Titan Pharmaceuticals Reports First Quarter 2019 Financial Results


SOUTH SAN FRANCISCO, Calif., May 15, 2019 /PRNewswire/ — Titan Pharmaceuticals, Inc. (TTNP) at present reported monetary outcomes for the primary quarter ended March 31, 2019 and supplied an replace on its enterprise.

“We have made vital progress on our Probuphine commercialization technique because the starting of 2019,” mentioned Titan’s President and CEO, Sunil Bhonsle. “We  considerably expanded our specialty pharmacy community by bringing on board two nationally-recognized specialty pharmacies Alliance Rx Walgreens Prime and Accredo, and established AppianRx because the ‘hub’ that can streamline Probuphine’s provide chain course of. These new partnerships will enhance entry to long-term upkeep therapy with Probuphine for eligible sufferers and facilitate extra environment friendly interactions amongst specialty pharmacies, physicians and payors. We have additionally made good progress in early-stage product improvement funded by grants from the National Institutes of Health and others, and proceed to discover alternatives to develop using our ProNeuraTM expertise by extra partnerships.” 

Titan’s Executive Chairman, Dr. Marc Rubin, commented, “In addition to increasing our specialty pharmacy community and enhancing affected person help companies, we now have continued to extend consciousness of Probuphine by exhibiting on the American Society of Addiction Medicine annual assembly in April, and have expanded our base of healthcare suppliers who can present therapy with Probuphine. We are happy with the CHMP’s adoption of a optimistic opinion concerning Sixmo in Europe. We stay up for the European Commission’s closing resolution, and to supporting our accomplice, Motleni, because it prepares to launch Sixmo on the earth’s second largest marketplace for buprenorphine-based merchandise.”

For the three months ended March 31, 2019, Titan reported roughly $zero.9 million in revenues, which replicate roughly $zero.three million in product revenues, representing a progress of roughly 46% sequentially over the prior quarter, $zero.three million of grant revenues and $zero.three million of amortization of deferred income from the sale of European mental property rights for Probuphine to Molteni. This in contrast with revenues of roughly $1.1 million in the identical interval in 2018, which had been primarily associated to the up-front cost from the sale of Titan’s European mental property rights for Probuphine to Molteni. 

Total working bills for the primary quarter of 2019 had been roughly $5.2 million, in contrast with roughly $three.5 million in 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 bought, inclusive of distribution bills. R&D bills for the quarter ended March 31, 2019 had been roughly $1.eight million, in contrast with roughly $1.9 million for a similar quarter in 2018. SG&A bills for the 2019 first quarter had been roughly $three.1 million and included roughly $1.7 million related to gross sales and advertising and roughly $1.four of basic administrative bills, in contrast with roughly $1.6 million in the identical quarter a 12 months in the past which had been primarily basic and administrative bills. Costs of products bought, which displays product prices and different distribution bills related to gross sales of Probuphine, had been roughly $zero.three million for the primary quarter of 2019. Titan didn’t have value of products bought for the three months ended March 31, 2018.

Net different expense was roughly $zero.2 million for the three month intervals ended March 31, 2019 and 2018, primarily attributable to curiosity expense on excellent loans.

Net loss relevant to frequent shareholders within the first quarter of 2019 was roughly $four.5 million, or roughly $zero.34 per share, in contrast with a internet loss relevant to frequent shareholders of roughly $2.6 million, or roughly $zero.74 per share, in the identical quarter in 2018.

As of March 31, 2019, Titan had money and money equivalents of roughly $5.9 million.

Conference Call Details

Titan administration will host a convention name at present at four:30 p.m. EDT at present 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 1059834. The name can even 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 comprised of a mix of ethylene-vinyl acetate and a drug substance. The ensuing assemble is a strong matrix that’s positioned subdermally, usually within the higher arm in an outpatient workplace process and eliminated in an analogous method on the finish of the therapy interval. The U.S. Food and Drug Administration (“FDA”) authorized Probuphine in May 2016, and it’s the first and solely buprenorphine implant out there for the upkeep therapy of opioid dependancy in eligible sufferers.

IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED WARNING

Indication

PROBUPHINE is an implant that comprises the medication 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 therapy 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 transmucosal buprenorphine-containing product.

PROBUPHINE is a part of a whole therapy program that additionally consists of counseling and behavioral remedy.

WARNING : COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE

See Full Prescribing Information for full Boxed Warning

Serious issues could occur from insertion and removing of PROBUPHINE, together with:

Nerve or blood vessel harm in your arm

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

Implant stands out of the pores and skin (protrusion)

Implant comes out by itself (expulsion)

Contraindications
Hypersensitivity to buprenorphine or every other substances in PROBUPHINE (e.g., EVA).

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 removing, together with extreme or worsening itching, ache, irritation, redness, or swelling
  • You have numbness or weak spot in your arm after the insertion or removing process
  • You have weak spot or numbness in your arm, or shortness of breath

Because of the chance of issues of, migration, protrusion, expulsion and nerve harm with insertion and removing of PROBUPHINE, it is just out there by a restricted program known as the PROBUPHINE REMS Program. Healthcare Providers who Prescribe and/or Insert PROBUPHINE have to be licensed with this system by enrolling and finishing reside coaching.

  • PROBUPHINE isn’t out there 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, should you manipulate them, or should you acquire important weight after insertion.  Your healthcare supplier could 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 critical and life-threatening issues, particularly should you take or use sure different medicines or medication.  Call your healthcare supplier immediately or get emergency assist should you really feel faint or dizzy, have psychological adjustments reminiscent of confusion, slower respiratory than you usually have, extreme sleepiness, blurred imaginative and prescient, issues with coordination, slurred speech, can’t assume effectively or clearly, excessive physique temperature, slowed reflexes, really feel agitated, stiff muscle tissues or have hassle strolling. These might be indicators of an overdose or different critical issues. 

Coma or demise can occur should you take nervousness medicines or benzodiazepines, sleeping capsules, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol throughout therapy with PROBUPHINE. Tell your healthcare supplier in case you are taking any of those medicines or should you drink alcohol.

Who shouldn’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 will not be best for you. Before beginning PROBUPHINE inform your physician about your whole medical situations, together with:
Trouble respiratory or lung issues, an enlarged prostate gland (males), a head harm or mind drawback, issues urinating, a curve in your backbone that impacts your respiratory, 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 (reminiscent of scleroderma), or historical past of MRSA infections, psychological issues reminiscent of hallucinations, an allergy to numbing medicines or medicines used to scrub your pores and skin, are pregnant or plan to grow to be 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 every other harmful actions till you understand how this remedy impacts you.
  • You shouldn’t drink alcohol throughout therapy. You shouldn’t take nervousness medicines or benzodiazepines, sleeping capsules, tranquilizers, or sedatives that aren’t prescribed to you throughout therapy with PROBUPHINE, as this could result in slowed respiratory, drowsiness, delayed response time, lack of consciousness and even demise.

What are the attainable unwanted effects of PROBUPHINE?
PROBUPHINE could cause critical unwanted effects, together with:

  • Infection on the insertion or removing web site. Infection could occur on the implant web site throughout insertion or removing. Do not attempt to take away PROBUPHINE your self.
  • Opioid withdrawal. If PROBUPHINE comes out of your arm or should you cease therapy, inform your physician immediately as you’ll be able to have signs of shaking, sweating greater than regular, feeling sizzling or chilly greater than regular, runny nostril, watery eyes, goose bumps, diarrhea, vomiting and muscle aches.
  • Physical dependency.
  • Liver issues. Call your physician immediately should you discover indicators of liver issues which will embody 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 stress, dizziness or lower in consciousness.
  • Decrease in blood stress. You could really feel dizzy if you rise up from sitting or mendacity down.

Tell your healthcare supplier should you develop any of the signs listed.
Common unwanted effects of PROBUPHINE embody: Headache, nausea, toothache, constipation, melancholy, 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 removing web site. Scarring across the insertion web site.

Please learn Full Prescribing Information, together with BOXED WARNING

Titan encourages you to report unfavourable unwanted 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. (TTNP), primarily based in South San Francisco, CA, is a business stage firm creating proprietary therapeutics with its ProNeura™ long-term, steady drug supply expertise. The firm’s lead product is Probuphine® (buprenorphine) implant, a novel and long-acting formulation of buprenorphine for the long-term upkeep therapy of opioid dependence. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is the primary and solely commercialized therapy of opioid dependence to offer steady, around-the-clock blood ranges of buprenorphine for six months following a single process. The ProNeura expertise additionally has the potential for use in creating merchandise for treating different persistent situations reminiscent of Parkinson’s illness and hypothyroidism, the place sustaining constant, around-the-clock blood ranges of remedy could 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 could comprise “forward-looking statements” inside the that means of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements embody, however will not be restricted to, any statements referring to our product improvement applications and every other 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 embody these dangers and uncertainties referring to the commercialization of Probuphine, the regulatory approval course of, the event, testing, manufacturing and advertising of our drug candidates, patent and mental property issues and strategic agreements and relationships.  We expressly disclaim any obligation or enterprise 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
skilmer@titanpharm.com

 

TITAN PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in 1000’s, besides per share quantity)

(unaudited)

Three Months Ended
March 31,

2019

2018

Revenue:

License income

$                      313

$                   1,064

Product income

317

Grant income

315

Total income

945

1,064

Operating expense:

Cost of products bought

304

Research and improvement

1,844

1,856

Selling, basic and administrative

three,082

1,615

Total working expense

5,230

three,471

Loss from operations

(four,285)

(2,407)

Other revenue (expense), internet

(232)

(198)

Net loss and complete loss

$                 (four,517)

$                 (2,605)

Basic and diluted internet loss per frequent share

$                   (zero.34)

$                   (zero.74)

Weighted common shares utilized in computing 

primary and diluted internet loss per frequent share

13,217

three,534

CONDENSED BALANCE SHEETS

(in 1000’s)

(unaudited)

March 31,

December 31,

2019

2018

Assets

Cash and money equivalents

$                   5,909

$                   9,295

Restricted money

361

Receivables

2,zero52

1,737

Inventory

1,246

1,262

Contract belongings

99

Prepaid bills and different present belongings

882

547

Total present belongings

10,zero89

13,301

Furniture and tools, internet

782

794

Operating lease right-of-use asset

569

Total belongings

$                 11,440

$                 14,095

Liabilities and Stockholders’ Equity 

Current liabilities

$                   four,761

$                   three,452

Operating lease legal responsibility, non-current

357

Long-term debt

three,242

three,787

Derivative legal responsibility

25

25

Stockholders’ fairness 

three,055

6,831

Total liabilities and stockholders’ fairness

$                 11,440

$                 14,095

 

View unique content material to obtain multimedia:http://www.prnewswire.com/news-releases/titan-pharmaceuticals-reports-first-quarter-2019-financial-results-300851068.html



Source hyperlink Weight Loss Without Pills

How do you feel about this post?
0
0
0
0
0
0

Add Comment