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About Theravance Biopharma, Inc.
Theravance Biopharma, Inc. (NASDAQ: TBPH) is a diversified biopharmaceutical company dedicated to discovering, developing, and commercializing organ-selective medicines designed to address unmet medical needs. The company's innovative approach focuses on leveraging its expertise in organ-selective pharmacology to develop therapies that maximize efficacy while minimizing systemic side effects. With a strong emphasis on respiratory and autonomic nervous system disorders, Theravance aims to improve the quality of life for patients suffering from chronic and rare diseases.
Core Products and Pipeline
Theravance Biopharma's portfolio includes both FDA-approved products and a robust pipeline of investigational therapies:
- YUPELRI® (revefenacin): The first and only once-daily, nebulized long-acting muscarinic antagonist (LAMA) approved in the U.S. for the maintenance treatment of chronic obstructive pulmonary disease (COPD). YUPELRI addresses the needs of COPD patients who require consistent and durable bronchodilation.
- Ampreloxetine: A late-stage investigational norepinephrine reuptake inhibitor developed for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). This therapy has received Orphan Drug Designation in the U.S. and is currently undergoing Phase 3 clinical trials.
- VIBATIV® (telavancin): An approved antibiotic for treating serious bacterial infections, discovered and developed internally by Theravance.
In addition to its proprietary products, Theravance has strategic collaborations with pharmaceutical companies to expand the reach and impact of its therapies. For example, its partnership with Viatris supports the commercialization of YUPELRI in the U.S.
Innovative Approach to Drug Development
Theravance Biopharma's research and development efforts are rooted in its organ-selective expertise. By targeting disease pathways at the site of action, the company aims to enhance the therapeutic index of its medicines. This approach is particularly evident in its lung-selective therapies for respiratory diseases and its investigational treatments for autonomic nervous system disorders.
Market Position and Competitive Landscape
Operating within the highly competitive biopharmaceutical industry, Theravance faces challenges such as regulatory scrutiny, patent litigation, and market competition. However, its focus on organ-selective therapies and its ability to secure strategic collaborations position it as a key player in its niche markets. The company's commitment to addressing complex medical conditions, such as COPD and nOH, differentiates it from competitors and underscores its value proposition.
Challenges and Opportunities
Theravance Biopharma navigates a complex landscape of challenges, including the need for continued clinical validation of its investigational therapies and the financial demands of drug development. However, its diversified portfolio, strategic partnerships, and focus on high-impact therapeutic areas provide significant growth opportunities. The company's ability to innovate and adapt to market dynamics will be critical to its long-term success.
Conclusion
Theravance Biopharma, Inc. exemplifies innovation in the biopharmaceutical industry, with a mission to deliver "Medicines that Make a Difference®." Through its organ-selective approach, the company addresses critical medical needs while striving to improve patient outcomes. With FDA-approved products like YUPELRI and a promising pipeline, Theravance continues to advance its vision of pioneering the next generation of small-molecule therapies.
Theravance Biopharma (NASDAQ: TBPH) announced significant strategic actions aimed at enhancing shareholder value, including a 75% workforce reduction, affecting around 270 positions, with expected completion by February 2022. The company anticipates annualized operating expense savings of approximately $165 million in 2022. Updated financial guidance projects R&D expenses to drop from $195-225 million in 2021 to $55-65 million in 2022, while SG&A expenses are expected to reduce to $30-40 million. The firm plans to focus on its respiratory therapeutic portfolio, notably YUPELRI and TRELEGY, aiming for positive cash flow in the second half of 2022.
Theravance Biopharma (NASDAQ: TBPH) announced that its Phase 3 study of ampreloxetine for treating symptomatic neurogenic orthostatic hypotension (nOH) did not meet the primary endpoint. While mild to moderate adverse events were reported, no serious side effects were attributed to the drug. The company plans to analyze the findings further and present results at a future scientific forum. CEO Rick E Winningham expressed disappointment, highlighting the unmet need for effective treatments for nOH.
Theravance Biopharma (NASDAQ: TBPH) announced disappointing top-line results from its Phase 2b induction study of izencitinib for ulcerative colitis. The study failed to meet its primary endpoint of change in total Mayo score and the secondary endpoint of clinical remission at week 8 compared to placebo. However, izencitinib was well-tolerated, showing similar adverse event rates to placebo. The company plans to further analyze the study data and upcoming results from ongoing studies, including a Crohn's Phase 2 study expected in early 2022.
Theravance Biopharma reported its Q2 2021 financial results, highlighting a total revenue of $12.9 million, a decrease of $2.1 million year-over-year. Revenue from YUPELRI collaboration with Viatris was $10.9 million, translating to a 35% share of net sales. R&D expenses reduced to $51.1 million, while SG&A expenses rose to $25.9 million. The company closed a public offering raising $115.6 million and anticipates key clinical results for its products in upcoming quarters. Cash position remains strong at $265 million.
Theravance Biopharma (NASDAQ: TBPH) will report its Q2 2021 financial results and provide a business update on August 3, 2021, after market close. A conference call will follow at 5:00 p.m. ET. The company focuses on organ-selective medicines for inflammation and immunology, aiming to enhance therapeutic effectiveness while minimizing side effects. They leverage expertise in developing lung-selective medicines, including FDA-approved YUPELRI for COPD. For more details, visit www.theravance.com.
Theravance Biopharma (NASDAQ: TBPH) has announced the pricing of its public offering of 6.7 million ordinary shares at $15.00 per share, aiming to raise approximately $100.5 million. The offering is set to close on June 29, 2021, subject to customary closing conditions. Additionally, underwriters have a 30-day option to purchase up to 1,005,000 additional shares. The offering is led by SVB Leerink and Evercore ISI. Theravance Biopharma has filed the necessary registration with the SEC and will publish a final prospectus supplement shortly.
Theravance Biopharma (NASDAQ: TBPH) announced a proposed public offering of its ordinary shares, which includes a 30-day underwriters' option for an additional 15% of shares. The offering is contingent upon market conditions. Proceeds will primarily fund the development of ampreloxetine for neurogenic orthostatic hypotension and izencitinib for ulcerative colitis and Crohn's disease. Remaining funds will support other clinical initiatives and working capital. The offering is subject to customary closing conditions, and no assurance can be given regarding its completion.
Theravance Biopharma (NASDAQ: TBPH) announced top-line results from its Phase 2 study of 3 mg once-daily nezulcitinib for hospitalized COVID-19 patients. Despite not meeting the primary endpoint, the trial showed a favorable trend in 28-day all-cause mortality (6 deaths in nezulcitinib group vs. 13 in placebo, HR: 0.42, p=0.08). The trial involved 210 patients and demonstrated good tolerability with lower adverse events compared to the placebo. The company plans to consult with regulatory agencies on further study protocols.
Theravance Biopharma, listed on NASDAQ as TBPH, will participate in the Bank of America 2021 Healthcare Conference on May 13 at 2:45 p.m. ET. CEO Rick E Winningham will present during the event, which can be accessed via a webcast on the company's website. The presentation will focus on the company's mission to develop organ-selective medicines aimed at improving patient outcomes in serious illnesses, particularly in inflammation and immunology.
Theravance Biopharma (TBPH) reported Q1 2021 total revenue of $14.3 million, a decrease of $5.6 million YOY, attributed mainly to collaboration revenue from Viatris. While YUPELRI's market share grew to 19%, overall net sales faced a slight decline. R&D expenses increased to $67.6 million, leading to an operating loss of $83.9 million. The company anticipates full-year R&D expenses between $195 million and $225 million. Notable upcoming clinical milestones include results for nezulcitinib and izencitinib trials expected in Q2 and Q3 2021.
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