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Axsome Therapeutics, Inc. AXSM incurred an adjusted loss of $1.34 per share in the third quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of $1.38. The company had incurred a loss of $1.32 per share in the year-ago quarter.
Axsome’s total revenues surged 81% year over year to $104.8 million in the third quarter, beating the Zacks Consensus Estimate of $99 million. The increase in revenues can be attributed to strong sales of Auvelity (AXS-05).
Shares of Axsome were up 9.4% on Nov. 12 owing to the better-than-expected results and strong sales uptake of Auvelity.
AXSM stock has rallied 25% so far this year against the industry’s decline of 0.9%.
Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.
More on AXSM’s Q3 Results
Total revenues in the third quarter consisted of product revenues from Auvelity and Sunosi (solriamfetol) and royalty revenues.
Net product revenues were $103.7 million in the quarter compared with $57.1 million reported in the year-ago period. The figure beat our model estimate of $94 million.
This marks the first time that Axsome generated product revenues of more than $100 million in a particular quarter.
Product revenues in the third quarter benefited from the strong sales uptake of its two marketed products, Auvelity for major depressive disorder and Sunosi for narcolepsy.
Auvelity, launched in 2022, recorded sales of $80.4 million, up 113% year over year, owing to strong underlying demand. Sales of the drug beat our model estimate of $71.1 million.
Per Axsome, around 144,000 prescriptions were recorded for Auvelity in the reported quarter, reflecting a sequential increase of 17% and a year-over-year increase of 108%.
Axsome acquired U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, from Jazz Pharmaceuticals JAZZ in May 2022. It began selling Sunosi in the U.S. market in May 2022 and in certain international markets in November 2022.
Jazz received approval for Sunosi as a treatment for narcolepsy in 2019.
Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia in February 2023. JAZZ is entitled to receive high single-digit royalty from AXSM on net sales of Sunosi in the United States.
Sunosi’s net product sales were $24.4 million, up 21% from the year-ago quarter’s level. Total prescriptions for Sunosi in the United States grew 5% sequentially to 47,000.
Royalty revenues totaled $1 million in the quarter, reflecting royalties on Sunosi sales in out-licensed territories.
Research and development expenses (including stock-based compensation) increased to $45.4 million, up 57.6% from the year-ago quarter’s level. The increase was due to higher costs associated with clinical studies, especially the label expansion study of Sunosi, as well as other pipeline candidates like AXS-05, AXS-12, AXS-07 and AXS-14.
Selling, general and administrative expenses (including stock-based compensation) totaled $95.6 million, up 14.9% year over year. The increase was due to higher commercial activities for Sunosi and Auvelity and other costs.
As of Sept 30, 2024, Axsome had cash and cash equivalents worth $327.3 million compared with $315.7 million as of June 30, 2024.
Guidance
Management believes that its cash balance of $327.3 million (as of September-end) is enough to fund future operations into cash flow positivity.
AXSM's Pipeline Updates
Axsome is evaluating Auvelity in several label expansion studies for other central nervous system disorders. The development program of AXS-05 in Alzheimer’s disease (AD) agitation consists of four pivotal, phase III efficacy studies, namely – ADVANCE-1 and ACCORD-1 studies (completed) and the ongoing ADVANCE-2 and ACCORD-2 studies.
Top-line data from ADVANCE-2 and ACCORD-2 is expected later in the fourth quarter of 2024.
Axsome plans to start a pivotal phase II/III study of Auvelity for smoking cessation in 2025.
Other pipeline candidates include AXS-07, AXS-12 and AXS-14, which target multiple central nervous system indications.
AXS-07 is being developed for the acute treatment of migraine. Last month, the FDA accepted AXSM’s resubmitted new drug application (NDA), seeking approval for AXS-07 for the acute treatment of migraine.
A final decision from the regulatory body is expected on Jan. 31, 2025.
The phase III EMERGE study is currently evaluating AXS-07 in adults with a prior inadequate response to an oral CGRP inhibitor for the acute treatment of migraine headaches. Top-line results from the EMERGE study are expected later in the fourth quarter of 2024.
AXS-12 is currently being evaluated in the two-period phase III ENCORE study for the treatment of narcolepsy. Top-line data is expected later in the fourth quarter of 2024.
Axsome plans to submit an NDA to the FDA to seek approval of AXS-14 for the treatment of fibromyalgia later in November.
The company is investigating Sunosi in a label expansion study — the phase III FOCUS study. The study evaluates the efficacy and safety of Sunosi for the treatment of attention deficit hyperactivity disorder. Top-line data from the study is expected in the first quarter of 2025.
Axsome is also evaluating Sunosi in separate phase III studies for the treatment of major depressive disorder and binge eating disorder. Data from both studies are expected in 2025.
A separate phase III study is evaluating Sunosi for the treatment of excessive sleepiness associated with shift work disorder. Top-line data from this study is expected in 2026.
Axsome Therapeutics, Inc. Price, Consensus and EPS Surprise
Axsome Therapeutics, Inc. price-consensus-eps-surprise-chart | Axsome Therapeutics, Inc. Quote
AXSM's Zacks Rank & Key Picks
Axsome currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are ANI Pharmaceuticals, Inc. ANIP and Castle Biosciences, Inc. CSTL, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.59 to $4.71. Earnings per share estimates for 2025 have improved from $4.82 to $5.65 during the same time. Year to date, shares of ANIP have increased 10.6%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 51.9%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
Zacks Investment Research
SpringWorks Therapeutics, Inc. SWTX incurred a loss of 72 cents per share in the third quarter of 2024, which was narrower than the Zacks Consensus Estimate of a loss of 76 cents. The company had reported a loss of $1.27 per share in the year-ago quarter.
In the third quarter, total revenues were $49.3 million, which missed the Zacks Consensus Estimate of $54 million. Total revenues comprised net product sales of Ogsiveo (nirogacestat), SpringWorks’ only marketed drug. The company did not generate any revenues in the year-ago quarter.
The FDA approved Ogsiveo for treating adult patients with progressing desmoid tumors who require systemic treatment in November 2023.
Following the FDA nod, Ogsiveo became the first approved product in the company’s portfolio and the first approved drug for treating desmoid tumors, a rare, aggressive tumor of the soft tissues.
Shares of SpringWorks have plunged 9.3% so far this year compared with the industry’s decline of 0.9%.
Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.
More on SWTX's Q3 Results
Net product revenues from Ogsiveo increased almost 23% on a sequential basis in the third quarter, driven by a strong commercial launch and high demand for the drug.
Management remains focused on making Ogsiveo the standard of care systemic therapy for patients with desmoid tumors.
Research and development expenses totaled $42.3 million in the third quarter, up 12.8% from the year-ago quarter’s level, owing to higher costs related to drug manufacturing and increased expenses related to ongoing clinical studies and consulting costs.
Selling, general and administrative expenses totaled $61.6 million, up around 32.5% year over year due to higher costs to support the launch of mirdametinib in the United States, upon potential approval.
As of Sept 30, 2024, SpringWorks had cash, cash equivalents and marketable securities worth $498.1 million compared with $521.9 million as of June 30, 2024. Management expects this cash balance to fund the company through profitability, which is expected in the first half of 2026.
SWTX's Pipeline Update
The marketing authorization application for Ogsiveo for treating adult patients with desmoid tumors is currently under review with the European Medicines Agency (“EMA”). A potential approval in the EU is expected in 2025.
Several additional studies on Ogsiveo, targeting different cancer indications, are currently ongoing.
Initial data from a phase II study evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors is expected in the first half of 2025.
In August 2024, the FDA accepted SWTX’s new drug application (“NDA”) seeking approval for its investigational MEK inhibitor, mirdametinib for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Feb. 28, 2025.
A marketing authorization application for mirdametinib for the treatment of adults and children with NF1-PN has also been validated by the European Medicines Agency.
SpringWorks is evaluating its investigational, oral, selective pan-TEAD inhibitor, SW-682, in a phase Ia study for treating patients with Hippo-mutant solid tumors.
SpringWorks Therapeutics Price, Consensus and EPS Surprise
SpringWorks Therapeutics price-consensus-eps-surprise-chart | SpringWorks Therapeutics Quote
SWTX's Zacks Rank & Key Picks
SpringWorks currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, ANI Pharmaceuticals, Inc. ANIP and Castle Biosciences, Inc. CSTL, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.67 to 96 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.70 during the same time. Year to date, shares of IMCR have declined 50.6%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.59 to $4.71. Earnings per share estimates for 2025 have improved from $4.82 to $5.65 during the same time. Year to date, shares of ANIP have increased 10.6%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 51.9%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
Zacks Investment Research
Shares of Jazz Pharmaceuticals (JAZZ) have gained 8.9% over the past four weeks to close the last trading session at $127.74, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $175.83 indicates a potential upside of 37.7%.
The average comprises 18 short-term price targets ranging from a low of $113 to a high of $230, with a standard deviation of $33.34. While the lowest estimate indicates a decline of 11.5% from the current price level, the most optimistic estimate points to an 80.1% upside. More than the range, one should note the standard deviation here, as it helps understand the variability of the estimates. The smaller the standard deviation, the greater the agreement among analysts.
While the consensus price target is a much-coveted metric for investors, solely banking on this metric to make an investment decision may not be wise at all. That's because the ability and unbiasedness of analysts in setting price targets have long been questionable.
But, for JAZZ, an impressive average price target is not the only indicator of a potential upside. Strong agreement among analysts about the company's ability to report better earnings than they predicted earlier strengthens this view. While a positive trend in earnings estimate revisions doesn't gauge how much a stock could gain, it has proven to be powerful in predicting an upside.
Here's What You Should Know About Analysts' Price Targets
According to researchers at several universities across the globe, a price target is one of many pieces of information about a stock that misleads investors far more often than it guides. In fact, empirical research shows that price targets set by several analysts, irrespective of the extent of agreement, rarely indicate where the price of a stock could actually be heading.
While Wall Street analysts have deep knowledge of a company's fundamentals and the sensitivity of its business to economic and industry issues, many of them tend to set overly optimistic price targets. Are you wondering why?
They usually do that to drum up interest in shares of companies that their firms either have existing business relationships with or are looking to be associated with. In other words, business incentives of firms covering a stock often result in inflated price targets set by analysts.
However, a tight clustering of price targets, which is represented by a low standard deviation, indicates that analysts have a high degree of agreement about the direction and magnitude of a stock's price movement. While that doesn't necessarily mean the stock will hit the average price target, it could be a good starting point for further research aimed at identifying the potential fundamental driving forces.
That said, while investors should not entirely ignore price targets, making an investment decision solely based on them could lead to disappointing ROI. So, price targets should always be treated with a high degree of skepticism.
Here's Why There Could be Plenty of Upside Left in JAZZ
There has been increasing optimism among analysts lately about the company's earnings prospects, as indicated by strong agreement among them in revising EPS estimates higher. And that could be a legitimate reason to expect an upside in the stock. After all, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
The Zacks Consensus Estimate for the current year has increased 6.4% over the past month, as seven estimates have gone higher compared to no negative revision.
Moreover, JAZZ currently has a Zacks Rank #2 (Buy), which means it is in the top 20% of more than the 4,000 stocks that we rank based on four factors related to earnings estimates. Given an impressive externally-audited track record, this is a more conclusive indication of the stock's potential upside in the near term. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here
Therefore, while the consensus price target may not be a reliable indicator of how much JAZZ could gain, the direction of price movement it implies does appear to be a good guide.
Zacks Investment Research
The proven Zacks Rank system focuses on earnings estimates and estimate revisions to find winning stocks. Nevertheless, we know that our readers all have their own perspectives, so we are always looking at the latest trends in value, growth, and momentum to find strong picks.
Looking at the history of these trends, perhaps none is more beloved than value investing. This strategy simply looks to identify companies that are being undervalued by the broader market. Value investors use fundamental analysis and traditional valuation metrics to find stocks that they believe are being undervalued by the market at large.
Zacks has developed the innovative Style Scores system to highlight stocks with specific traits. For example, value investors will be interested in stocks with great grades in the "Value" category. When paired with a high Zacks Rank, "A" grades in the Value category are among the strongest value stocks on the market today.
Collegium Pharmaceutical (COLL) is a stock many investors are watching right now. COLL is currently holding a Zacks Rank of #2 (Buy) and a Value grade of A.
Value investors also frequently use the P/S ratio. This metric is found by dividing a stock's price with the company's revenue. This is a prefered metric because revenue can't really be manipulated, so sales are often a truer performance indicator. COLL has a P/S ratio of 1.69. This compares to its industry's average P/S of 3.29.
Finally, investors will want to recognize that COLL has a P/CF ratio of 5.51. This metric takes into account a company's operating cash flow and can be used to find stocks that are undervalued based on their solid cash outlook. This stock's P/CF looks attractive against its industry's average P/CF of 10.45. Within the past 12 months, COLL's P/CF has been as high as 8.61 and as low as 5.26, with a median of 6.44.
Another great Medical - Drugs stock you could consider is Jazz Pharmaceuticals (JAZZ), which is a # 2 (Buy) stock with a Value Score of A.
Jazz Pharmaceuticals is trading at a forward earnings multiple of 5.87 at the moment, with a PEG ratio of 0.84. This compares to its industry's average P/E of 58.22 and average PEG ratio of 2.36.
JAZZ's Forward P/E has been as high as 6.87 and as low as 4.97, with a median of 5.62. During the same time period, its PEG ratio has been as high as 1.44, as low as 0.64, with a median of 1.07.
Jazz Pharmaceuticals sports a P/B ratio of 1.88 as well; this compares to its industry's price-to-book ratio of 1.35. In the past 52 weeks, JAZZ's P/B has been as high as 2.27, as low as 1.59, with a median of 1.89.
These are only a few of the key metrics included in Collegium Pharmaceutical and Jazz Pharmaceuticals strong Value grade, but they help show that the stocks are likely undervalued right now. When factoring in the strength of its earnings outlook, COLL and JAZZ look like an impressive value stock at the moment.
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
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