Titan Pharmaceuticals Reports Fourth Quarter And Full Year 2019 Financial Results
SOUTH SAN FRANCISCO, Calif., March 30, 2020 /PRNewswire/ -- Titan Pharmaceuticals, Inc., (NASDAQ: TTNP) ("Titan" or the "Company") today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on its business.
Full Year 2019 Business Highlights
Year-to-Date 2020 Business Highlights
"Throughout 2019, we focused on initiatives to successfully transition to a commercial-stage company," said Titan's President and CEO, Sunil Bhonsle. "I am very pleased with our team's progress during 2019, which, among other things, includes executing arrangements with multiple top tier specialty pharmacy companies, establishing a new patient services 'hub,' and obtaining insurance coverage from a broad range of third party payors – all of which served to broaden product access for healthcare providers and patients. While we primarily focused on stabilizing our product revenue during the transition, our goal during the remainder of 2020 is to focus on executing our sales growth initiatives in the U.S. and extending the commercial reach of Probuphine to eligible patients suffering from OUD."
Probuphine is indicated for the maintenance treatment of OUD in eligible patients. Please see Full Prescribing Information including Boxed Warning below.
"An important 2019 milestone for Titan was the European Commission's approval of Sixmo, Probuphine's brand name in the EU," said Titan's Executive Chairman, Dr. Marc Rubin. "Our EU commercialization partner, Molteni, is located in Italy, one of the countries hit hardest by the global COVID-19 pandemic. While the launch of Sixmo may be delayed as a result, we are confident that Molteni is poised to aggressively roll-out the product across Europe once the situation allows."
Dr. Rubin continued, "As the developments involving the COVID-19 pandemic continue to evolve, we are monitoring and implementing recommendations from local, national and global health organizations. Titan's top priorities are the health and safety of our employees, customers and the communities in which we live and work. To that end, we have put proactive, precautionary measures in place, such as sheltering in place and working from home, freezing all non-essential travel, and we have pivoted to virtual sales and business meetings only, with the goal of keeping everyone safe. At the same time, we remain deeply committed to continuing to execute additional components of our growth plan throughout 2020. These include initiatives to increase awareness and adoption of Probuphine, advance our Nalmefene program toward the clinic, and explore opportunities for the use of our ProNeura platform technology in additional important medical applications. Everyone at Titan is working remotely and being productive. We sincerely hope that all of our stakeholders will be safe and healthy as well."
Fourth Quarter 2019 Financial Results
For the three months ended December 31, 2019, Titan reported approximately $1.2 million in revenue, which reflect approximately $0.2 million in product sales and approximately $1.0 million related to the Company's NIDA grant. This compared with revenues of approximately $1.2 million in the same period in 2018, which was comprised of $0.2 million in product sales, $0.3 million related to the amortization of deferred revenue related to the sale to Molteni of the European intellectual property rights to Probuphine and $0.7 million related to the NIDA grant.
Total operating expenses for the fourth quarter of 2019 were approximately $5.0 million, compared with approximately $4.5 million from the same quarter in 2018, and consisted primarily of research and development ("R&D") and selling, general and administrative ("SG&A") expenses and costs of goods sold, inclusive of distribution expenses. R&D expenses for both the quarter ended December 31, 2019 and the same quarter in 2018 were approximately $1.9 million. SG&A expenses for the 2019 fourth quarter were approximately $2.6 million, compared with approximately $2.4 million in the same quarter a year ago. Costs of goods sold for the fourth quarter of 2019 were approximately $0.6 million, compared with approximately $0.3 million in the 2018 fourth quarter.
Net other expense, consisting primarily of interest expense, was approximately $0.1 million in the fourth quarter of 2019, compared with net other expense of approximately $0.2 million in the fourth quarter of 2018.
Net loss applicable to common stockholders in the fourth quarter of 2019 was approximately $4.0 million, or approximately $0.08 per share, compared with a net loss applicable to common stockholders of approximately $3.5 million, or approximately $0.29 per share, in the same quarter in 2018.
Full Year 2019 Financial Results
Total revenues for the full year ended December 31, 2019 were approximately $3.6 million, reflecting approximately $0.3 million in license revenue, approximately $1.0 million from sales of Probuphine and approximately $2.3 million related to Titan's NIDA grant. This compares to total revenues of approximately $6.6 million in 2018 which included approximately $5.4 million in license revenue, approximately $0.5 million from sales of Probuphine and approximately $0.7 million related to Titan's NIDA grant. The approximately $3.0 million decrease resulted primarily from non-recurring license revenue in 2018 of approximately $3.2 million in upfront and milestone payments from Molteni, and approximately $2.1 million related to reacquiring the rights to Probuphine from our former licensee which was partially offset by increases in product revenue of approximately $0.5 million, and grant revenues of approximately $1.6 million in 2019 and approximately $0.3 million of license revenue which represented the remaining amortization of the Molteni upfront payment in 2019.
Total operating expenses in 2019 were approximately $20.5 million, compared with approximately $14.9 million in 2018, and consisted primarily of R&D and SG&A expenses. R&D expenses for the year ended December 31, 2019 were approximately $7.3 million compared to approximately $7.5 million in 2018. The decrease in R&D costs was primarily associated with decreases in employee-related expenses and other research and development expenses, partially offset by increased activities related to the NIDA grant and an increase in our contract manufacturing costs. SG&A expenses for 2019 were approximately $11.9 million, compared to approximately $6.9 million in 2018. The increase in SG&A expenses was primarily due to higher sales and marketing expenses related to establishing the infrastructure to streamline the Probuphine ordering and distribution network and the increased expenses associated with expanding Titan's Probuphine commercial activities.
Net other income for the year ended December 31, 2019 was approximately $0.4 million, compared to net other expense of approximately $0.8 million in 2018. Net other income in 2019 was primarily due to non-cash gain on changes in the fair value of warrants. Net other expense in 2018 was primarily due to interest expense on the Company's debt.
Net loss applicable to common stockholders for 2019 was approximately $16.5 million, or $0.72 per share, compared with net loss applicable to common stockholders of approximately $9.3 million, or $1.64 per share, for 2018.
As at December 31, 2019, Titan had cash and cash equivalents of approximately $5.2 million, which the Company believes, together with the net cash proceeds of approximately $8.0 million received from the January 2020 offering and exercises of warrants in the first quarter of 2020, are sufficient to fund planned operations into the fourth quarter of 2020.
Conference Call Details
Titan management will host a conference call today at 4:30 p.m. ET / 1:30 p.m. PT to review these financial results and discuss business developments in the period. The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Dane Hallberg, Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.
The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 2248161. The call will also be broadcast live and archived on Titan's website at www.titanpharm.com/news/events.
Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following insertion.
Probuphine was developed using ProNeura®, the continuous drug delivery system developed by Titan that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper inner arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period. The U.S. Food and Drug Administration ("FDA") approved Probuphine in May 2016, and it is the first and only buprenorphine implant available for the maintenance treatment of opioid addiction in eligible patients.
IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING
PROBUPHINE is an implant that contains the medicine buprenorphine. PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine-containing product.
PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.
It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.
IMPORTANT SAFETY INFORMATION
Call your healthcare provider right away if:
If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.
Because of the risk of complications of, migration, protrusion, expulsion and nerve injury with insertion and removal of PROBUPHINE, it is only available through a restricted program called the PROBUPHINE REMS Program. Healthcare providers who prescribe and/or insert PROBUPHINE must be certified with the program by enrolling and completing live training.
Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion. Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.
The medicine in PROBUPHINE can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:
Feel faint or dizzy, have mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or have trouble walking.
These can be signs of an overdose or other serious problems.
Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with PROBUPHINE. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.
Who should not use PROBUPHINE?
Do not use PROBUPHINE if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.
PROBUPHINE may not be right for you. Before starting PROBUPHINE tell your doctor about all of your medical conditions, including:
Trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison's disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
What should I avoid while being treated with PROBUPHINE?
What are the possible side effects of PROBUPHINE?
PROBUPHINE can cause serious side effects, including:
Tell your healthcare provider if you develop any of the symptoms listed.
Common side effects of PROBUPHINE include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.
Common risks with the minor surgical procedure: Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site.
Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.
Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The Company's lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology also has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; Titan's ability to access capital; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
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SOURCE Titan Pharmaceuticals, Inc.
Company Codes: NASDAQ-SMALL:TTNP