Latest news with #TheravanceBiopharma
Yahoo
6 days ago
- Business
- Yahoo
Theravance Biopharma Inc (TBPH) Q2 2025 Earnings Call Highlights: Strong Sales and Strategic ...
Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Theravance Biopharma Inc (NASDAQ:TBPH) reported a strong quarter with net sales reaching approximately $66 million, driven by demand growth and favorable pricing. The company completed a $225 million sale of its remaining royalty interests in Trilogy to GSK, significantly strengthening its balance sheet. The phase 3 Cypress trial for amproloxetine is progressing well, with enrollment nearing completion and top-line data expected in six months. Theravance Biopharma Inc (NASDAQ:TBPH) ended the quarter with approximately $340 million in cash and no debt, maintaining a strong financial position. The company is on track to achieve significant milestones, including a potential $150 million from royalty Pharma over the next 18 months. Negative Points The company did not provide guidance on the formal launch timing for Upellry in China, as Beatrice is still finalizing the commercialization plan. There is uncertainty regarding the pricing strategy for amproloxetine, as it is still early to determine a specific price point. The company faces challenges in ensuring proper education for clinicians to make the best decisions for patient needs, particularly in specialty pharmacy channels. Theravance Biopharma Inc (NASDAQ:TBPH) expects to pay approximately $27 million in taxes related to the Trilogy royalty sale in the second half of the year. There is potential for pushback on amproloxetine pricing and reimbursement, given the presence of generics with less efficacy and clear side effects. Q & A Highlights Warning! GuruFocus has detected 7 Warning Signs with TBPH. Q: What factors contributed to the improved pull-through performance for Upellary this quarter? A: Rhonda Farnham, Chief Business Officer, explained that the improved pull-through was driven by the transition of volume to specialty pharmacy, which enhances pricing and persistency. The support patients receive in this channel improves fulfillment and persistency compared to conventional retail pharmacy. The company remains focused on providing options that best meet individual patient needs while educating clinicians to make informed decisions. Q: Can you provide an update on the outlook for Upellary's growth in China and the Cyprus trial enrollment? A: Rhonda Farnham stated that Beatrice is leading the commercialization efforts in China, and further details will be shared once their market plan is unveiled. Anya Miller, Head of Development, noted that the Cyprus trial's US versus ex-US enrollment is expected to mirror previous studies, with all data to be disclosed at the topline readout. A press release will be issued upon full enrollment of the open-label portion. Q: How is Theravance Biopharma approaching the pricing strategy for amproloxetine, and what are the considerations for reimbursement in the US? A: Rhonda Farnham mentioned that while it's early to finalize pricing, an analysis of recent rare neuro drug launches suggests an average price of approximately $380,000 per year. The company is actively engaging with payers to highlight the unmet need and the potential benefits of amproloxetine, focusing on its safety profile and durability of effect. Q: What are the expectations for SG&A expenses related to amproloxetine's commercialization, and how might they change post-data readout? A: Aziz Sala, Chief Financial Officer, indicated that SG&A expenses are expected to remain stable through the year, with some pre-launch activities already underway. Post-data readout, if positive, there will be an increase in SG&A spend, but it will be targeted and not excessively large, focusing on supporting the launch and marketing efforts. Q: Can you elaborate on the operating leverage observed in the collaboration revenue growth compared to Upellary's net sales increase? A: Aziz Sala explained that the collaboration revenue growth outpaced net sales growth due to cost reimbursements between the companies. While this quarter showed a significant gap, future quarters may not see the same level of disparity. However, profit margins are expected to continue improving as net sales grow. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
17-07-2025
- Business
- Yahoo
Zacks Industry Outlook Highlights Catalyst Pharmaceuticals, Zevra Therapeutics, Theravance Biopharma, Aldeyra Therapeutics and Larimar Therapeutics
For Immediate Release Chicago, IL – July 17, 2025 – Today, Zacks Equity Research discusses Catalyst Pharmaceuticals CPRX, Zevra Therapeutics ZVRA, Theravance Biopharma TBPH, Aldeyra Therapeutics ALDX and Larimar Therapeutics LRMR. Industry: Small Drugs Link: The uncertainty around tariffs and trade production measures has muted economic growth. President Trump has once again threatened to impose heavy tariffs, as high as 200%, on pharmaceutical imports. Trump's repeated threats to impose tariffs on pharmaceutical imports are aimed at encouraging American pharmaceutical companies to shift their production back to the United States, primarily from European and Asian countries. Trump has said that drugmakers have about one to one and a half years to bring production back to the United States before the new tariffs are imposed. However, despite the threat of a 200% tariff, the biotech sector remained stable. The delay brings relief for the sector. Moreover, most global pharma companies have already committed to investing in boosting domestic manufacturing. Amid the tariff headwinds, the Zacks Medical-Drugs industry is showing promising trends backed by positive pipeline and regulatory developments. Innovation is at its peak with key spaces like rare diseases, next-generation oncology treatments, obesity, immunology and neuroscience attracting investor attention. M&A activity also remains healthy. These factors should continue to drive stocks like Catalyst Pharmaceuticals, Zevra Therapeutics, Theravance Biopharma, Aldeyra Therapeutics and Larimar Therapeutics. Industry Description The Zacks Medical-Drugs industry comprises small and some medium-sized drug companies that make medicines for both human and veterinary use. We have a separate industry outlook discussion on big drugmakers. Small drugmakers have a limited portfolio of marketed drugs or no commercial-stage drugs at all. Some drugmakers are dependent on just one marketed drug or pipeline candidate. For such companies, upfront or milestone payments from collaboration partners — in most cases, their larger counterparts — are the main sources of revenues. These companies need ample free cash flow to fund their R&D activities. Factors Shaping the Future of the Medical-Drugs Industry The success or failure of key pipeline candidates in clinical studies can significantly drive the stock price of industry players. Successful innovation and product line extensions in important therapeutic areas and strong clinical study results may act as important catalysts for the stocks. These companies regularly seek external partners and collaborators for complementary strengths. A partnership deal with a popular drugmaker is a good sign about the potential of small pharma companies, especially when an equity investment is included in the deal. M&A deals are in full swing in the sector, signaling growth. For smaller companies, succeeding in a shifting global market and evolving healthcare landscape requires adopting innovative business models, investing in new technologies and increasing investments in personalized medicines. Over the past few years, scientific and technological advancements have made it possible to develop personalized therapies. Other than that, adoption and information exchange through the meaningful use of health IT, development of therapies that improve overall patient outcomes and investment in developing and emerging markets are some of the key priorities for drug companies. Artificial intelligence and machine learning techniques are being used for the rapid advancement of drug discovery and target identification processes. The smaller companies have their share of risk in the form of unstable cash flows. Also, the failure of key pipeline candidates in pivotal studies and regulatory and pipeline delays can be huge setbacks for these smaller companies and significantly hurt their share prices. Zacks Industry Rank Indicates Bright Prospects The group's Zacks Industry Rank is basically the average of the Zacks Rank of all the member stocks. The Zacks Medical-Drugs industry currently carries a Zacks Industry Rank #96, which places it in the top 39% of the 245 Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Before we present you with a few top-ranked stocks to capitalize on the thriving prospects of the small and medium-sized drugmakers' space, let's take a look at the industry's recent stock-market performance and the valuation picture. Industry Versus S&P 500 and Sector The Zacks Medical-Drugs industry is a huge 155-stock group within the broader Medical sector. The industry has outperformed the Zacks Medical sector while slightly underperforming the S&P 500 so far this year. Stocks in this industry have collectively risen 5.6% year to date against the Zacks Medical sector's decrease of 2.9%. The Zacks S&P 500 composite has risen 6.9% in the said time frame. Industry's Current Valuation Based on the trailing 12 months price-to-sales ratio (P/S TTM), which is a commonly used multiple for valuing these small drugmakers, the industry is currently trading at 2.32, compared with the S&P 500's 5.66 and the Zacks Medical sector's 2.37. Over the last five years, the industry has traded as high as 3.56, as low as 1.93 and at the median of 2.42, as the chart below shows. 5 Drug Stocks to Bet On Catalyst Pharmaceuticals: Coral Gables, FL-based Catalyst Pharmaceuticals' lead drug is Firdapse, which is approved for treating Lambert-Eaton Myasthenic Syndrome (LEMS), an ultra-rare disease. The drug has been witnessing strong demand driven by increasing prescription rates and new patient starts. In January 2025, Catalyst settled Firdapse patent litigation with Teva, protecting the drug's exclusivity in the United States till Feb. 25, 2035. Agamree, its newest acquired muscle disorder drug, was launched in the U.S. market in 2024. With Agamree's approval and launch, Catalyst has further diversified its commercial portfolio. The stock of Catalyst Pharmaceuticals has risen 0.4% so far this year. The consensus estimate for 2025 earnings has risen from $2.23 per share to $2.25 per share over the past 60 days. The company has a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Theravance Biopharma: Cayman Islands-based Theravance Biopharma generates revenues in the United States from its collaboration with Viatris related to the sales of Yupelri, a nebulized therapy for chronic obstructive pulmonary disease. The product has been witnessing a strong sales uptake owing to increased customer demand, resulting in increased collaboration revenues for Theravance. The company's ongoing restructuring initiatives are saving costs. Theravance is currently focusing on developing its pipeline candidate, ampreloxetine, a norepinephrine reuptake inhibitor for the treatment of symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy in the phase III CYPRESS study. The CYPRESS study is expected to complete patient enrollment by late summer of 2025. Top-line data from the same is expected six months after enrollment is completed. The stock of Theravance Biopharma has risen 22.6% so far this year. The consensus estimate for 2025 earnings has declined from 3 cents per share to 1 cent per share over the past 60 days. The company has a Zacks Rank #2. Larimar Therapeutics: CA-based Larimar Therapeutics is a clinical-stage company making medicines for rare diseases. Its lead pipeline candidate is nomlabofusp (CTI-1601), being developed as a potential treatment for Friedreich's ataxia (FA). Larimar Therapeutics plans to file a biologics license application seeking accelerated approval of nomlabofusp for FA in the second quarter of 2026. Larimar plans to expand the nomlabofusp clinical program to patients around the world with the initiation of a global phase III study. The company believes that nomlabofusp has the potential to be the first frataxin protein replacement therapy for patients with FA. The stock of Larimar Therapeutics has declined 18.3% so far this year. The consensus estimate for 2025 loss has narrowed from $1.90 per share to $1.89 per share over the past 60 days. The company has a Zacks Rank #2. Zevra Therapeutics: Early adoption of ZVRA's newly approved Miplyffa capsules for treating Niemann-Pick disease type C (NPC) has exceeded the company's expectations. Miplyffa was approved by the FDA in September 2024 as the first treatment for this ultra-rare disease. Zevra plans to file a regulatory application seeking approval of Miplyffa capsules in the EU in the second half of 2025. In April 2025, Zevra sold its Pediatric Rare Disease Priority Review Voucher ("PRV") for gross proceeds of $150 million, which has strengthened its cash position. The stock of Zevra Therapeutics has risen 53.4% so far this year. The earnings estimate for 2025 has risen from 31 cents per share to 76 cents per share over the past 60 days. The company has a Zacks Rank #2. Aldeyra Therapeutics: Burlington, MA-based Aldeyra Therapeutics is a leader in the development of RASP (reactive aldehyde species) modulators for the treatment of immune-mediated disease. Its late-stage pipeline candidates are reproxalap, a RASP modulator for the treatment of signs and symptoms of dry eye disease, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of retinitis pigmentosa. In June, Aldeyra Therapeutics resubmitted a new drug application (NDA) to the FDA for reproxalap, including data from the Dry Eye Chamber study, which achieved the primary endpoint. The FDA had earlier issued a complete response letter to Aldeyra's NDA for reproxala in April, requiring the company to conduct an additional symptom study for resubmission. Its other product candidates include RASP (reactive aldehyde species) modulators ADX-629, ADX-248, ADX-743 and ADX-631. The stock of Aldeyra Therapeutics has declined 0.4% so far this year. The consensus estimate for 2025 loss has narrowed from $1.03 per share to 90 cents per share over the past 60 days. The company has a Zacks Rank #2. Research Chief Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. This company targets millennial and Gen Z audiences, generating nearly $1 billion in revenue last quarter alone. A recent pullback makes now an ideal time to jump aboard. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months. Free: See Our Top Stock And 4 Runners Up Join us on Facebook: Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates. Media Contact Zacks Investment Research 800-767-3771 ext. 9339 support@ Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit for information about the performance numbers displayed in this press release. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Catalyst Pharmaceuticals, Inc. (CPRX) : Free Stock Analysis Report Theravance Biopharma, Inc. (TBPH) : Free Stock Analysis Report Aldeyra Therapeutics, Inc. (ALDX) : Free Stock Analysis Report Larimar Therapeutics, Inc. (LRMR) : Free Stock Analysis Report Zevra Therapeutics, Inc. (ZVRA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Business Insider
27-06-2025
- Business
- Business Insider
BTIG Sticks to Their Buy Rating for Theravance Biopharma (TBPH)
In a report released today, Julian Harrison from BTIG maintained a Buy rating on Theravance Biopharma (TBPH – Research Report), with a price target of $25.00. The company's shares closed today at $10.73. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter According to TipRanks, Harrison is a 4-star analyst with an average return of 4.1% and a 43.80% success rate. Harrison covers the Healthcare sector, focusing on stocks such as Liquidia Technologies, Theravance Biopharma, and Tvardi Therapeutics. Currently, the analyst consensus on Theravance Biopharma is a Moderate Buy with an average price target of $18.75, which is a 74.74% upside from current levels. In a report released today, JonesTrading also reiterated a Buy rating on the stock with a $24.00 price target.
Yahoo
13-05-2025
- Business
- Yahoo
Theravance Biopharma to Participate in an Upcoming Investor Conference
DUBLIN, May 13, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will participate in a Fireside Chat at the H.C. Wainwright 3rd Annual BioConnect Investor Conference in New York City at NASDAQ Tuesday, May 20 at 10:30 AM EDT (7:30 AM PDT / 3:30 PM IST) and will be hosting in-person meetings with the investment community at the conference. A webcast of the event may be accessed by visiting under the Investors section, Events and Presentations. A replay of the webcast will be archived on the Company's website for 30 days. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: View original content to download multimedia: SOURCE Theravance Biopharma, Inc.
