TFF Pharmaceuticals, Inc.

TFFP Details

TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) is an early-stage biopharmaceutical business focusing on developing and commercializing novel therapeutic solutions for the treatment of pulmonary disorders through the utilization of its patented Thin Film Freezing (TFF) technology platform. Voriconazole Inhalation Powder (TFF VORI) and Tacrolimus Inhalation Powder (TFF TAC) are the company's key product candidates. TFFP does not presently have a commercial product, but it is advancing its ideas with current partners and developing new license agreements with big pharmaceutical companies.

Latest News:

• Powerful Collaborations: On March 17, 2022, TFFP announced the signing of a Cooperative Research and Development Agreement (CRADA) with the US Army Medical Research Institute of Infectious Diseases (USAMRIID), a component of the US Army Medical Research and Development Command and the US Army's premier institution and facility for defensive research into countermeasures against biological warfare, and The Geneva Foundation, a non-profit that promotes innovative medical research in the United States.

• Strategic Partnership: On March 01, 2022, TFFP and Catalent, a global leader in enabling pharma, biotech, and consumer health partners, signed a collaboration agreement centered on developing, testing, and manufacturing dry powder formulations. Catalent will offer TFFP's revolutionary Thin Film Freezing technology to complement its spray-drying capabilities for dry powder inhalation under the terms of the partnership.

9MFY21 Results:

• Grant Revenues: TFFP has reported nil commercial operations as of now. During 9MFY21, however, it had a grant revenue of USD 76.17 thousand (ended September 30, 2021).
• Increase in Net Losses: Net losses increased to USD 20.99 million in 9MFY21 compared to USD 12.67 million in 9MFY20.
• Decent Balance Sheet: The company had USD 44.72 million in cash and cash equivalents as of September 30, 2021, with no outstanding debt.

Key Risks:

• Regulatory Risk: The success of the three TFF product candidates is critical to the future expansion of TFFP. It has made significant investments in the development of medications. As a result, if it cannot secure marketing authorization or establish an efficient manufacturing and distribution network, its operations may suffer.

Outlook:

• FY22 Outlook: According to the Q3FY21 press release from TFFP, the Phase 2 studies for inhaled voriconazole and inhalation tacrolimus powder will begin with an interim data analysis, with datasets scheduled to be completed by mid-2022. It will start looking for license partners in Q1FY22 in order to finally commercialize its assets. The firm intends to have made significant progress toward developing its Phase 2 clinical trial of inhaled tacrolimus powder by the end of FY21.

Valuation Methodology: EV/Sales Multiple Based Relative Valuation

 (Analysis by Kalkine Group)

* % Premium/(Discount) is based on our assessment of the company's NTM trading multiple after considering its key growth drivers, economic moat, stock's historical trading multiples versus peer average/median, and investment risks.

Stock Recommendation:

TFFP's share price has remained on a bearish trend, fallen 57.50% in the past twelve months and is currently leaning towards the lower end of its 52-week range of USD 5.09 to USD 17.45. We have valued the stock using the EV/Sales-based relative valuation methodology and arrived at a target price of USD 8.00.

Considering the significant correction in the stock price in the past twelve months, debt-free company, strong product pipeline, recent collaborations, current valuation, and associated risks, we recommend a "Speculative Buy" rating on the stock at the current price of USD 6.60, up 2.17% as of March 18, 2022, at 12:23 PM ET.

Three-Year Technical Price Chart (as on March 18, 2022, at 12:23 PM ET). Source: REFINITIV, Analysis by Kalkine Group

Technical Analysis Summary:

Technical Indicators Defined: -

Support: A level where-in the stock prices tend to find support if they are falling, and downtrend may take a pause backed by demand or buying interest.

Resistance: A level where-in the stock prices tend to find resistance when they are rising, and uptrend may take a pause due to profit booking or selling interest.

Stop-loss: It is a level to protect further losses in case of unfavourable movement in the stock prices.

Note 1: The reference data in this report has been partly sourced from REFINITIV.  

Note 2: Investment decision should be made depending on the investors’ appetite on upside potential, risks, holding duration, and any previous holdings. Investors can consider exiting from the stock if the Target Price mentioned as per the Valuation has been achieved and subject to the factors discussed above. 

Trevena, Inc.

TRVN Details

Trevena, Inc. (NASDAQ: TRVN) is a biopharmaceutical company focused on researching and marketing novel treatments for people suffering from CNS disorders. TRVN currently has only one approved medication, OLINVYK (oliceridine) injection, which is used to treat persons who have severe acute pain that requires an intravenous opioid analgesic and has failed earlier treatments. The company's other drugs in development include TRV027 for critical lung damage, TRV250 for migraines, TRV734 for chronic pain and opioid use disorder, and TRV045 for epilepsy.

Latest News:

• Submission of NDA: TRVN stated on January 27, 2022, that China's National Medical Products Administration (NMPA) had approved the submission of an NDA for Oliceridine injection. TRVN's partner, Jiangsu Nhwa Pharmaceutical, submitted the NDA after completing a Phase 3 bridging trial for OLINVYK (oliceridine) injection, a novel IV analgesic approved by the US Food and Drug Administration (USFDA) for use in adults for the management of acute pain severe enough to require an intravenous opioid analgesic.

Q3FY21 Results:

• Clocking Product Revenues: TRVN's total revenue for Q3FY21 (ended September 30, 2021) was USD 0.18 million, down from USD 3.0 million (only license revenues) in Q3FY20. However, no product revenue was reported in Q3FY20.
• Incurred Net Losses: TRVN's net loss increased to USD 13.77 million in Q3FY21, up from USD 5.55 million in Q3FY20.
• Strong Balance Sheet: The company had USD 78.65 million in cash and cash equivalents as of September 30, 2021, and total debt of USD 0.01 million.

Key Risks:

• Product Concentration Risk: TRVN's prospects are heavily reliant on the commercial success of its single approved medicine, OLINVYK. The commercialization of OLINVYK is contingent on physician prescription and patient acceptance; their unwillingness to prescribe/continue the treatment could jeopardize the company's financial performance.

Valuation Methodology: EV/Sales Multiple Based Relative Valuation

(Analysis by Kalkine Group)

* % Premium/(Discount) is based on our assessment of the company's NTM trading multiple after considering its key growth drivers, economic moat, stock's historical trading multiples versus peer average/median, and investment risks.

Stock Recommendation:

TRVN's share price has been on a bearish trend, fallen 63.08% in the past six months and is currently leaning towards the lower end of its 52-week range of USD 0.40 to USD 2.31. We have valued the stock using the EV/Sales-based relative valuation methodology and arrived at a target price of USD 0.63. At present levels, the company has an intriguing risk-reward ratio.

Considering the correction in the stock price in the past nine months, robust product pipeline, and associated risks, we recommend a "Speculative Buy" rating on the stock at the current price of USD 0.502, up 7.49% as of March 18, 2022, at 12:11 PM ET.

Three-Year Technical Price Chart (as of March 18, 2022, at 12:11 PM ET). Source: REFINITIV, Analysis by Kalkine Group

Technical Summary Analysis

Technical Indicators Defined: -

Support: A level where-in the stock prices tend to find support if they are falling, and downtrend may take a pause backed by demand or buying interest.

Resistance: A level where-in the stock prices tend to find resistance when they are rising, and uptrend may take a pause due to profit booking or selling interest.

Stop-loss: It is a level to protect further losses in case of unfavorable movement in the stock prices.

Note 1: The reference data in this report has been partly sourced from REFINITIV.  

Note 2: Investment decision should be made depending on the investors' appetite on upside potential, risks, holding duration, and any previous holdings. Investors can consider exiting from the stock if the Target Price mentioned as per the valuation has been achieved and subject to the factors discussed above. 

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