Devastated and Resurrected Good Biotech Firms: Theravance Biopharma

The Market Devastation and Resurrection of Good Biotech Firms

Due to the market’s instability that we have been experiencing for a while now, we decided to look back at some biotech firms whose values tumbled and stocks tanked as a result of both internal and external bad circumstances and other reasons. The decision to retackle these firms is in our conviction that they will rebound and reach higher values than those we expected when their stocks were flying high. These biotech firms’ resurrection is new to us. Our latest  examples are Celldex Therapeutics (CLDX) and IVERIC bio (ISEE) – both had tumbled and were buried in the Prohost Portfolio Table #7, the Aggressive Portfolio.

Following their resurrection, these two firms were moved to the Prohost Portfolio Table #2.   

Our list includes many stocks, which we will discuss in our forthcoming, continuing series of seven Comprehensive Prohost Letter Issues.

We believe that these Comprehensive Issues will serve our readers as support in their biotech investment decisions.  

The first firm we will tackle from this group of the devastated firms is Theravance Biopharma. 

Theravance Biopharma

Theravance Biopharma (TBPH) focuses on respiratory medicines. The firm’s target is creating  products that improve the lives of patients suffering from respiratory illness.

The firm leverages decades of respiratory expertise to discover and develop transformational medicines that make a difference. Theravance’s products are already making a big difference in the treatment of chronic obstructive pulmonary disease (COPD) and Asthma.

Theravance product YUPELRI® (revefenacin) inhalation solution was created as a maintenance treatment of patients with COPD. The product has been FDA approved and marketed.

YUPELRI® (revefenacin) is the first and only once-daily, nebulized bronchodilator approved in the U.S. for the maintenance treatment of patients with COPD. The firm continued to increase its share of the long-acting nebulized COPD market, increasing to 21% in April 2021, up from 19% in January 2021, and net sales increased by 38% year-over-year (Q2 2020 vs. Q2 2021).

The Company, in collaboration with its partner Viatris, was studied in a Phase 4 trial comparing improvements in the lung function in adults with severe lung COPD. It is also initiating to very severe COPD and suboptimal inspiratory flow rate following once-daily treatment with either YUPELRI® (revefenacin) delivered via standard jet nebulizer or tiotropium delivered via a dry powder inhaler (Spiriva®HandiHaler®).

This study helps physicians to make better decisions when they are designing a personalized COPD treatment plan with patients.

Theravance inhaled product TRELEGY is also approved.

  • TRELEGY is unique in its composition and in its use. It is the first and only once-daily, 3-in-1 treatment for COPD. With 3 medicines in 1 inhaler, Trelegy can help breathe easier and help improve lung function. It can also help prevent future flare-ups.
  • TRELEGY does not replace a rescue inhaler.
  • The product is used once in 24 hours. It is currently approved for adults with COPD and with Asthma. Treating COPD means also treating chronic bronchitis, emphysema, or both, in addition to asthma in adults.
  • TRELEGY 100/62.5/25 mcg is the only strength approved for COPD.
  • TRELEGY is not used to relieve sudden breathing problems
  • TRELEGY should not be used in children younger than 18 years of age.
  • TRELEGY posted second quarter 2021 global net sales of $405 million (up from $241 million, 68%, in the second quarter of 2020); Theravance Biopharma is entitled to tiered payments equal to approximately 5.5% to 8.5% of TRELEGY global net sales.3
  • TRELEGY Q3 2021 global net sales: $449 million, up 77% from Q3 2020[2]

Other Theravance Biopharma Clinical Milestones

Q3 2021: Izencitinib (gut-selective oral pan-Janus kinase (JAK) inhibitor for inflammatory intestinal diseases) Phase 2b in ulcerative colitis (study 0157) 

Q3 2021: Ampreloxetine (norepinephrine reuptake inhibitor) Phase 3 for symptomatic neurogenic orthostatic hypotension (study 0169).   

Q4 2021/Q1 2022: Izencitinib (gut-selective oral pan-JAK inhibitor for inflammatory intestinal diseases) Phase 2 in Crohn’s disease (study 0173) – top-line results expected in late Q4 2021or early Q1 2022. 

Nezulcitinib – an investigational, inhaled, lung-selective, pan-JAK inhibitor in development for hospitalized patients with COVID-19, reported Phase 2 top-line results

Ampreloxetine – an investigational, Theravance Biopharma-discovered, potent, long-acting, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH), reported Phase 3 top-line results (Study 0169 – read more about the data here).

Cash Position: Cash, equivalents and marketable securities totaled $216.2 million as of September 30, 2021.

Prohost Observations

We think the time has come for TBPH to rally. 

We obviously have interest in Celldex and IVERIC bio as well.

Click here to read more about Theravance Biopharma.

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