Wednesday, November 09, 2016 7:16:53 AM
November 09, 2016
Click For PR
Titan Management Team to Host Conference Call at 4:15 p.m. EST / 1:15 p.m. PST
SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 11/09/16 -- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP), a company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura™ long-term, continuous drug delivery platform, today reported financial results for the third quarter ended Sept. 30, 2016.
Titan reported $26,000 in license revenue for the third quarter of 2016, compared with no revenue for the comparable quarter in 2015. License revenue in the third quarter of 2016 included recognition of royalties earned on net sales of Probuphine® by Titan's development and commercialization partner Braeburn Pharmaceuticals. Probuphine was approved by the U.S. Food and Drug Administration (FDA) in May 2016.
During this last quarter, in keeping with its planned methodical product launch, Braeburn has focused primarily on two key activities: training and certifying healthcare providers and obtaining third-party payor coverage for treatment with Probuphine.
Total operating expenses, consisting primarily of research and development (R&D) expenses and general and administrative (G&A) expenses, were approximately $2.6 million in the third quarter of 2016, compared with approximately $1.8 million in the third quarter of 2015.
R&D expenses for the quarter ended Sept. 30, 2016 were approximately $1.6 million, compared with approximately $1.0 million for the same period in 2015, an increase of approximately $0.6 million. The increase in R&D costs was primarily a result of increases in external R&D expenses related to the support of ProNeura product development programs, and increases in employee-related expenses and other R&D expenses.
These expenses were partially offset by the reimbursement by Braeburn of approximately $0.4 million of Probuphine-related expenses.
G&A expenses for the third quarter 2016 were approximately $1.1 million, compared with approximately $0.8 million for the same quarter in 2015, an increase of approximately $0.3 million. The increase in G&A expenses was primarily related to increases in non-cash stock compensation, employee related costs and professional fees.
Net loss for the quarter ended Sept. 30, 2016 was approximately $2.6 million, or approximately $0.12 per share, compared with a net loss of approximately $1.8 million, or approximately $0.09 per share for the comparable quarter in 2015.
At Sept. 30, 2016, Titan had cash of approximately $16.5 million, which the company believes is sufficient to fund operations into early 2018. In September 2016, Titan entered into an agreement with Cantor Fitzgerald & Co. to enable the company to sell up to $20 million of shares in an at-the-market offering (the "ATM"). To date, Titan has elected not to sell any shares pursuant to the ATM, given the company's current financial position and the market price of its stock.
Probuphine Launch Highlights
To date, Braeburn has trained and certified more than 2,400 health care providers from all 50 states and Puerto Rico to provide Probuphine to their patients. Braeburn continues to provide direct support to these health care providers to identify eligible patients and enable initiation of treatment with Probuphine.
Braeburn has been successful in obtaining third-party payor coverage for Probuphine from large and regional insurance companies, as well as coverage under Medicare, Medicaid and the Veterans Administration plans.
While Probuphine is gaining strong early acceptance by the medical community, the paperwork required to be reviewed from initiation to final treatment is currently time-consuming, resulting in a longer-than-desired sales cycle. Braeburn is devoting resources to streamline the process and minimize delays.
Braeburn is planning for a full-scale commercial launch of Probuphine with a fully-deployed field force of about 60 addiction sales representatives, clinical educators, and national account executives.
Business Highlights
In October, Probuphine was recognized as one of the "12 Most Important Innovations of the Year" in the Health category in Popular Science's annual "Best of What's New" issue.
In October, three Probuphine presentations were featured at the International Society of Addiction Medicine (ISAM) annual meeting in Montreal.
These included a description of the Probuphine REMS program that was implemented to train and certify healthcare providers to prescribe and implant Probuphine; an evaluation of buprenorphine implants, extended-release injectable naltrexone and sublingual buprenorphine in a Markov model demonstrating buprenorphine implants to have clinical and economic benefits in clinically stable adults with opioid dependence; and an encore presentation of Probuphine pivotal trial results.
"We are very pleased with the progress Braeburn has made in training health care providers to provide Probuphine to their patients, and in rapidly obtaining third-party payor coverage," said Titan President and CEO Sunil Bhonsle. "We believe that these efforts along with Braeburn's aggressive commercialization plans lay a strong foundation for the increasing adoption of Probuphine.
While this positive activity was not fully reflected in our third quarter financial results due to the current lag times between ordering of implants and the shipment of product, we look forward to increasing revenues from Probuphine as Braeburn's commercialization efforts bear fruit. Our current cash position is strong, and we remain well positioned to advance our ProNeura-based product portfolio."
Marc Rubin, M.D., executive chairman of Titan, added, "The board is very enthusiastic about the launch of Probuphine and the prospects of Titan's product pipeline. The non-clinical studies in support of the investigational new drug application (IND) for our ropinirole implant for Parkinson's disease are now completed and the reports are being finalized. We expect to file the IND by the end of this year or early January 2017. Additionally, we are preparing for a pre-IND meeting with the FDA for our T-3 implant product candidate and hope to receive feedback from the FDA and commence non-clinical studies early next year."
Conference Call
Titan management will host a live conference call at 1:15 p.m. PST / 4:15 p.m. EST on Wednesday, Nov. 9, 2016 to discuss the company's financial results for the third quarter ended Sept. 30, 2016 and to provide an update on the ongoing product development plans. The call will be hosted by Sunil Bhonsle, president and CEO; Kate Beebe, Ph.D., executive vice president and chief development officer; Brian Crowley, vice president of finance; and Marc Rubin, M.D., executive chairman.
The live webcast of the call may be accessed by visiting the Titan website at www.titanpharm.com. The call can also be accessed by dialing 888-203-7667, participant passcode 1553379, five minutes prior to the start time. A replay of the call will be available on the company website approximately two hours after completion of the call and will be archived for two weeks.
Blessings to All
TRUTH
I've never claimed to have all the answers but feel i'm beginning to corner the market in questions worthy of them.
Recent TTNP News
- Form SC 13D/A - General Statement of Acquisition of Beneficial Ownership: [Amend] • Edgar (US Regulatory) • 08/21/2024 12:32:38 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 08/19/2024 08:23:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/19/2024 08:22:56 PM
- Titan Pharmaceuticals Enters Into Merger Agreement With KE Sdn. Bhd. • GlobeNewswire Inc. • 08/19/2024 08:11:12 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/15/2024 01:29:55 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 08/15/2024 01:29:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/25/2024 09:33:11 PM
- Titan Pharmaceuticals Fully Compliant With NASDAQ Listing Criteria • GlobeNewswire Inc. • 01/25/2024 09:29:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/18/2024 09:59:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2024 10:13:45 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/28/2023 09:30:20 PM
- Titan Pharmaceuticals Announces Reverse Stock Split and Ratio • GlobeNewswire Inc. • 12/28/2023 09:15:00 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 11/28/2023 09:47:46 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 11/17/2023 09:03:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/15/2023 09:05:15 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:33:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:31:25 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:29:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:25:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/26/2023 08:23:37 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 10/24/2023 09:26:34 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 10/23/2023 07:07:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/16/2023 09:08:35 PM
- Titan Pharmaceuticals Announces Appointment of Dato' Seow Gim Shen and Brynner Chaim to the Company's Board of Directors • GlobeNewswire Inc. • 10/16/2023 08:37:23 PM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 10/04/2023 09:30:18 PM
FEATURED Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • Sep 24, 2024 8:50 AM
FEATURED Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM