Apricus Biosciences, Inc. : Apricus Biosciences Provides Corporate Update, Fourth Quarter and Full Year 2017 Financial Results
Company Expects to Submit Vitaros End of Review Meeting Request This Month
Vitaros End-of-Review Meeting Expected to Occur in April 2018
Company Expects Cash Runway Through 2018
Conference Call / Webcast Today, March 1, 2018 at 4:30 p.m. ET
SAN DIEGO, March 01, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported financial results for the fourth quarter of 2017 and provided a corporate update on its near-term priorities.
"Since the end of the third quarter of 2017, we have been focused on supporting the Vitaros NDA resubmission and strengthening our balance sheet. While we were successful achieving the latter, we were extremely disappointed with the FDA's recent decision regarding the approval of Vitaros. As such, we will submit a request to the FDA for an end-of-review meeting in the coming weeks with a meeting expected to be scheduled in April per FDA guidelines. Our objective for this meeting is to determine the specific requirements needed to address the deficiencies noted in the Complete Response," stated Richard W. Pascoe, Chief Executive Officer. "In parallel, we will focus our efforts on identifying and evaluating opportunities or business combinations to maximize shareholder value, as we look reduce our expenses and extend our cash runway."
Fourth Quarter and Full Year Financial Results
Net loss during the quarter ended December 31, 2017 was $2.4 million, or loss per share of $0.16, compared to a net loss of $0.3 million, or loss per share of $0.04, during the fourth quarter of 2016. Net income during the year ended December 31, 2017 was $0.3 million, or income per share of $0.02, compared to a net loss of $7.4 million, or loss per share of $1.15, during the year ended December 31, 2016.
Net income during the year ended December 31, 2017 was primarily due to the $12.3 million gain recorded upon the sale of our ex-U.S. Vitaros rights and assets to Ferring, offset by the $1.5 million regulatory milestone payment made to Allergan upon the FDA's acknowledgment of our Vitaros NDA resubmission, Vitaros commercial preparation activities, as well as other general and administrative expenses.
For all periods presented, financial statement activity related to our ex-U.S. Vitaros business has been presented as discontinued operations. As of December 31, 2017, the Company's cash totaled $6.3 million, compared to $2.1 million as of December 31, 2016. As of February 26, 2018, the Company's cash totaled $6.3 million, which is expected to fund operations through the end of 2018.
Conference Call Details
Apricus will host a live conference call and webcast today at 4:30 p.m. Eastern Time to discuss the Company's financial results and provide a corporate update. To participate by telephone, please dial (855) 780-7196 (Domestic) or (631) 485-4867 (International). The conference ID number is 3687726. The live and archived audio webcast can be accessed through the Investors Relations' section of the Company's website at www.apricusbio.com. Please log in approximately five to ten minutes before the event to ensure a timely connection. The archived webcast will be available for 30 days following the live call.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates: Vitaros, a product candidate in the United States for the treatment of erectile dysfunction, which is in-licensed from Warner Chilcott Company, Inc., now a subsidiary of Allergan plc (Allergan); and RayVa, a product which has completed a Phase 2a clinical trial for the treatment of the circulatory disorder Raynaud's phenomenon, secondary to scleroderma, for which Apricus owns worldwide rights.
For further information on Apricus, visit http://www.apricusbio.com.
Vitaros(TM) is Apricus' trademark in the United States, which is pending registration and subject to the agreement with Allergan. Vitaros® is a registered trademark of Ferring International Center S.A. in certain countries outside of the United States. RayVa(TM) is Apricus' trademark, which is registered in certain countries throughout the world and pending registration in the United States.
Forward Looking Statements
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: the timing of Apricus' request for, and the occurrence of, an end-of-review meeting with the FDA regarding the complete response for Vitaros; Apricus' efforts and plans on identifying opportunities or business combinations; and that Apricus' current cash will be sufficient to fund operations through December 2018. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: the failure to meet with the FDA to discuss the complete response in a timely manner and the failure to gain further clarity on a path forward for Vitaros; Apricus' ability to successfully identify and consummate transactions to enhance shareholder value; the FDA could require additional clinical and pre-clinical data; Apricus' ability to address any conditions for approvability raised by the FDA in the complete response or during the planned end-of-review meeting; Apricus' ability to carry out further clinical studies for Vitaros, if required, as well as the timing and success of the results of such studies; the failure to remain in compliance with Nasdaq continued listing requirements which could result in Apricus' common stock being delisted from the exchange; Apricus' ability to retain and attract key personnel; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to secure a strategic partner for RayVa; and Apricus may expend cash resources more quickly than it anticipates. 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 Apricus' 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 Apricus.
(Financial Information to Follow)
CONTACT: Matthew Beck
Selected Financial Information
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
|Research and development||$||(3,463||)||$||(5,880||)|
|General and administrative||(7,210||)||(7,778||)|
|Total other income (expense)||(1,074||)||6,013|
|Loss from continuing operations||(11,747||)||(7,645||)|
|Income from discontinued operations||12,070||226|
|Net income (loss)||$||323||$||(7,419||)|
|Basic and diluted earnings (loss) per share|
|Total earnings (loss) per share||$||0.02||$||(1.15||)|
|Weighted average common shares outstanding for basic and diluted earnings (loss) per share||11,892||6,517|
Condensed Consolidated Balance Sheets
|Other current assets||261||177|
|Property and equipment, net||79||164|
|Other long term assets||35||60|
|Assets of discontinued operations||-||2,212|
|Liabilities and stockholders' equity (deficit)|
|Current liabilities of discontinued operations||-||1,934|
|Notes payable, net||-||6,650|
|Other long term liabilities||58||76|
|Stockholders' equity (deficit)||4,371||(7,516||)|
|Total liabilities and stockholders' equity (deficit)||$||6,706||$||4,700|
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Apricus Biosciences, Inc. via Globenewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
Compuware Announces Day One Support for IBM CICS Transaction Server for z/OS V5.514.12.2018 18:02 | Pressemelding
SoftServe Achieves Machine Learning Specialization in Google Cloud Partner Program14.12.2018 13:00 | Pressemelding
Google Cloud recognizes SoftServe’s technical proficiency and proven success AUSTIN, Texas, Dec. 14, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, announces it achieved the Machine Learning Partner Specialization in the Google Cloud Premier Partner Program. The Partner Specialization affirms SoftServe’s expertise and success building customer solutions in the machine learning field using Google Cloud Platform (GCP) technology. The Google Cloud Partner Specialization Program is designed to provide Google Cloud customers with qualified partners that demonstrate technical proficiency in the specialized solution and service areas. Specifically, the Machine Learning Specialization demonstrates SoftServe’s expertise in data exploration, preprocessing, model training, model evaluation, model deployment, online prediction, and Google Cloud’s pre-trained machine learning APIs. “We teach machines to learn, read, see and understand business data, and make
Minerals Technologies Announces Price Increases for Specialty Minerals Products in Europe14.12.2018 00:01 | Pressemelding
NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Specialty Minerals Inc. (“SMI”), a subsidiary of Minerals Technologies Inc., announced today that effective February 1, 2019, it will increase prices by up to 10% for all coated ultrafine precipitated calcium carbonate (PCC) from SMI’s Lifford Specialty PCC facility in Birmingham, UK, subject to individual customer contracts and market provisions. The price increases reflect increased market demand for higher performance materials, as well as significant inflation in input, raw material and logistics costs. About Minerals Technologies Inc. New York-based Minerals Technologies Inc. (MTI) is a resource- and technology-based growth company that develops, produces and markets worldwide a broad range of specialty mineral, mineral-based and synthetic mineral products and related systems and services. MTI serves the paper, foundry, steel, construction, environmental, energy, polymer and consumer products industries. The Company reported sales of $1.
Synthesio to Bring Proven Ipsos Data Science to Artificial Intelligence13.12.2018 17:03 | Pressemelding
Synthesio's Next-Generation Social Media Intelligence to Raise Unseen Insights to the Surface, Faster NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Synthesio, an Ipsos company, and also the leading Social Media Intelligence Suite, today announced the plans for its next-generation Artificial Intelligence (AI) engine. The project will combine Synthesio’s AI technology with Ipsos’ data science. The combination will power upcoming Synthesio capabilities to help users find insights faster, remove guesswork, and make informed business decisions across a variety of use cases. “Our goal has always been to provide customers with meaningful data, visualized so that they can make strategic business decisions,” explained Loic Moisand, CEO & Founder of Synthesio. “The less guesswork that a company has to make, and the less time that it takes users to find meaningful insights, the more time for data-backed business decisions. We are really pleased that we can leverage the data science capabilities dev
XBiotech Announces Publication of Post-Hoc Analysis for Phase III Colorectal Cancer Study13.12.2018 14:00 | Pressemelding
Biomarkers Predict Significantly Higher Rates of Treatment Response to Bermekimab in Advanced Cancer Patients AUSTIN, Texas, Dec. 13, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today the publication of findings on key biomarker analysis of colorectal cancer patients treated with bermekimab in its European Phase III study. The manuscript, entitled, “Interleukin-1 Receptor Antagonist (IL-1ra) Levels Predict Favorable Outcome after Bermekimab, a First-in-Class True Human Interleukin-1α Antibody, in a Phase III Randomized Study of Advanced Colorectal Cancer”, has been published online in the journal OncoImmunology. The findings report that patients with relatively low levels of IL-1ra or IL-6 were more likely to respond to bermekimab therapy and achieve the study’s primary endpoint. The study’s primary endpoint measured a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—which tend to worsen with advanced cancer, to assess whether these sympto
FROM CUTE TO CONFIDENT: MARY KAY INC. TALKS PINK AT THE MUSEUM AT FIT13.12.2018 14:00 | Pressemelding
Mary Kay Inc. and The Museum at The Fashion Institute of Technology Partner for a Pink-Centric Panel Discussion in Conjunction with Special Exhibition ‘Pink: The History of a Punk, Pretty, Powerful Color’ NEW YORK, N.Y., Dec. 13, 2018 (GLOBE NEWSWIRE) -- From pink makeup compacts to the iconic pink Cadillac, global beauty brand Mary Kay has been synonymous with the color pink for more than five decades. On December 13, 2018, Mary Kay will partner with The Museum at FIT (MFIT) to host a scholarly panel discussion, ‘Powerful Pink: From Cute to Confident,’ at the Katie Murphy Amphitheatre on the New York City FIT campus. Panelists include Luis Casco, Mary Kay Global Beauty Ambassador and celebrity makeup artist; Kate Greene, Vice President of Communications and Creative Direction at Givaudan and Karen Young, FIT adjunct professor and founder of The Young Group. The panel discussion will be moderated by Sheryl Adkins-Green, Chief Marketing Officer for Mary Kay Inc. The scholarly panel disc