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TTNP new 52 week low
TTNP new 52 week low
UNVEILING TITAN PHARMACEUTICALS (TTNP)'s VALUE: IS IT REALLY PRICED RIGHT? A COMPREHENSIVE GUIDE
By GuruFocus Research-August 28, 2023
LINK
Titan Pharmaceuticals Inc (NASDAQ:TTNP) experienced a loss of -8.52% in its daily trading and a 3-month loss of -30.01%. With a Loss Per Share of $0.57, the question arises: is the stock significantly overvalued? This article seeks to explore this valuation question by providing an in-depth analysis. Let's dive in.
Company Introduction
* Warning! GuruFocus has detected 7 Warning Signs with TTNP. Click here to check it out.
* TTNP 30-Year Financial Data
* The intrinsic value of TTNP
Titan Pharmaceuticals Inc is a pharmaceutical company that develops therapeutics utilizing its proprietary long-term drug delivery platform, ProNeura. This platform is used for the treatment of select chronic diseases where steady state delivery of a drug provides efficacy and/or safety benefits.
The company's first product based on ProNeura technology, the Probuphine (buprenorphine) implant, has been approved in the United States, Canada, and the European Union for the maintenance treatment of opioid use disorder in clinically stable patients taking 8 mg or less a day of oral buprenorphine.
At a price of $0.5 per share, Titan Pharmaceuticals (NASDAQ:TTNP) has a market cap of $7.60 million. However, the GF Value, an estimation of its fair value, stands at $0.01, indicating that the stock may be
significantly overvalued.
Understanding GF Value
The GF Value represents the current intrinsic value of a stock, derived from our proprietary method. This value is calculated based on historical multiples, GuruFocus adjustment factor based on the company's past returns and growth, and future estimates of business performance. In the case of Titan Pharmaceuticals (NASDAQ:TTNP), the stock appears to be significantly overvalued based on the GF Value calculation.
Because Titan Pharmaceuticals (NASDAQ:TTNP) is significantly overvalued, the long-term return of its stock is likely to be much lower than its future business growth.
Financial Strength
Investing in companies with poor financial strength carries a higher risk of permanent loss of capital. It's essential to review a company's financial strength before deciding whether to buy its stock. Titan Pharmaceuticals has a cash-to-debt ratio of 0.82, which is worse than 81.53% of companies in the Biotechnology industry. This indicates that the financial strength of Titan Pharmaceuticals is poor.
Profitability and Growth
Companies that have been consistently profitable over the long term offer less risk for investors. Titan Pharmaceuticals has been profitable 2 over the past 10 years. However, its operating margin is -15248.21%, which ranks worse than 92.93% of companies in the Biotechnology industry, indicating poor profitability.
Growth is a crucial factor in the valuation of a company. Titan Pharmaceuticals's 3-year average revenue growth rate is worse than 98.95% of companies in the Biotechnology industry. However, its 3-year average EBITDA growth rate is 55%, which ranks better than 92.63% of companies in the industry.
ROIC vs WACC
Comparing a company's return on invested capital (ROIC) and the weighted cost of capital (WACC) is another way to assess its profitability. For the past 12 months, Titan Pharmaceuticals's ROIC is -669.31, and its WACC is 12.15.
Conclusion
In conclusion, the stock of Titan Pharmaceuticals (NASDAQ:TTNP) appears to be significantly overvalued. The company's financial condition is poor, and its profitability is weak. However, its growth ranks better than 92.63% of companies in the Biotechnology industry.
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Subsequent Events
We have evaluated events that have occurred after June 30, 2023 and through the date that our condensed financial statements are issued.
In July 2023, we entered into an asset purchase agreement, or the Asset Purchase Agreement, with Fedson for the sale of certain ProNeura assets including our portfolio of drug addiction products, in addition to other early development programs based on the ProNeura drug delivery technology, or ProNeura Assets.
Our addiction portfolio consists of the Probuphine and Nalmefene implant programs. The ProNeura Assets constitute only a portion of our assets.
Under the terms of the Asset Purchase Agreement, Fedson will purchase the ProNeura Assets for an upfront purchase price of $2 million ($1 million at closing, $1 million to be held in escrow pending completion of certain conditions) with potential milestone payments to us of up to $50 million on future net sales of the products.
We will also receive certain royalties on future net sales of the products. As further consideration, Fedson will assume all liabilities related to a pending employment claim against us. The transaction is expected to close shortly following the signing of the Asset Purchase Agreement, subject to the satisfaction of customary closing conditions.
In July 2023, we received $250,000 in funding in exchange for the issuance of an unsecured promissory note for that principal amount to David E. Lazar, our Chief Executive Officer and chairman of our Board of Directors (the “Lazar Promissory Note”). Pursuant to the Lazar Promissory Note, the principal amount will accrue interest at a rate of the Prime Rate + 2.00% per annum, and all principal and accrued interest will be due and payable on the earlier of January 1, 2024 or such time as we receive debt or equity financing or proceeds in excess of $500,000 from the aforementioned transaction with Fedson.
In July 2023, we granted, pursuant to our Fifth Amended and Restated 2015 Omnibus Equity Incentive Plan, and as approved by our Board of Directors, an aggregate of 450,000 shares of fully vested unrestricted common stock to six members of the Board of Directors and one member of the management team.
In August 2023, we received $500,000 in funding in exchange for the issuance of a convertible promissory note for that principal amount to Choong Choon Hau (the “Hau Promissory Note”). Pursuant to the Hau Promissory Note, the principal amount will accrue interest at a rate of 10% per annum and will be payable monthly.
All principal and accrued interest shall be due and payable on January 1, 2024, unless extended as provided.
All or part of the Hau Promissory Note can be converted into our common stock at a conversion price of $0.5287 per share from time to time following the issuance date and ending on the maturity date.
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DEA EXTENDS TELEMEDICINE OPTION FOR PRESCRIBING CONTROLLED MEDICATION
By Arielle Zionts July 03, 2023
ARTICLE
Telehealth rules, which were created during the pandemic, allowed for the prescribing of controlled substances without an in-person visit, will stay in place until November 11.
Federal regulators want most patients to see a health care provider in person before receiving prescriptions for potentially addictive medicines through telehealth — something that hasn’t been required in more than three years.
During the COVID-19 public health emergency, the Drug Enforcement Administration allowed doctors and other health care providers to prescribe controlled medicine during telehealth appointments without examining the patient in person. The emergency declaration ended May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.
Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.
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A FIRST-OF-ITS-KIND TRIAL STUDIES THE USE OF INJECTABLE BUPRENORPHINE TO TREAT METHAMPHETAMINE USE DISORDER AND OPIOD CO-USE
JUNE 28, 2023
ARTICLE
OAKLAND, Calif., June 28, 2023 /PRNewswire/ -- Investigators at Alameda Health System's (AHS) Bridge Clinic are participating in a new, six-city trial of injectable buprenorphine for the treatment of methamphetamine use disorder in adults who also use opioids. This is the first study to investigate the drug's efficacy in treating the two co-addictions simultaneously.
"People who use methamphetamine are involved in over half of all overdose deaths and there is a desperate need to find effective treatments for this patient population," said Erik Anderson, MD, principal investigator at AHS and Associate Medical Director of the Bridge Program. "Many patients use opioids in addition to methamphetamine, and examining treatment options for people using multiple substances is particularly important."
While buprenorphine has been used to treat opioid use disorder since 2002, there are currently no FDA-approved treatments for methamphetamine use disorder or methamphetamine use disorder together with opioid co-use.
The first-of-its-kind trial, available locally at AHS's Bridge Clinic at the Wilma Chan Highland Hospital Campus in Oakland, CA, is a 12-week randomized, double-blind, placebo-controlled study. The Bridge Clinic hopes to enroll 41 of the 246 participants to be recruited nationwide over the next two years.
The study is designated for those with moderate to severe methamphetamine use disorder coupled with mild opioid use disorder or opioid misuse. It is funded by the National Institute on Drug Abuse, part of the National Institutes of Health, and the Helping to End Addiction Long-term (HEAL) Initiative.
"Using buprenorphine as a treatment for methamphetamine use disorder and opioid co-use is a promising option for this high-risk patient population. Our hope is that the extended-release buprenorphine formulation will help patients use less methamphetamine and improve their quality of life," said Anderson.
To be considered for the study, participants must be seeking treatment for methamphetamine use disorder and opioid co-use, be 18-65 in age, and be able to attend twice-weekly outpatient clinic visits. The trial evaluates patients with twice-weekly urine drug screens as well as self-reported frequency of methamphetamine and opioid co-use.
In addition to AHS's Bridge Clinic, participating institutions include: University of Texas Southwestern Medical Center, University of California Los Angeles, Comprehensive Options for Drug Addiction (CODA), Oklahoma State University Center for Health Sciences, and the University of Washington Harborview Medical Center.
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OVER 40% OF U.S. PHARMACIES REPORT NO BUPRENORPHINE IN STOCK, ACCORDING TO NEW PEER-REVIEWED STUDY FROM BICYCLE HEALTH PUBLISHED IN JAMA NETWORK OPEN
Bicycle Health-June 7, 2023
LINK
Florida pharmacies were least likely to have stock (37.1%), while Washington State pharmacies were most likely (83.9%)
Availability of buprenorphine for opioid use addiction in the United States by county
BOSTON, June 07, 2023 (GLOBE NEWSWIRE) -- Bicycle Health, the leading telehealth provider of integrated medical and behavioral health care for opioid use disorder (OUD) in the United States, announced new research published in JAMA Network Open that highlights the limitations of buprenorphine availability in pharmacies across America.
Medications for opioid use disorder (MOUD) – including buprenorphine – are widely considered to be a gold-standard of care for OUD. Adherence to MOUD has been shown to reduce ER visits, non-fatal drug overdoses, and healthcare costs. A 2019 study in the Journal of Substance Abuse Treatment found that 3.6% of patients who were adherent to MOUD experienced a nonfatal drug-related overdose, compared to 13.2% of MOUD patients who were non-adherent.
In spite of the success of MOUD with buprenorphine, access to the medication continues to be a challenge for patients and their providers. This peer-reviewed study showed that 42.1% of the nearly 5,300 unique retail pharmacies contacted by Bicycle Health’s team on behalf of its patients did not report buprenorphine stock at the time of the request. Importantly, access to buprenorphine stock varied heavily depending on the state the patient resided in or type of pharmacy queried.
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Key findings include:
* Pharmacy chains were more likely to have buprenorphine stock, with 61.6% of chain pharmacies reporting availability vs. 45.3% of independent pharmacies;
* Despite being more likely to have buprenorphine stock, there was still significant variability across chain pharmacy locations, based on chains where more than 40 locations reported stock;
* Over the course of this study, Bicycle Health made the most buprenorphine stock inquiries on behalf of patients to CVS and Walgreens locations. Buprenorphine availability was reported 59.7% and 70.3% of the time, respectively;
* Buprenorphine availability varied widely across the 32 states included in this study. Of states with more than 100 pharmacies queried, Florida locations were least likely to have stock (37.1%) and Washington State locations were most likely to have stock (83.9%);
* Over the course of this study, Bicycle Health made the most buprenorphine stock inquiries on behalf of patients in Florida and California. Buprenorphine availability was reported 37.1% and 46.8% of the time, respectively.
A full summary of the key outcomes and insights from the research are available online HERE in Bicycle Health’s resource center for strategic partners.
“Buprenorphine is a critical tool in the fight against the opioid overdose epidemic, but to be safely and effectively administered to patients with OUD, they must have consistent, timely, and convenient access,” said Bicycle Health’s Director of Research Scott G. Weiner, MD, MPH. “This study highlights how medication availability still represents a major barrier to care for many of Bicycle Health’s patients – as well as others seeking MOUD treatment across the United States.”
“At Bicycle Health, we talk a lot about defiant hope, which is essentially the need to stay upbeat and hopeful, even when it feels like we cannot help enough people, or that too few people care about our patients. Seeing this research published in JAMA is a ‘defiant hope day’ for me, because it means this issue will get the attention it deserves,” said Ankit Gupta, Bicycle Health’s Founder and CEO. “The responses we’ve gotten from some of the nation’s leading pharmacies have been inspiring, with their leaders pledging to partner with us to do better for patients long-term.”
Gupta continued, “This mission we’re on, to end opioid use disorder and increase access to treatment, needs an army of advocates working together if we’re going to overcome this epidemic. I’m grateful to see this research published and for the opportunities it’s creating for us to accelerate our mission in partnership with major pharmacies.”
"This data helps illustrate a major gap in our ability to care for patients with OUD, but the good news is it's a problem with a clear solution, “said Brian Clear, Bicycle Health’s Chief Medical Officer. “We've already had a positive response and commitment to improve stock rates from pharmacies."
The stigma associated with opioid use, the cost of in-person treatment options, and the lack of absence of telehealth treatment programs prior to the COVID public health emergency have all been consistent impediments in efforts to expand access to MOUD treatment with buprenorphine. As the Drug Enforcement Administration (DEA) looks to outline the regulations for prescribing via telehealth and continues setting stocking limits for buprenorphine, understanding the role these drugs play in addressing opioid use disorder is an important consideration. Bicycle Health’s evidence-based, clinically proven virtual care model is helping to increase access to these life-saving medications and address the opioid overdose epidemic head-on.
Bicycle Health is committed to working alongside America’s leading pharmacies, policymakers, and regulators to ensure patients across this country can safely and conveniently access the medications they need to maintain a healthy recovery.
About Bicycle Health
Bicycle Health is the leading telehealth provider of medications for opioid use disorder (MOUD) in the United States, offering an evidence-based clinical care model that includes FDA-approved Medications for Addiction Treatment (MAT), access to a highly-trained team of medical experts, therapy, a customized treatment plan, and peer support groups.
Bicycle Health’s mission is to address the country’s number one public health crisis by helping to reduce stigmas associated with opioid addiction and providing access to affordable, convenient, and confidential teleMOUD treatment for individuals in need. The company’s “whole person” approach to treatment encourages patients to focus on their life passions and goals, which has been shown to play a vital role in recovery. For more information, visit www.bicyclehealth.com.
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ONLY 1 IN 4 ADOLESCENT TREATMENT FACILITIES OFFER BUPRENORPHINE FOR OPIOD USE DISORDER
JUNE 13, 2023
LINK
NIH-funded study indicates substantial need to expand access to evidence-based treatment among young people
Peer-Reviewed Publication
Only 1 in 4 residential addiction treatment facilities caring for U.S. adolescents under 18 years old offer buprenorphine, a medication used to treat opioid use disorder, according to a NEW STUDY Only 1 in 8 offer buprenorphine for ongoing treatment. These findings highlight a significant gap in access to evidence-based addiction treatment among young people. Published in JAMA, this study was supported by the National Institute on Drug Abuse (NIDA) and the National Center for Advancing Translational Sciences (NCATS), both part of the National Institutes of Health, and led by researchers at Oregon Health & Science University (OHSU).
There has been a dramatic rise in overdose deaths among young people aged 14-18 in recent years, likely driven by illicit counterfeit pills containing fentanyl. For those with opioid use disorder, medications are the most effective treatment options for preventing both return to opioid use and overdose deaths. Buprenorphine is the only medication for opioid use disorder that is approved by the U.S. Food and Drug Administration for use in people aged 16-18. Although buprenorphine is not approved for use among people under the age of 16 in the U.S., some professional medical societies recommend that buprenorphine be considered as a treatment option for opioid use disorder in younger people.
“It is tragic to see that young people with opioid use disorder are unable to access buprenorphine in most treatment facilities, despite this medication being the standard of care for people aged 16 and older” said Nora Volkow, M.D., director of NIDA. “Residential treatment facilities provide an opportunity to reach young people with a range of evidence-based supports at a pivotal time in their lives, and it is crucial that buprenorphine is made available as one of those options.”
Residential treatment facilities are part of the continuum of care for adolescents with opioid use disorder. However, little is known about specific evidence-based treatment options offered to young people at these facilities, including medications for opioid use disorder. To address this gap, researchers at OHSU sought to determine how many adolescent treatment centers in the U.S. were offering buprenorphine to treat opioid use disorder.
Using the FindTreatment.gov database, which is maintained by the Substance Abuse and Mental Health Services Administration (SAMSHA), the researchers identified a list of 354 centers across the U.S. that offered treatment for “substance use,” in a “residential/24-hour residential” service setting, and for “children/adolescents” (defined as people aged 17 and younger) to include in the analysis.
Researchers called these facilities to inquire about treatment and services offered as potential users of these services for a 16-year-old with a recent non-fatal fentanyl overdose. Between October and December 2022, the study team called the facilities in a random order and confirmed that 160 (45%) of these facilities provided residential treatment to patients under the age of 18.
Of the 160 residential addiction treatment facilities found to provide treatment to young patients, the researchers found that 39 facilities (24%) said that they offered buprenorphine to patients aged 16 or older, including through partnership with outside prescribing clinicians, though specific parameters for offering buprenorphine varied by site. For instance, only 20 facilities (12.5%) said that they offered buprenorphine for ongoing treatment. 12 facilities (7.5%) said that they offered buprenorphine to adolescents under 16 years of age.
Among the other 121 facilities that did not offer buprenorphine to adolescents or weren’t sure, 57 (47%) indicated that adolescents prescribed buprenorphine by their own clinician could stay on it at least temporarily, although some stated they would discontinue it before discharge. And 27 (22%) required that adolescents were not taking buprenorphine in order to be admitted for residential treatment.
Based on these findings, the average person would need to call nine facilities on the SAMHSA list to find one that offered buprenorphine. To find one for an adolescent under 16, they would need to call 29 facilities.
“These residential treatment centers see some of the most vulnerable adolescents in our communities,” said lead author Caroline King, M.D., Ph.D., who completed this research as a student in the OHSU School of Medicine. “We need to support these centers to make evidence-based care the norm.”
“Buprenorphine is the one medication that’s approved for use in adolescents, and it’s underused in facilities taking care of kids with the most severe opioid use disorder,” said co-author Todd Korthuis, M.D., M.P.H., head of addiction medicine at OHSU. “It’s a big issue, but it’s something that we can change by supporting these treatment centers with education and technical assistance about buprenorphine, better funding to staff these centers, and by letting the public know that buprenorphine is necessary treatment in healing brains.”
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Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder
Article/PR
BRIXADI is the first and only long-acting buprenorphine injectable with both weekly and monthly doses.
Patients currently on a transmucosal buprenorphine-containing product can be switched to an equivalent dose of BRIXADI Weekly or Monthly.
BRIXADI will be available through a restricted distribution program via the BRIXADI REMS Program and is administered only by a healthcare professional.
PLYMOUTH MEETING, Pa., May 23, 2023 /PRNewswire/ -- Braeburn announces that the U.S. Food and Drug Administration (FDA) has approved BRIXADI (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product.
BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support. BRIXADI is to be administered only by healthcare providers in a healthcare setting and will be available in the U.S. in September 2023.
BRIXADI is the first and only weekly and monthly subcutaneous injection for moderate to severe OUD and is the only buprenorphine injectable that utilizes FluidCrystal®* Injection Depot Technology. Patients currently being treated with oral buprenorphine-containing products can be switched to equivalent doses of BRIXADI Weekly or BRIXADI Monthly in accordance with the Prescribing Information for BRIXADI.
"Today's FDA approval of BRIXADI is a significant step forward in the fight against OUD," said Mike Derkacz, President and CEO of Braeburn. "Over the last three years the US experienced a significant increase in opioid overdoses in part related to the economic and social upheaval that negatively impacted all of us, especially people with opioid use disorder and people in recovery.
Additional medication options for opioid use disorder will support healthcare providers in addressing the needs of their patients with opioid use disorder."
Due to the risk of serious harm resulting from accidental intravenous (IV) administration, BRIXADI has a Boxed Warning and will be made available through a restricted distribution program called the BRIXADI Risk Evaluation and Mitigation Strategy (REMS). Healthcare settings and pharmacies that order and dispense BRIXADI must be certified in this program and comply with the REMS requirements. Information on the BRIXADI REMS program will be available at www.BRIXADIREMS.com.
BRIXADI is the only injectable buprenorphine studied against sublingual buprenorphine/naloxone (SL BPN/NX) in a 24-week Phase 3, double-blind study, which randomized 428 adults with moderate to severe OUD. The trial enrolled patients representative of the real-world population, including patients that injected opioids (52%), patients that primarily used heroin (71%), patients with evidence of fentanyl use (26%) and patients using nonopioid substances at screening (71%).
In this pivotal Phase 3 efficacy and safety trial, weekly and monthly BRIXADI met the primary endpoint of non-inferiority for responder rate versus daily SL BPN/NX (16.9% vs. 14.0%, respectively; p<0.001). Additionally, BRIXADI demonstrated superiority to SL BPN/NX based on the cumulative distribution function (CDF) of the percentage of negative opioid assessments from week 4 through week 24 (p=0.004; secondary endpoint).
"A weekly and monthly buprenorphine injection with different dose options can align with clinical practice and patient care needs," said Dr. Michelle Lofwall, Professor of Behavioral Science and Psychiatry at the University of Kentucky Center on Drug and Alcohol Research and Primary Investigator in the Phase 3 efficacy and safety study. "Some patients need help with taking their medication as prescribed, some prefer not taking a daily medication or visiting a pharmacy to pick up their medication, so having a weekly and monthly option that provides buprenorphine over one week or one month could benefit patients, their loved ones and the treatment providers."
The safety profile of BRIXADI was consistent with the known systemic safety profile of oral buprenorphine with the exception of mild-to-moderate injection-site reactions. The most common adverse reactions included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia and urinary tract infections.
BRIXADI is formulated using FluidCrystal® Injection Depot Technology, allowing for a low volume pre-filled syringe. Upon injection and contact with fluids in the tissue, the solution transforms into a nanostructured liquid-crystalline gel allowing for a slow release of buprenorphine at a steady rate over a one-week or one-month period. BRIXADI is delivered with a 23-gauge needle and may be administered in the buttock, thigh, stomach (abdomen) or upper arm.** BRIXADI does not require refrigeration.
*FluidCrystal® is a trademark owned by Camurus and used under license by Braeburn.
**In patients who are not currently receiving buprenorphine treatment, for BRIXADI Weekly, the upper arm site should only be used after steady state has been achieved (4 weeks).
May soon be experiencing deja vu all over again.
May soon be experiencing deja vu all over again.
Was just a matter of time until the share price dipped under $1.00. 
Shaking things up a bit.
A necessary evil, if you will.
Activist Investing Nominates Slate Of Highly Qualified Director Candidates For Election To the Board Of Directors Of Titan Pharmaceuticals At Upcoming Special Meeting Of Stockholders
Yes sir 
