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”) at the moment reported monetary outcomes for the fourth quarter and full yr ended December 31, 2019 and offered an replace on its enterprise.

“Throughout 2019, we focused on initiatives to successfully transition to a commercial-stage company,” stated 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 upkeep remedy of OUD in eligible sufferers. Please see Full Prescribing Information together with Boxed Warning under.

“An important 2019 milestone for Titan was the European Commission’s approval of Sixmo, Probuphine’s brand name in the EU,” stated Titan’s Executive Chairman, Dr. Marc Rubin. “Our EU commercialization accomplice, Molteni, is positioned in Italy, one of many nations hit hardest by the worldwide COVID-19 pandemic. While the launch of Sixmo could also be delayed consequently, we’re assured that Molteni is poised to aggressively roll-out the product throughout Europe as soon as the scenario permits.”

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.”

For the three months ended December 31, 2019, Titan reported roughly $1.2 million in income, which replicate roughly $zero.2 million in product gross sales and roughly $1.zero million associated to the Company’s NIDA grant. This in contrast with revenues of roughly $1.2 million in the identical interval in 2018, which was comprised of $zero.2 million in product gross sales, $zero.three million associated to the amortization of deferred income associated to the sale to Molteni of the European mental property rights to Probuphine and $zero.7 million associated to the NIDA grant.

Total working bills for the fourth quarter of 2019 had been roughly $5.zero million, in contrast with roughly $four.5 million from the identical quarter in 2018, and consisted primarily of analysis and improvement (“R&D”) and promoting, basic and administrative (“SG&A”) bills and prices of products offered, inclusive of distribution bills. R&D bills for each the quarter ended December 31, 2019 and the identical quarter in 2018 had been roughly $1.9 million. SG&A bills for the 2019 fourth quarter had been roughly $2.6 million, in contrast with roughly $2.four million in the identical quarter a yr in the past. Costs of products offered for the fourth quarter of 2019 had been roughly $zero.6 million, in contrast with roughly $zero.three million within the 2018 fourth quarter.

Net different expense, consisting primarily of curiosity expense, was roughly $zero.1 million within the fourth quarter of 2019, in contrast with web different expense of roughly $zero.2 million within the fourth quarter of 2018.

Net loss relevant to frequent stockholders within the fourth quarter of 2019 was roughly $four.zero million, or roughly $zero.08 per share, in contrast with a web loss relevant to frequent stockholders of roughly $three.5 million, or roughly $zero.29 per share, in the identical quarter in 2018.

Full Year 2019 Financial Results

Total revenues for the total yr ended December 31, 2019 had been roughly $three.6 million, reflecting roughly $zero.three million in license income, roughly $1.zero million from gross sales of Probuphine and roughly $2.three million associated to Titan’s NIDA grant. This compares to whole revenues of roughly $6.6 million in 2018 which included roughly $5.four million in license income, roughly $zero.5 million from gross sales of Probuphine and roughly $zero.7 million associated to Titan’s NIDA grant. The roughly $three.zero million lower resulted primarily from non-recurring license income in 2018  of roughly $three.2 million in upfront and milestone funds from Molteni, and roughly $2.1 million associated to reacquiring the rights to Probuphine from our former licensee which was partially offset by will increase in  product income of roughly $zero.5 million, and grant revenues of roughly $1.6 million in 2019 and roughly $zero.three million of license income which represented the remaining amortization of the Molteni upfront fee in 2019.

Total working bills in 2019 had been roughly $20.5 million, in contrast with roughly $14.9 million in 2018, and consisted primarily of R&D and SG&A bills. R&D bills for the yr ended December 31, 2019 had been roughly $7.three million in comparison with roughly $7.5 million in 2018. The lower in R&D prices was primarily related to decreases in employee-related bills and different analysis and improvement bills, partially offset by elevated actions associated to the NIDA grant and a rise in our contract manufacturing prices. SG&A bills for 2019 had been roughly $11.9 million, in comparison with roughly $6.9 million in 2018. The enhance in SG&A bills was primarily because of larger gross sales and advertising and marketing bills associated to establishing the infrastructure to streamline the Probuphine ordering and distribution community and the elevated bills related to increasing Titan’s Probuphine industrial actions.

Net different earnings for the yr ended December 31, 2019 was roughly $zero.four million, in comparison with web different expense of roughly $zero.eight million in 2018. Net different earnings in 2019 was primarily because of non-cash acquire on adjustments within the honest worth of warrants. Net different expense in 2018 was primarily because of curiosity expense on the Company’s debt.

Net loss relevant to frequent stockholders for 2019 was roughly $16.5 million, or $zero.72 per share, in contrast with web loss relevant to frequent stockholders of roughly $9.three million, or $1.64 per share, for 2018.

As at December 31, 2019, Titan had money and money equivalents of roughly $5.2 million, which the Company believes, along with the web money proceeds of roughly $eight.zero million obtained from the January 2020 providing and workout routines of warrants within the first quarter of 2020, are enough to fund deliberate operations into the fourth quarter of 2020.

Conference Call Details

Titan administration will host a convention name at the moment at four:30 p.m. ET / 1:30 p.m. PT to overview these monetary outcomes and talk about enterprise developments within the interval. The convention name shall 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 reside convention name could also be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (worldwide) and offering passcode 2248161. The name may also be broadcast reside and archived on Titan’s web site at www.titanpharm.com/information/occasions.    

About Probuphine

Probuphine is the one subdermal implant designed to ship buprenorphine repeatedly for six months following insertion.

Probuphine was developed utilizing ProNeura®, the continual drug supply system developed by Titan that consists of a small, strong implant constructed from a combination of ethylene-vinyl acetate and a drug substance. The ensuing assemble is a strong matrix that’s positioned subdermally, usually within the higher internal arm in an outpatient workplace process and eliminated in an identical method on the finish of the remedy interval. The U.S. Food and Drug Administration (“FDA”) accredited Probuphine in May 2016, and it’s the first and solely buprenorphine implant accessible for the upkeep remedy of opioid habit in eligible sufferers.

IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

INDICATION

PROBUPHINE is an implant that accommodates the drugs buprenorphine. PROBUPHINE is used to deal with sure adults who’re hooked on (depending on) opioid medication (both prescription or unlawful). PROBUPHINE is indicated for the upkeep remedy of opioid dependence in sufferers who’ve achieved and sustained extended scientific stability on low-to-moderate doses (doses not more than eight mg per day) of a buprenorphine-containing product.

PROBUPHINE is a part of an entire remedy program that additionally consists of counseling and behavioral remedy.

It shouldn’t be recognized if PROBUPHINE is protected or efficient in youngsters lower than 16 years of age.

IMPORTANT SAFETY INFORMATION

WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

See Full Prescribing Information for full Boxed Warning

Serious problems might occur from insertion and elimination of PROBUPHINE, together with:

Nerve or blood vessel damage in your arm

Movement of implant (migration). PROBUPHINE or items of it may possibly transfer into blood vessels, presumably to your lung, and will result in demise

Implant stands out of the pores and skin (protrusion)

Implant comes out by itself (expulsion)

Call your healthcare supplier immediately if: 

  • PROBUPHINE stands out of the pores and skin or comes out by itself
  • You have bleeding or signs of an infection on the web site after insertion or elimination, together with extreme or worsening itching, ache, irritation, redness, or swelling
  • You have numbness or weak point in your arm after the insertion or elimination process
  • You have weak point or numbness in your arm, or shortness of breath

If the implant comes out by itself, preserve it away from others, particularly youngsters, as it could trigger extreme issue in respiration and presumably demise.

Because of the danger of problems of, migration, protrusion, expulsion and nerve damage with insertion and elimination of PROBUPHINE, it’s only accessible by means of a restricted program referred to as the PROBUPHINE REMS Program. Healthcare suppliers who prescribe and/or insert PROBUPHINE have to be licensed with this system by enrolling and finishing reside coaching.

  • PROBUPHINE shouldn’t be accessible in retail pharmacies
  • PROBUPHINE have to be inserted or eliminated solely within the facility of the licensed prescriber

Implants could also be tough to find if inserted too deeply, for those who manipulate them, or for those who acquire important weight after insertion.  Your healthcare supplier might do particular procedures or exams, or refer you to a surgical specialist to take away the implants if they’re tough to find.

The medication in PROBUPHINE could cause severe and life-threatening issues, particularly for those who take or use sure different medicines or medication.  Call your healthcare supplier immediately or get emergency assist for those who:

Feel faint or dizzy, have psychological adjustments similar to confusion, slower respiration than you usually have, extreme sleepiness, blurred imaginative and prescient, issues with coordination, slurred speech, can’t assume nicely or clearly, excessive physique temperature, slowed reflexes, really feel agitated, stiff muscle tissue or have bother strolling.

These could be indicators of an overdose or different severe issues. 

Coma or demise can occur for those who take anxiousness medicines or benzodiazepines, sleeping tablets, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol throughout remedy with PROBUPHINE. Tell your healthcare supplier in case you are taking any of those medicines or for those who drink alcohol.

Who mustn’t use PROBUPHINE?

Do not use PROBUPHINE in case you are allergic to buprenorphine or any of its substances, this consists of buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

PROBUPHINE might not be best for you. Before beginning PROBUPHINE inform your physician about all your medical situations, together with:

Trouble respiration or lung issues, an enlarged prostate gland (males), a head damage or mind downside, issues urinating, a curve in your backbone that impacts your respiration, liver issues, gallbladder or adrenal gland issues, Addison’s illness, low thyroid hormone ranges (hypothyroidism), a historical past of alcoholism, a historical past of keloid formation, connective tissue illness (similar to scleroderma), or historical past of MRSA infections, psychological issues similar to hallucinations, an allergy to numbing medicines or medicines used to scrub your pores and skin, are pregnant or plan to turn into pregnant or are breastfeeding or plan to breastfeed.

Tell your physician about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins and natural dietary supplements.

 What ought to I keep away from whereas being handled with PROBUPHINE?

  • Do not drive, function heavy equipment, or carry out another harmful actions till you understand how this remedy impacts you
  • You mustn’t drink alcohol throughout remedy. You mustn’t take anxiousness medicines or benzodiazepines, sleeping tablets, tranquilizers, or sedatives that aren’t prescribed to you throughout remedy with PROBUPHINE, as this will result in slowed respiration, drowsiness, delayed response time, lack of consciousness and even demise

What are the doable unwanted side effects of PROBUPHINE?

PROBUPHINE could cause severe unwanted side effects, together with:

  • Infection on the insertion or elimination web site. Infection might occur on the implant web site throughout insertion or elimination. Do not attempt to take away PROBUPHINE implants your self 
  • Opioid withdrawal. If PROBUPHINE comes out of your arm or for those who cease remedy, inform your physician immediately as you may have signs of shaking, sweating greater than regular, feeling scorching or chilly greater than regular, runny nostril, watery eyes, goose bumps, diarrhea, vomiting and muscle aches
  • Physical dependency
  • Liver issues. Call your physician immediately for those who discover indicators of liver issues that will embrace your pores and skin or the white a part of your eyes turning yellow (jaundice)
  • Allergic response. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood strain, dizziness or lower in consciousness
  • Decrease in blood strain. You might really feel dizzy whenever you rise up from sitting or mendacity down
  • Sleep Apnea. Call your physician immediately for those who or somebody near you notices:  Observed episodes of stopped respiration or irregular respiration patterns throughout sleep

Tell your healthcare supplier for those who develop any of the signs listed.

Common unwanted side effects of PROBUPHINE embrace: Headache, nausea, toothache, constipation, despair, vomiting, again ache, mouth and throat ache.

Common dangers with the minor surgical process:  Itching, ache, irritation, redness, swelling, bleeding, or bruising on the insertion or elimination web site. Scarring across the insertion web site. 

Please learn Full Prescribing Information, together with BOXED WARNING relating to IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

Titan encourages you to report adverse unwanted side effects of prescribed drugs to the FDA. You can go to www.fda.gov/security/medwatch/ or name 1-800-FDA-1088.

About Titan Pharmaceuticals

Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), primarily based in South San Francisco, CA, is a industrial stage firm growing proprietary therapeutics with its ProNeura® long-term, steady drug supply know-how. The Company’s lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term upkeep remedy of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the primary and solely commercialized remedy of opioid dependence to supply steady, around-the-clock blood ranges of buprenorphine for six months following a single process. The ProNeura know-how additionally has the potential for use in growing merchandise for treating different continual situations similar to Parkinson’s illness and hypothyroidism, the place sustaining constant, around-the-clock blood ranges of remedy might profit the affected person and enhance medical outcomes. For extra details about Titan, please go to www.titanpharm.com.

Forward-Looking Statements

This press launch might comprise “forward-looking statements” throughout the that means of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements embrace, however should not restricted to, any statements referring to our product improvement applications and another statements that aren’t historic details. Such statements contain dangers and uncertainties that might negatively have an effect on our enterprise, working outcomes, monetary situation and inventory value. Factors that might trigger precise outcomes to vary materially from administration’s present expectations embrace these dangers and uncertainties referring to the commercialization of Probuphine; the regulatory approval course of; Titan’s potential to entry capital; the event, testing, manufacturing and advertising and marketing of our drug candidates; patent and mental property issues; and strategic agreements and relationships.  We expressly disclaim any obligation or endeavor to launch publicly any updates or revisions to any forward-looking statements contained herein to replicate any change in our expectations or any adjustments in occasions, situations or circumstances on which any such assertion relies, besides as required by regulation.

CONTACTS:

Sunil Bhonsle
President & CEO
(650) 244-4990

Stephen Kilmer
Investor Relations
(650) 989-2215

TITAN PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in hundreds, besides per share quantity*)

(unaudited)

Three Months Ended
December 31,

Year Ended
December 31,

2019

2018

2019

2018

Revenue:

License income

$                  2

$                313

$                315

$             5,376

Product income

195

217

1,zero06

535

Grant income

1,zero20

707

2,290

707

Total income

1,217

1,237

three,611

6,618

Operating expense:

Cost of products offered

550

290

1,288

538

Research and improvement

1,872

1,855

7,242

7,478

Selling, basic and administrative

2,589

2,358

11,925

6,866

Total working expense

5,zero11

four,503

20,455

14,882

Loss from operations

(three,794)

(three,266)

(16,844)

(eight,264)

Other earnings (expense), web

(147)

(238)

386

(759)

Net loss and complete loss

$           (three,941)

$           (three,504)

$         (16,458)

$           (9,023)

Deemed dividend on set off of down spherical provision

(285)

Net loss attributable to frequent stockholders

$           (three,941)

$           (three,504)

$         (16,458)

$           (9,308)

Basic web loss per share

$             (zero.08)

$             (zero.29)

$             (zero.72)

$             (1.64)

Diluted web loss per share

$             (zero.08)

$             (zero.29)

$             (zero.72)

$             (1.66)

Weighted common shares utilized in computing primary web loss per share

49,206

11,960

22,957

5,688

Weighted common shares utilized in computing diluted web loss per share

49,206

11,960

22,957

5,688

* Adjusted to replicate the impression of the 1:6 reverse cut up efficient January 24, 2019.

 

CONDENSED BALANCE SHEETS

(in hundreds)

(unaudited)

December 31,

December 31,

2019

2018

Assets

Cash and money equivalents

$             5,223

$             9,295

Restricted money

361

Receivables

993

1,737

Inventory

998

1,262

Contract property

99

Prepaid bills and different present property

1,094

547

Total present property

eight,308

13,301

Property and gear, web

817

794

Operating lease right-of-use asset

397

Total property

$             9,522

$           14,095

Liabilities and Stockholders’ Equity 

Current liabilities

$             three,600

$             three,452

Long-term debt

four,019

three,787

Warrant legal responsibility

320

Derivative legal responsibility

25

Operating lease legal responsibility, non-current

150

Stockholders’ fairness 

1,433

6,831

Total liabilities and stockholders’ fairness 

$             9,522

$           14,095

 

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SOURCE Titan Pharmaceuticals, Inc.



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