Titan Pharmaceuticals Reports First Quarter 2020 Financial Results | State


SOUTH SAN FRANCISCO, Calif., May 15, 2020 /PRNewswire/ — Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) (“Titan” or the “Company”) as we speak reported monetary outcomes for the primary quarter ended March 31, 2020 and supplied an replace on its enterprise.

First Quarter 2020 Highlights

  • In January 2020, Titan accomplished an providing leading to internet money proceeds of roughly $1.9 million.
  • Since January 1, 2020, the Company acquired proceeds of roughly $6.7 million on account of the train of beforehand issued frequent inventory buy warrants.

COVID-19 Impact and Adjusted Probuphine Commercial Strategy

Titan’s business operations growth has continued all through the previous a number of months, with additions to its gross sales and medical liaison groups, together with assist from extra advertising and marketing and medical entry employees, that now present protection for all 50 states and Puerto Rico. Unfortunately, the emergence of the COVID-19 pandemic through the latter half of the primary quarter and the ensuing restrictions on journey and social distancing guidelines which have minimized private doctor/affected person interplay, besides in emergencies, has hindered the effectiveness of the business workforce. In order to try to mitigate the impression of the continuing public heath disaster, Titan has undertaken quite a lot of key actions throughout this era, together with:

  • Preparatory work utilizing digital communication strategies to determine relationships with new well being care suppliers (“HCPs”) and their employees;
  • Providing digital communication instruments for HCPs to make use of with their sufferers and to focus on the potential advantages of Probuphine as a remedy modality within the rising telemedicine surroundings; and
  • Establishing a social media presence in choose geographies to extend consciousness of Probuphine and improve its share of voice within the remedy assisted remedy house.

“Our first quarter of 2020 financial results were affected by the COVID-19 pandemic, and we have had to make several adjustments to our commercial tactics to best position Titan in the current environment,” mentioned Titan’s President and CEO, Sunil Bhonsle. “We have been working in a virtual environment and have focused our efforts on using digital communication tools to establish strong relationships with the medical community as well as inform patients of Probuphine’s long acting treatment option, which may be well-suited for telemedicine. In addition, our Medical Affairs team continues to develop a virtual process for providing training to health care providers, which, if approved by the FDA, could be a very valuable tool for Titan and health care providers alike.”

Probuphine is indicated for the upkeep remedy of OUD in eligible sufferers.

Please see Full Indication and Important Safety Information beneath, and hyperlink beneath to Full Prescribing Information.

“The board has been very supportive of the team’s initiative in the face of these new challenges, and I am very pleased with our progress,” mentioned Titan’s Executive Chairman, Dr. Marc Rubin. “The unfortunate reality is that patients suffering from OUD are now facing more challenges to getting proper treatment during this pandemic, and we are working hard to ensure we can support their needs, as well as the needs of their health care providers.”

First Quarter 2020 Financial Results

For the three months ended March 31, 2020, Titan reported roughly $1.three million in income, which displays roughly $zero.2 million in product gross sales and roughly $1.1 million associated to the Company’s National Institute on Drug Abuse (“NIDA”) grant. This in contrast with revenues of roughly $zero.9 million in the identical interval in 2019, which was comprised of $zero.three 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.three million associated to the NIDA grant.

Total working bills for the primary quarter of 2020 have been roughly $5.6 million, in contrast with roughly $5.2 million from the identical quarter in 2019, and consisted primarily of analysis and growth (“R&D”) and promoting, normal and administrative (“SG&A”) bills and prices of products offered, inclusive of distribution bills. R&D bills for the quarter ended March 31, 2020 have been roughly $2.three million, in contrast with roughly $1.eight million for a similar three month interval in 2019. SG&A bills for the 2020 first quarter have been roughly $three.1 million, basically unchanged from the identical quarter a 12 months in the past. Costs of products offered for the primary quarter of 2020 have been roughly $zero.2 million, in contrast with roughly $zero.three million within the 2019 first quarter.

Net different expense, consisting primarily of curiosity expense, non-cash losses on modifications within the honest worth of warrants and prices attributable to the issuance of warrants was roughly $1.four million within the first quarter of 2020, in contrast with internet different expense of roughly $zero.2 million within the first quarter of 2019.

Net loss relevant to frequent stockholders within the first quarter of 2020 was roughly $5.6 million, or roughly $zero.07 per share, in contrast with a internet loss relevant to frequent stockholders of roughly $four.5 million, or roughly $zero.34 per share, in the identical quarter in 2019.

As of March 31, 2020, Titan had money and money equivalents of roughly $eight.zero million, which the Company believes, along with proceeds from a Paycheck Protection Program mortgage and the following train of warrants, are adequate to fund deliberate operations via the third quarter of 2020.

Conference Call Details

Titan administration will host a convention name as we speak at 12:00 p.m. ET / 9:00 a.m. PT to overview these monetary outcomes and focus on 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; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

The dwell convention name could also be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (worldwide) and offering passcode 3367973. The name may even be broadcast dwell 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 constantly 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 inside arm in an outpatient workplace process and eliminated in the same method on the finish of the remedy 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 remedy of opioid habit 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 medicine (both prescription or unlawful). PROBUPHINE is indicated for the upkeep remedy of opioid dependence in sufferers who’ve achieved and sustained extended medical stability on low-to-moderate doses (doses not more than eight mg per day) of a buprenorphine-containing product.

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

It shouldn’t be identified if PROBUPHINE is secure 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 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 well transfer into blood vessels, probably to your lung, and will result in loss of life

Implant stands proud of the pores and skin (protrusion)

Implant comes out by itself (expulsion)

Call your healthcare supplier immediately if: 

  • PROBUPHINE stands proud 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

If the implant comes out by itself, maintain it away from others, particularly youngsters, as it could trigger extreme problem in respiration and probably loss of life.

Because of the danger of issues of, migration, protrusion, expulsion and nerve harm with insertion and removing of PROBUPHINE, it is just out there via a restricted program known as the PROBUPHINE REMS Program. Healthcare suppliers who prescribe and/or insert PROBUPHINE should be licensed with this system by enrolling and finishing dwell coaching.

  • PROBUPHINE shouldn’t be out there in retail pharmacies
  • PROBUPHINE should 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 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 drugs in PROBUPHINE could cause severe and life-threatening issues, particularly for those who take or use sure different medicines or medicine.  Call your healthcare supplier immediately or get emergency assist for those who:

Feel faint or dizzy, have psychological modifications akin to confusion, slower respiration than you usually have, extreme sleepiness, blurred imaginative and prescient, issues with coordination, slurred speech, can not assume nicely or clearly, excessive physique temperature, slowed reflexes, really feel agitated, stiff muscle mass or have hassle strolling.

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

Coma or loss of life can occur for those who take nervousness medicines or benzodiazepines, sleeping capsules, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol throughout remedy with PROBUPHINE. Tell your healthcare supplier if you’re taking any of those medicines or for those who drink alcohol.

Who mustn’t use PROBUPHINE?

Do not use PROBUPHINE if you’re allergic to buprenorphine or any of its substances, this contains buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

PROBUPHINE is probably not best for you. Before beginning PROBUPHINE inform your physician about your entire medical circumstances, together with:

Trouble respiration or lung issues, an enlarged prostate gland (males), a head harm 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 (akin to scleroderma), or historical past of MRSA infections, psychological issues akin to hallucinations, an allergy to numbing medicines or medicines used to wash 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 every other harmful actions till you understand how this remedy impacts you
  • You mustn’t drink alcohol throughout remedy. You mustn’t take nervousness medicines or benzodiazepines, sleeping capsules, tranquilizers, or sedatives that aren’t prescribed to you throughout remedy with PROBUPHINE, as this may result in slowed respiration, drowsiness, delayed response time, lack of consciousness and even loss of life

What are the potential uncomfortable side effects of PROBUPHINE?

PROBUPHINE could cause severe uncomfortable side 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 implants your self 
  • Opioid withdrawal. If PROBUPHINE comes out of your arm or for those who cease remedy, inform your physician immediately as you possibly can 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 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 could really feel dizzy if you stand 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 uncomfortable side effects of PROBUPHINE embrace: 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 concerning IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.

Titan encourages you to report damaging uncomfortable 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 business stage firm creating proprietary therapeutics with its ProNeura® long-term, steady drug supply expertise. 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 expertise additionally has the potential for use in creating merchandise for treating different continual circumstances akin to 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 include “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 usually are not restricted to, any statements regarding our product growth applications and every other statements that aren’t historic info. 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 regarding the commercialization of Probuphine; the regulatory approval course of; Titan’s skill 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 mirror any change in our expectations or any modifications in occasions, circumstances or circumstances on which any such assertion is predicated, besides as required by legislation.

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,

2020

2019

Revenue:

License income

$                        –

$                      313

Product income

210

317

Grant income

1,126

315

Total income

1,336

945

Operating expense:

Cost of products offered

171

304

Research and growth

2,277

1,844

Selling, normal and administrative

three,114

three,zero82

Total working expense

5,562

5,230

Loss from operations

(four,226)

(four,285)

Other expense, internet

(1,358)

(232)

Net loss and complete loss

$                 (5,584)

$                 (four,517)

Basic and diluted internet loss per frequent share

$                   (zero.07)

$                   (zero.34)

Weighted common shares utilized in computing fundamental and diluted internet loss per frequent share

82,641

13,217

 

CONDENSED BALANCE SHEETS

(in 1000’s)

(unaudited)

March 31,

December 31,

2020

2019

Assets

Cash and money equivalents

$                   eight,038

$                   5,223

Receivables

1,551

993

Inventory

1,064

998

Prepaid bills and different present property

1,493

1,094

Total present property

12,146

eight,308

Furniture and gear, internet

780

817

Operating lease right-of-use asset

336

397

Total property

$                 13,262

$                   9,522

Liabilities and Stockholders’ Equity 

Current liabilities

$                   four,410

$                   three,600

Operating lease legal responsibility, non-current

76

150

Long-term debt

three,500

four,zero19

Warrant legal responsibility

320

Stockholders’ fairness 

5,276

1,433

Total liabilities and stockholders’ fairness

$                 13,262

$                   9,522

 



Source hyperlink Weight Loss Without Pills

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

Add Comment