to obtain and maintain intellectual property protection for Vitaros; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to obtain the requisite governmental approval for Femprox and RayVa; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from the Company.
1 Barnes J and Mayes MD. Epidemiology of systemic sclerosis: incidence, prevalence, survival, risk factors, malignancy, and environmental triggers. Curr Opin Rheumatol 2012, 24:165–170. American College of Rheumatology (http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Scleroderma).
2 Pope JE. The Diagnosis and Treatment of Raynaud's Phenomenon. Drugs 2007; 67: 517-525.
3 2012 U.S. Census Bureau: State and County QuickFacts (http://quickfacts.census.gov/qfd/states/00000.html).
|Apricus Biosciences, Inc. and Subsidiaries|
|Condensed Consolidated Balance Sheets (Unaudited)|
|March 31,||December 31,|
|Cash and cash equivalents||$ 22,491||$ 21,405|
|Property and equipment, net||1,360||955|
|Other current and non-current assets||1,143||950|
|Total assets||$ 24,994||$ 23,310|
|Liabilities and stockholders' equity|
|Convertible notes payable, net||$ 2,659||$ 2,600|
|Deconsolidation of French subsidiaries||2,846||2,846|
|Other current and non-current liabilities||5,145||5,092|
|Total stockholders' equity||8,890||10,972|
|Total liabilities and stockholders' equity||$ 24,994||$ 23,310|
|As of March 31, 2014, the Company has 37,855,072 shares of common stock outstanding.|
|These financial statements were derived from the Company's Consolidated|
|Financial Statements as filed in its March 31, 2014 Report on Form 10-Q.|
|Apricus Biosciences, Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations (Unaudited)|
|(In thousands, except share and per share data)|
|Three Months Ended March 31,|
|License fee revenue||$ --||$ 32|
|Contract service revenue||--||882|
|Cost of product sales||--||4|
|Cost of service revenue||--||1,847|
|Gross profit (loss)||--||(922)|
|Costs and expenses, net|
|Research and development||1,444||1,413|
|General and administrative||3,059||3,826|
|Gain on contract settlement||(910)||--|
|(Recovery) loss on sale of subsidiary||(50)||--|
|Total costs and expenses, net||3,543||5,239|
|Loss from continuing operations before other income (expense)||(3,543)||(6,161)|
|Total other income (expense)||281||(789)|
|Loss from continuing operations||(3,262)||(6,950)|
|Income (loss) from discontinued operations||--||(1,723)|
|Net loss||$ (3,262)||$ (8,673)|
|Basic and diluted loss per common share|
|Loss per share from continuing operations||$ (0.09)||$ (0.23)|
|Loss per share from discontinued operations||$ --||$ (0.06)|
|Net loss per share||$ (0.09)||$ (0.29)|
|Weighted average common shares outstanding used for basic and diluted loss per share||37,872,179||30,178,265|
|These financial statements were derived from the Company's Consolidated Financial Statements as filed in its March 31, 2014 Report on Form 10-Q.|
CONTACT: Steve Martin Apricus Biosciences Chief Financial Officer firstname.lastname@example.org (858) 222-8041 Investors: Angeli Kolhatkar Burns McClellan Senior Vice President email@example.com (212) 213-0006
Source:Apricus Biosciences, Inc.