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®, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence.

The share price of TTNP experienced a massive (+50%) surge with strong volumes post the company reported a Double-Digit Increase in Probuphine Shipments. On Jan 31st, 2019, the company provided an extremely promising update on the U.S. commercial relaunch of Probuphine (buprenorphine) implant, its unique six-month treatment for Opioid Use Disorder (OUD).

Titan has successfully completed the program’s planned transition from Braeburn Pharmaceuticals. Important commercialization accomplishments include the recruitment and onboarding of highly qualified commercial and medical affairs personnel for all targeted geographies; the engagement of a leading public relations agency for the re-branding of Probuphine; and the retention of a well-known government relations firm to plan and execute a new lobbying strategy for the product.

As per management, these accomplishments and other activities have contributed to a double-digit increase in total product shipments in the period following Titan’s assumption of responsibility for Probuphine sales in mid-June 2018. Based on preliminary information, total shipments of Probuphine during the rest of the year increased sequentially by over 20%.  Titan expects to provide more details in its fourth quarter and full-year 2018 financial results, which it expects to release in late March 2019.

Management Commentary:

“We are pleased that the initial stages of our relaunch have shown that the current market is highly receptive to our market segmentation strategy and core messaging,” said Titan’s Chief Commercial Officer, Dane Hallberg. “Along with the positive feedback we have received from both health care providers, and their patients, the increase in product shipments suggests that our relaunch strategy is sound, and we look forward to updating investors as this initiative progresses.”

Upcoming catalysts/guidance:

• The company is aggressively evaluating the market for opioid use disorder and start laying the necessary groundwork and strategies to position Probuphine for full-fledged success. The market continues to remain bullish about the significant and growing market for Probuphine, which has the potential to address critical unmet needs in this global epidemic.
• TTNP will be initiating the required Probuphine Phase 4 clinical studies next year.
• While the company’ other product development programs remain a very important part of its growth strategy, the management shall advance these as resources allow.
• Titan has recognized that its ProNeura platform has the potential to benefit patients with chronic disease, and will continue to pursue the development of other ProNeura-based products, once it has fully executed on the Probuphine re-launch.
• More details are expected with the next earnings release, due in late March.

Before this on Nov 14th, the company reported financial results for the third quarter ended Sep 30, 2018, and provided an update on its business. In order to maximize the significant market opportunity represented by its lead product, Probuphine®, TTNP was focused during the third quarter on successfully completing its transition to a commercial-stage company. TTNP strengthened its balance sheet via a public offering and completed the transfer of supply chain and logistics functions.  More recently, Titan appointed Dane Hallberg to the newly created position of Executive Vice President and Chief Commercial Officer.  Under Dane’s leadership, Titan has rapidly built its commercial infrastructure, including a small, experienced and highly-accomplished sales, marketing and medical liaison team that has hit the ground running.

Key & unique differentiating factor of the company:

Lead product, Probuphine, is an implant formulation of buprenorphine for the long-term maintenance treatment of opioid use disorder (OUD)

• Approved in U.S. and Canada, under regulatory review in EU

• An important therapeutic option to fight the growing opioid addiction pandemic

ProNeura™ platform technology provides continuous delivery, maintaining a stable blood level of selected drugs for the treatment of addiction and other disease categories

• Pain, Parkinson’s disease, malaria, diabetes, thyroid disease

Analysts views:

Driven by its favorable fundamentals, Titan has become a momentum stock in the recent past. The company is continuously progressing towards commercialization stage following reacquisition of Probuphine® rights in the U.S.

Research firms are positive about the performance of Titan Pharmaceuticals, Inc. (TTNP) with most of them predicting a possible re-rating over the near to medium term. Per www.marketbeat.com, Their average twelve-month price target is $12.00, suggesting that the stock has a possible upside of 527.45%. Considering all this, the company is in an extremely favorable risk-reward position, and value investors should consider exposure in this sector as the backdrop remains favorable.

Description & about the Company: Titan Pharmaceuticals, Inc. (NASDAQ: TTNP), based in South San Francisco, CA, is developing proprietary therapeutics primarily for the treatment of select chronic diseases.

The company’s lead product is Probuphine®, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Probuphine employs Titan’s proprietary drug delivery system ProNeura™, which is capable of delivering sustained, consistent levels of medication for three months or longer.  

Approved by the FDA 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 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.

Robust Pipeline:

Third Quarter 2018 Business Highlights/achievements:

• In August 2018, Titan entered into an amendment of the previously announced definitive asset purchase, supply and support agreement with L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., and in connection with the amendment received approximately $1.7 million during the quarter.
• In September 2018, Titan initiated a pilot program in collaboration with the Nevada Center for Behavioral Health to evaluate a medication-assisted treatment (MAT) program utilizing the Probuphine® (buprenorphine) implant within the State of Nevada criminal justice system.
• In September 2018, Titan was awarded a two-year grant of approximately $6.7 million from the National Institutes of Health’s National Institute on Drug Abuse (NIDA) for the development of a ProNeura-based six-month implantable formulation of the opioid antagonist, Nalmefene.
• In September 2018, Titan closed an underwritten public offering, which provided net proceeds of approximately $8.5 million. Additionally, in October and November 2018, Titan received approximately $4.6 million from the full exercise of the Underwriters’ over-allotment option and the exercise of 13,070,900 common stock purchase warrants issued in the financing.

Quarterly Financial Results (in, thousands):

• Revenue: For the three months ended September 30, 2018, Titan reported approximately $1.7 million in revenue, compared with approximately $40,000 in the same period in 2017. Revenues for the third quarter of 2018 reflect approximately $0.2 million in product sales, approximately $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 approximately $1.1 million related to the amendment to the Molteni Purchase Agreement in August 2018.
• Profitability: Net loss applicable to common shareholders in the third quarter of 2018 was approximately $2.3 million, or approximately $0.11 per share, compared with a net loss applicable to common shareholders of approximately $4.2 million, or approximately $0.20 per share, in the same quarter in 2017.
• Comfortable Liquidity and financial flexibility: In September 2018, TTNP closed a previously announced underwritten public offering, which provided net proceeds of $8.5 million. At the end of the third quarter, the company had cash and cash equivalents of $8.4 million. Management believes that this combined with $4.6 million received from the sale of shares as a result of the underwriters exercise of the remaining overallotment option and the recent exercises of outstanding warrants is sufficient to fund its planned operations through the third quarter of 2019.

Key risk factors and potential stock drivers:

• Successful commercialization of Probuphine would lead future direction for the company. Any adversities related to this might adversely impact the overall investor sentiments.
• TTNP is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it. 
• The company is offering several new convertible securities, which would have the potential dilution risk for the existing shareholders.
• TTNP has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor. 

Stock Performance

Comments:

• On Friday, February 1, 2019, TTNP is trading at $1.91 + 56.07%, with a robust average volume of 3.7 million shares exchanging hands. Market capitalization is $24.905 million. The current RSI is 65.51
• At $1.91, shares of TTNP are trading above its 50-day moving average (MA) at $1.59 and below its 200-day moving average (MA) at $3.60

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