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Theravance Biopharma, Inc. (NASDAQ: TBPH) is a leading biopharmaceutical company focused on the discovery, development, and commercialization of organ-selective medicines. The company's mission is to pioneer a new generation of small-molecule drugs that better meet patient needs by maximizing efficacy while limiting systemic side effects.
Theravance Biopharma has a strong focus on inflammation and immunology and aims to deliver Medicines that Make a Difference® in people's lives. The company's research expertise has led to the development of the FDA-approved YUPELRI® (revefenacin) inhalation solution, the first once-daily, nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Theravance Biopharma co-promotes YUPELRI with Viatris Inc. under a profit and loss sharing arrangement.
Another promising product in Theravance Biopharma's pipeline is ampreloxetine, a late-stage investigational norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). This drug has the potential to be a first-in-class therapy, addressing a significant unmet medical need for MSA patients.
The company is also involved in strategic collaborations with other pharmaceutical companies to expand its reach and enhance its product pipeline. Their current projects and partnerships are aimed at furthering the development and commercialization of innovative therapies.
Financially, Theravance Biopharma has shown consistent performance, with significant growth in YUPELRI net sales and robust clinical trial activity. Recent achievements include positive results from a Phase III clinical trial of YUPELRI in China and ongoing enrollment in the Phase 3 CYPRESS study for ampreloxetine. These milestones underscore the company's commitment to delivering impactful therapies and driving shareholder value.
Theravance Biopharma continues to leverage its organ-selective drug development expertise to create value and improve patient outcomes. For more information, please visit www.theravance.com.
Theravance Biopharma (TBPH) will announce its fourth quarter and full-year 2022 financial results on February 27, 2023, after market close. A conference call and webcast are scheduled for 5:00 PM ET on the same day, allowing investors to gain insights into the company's performance. Interested parties can participate by pre-registering online. The company is known for its FDA-approved drug, YUPELRI, aimed at treating COPD and continues to focus on developing new therapies for unmet medical needs.
Theravance Biopharma (NASDAQ: TBPH) will participate in a Fireside Chat at the SVB Securities Global Biopharma Conference on February 15, 2023, at 8:00 am ET. The event can be accessed via a webcast on Theravance.com in the Investors section. A replay will be available for 30 days post-event. Theravance Biopharma is committed to delivering Medicines that Make a Difference and is known for its FDA-approved YUPELRI® inhalation solution for COPD. The company focuses on addressing significant unmet patient needs through its innovative pipeline.
Theravance Biopharma (TBPH) announced significant 2022 achievements and 2023 objectives. Key highlights include strategic advances in YUPELRI sales growth, with all-time high net sales reported in Q2 and Q3. The company initiated the Phase 3 CYPRESS study for ampreloxetine in patients with symptomatic neurogenic orthostatic hypotension (nOH) planned for Q1 2023, alongside a $250 million capital return program. With FDA discussions and a $1.1 billion royalty sale, Theravance aims for Non-GAAP profitability by 2H 2023, reinforcing its commitment to delivering impactful medicines.
On November 22, 2022, Theravance Biopharma (NASDAQ: TBPH) announced the final results of its Dutch auction tender offer, which aimed to purchase up to $95 million of its ordinary shares. The offer expired on November 17, 2022, with a total of 115,967 shares tendered and accepted at $10.50 each, totaling approximately $1.2 million. This amount represents about 0.2% of the shares outstanding. The company plans to use the unused funds for an open market share repurchase program expected to commence after the tender offer's completion.
Theravance Biopharma (NASDAQ: TBPH) announced the preliminary results of its Dutch auction tender offer, intending to purchase up to $95 million of ordinary shares. The offer expired on November 17, 2022, with 115,967 Shares tendered. The company plans to purchase these shares at $10.50 each, totaling approximately $1.2 million. This represents about 0.2% of the total shares outstanding. Additionally, the unused portion of the offer will fund an open market share repurchase plan expected to begin after the tender offer concludes.
Theravance Biopharma (NASDAQ: TBPH) reported a record quarter for YUPELRI® (revefenacin) with Q3 2022 net sales reaching $18.7 million, a 35% increase year-over-year. The company completed a significant transaction selling TRELEGY ELLIPTA royalty rights to Royalty Pharma for $1.1 billion in upfront cash and potential milestones. With a strong cash position of $487 million, Theravance is debt-free and initiated a $250 million capital return program. R&D expenses decreased significantly to $9.9 million, while total revenue for Q3 was $12.5 million.
Theravance Biopharma (NASDAQ: TBPH) announced promising Phase 3 results for its investigational drug, Ampreloxetine, targeting neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). Data presented at the 33rd International Symposium on the Autonomic Nervous System shows significant symptom improvement across multiple scales compared to placebo. Ampreloxetine demonstrated a similar safety profile to placebo, with no significant adverse effects. The company plans to initiate a new registrational Phase 3 study in early 2023, aiming to file for NDA with the FDA.
Theravance Biopharma, Inc. (NASDAQ: TBPH) will announce its third quarter 2022 financial results and provide a business update after market close on November 7, 2022. A conference call and webcast will follow at 5:00 pm ET. The company focuses on delivering Medicines that Make a Difference and has developed the FDA-approved YUPELRI inhalation solution for COPD patients. Investors can listen to the live call via Theravance's website and access a replay for 30 days post-event.
Theravance Biopharma (NASDAQ: TBPH) announced new data on ampreloxetine for neurogenic orthostatic hypotension (nOH) to be presented at the 33rd International Symposium on the Autonomic Nervous System, scheduled for November 2-5, 2022, in Maui, Hawaii. The data includes three presentations on November 2, covering a Phase 3 study and the drug's effects on patients with multiple system atrophy (MSA). Ampreloxetine is a norepinephrine reuptake inhibitor aimed at alleviating nOH symptoms, which affect a significant percentage of MSA patients.
Theravance Biopharma (NASDAQ: TBPH) announced a $95 million modified Dutch auction tender offer to repurchase its ordinary shares. The company will buy shares at prices between $9.75 and $10.50 each through November 10, 2022. As of September 27, 2022, there are 67,365,912 shares outstanding. If fully subscribed, the offer could buy approximately 13.4% to 14.5% of outstanding shares. The offer is not contingent on a minimum number of shares being tendered, and will be funded using cash on hand.