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Theravance Biopharma TBPH reported third-quarter 2024 adjusted net loss of 6 cents per share, narrower than the Zacks Consensus Estimate of a loss of 10 cents. In the year-ago quarter, the company had incurred an adjusted loss of 1 cent per share.
The reported loss excludes share-based compensation expense, non-cash impairment of long-lived assets, income tax expense and non-cash interest expense. Including these items, the company reported a loss of 26 cents per share in the third quarter compared with a loss of 17 cents in the year-ago quarter.
Total revenues came in at $16.9 million, beating the Zacks Consensus Estimate of $16 million. Revenues rose 8% year over year owing to increased collaboration revenues from partner Viatris VTRS.
Find the latest EPS estimates and surprises on Zacks Earnings Calendar.
TBPH’s Q3 Results in Detail
The top line fully comprised Viatris’ collaboration revenues in relation to Yupelri (revefenacin) sales. Theravance and Viatris have collaborated for the development and commercialization of Yupelri, which is approved in the United States for the maintenance treatment of patients with chronic obstructive pulmonary disease.
Viatris and Theravance share U.S. profits and losses received in connection with the commercialization of Yupelri. While Viatris gets 65% of the profits, Theravance receives 35%. Viatris collaboration revenues include Theravance’s 35% share of net sales of Yupelri, as well as its proportionate amount of the total shared costs incurred by the two companies.
VTRS recognizes product sales from Yupelri and also owns a stake in Theravance.
Shares of Theravance have plunged 20.7% year to date compared with the industry’s decline of 0.1%.
Research and development expenses (excluding share-based compensation) totaled $8.2 million, up almost 30% from the year-ago quarter’s level. Selling, general and administrative expenses (excluding share-based compensation) increased around 10% year over year to $13 million.
As of Sept. 30, 2024, Theravance had cash, cash equivalents and marketable securities worth $91.4 million compared with $96.1 million as of June 30, 2024.
TBPH Reiterates 2024 Financial Guidance
Theravance continues to expect adjusted R&D expenses (excluding share-based compensation) in the $30-$36 million range. Adjusted SG&A expenses (excluding share-based compensation) are projected between $45 million and $55 million.
TBPH continues to expect share-based compensation expenses of $18-$22 million in 2024.
TBPH expects the levels of both adjusted losses and cash burn in the second half of 2024 to be the same as in the first half of 2024.
TBPH’s Pipeline Updates
Theravance is developing an investigational candidate, ampreloxetine (TD-9855), a norepinephrine reuptake inhibitor for the treatment of neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The FDA has granted Orphan Drug designation to ampreloxetine for the given indication.
The company initiated the phase III CYPRESS study evaluating ampreloxetine for nOH MSA earlier in 2024. The CYPRESS study is expected to complete patient enrollment by mid-2025. Top-line data from the same is expected six months after enrollment is completed. TBPH plans to submit regulatory filings for ampreloxetine if the study data is found to be positive.
Theravance Biopharma, Inc. Price and Consensus
Theravance Biopharma, Inc. price-consensus-chart | Theravance Biopharma, Inc. Quote
Other Updates Regarding TBPH
With the purpose of maximizing shareholder value, Theravance announced the formation of a Strategic Review Committee, composed entirely of independent directors, to assess all strategic alternatives available to the company, including those related to Yupelri, ampreloxetine and Trelegy. However, the company has not provided any assurance that the strategic review process will result in any transaction. Further updates will be shared later.
In September 2024, Theravance and Viatris entered into a settlement agreement with Qilu Pharmaceutical regarding Yupelri. The settlement agreement resolves the ongoing patent litigation brought by TBPH and VTRS against Qilu after Qilu filed a regulatory application seeking approval to market a generic version of Yupelri in the United States, infringing upon listed patents for the drug.
Per the terms of the settlement agreement, Theravance and Viatris have granted Qilu a license to produce and sell a generic version of Yupelri in the United States, starting April 23, 2039, subject to certain customary exceptions. This settlement is under review by the U.S. Department of Justice and Federal Trade Commission, while patent litigation continues against three other generic applicants.
TBPH’s Zacks Rank & Other Stocks to Consider
Theravance currently carries a Zacks Rank #2 (Buy).
Some other top-ranked pharma stocks are Allogene Therapeutics ALLO and Biogen BIIB, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Allogene Therapeutics’ loss estimates per share have narrowed from $1.41 to $1.36 for 2024 over the past 60 days, while that for 2025 has narrowed from $1.46 to $1.36 per share. ALLO’s shares have lost 11.5% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.
Biogen’s earnings estimates have risen from $16.12 to $16.38 per share for 2024 over the past 60 days, while that for 2025 has increased from $17.09 to $17.16. BIIB’s shares have lost 35% year to date.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 9.99%.
Zacks Investment Research
Xenon Pharmaceuticals Inc. XENE reported a loss of 81 cents per share for the third quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 82 cents. The company had incurred a loss of 73 cents per share in the year-ago quarter.
In the reported quarter, Xenon did not generate any revenues. Due to the absence of a marketed product, the company only recognizes periodic collaboration revenues in its top line from its ongoing partnership with Neurocrine Biosciences NBIX for XEN901, now known as NBI-921352. The company did not recognize any revenues in the year-ago quarter as well.
NBI-921352 is a selective Nav1.6 sodium channel inhibitor. Neurocrine is currently evaluating NBI-921352 in a phase II study to treat patients aged 2-21 years with SCN8A developmental and epileptic encephalopathy. Per the terms of the agreement with NBIX, Xenon is eligible to receive certain clinical, regulatory and commercial milestone-based payments, as well as royalties on future sales.
Xenon, in collaboration with Neurocrine, is also currently evaluating the next lead candidate, a Nav1.2/1.6 inhibitor, in pre-clinical studies, aiming to progress into clinical studies in 2025 as a potential treatment for focal onset seizures (FOS).
Find the latest EPS estimates and surprises on Zacks Earnings Calendar.
XENE’s Q3 Results in Detail
In the third quarter of 2024, research and development (R&D) expenses increased 33% to $57 million compared with $42.9 million in the year-ago period. The uptick was primarily due to increased expenses related to the company’s azetukalner late-stage epilepsy studies, as well as pre-clinical and discovery programs to advance multiple potential drug candidates.
Year to date, shares of XENE have lost 5.8% compared with the industry’s 0.9% decline.
General and administrative expenses were $16.7 million in the reported quarter, up 30% year over year. The significant rise was on the grounds of increased personnel-related costs due to higher employee headcount and stock-based compensation expenses.
Xenon had cash, cash equivalents and marketable securities worth $803.3 million as of Sept. 30, 2024, compared with $850.6 million as of June 30, 2024. The company expects its existing cash balance to fundits current operating plans,which include the completion of the azetukalner phase III epilepsy studies and fully supporting late-stage clinical development of azetukalner in major depressive disorder (MDD) into 2027.
XENE’s Pipeline Updates
Xenon has no approved products in its portfolio at the moment. Therefore, pipeline development remains the key focus of the company.
XENE is currently developing azetukalner in late-stage studies for treatingFOS. Under the phase III epilepsy program, two identical phase III studies, X-TOLE2 and X-TOLE3, are evaluating 15 mg or 25 mg doses of azetukalner, administered with food as adjunctive treatment in patients with FOS. The first top-line data readout from the X-TOLE2 study is anticipated in the second half of 2025.
The company is also evaluating azetukalner for primary generalized tonic-clonic seizures in a phase III X-ACKT study, which is currently enrolling patients and intends to support potential regulatory submissions in this additional epilepsy indication.
Xenon Pharmaceuticals Inc. Price and Consensus
Xenon Pharmaceuticals Inc. price-consensus-chart | Xenon Pharmaceuticals Inc. Quote
Xenon has also completed a phase II proof-of-concept study on azetukalner called X-NOVA for patients with MDD. Based on the success of the mid-stage study, the company expects to initiate the X-NOVA2 study, the first of three phase III studies evaluating azetukalner in patients with MDD, before 2024 ends.
Xenon is also currently collaborating with the Icahn School of Medicine at Mount Sinai to support an ongoing investigator-sponsored phase II proof-of-concept study of azetukalner for the treatment of MDD in approximately 60 subjects. Patient enrollment in the same has been completed and top-line results are anticipated in the first half of 2025.
Furthermore, XENE is currently evaluating multiple preclinical therapeutic candidates targeting Kv7, Nav1.7 and Nav1.1 across various indications, aiming to advance them into clinical development in 2025.
XENE’s Zacks Rank & Stocks to Consider
Xenon currently carries a Zacks Rank #3 (Hold).
Some better-ranked pharma stocks are Allogene Therapeutics ALLO and Biogen BIIB, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Allogene Therapeutics’ loss estimates per share have narrowed from $1.41 to $1.36 for 2024 over the past 60 days, while that for 2025 has narrowed from $1.46 to $1.36 per share. ALLO’s shares have lost 11.5% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.
Biogen’s earnings estimates have risen from $16.12 to $16.38 per share for 2024 over the past 60 days, while that for 2025 has increased from $17.09 to $17.16. BIIB’s shares have lost 35% year to date.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 9.99%.
Zacks Investment Research
Novavax NVAX incurred a third-quarter 2024 loss of 76 cents per share, narrower than the Zacks Consensus Estimate of a loss of 87 cents. In the year-ago quarter, the company reported a loss of $1.26 per share.
Revenues in the quarter amounted to $85 million, which beat the Zacks Consensus Estimate of $57 million. However, the top line declined 55% on a year-over-year basis.
Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.
More on NVAX’s Earnings
Novavax recorded $38.2 million in product sales compared with $2.2 million in the year-ago quarter. This upside was primarily driven by sales of the company’s protein-based COVID-19 vaccine, also the company’s sole marketed product, in the United States.
While the reported figure beat our model estimates of $23 million, it missed the Zacks Consensus Estimate of $49 million.
Licensing, royalties and other revenues rose 133% year over year to $46.3 million in the quarter, driven by a combination of activities as part of the recently signed agreement with pharma giant Sanofi SNY for its protein-based COVID-19 vaccine and adjuvant sales.
Starting next year, Sanofi will market the company’s COVID-19 vaccine and also use it to develop novel COVID-19-influenza combination vaccines. As part of this deal, the company received a payment of $570 million from SNY, which includes $70 million in equity investment. NVAX is also eligible to receive milestone payments of up to $700 million and royalties on sales of the COVID-19 vaccine from Sanofi.
Management did not record grant revenues during the quarter. The company reported about $165 million in grant revenues in the year-ago period.
NVAX’s Costs & Cash Balance
In the reported quarter, research and development (R&D) expenses totaled $87 million, down 18% year over year. The downside was caused by a reduction in clinical and manufacturing spending during the quarter.
Selling, general and administrative (SG&A) expenses were down 34% year over year to $71 million, primarily due to management's restructuring activities to reduce costs.
As of Sept. 30, 2024, the company had $924 million of cash and cash equivalents compared with $1.1 billion as of June 30, 2024.
NVAX’s Guidance
For 2024
Novavax expects 2024 total revenues to be in the range of $650-$700 million, down from its previously issued guidance of $700-$800 million. This was likely due to lower COVID-19 vaccine uptake in ex-U.S. markets.
This revised guidance includes nearly $475 million in licensing, royalties and other revenues. This includes $450 million of revenue recognition associated with the $500 million upfront payment from the Sanofi agreement and the rest in royalty and other revenues from partner-related activities.
It expects full-year product revenue guidance of $175-$225 million, down from the earlier projection of $275-$375 million.
Post the earnings release, Novavax’s share price fell 6% on Tuesday likely due to the curtailed guidance. Year to date, the stock has surged 76.2% against the industry’s 0.9% decline.
The company has maintained its projection for full-year combined R&D and SG&A expenses in the band of $700-$750 million.
Beyond 2024
Management has maintained its guidance on combined R&D and SG&A expenses for full-year 2025 and 2026. It expects the combined expenses to be nearly $500 million for 2025 and around $350 million for 2026. It also anticipates a portion of the costs of both these years to be reimbursed by Sanofi.
Updates on NVAX’s Pipeline & Other News
On Monday, Novavax announced that the FDA has lifted the clinical hold on its two pipeline programs, COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The agency had initially placed this hold in September after a study participant who took the CIC shot as part of a phase II study reported nerve damage. With this hold removed, management is working with study investigators and other partners to start the phase III immunogenicity study on both vaccines as quickly as possible.
Novavax is on track to complete the database lock of a pediatric clinical study on its COVID-19 vaccine before the end of this year. Achieving this target will trigger a $50-million milestone payment from Sanofi.
A regulatory filing is currently under the FDA’s review seeking full approval for the COVID-19 vaccine, with a final decision expected next year in April. If this filing is approved, it will trigger a $175-million milestone payment from Sanofi.
Novavax is also focused on advancing its pre-clinical programs on pandemic influenza and RSV through investigational new drug (IND) filings. Management intends to focus on exploring RSV-combination options.
Management also signed a deal with an unnamed ‘leading pharmaceutical company’ to use its patented Matrix-M adjuvant with the latter’s pipeline candidates.
NVAX’s Zacks Rank
Novavax currently carries a Zacks Rank #2 (Buy).
Novavax, Inc. Price
Novavax, Inc. price | Novavax, Inc. Quote
Other Key Picks Among Biotech Stocks
Some other top-ranked stocks from the sector are Castle Biosciences CSTL and Biogen BIIB. While CSTL currently sports a Zacks Rank #1 (Strong Buy), BIIB carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.88. Year to date, shares of Castle Biosciences have surged 56.5%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for Biogen’s 2024 EPS have increased from $16.12 to $16.38. EPS estimates for 2025 have improved from $17.09 to $17.16. Year to date, shares of Biogen have lost 33.5%.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 9.99%.
Zacks Investment Research
Theravance Biopharma (TBPH) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to loss of $0.01 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of 40%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.09 per share when it actually produced a loss of $0.13, delivering a surprise of -44.44%.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
Theravance Bio, which belongs to the Zacks Medical - Drugs industry, posted revenues of $16.87 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 4.71%. This compares to year-ago revenues of $15.69 million. The company has topped consensus revenue estimates two times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Theravance Bio shares have lost about 19.2% since the beginning of the year versus the S&P 500's gain of 25.8%.
What's Next for Theravance Bio?
While Theravance Bio has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Theravance Bio: favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.05 on $34.22 million in revenues for the coming quarter and -$0.45 on $79.17 million in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 27% of the 250 plus 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.
ProPhase Labs, Inc. (PRPH), another stock in the same industry, has yet to report results for the quarter ended September 2024. The results are expected to be released on November 13.
This company is expected to post quarterly loss of $0.31 per share in its upcoming report, which represents a year-over-year change of -3.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
ProPhase Labs, Inc.'s revenues are expected to be $2.82 million, down 66.3% from the year-ago quarter.
Zacks Investment Research
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