Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company, develops programmed cellular immunotherapies for cancer and immune disorders worldwide. The company's chimeric antigen receptor (CAR)-targeted NK and T-cell product candidates include FT576 to treat multiple myeloma, and FT522, to treat lymphoma and autoimmune disorders. Its CAR T-cell programs include FT819 to treat hematologic malignancies and solid tumors, and FT825 to treat solid tumors. The company has a collaboration and option agreement with Ono Pharmaceutical Co. Ltd. for the development and commercialization of off-the-shelf, iPSC-derived CAR T-cell product candidates for the treatment of cancer. Fate Therapeutics, Inc. was incorporated in 2007 and is headquartered in San Diego, California.

Fate Therapeutics, Inc.

Fate Therapeutics FATE reported a loss of 31 cents per share (excluding impairment loss) in the fourth quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 44 cents. The company reported a loss of 45 cents per share in the year-ago period.
Including the impairment loss of $14.7 million, loss per share was 44 cents.
The company earned collaboration revenues of $1.9 million, surpassing the Zacks Consensus Estimate of $1 million. The figure also increased from $1.7 million reported in the year-ago quarter.
Revenues were derived from preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with Ono Pharmaceutical.
R&D expenses increased 5.6% to $33.6 million. G&A expenses decreased 14.9% to $15.3 million.
Cash, cash equivalents and investments as of Dec. 31, 2024, totaled $306.7 million. Fate expects the current cash balance to sustain an operating runway through 2026.
Shares of Fate have lost 88.7% year to date compared with the industry’s decline of 7.6%.
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FATE’s Key Pipeline Update
FATE is focused on developing and manufacturing universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. Its immuno-oncology pipeline includes iPSC-derived natural killer (NK) cells and T-cell product candidates.
A phase I study of FT819, a T-cell product candidate for patients with systemic lupus erythematosus (SLE), is currently ongoing. The company has initiated dose expansion in up to 10 patients at 360 million cells, based on clinical data from the first three patients treated with FT819 in the ongoing multi-center, phase I study.
The dose expansion stage is designed to evaluate the safety and efficacy of a fludarabine (flu)-free conditioning regimen, consisting of either bendamustine or cyclophosphamide alone, followed by a single dose of FT819.
FATE is also assessing the safety, pharmacokinetics, and anti-B cell activity of FT819 at 900 million cells in dose escalation. It presented data from the first three patients at the American Society of Hematology Annual Meeting. As of a data cutoff date of Dec. 4, 2024, FATE did not observe dose-limiting toxicities (DLTs) or any event of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD).
FATE also amended the clinical protocol of its phase I autoimmunity study on FT819 to include a new treatment arm to assess the safety, pharmacokinetics, and anti-B cell activity of a single dose of FT819 as an add-on to maintenance therapy without conditioning chemotherapy in patients with SLE.
In December 2024, FATE reached an agreement with the FDA to allow for the clinical investigation of additional B cell-mediated autoimmune diseases under the current phase 1 clinical trial of FT819.
The company has submitted an amended clinical protocol to the FDA that enables the conduct of independent dose-expansion cohorts for SLE as well as anti-neutrophilic cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc).
Fate plans to initiate dose-expansion cohorts in one or more of AAV, IIM and SSc in 2025. The regulatory body also agreed to allow the investigation of a multi-dose treatment cycle and for re-treatment upon disease progression, making the treatment dosing paradigm more aligned with traditional biological therapies. The FDA also permitted the expansion of study eligibility criteria, including the inclusion of patients between the ages of 12 and 17.
Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate, with ONO Pharmaceutical. It is conducting a multi-center, phase I study to assess the safety, pharmacokinetics and activity of FT825/ONO-8250 in patients with advanced solid tumors.
Enrollment is currently ongoing at the third dose level of 900 million cells as monotherapy and at the second dose level of 300 million cells in combination with epidermal growth factor receptor (EGFR)-targeted monoclonal antibody therapy.
The company presented initial clinical data from three heavily pre-treated patients at a medical conference. All three patients were previously treated with at least five prior lines of therapy, including HER2-targeted treatment. Each patient was administered conditioning chemotherapy and a single dose of FT825/ONO-8250 at the first dose level of 100 million cells.
As of a data cutoff date of Oct. 25, 2024, FT825 / ONO-8250 demonstrated a favorable safety profile with no DLTs and no event of any grade of CRS, ICANS, or GvHD.
In November 2024, FATE presented initial translational data from its ongoing multi-center, phase I study of FT522 in patients with relapsed/refractory B-cell lymphoma (NCT05950334). Data showed that live FT522 cells with anti-B cell activity were detected in the patients’ peripheral blood through Day 15. This data demonstrated the potential of FT522 to persist and function in the presence of an unmatched, fully intact immune system. FATE intends to assess any further clinical development of FT522 in relapsed/refractory BCL upon completion of dose escalation at the second dose level of 900 million cells.
Meanwhile, the FDA allowed the company’s investigational new drug (IND) application to assess the safety, pharmacokinetics, and activity of FT522 across a basket of B cell-mediated autoimmune diseases. The phase I study is intended to treat patients with multiple doses of FT522 without conditioning chemotherapy as an add-on to rituximab induction therapy (Regimen A) and maintenance therapy in combination with rituximab (Regimen B).
Fate Therapeutics, Inc. Price, Consensus and EPS Surprise
Fate Therapeutics, Inc. price-consensus-eps-surprise-chart | Fate Therapeutics, Inc. Quote
FATE's 2024 Results
Loss per share in 2024 was $1.64, marginally wider than the Zacks Consensus Estimate of a loss of $1.63. The loss remained flat on a year-over-year basis. Collaboration revenues earned were $13.6 million, which surpassed the Zacks Consensus Estimate of $12.,53 million. The top line was down from $63.5 million in 2023.
Zacks Rank & Stocks to Consider
FATE currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Gilead Sciences GILD and BioMarin Pharmaceutical BMRN, 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.
Gilead Sciences
In the past 30 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.55 to $7.86. During the same timeframe, the figure for 2026 has increased to $8.17 from $7.82.
GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.
BioMarin Pharmaceutical
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 EPS have increased from $4.01 to $4.24. Estimate for 2026 EPS has increased to $5.25 from $5.20 during the same timeframe. BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

FATE Q4 Earnings Beat, Autoimmunity, Oncology Programs in Focus

(RTTNews) - Fate Therapeutics, Inc (FATE) reported Loss for fourth quarter that missed the Street estimates.
The company's earnings came in at -$52.15 million, or -$0.44 per share. This compares with -$44.12 million, or -$0.45 per share, last year.
Analysts on average had expected the company to earn -$0.42 per share. Analysts' estimates typically exclude special items.
The company's revenue for the period rose 10.7% to $1.86 million from $1.68 million last year.
Fate Therapeutics, Inc earnings at a glance (GAAP) :
-Earnings: -$52.15 Mln. vs. -$44.12 Mln. last year. -EPS: -$0.44 vs. -$0.45 last year. -Revenue: $1.86 Mln vs. $1.68 Mln last year.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Fate Therapeutics, Inc Q4 Loss Misses Estimates

(RTTNews) - Fate Therapeutics Inc. (FATE) announced that its President and Chief Executive Officer, Scott Wolchko will retire effective December 31, 2024. Fate's current President of Research and Development (R&D), Bob Valamehr, will assume the role of President and Chief Executive Officer, as of January 1, 2025.
For nearly 15 years, Dr. Valamehr has led the development of the Company's iPSC platform.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Fate Therapeutics CEO Scott Wolchko To Retire; Names Bob Valamehr CEO

Protagonist Therapeutics (PTGX) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $0.59. This compares to loss of $0.58 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of 8.47%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.50 per share when it actually produced a loss of $0.50, delivering no surprise.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
Protagonist Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $4.68 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 3.89%. This compares to zero revenues a year ago.
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.
Protagonist Therapeutics shares have added about 107.6% since the beginning of the year versus the S&P 500's gain of 24.3%.
What's Next for Protagonist Therapeutics?
While Protagonist Therapeutics has outperformed 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 Protagonist Therapeutics: mixed. 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 #3 (Hold) for the stock. So, the shares are expected to perform in line with 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 $0.09 on $60.2 million in revenues for the coming quarter and $2.80 on $308.15 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 - Biomedical and Genetics is currently in the top 36% 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.
Another stock from the same industry, Fate Therapeutics (FATE), has yet to report results for the quarter ended September 2024.
This clinical-stage biotech company that develops stem cell treatments is expected to post quarterly loss of $0.42 per share in its upcoming report, which represents a year-over-year change of +8.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Fate Therapeutics' revenues are expected to be $0.88 million, down 54.6% from the year-ago quarter.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Protagonist Therapeutics (PTGX) Reports Q3 Loss, Tops Revenue Estimates

In trading on Tuesday, the Invesco China Technology ETF is outperforming other ETFs, up about 7% on the day. Components of that ETF showing particular strength include shares of PDD, up about 8.4% and shares of Weibo, up about 7.5% on the day.
And underperforming other ETFs today is the SPDR S&P Biotech ETF, off about 1.2% in Tuesday afternoon trading. Among components of that ETF with the weakest showing on Tuesday were shares of Ocugen, lower by about 8.8%, and shares of Fate Therapeutics, lower by about 5.9% on the day.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Tuesday's ETF Movers: CQQQ, XBI

Fate Therapeutics (FATE) came out with a quarterly loss of $0.33 per share versus the Zacks Consensus Estimate of a loss of $0.47. This compares to loss of $0.54 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of 29.79%. A quarter ago, it was expected that this clinical-stage biotech company that develops stem cell treatments would post a loss of $0.47 per share when it actually produced a loss of $0.47, delivering no surprise.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
Fate Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $6.77 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 361.94%. This compares to year-ago revenues of $0.93 million. The company has topped consensus revenue estimates four 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.
Fate Therapeutics shares have lost about 11% since the beginning of the year versus the S&P 500's gain of 12.1%.
What's Next for Fate Therapeutics?
While Fate Therapeutics 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 Fate Therapeutics: mixed. 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 #3 (Hold) for the stock. So, the shares are expected to perform in line with 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 -$0.48 on $0.8 million in revenues for the coming quarter and -$1.90 on $4.34 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 - Biomedical and Genetics is currently in the top 29% 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.
One other stock from the same industry, Cyclo Therapeutics, Inc. (CYTH), is yet to report results for the quarter ended June 2024.
This company is expected to post quarterly loss of $0.14 per share in its upcoming report, which represents a year-over-year change of +57.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Cyclo Therapeutics, Inc.'s revenues are expected to be $0.4 million, up 233.3% from the year-ago quarter.
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Fate Therapeutics (FATE) Reports Q2 Loss, Tops Revenue Estimates

Eyenovia, Inc. (EYEN) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.16 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of -5.88%. A quarter ago, it was expected that this company would post a loss of $0.18 per share when it actually produced a loss of $0.18, delivering no surprise.
Over the last four quarters, the company has surpassed consensus EPS estimates just once.
Eyenovia, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $0.02 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 98.33%. This compares to zero revenues a year ago.
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.
Eyenovia shares have lost about 58.7% since the beginning of the year versus the S&P 500's gain of 12%.
What's Next for Eyenovia?
While Eyenovia 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 Eyenovia: mixed. 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 #3 (Hold) for the stock. So, the shares are expected to perform in line with 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 -$0.18 on $1.6 million in revenues for the coming quarter and -$0.76 on $5.03 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 - Biomedical and Genetics is currently in the top 30% 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.
Fate Therapeutics (FATE), another stock in the same industry, has yet to report results for the quarter ended June 2024.
This clinical-stage biotech company that develops stem cell treatments is expected to post quarterly loss of $0.47 per share in its upcoming report, which represents a year-over-year change of +13%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Fate Therapeutics' revenues are expected to be $1.47 million, up 57.6% from the year-ago quarter.
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Eyenovia, Inc. (EYEN) Reports Q2 Loss, Misses Revenue Estimates

Merck MRK will report first-quarter 2024 results on Apr 25, before market open. In the last reported quarter, the company delivered an earnings surprise of 133.3%.
Factors to Consider
The Zacks Consensus Estimate for Merck’s total revenues is $15.34 billion. The Zacks Consensus Estimate for Merck’s Pharmaceutical unit is $13.53 billion, while our estimate is $13.50 billion.
In the Pharmaceuticals segment, strong global underlying demand across its business, particularly for cancer drug Keytruda and HPV vaccine, Gardasil, is likely to have boosted sales growth in the first quarter like several previous quarters.
In oncology drugs, Keytruda sales are likely to have been driven by increased uptake across earlier-stage indications globally, like triple-negative breast cancer and renal cell carcinoma, and continued strong momentum in metastatic indications. In addition, Keytruda’s approval for early-stage non-small cell lung cancer (NSCLC) in October 2023 is likely to have contributed to sales growth. The Zacks Consensus Estimate for Keytruda’s sales is $6.80 billion, while our estimate is $6.81 billion.
Keytruda alone accounts for around 42% of the company’s pharmaceutical sales. Keytruda has played an instrumental role in driving Merck’s steady revenue growth in the past few years. Though Keytruda may be Merck’s biggest strength and a solid reason to own the stock, it can also be argued that the company is excessively dependent on the drug and should look for ways to diversify its product lineup. Keytruda stands to lose patent exclusivity post 2028.
Merck is working on different strategies to drive the long-term growth of Keytruda. These include innovative immuno-oncology combinations, including Keytruda with TIGIT, LAG3 and CTLA-4 inhibitors. In partnership with Moderna MRNA, Merck is developing a personalized mRNA therapeutic cancer vaccine (V940/mRNA-4157) in combination with Keytruda for the treatment of adjuvant melanoma. Merck and Moderna initiated a pivotal phase III study in adjuvant melanoma in July 2023, while a phase III study in earlier stage NSCLC began in December 2023.
With regard to the HPV vaccine, Gardasil, ex-U.S. sales are expected to have been driven by strong demand in international markets like China. In the United States, higher pricing could have benefited sales.
The Zacks Consensus Estimate for Gardasil is $2.28 billion, while our estimate is $2.33 billion.
Sales of Gardasil vaccine have been growing in the double-digit range for the past several years. Merck expects Gardasil growth to benefit from increased supply as it is investing in expanding manufacturing capacity, greater penetration in the low- and middle-income markets and expansion to broader age cohorts like the mid-adult segment.
The company is consistently investing in M&A activity to strengthen its pipeline. In March, Merck completed its previously announced agreement to acquire Harpoon Therapeutics. The acquisition has added Harpoon Therapeutics’ lead pipeline candidate, HPN328, a T cell engager targeting delta-like ligand 3 (DLL3). HPN328 is currently being evaluated in a phase I/II study in certain patients with small cell lung cancer (SCLC) and other neuroendocrine tumor types.
Merck also has some key new products lined up for launch. Between 2025 and 2030, Merck expects eight potential new product approvals. We believe that among these, V116 and Winrevair have the potential to generate significant revenues for Merck over the long term. Winrevair (sotatercept) was approved for pulmonary arterial hypertension in March 2024. V116 is Merck’s 21-valent pneumococcal conjugate vaccine, which is under priority review in the United States, with an FDA decision scheduled for Jun 17, 2024.
Overall, the strong sales performance of Keytruda and Gardasil, regular strategic M&A activity, and an attractive pipeline (including Keytruda) are some of the reasons that makes the stock attractive despite concerns about Merck’s ability to grow its non-oncology business ahead of Keytruda’s loss of exclusivity later in the decade.
Earnings Surprise History
This large drugmaker beat earnings expectations in each of the trailing four quarters. The company delivered a four-quarter earnings surprise of 38.17%, on average.
Merck & Co., Inc. Price and EPS Surprise
Merck’s stock has risen 8.5% in the past year compared with an increase of 13.0% for the industry.
Image Source: Zacks Investment Research
Earnings Whispers
Our proven model does not conclusively predict an earnings beat for Merck this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. But that is not the case here.
Earnings ESP: Merck’s Earnings ESP is -1.16% as the Most Accurate Estimate is pegged at $1.99 per share, while the Zacks Consensus Estimate is pegged higher at $2.01 per share. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Merck has a Zacks Rank #3.
Stocks to Consider
Here are some biotech stocks that have the right combination of elements to beat on earnings this time around:
Fate Therapeutics FATE has an Earnings ESP of +2.53% and a Zacks Rank #3.
Fate Therapeutics’ stock has declined 24.5% in the past year. Fate Therapeutics topped earnings estimates in each of the last four quarters. FATE has a four-quarter earnings surprise of 28.86%, on average.
Novavax NVAX has an Earnings ESP of +7.34% and a Zacks Rank #3.
Novavax’s stock has declined 50.9% in the past year. Novavax beat earnings estimates in two of the last four quarters while missing in the other two. NVAX has a four-quarter negative earnings surprise of 4.31%, on average.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
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How Should You Play Merck (MRK) Stock Ahead of Q1 Earnings?

Gilead Sciences Inc. GILD is set to report first-quarter 2024 results on Apr 25, after market close. In the last reported quarter, the company posted an earnings surprise of -2.27%.
Gilead Sciences, Inc. Price, Consensus and EPS Surprise
Factors to Note
Gilead has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy and Descovy. However, revenues in the first quarter might have been impacted by a decline in HIV franchise sales. The first quarter is typically impacted by the reset of patient copays and deductibles. In addition, inventory build-up in the fourth quarter leads to notable draw-downs by wholesalers in the first quarter, thereby impacting revenues. Gilead expects a 10-12% decline in HIV sales in the first quarter of 2024.
While market share gains and continued double-digit growth in demand for HIV prevention for Biktarvy drove sales in 2023, Biktarvy missed the consensus mark in the fourth quarter of 2023. The trend is likely to have continued in the first quarter. Descovy’s revenues, too, missed the consensus estimate in the previous quarter. The top line is expected to have declined in the first quarter.
The first-quarter top-line estimate for Biktarvy and Descovy is pegged at $2.9 billion and $476 million, respectively, and our model estimate for the same is pinned at $2.8 billion and $460 million.
The Liver Disease portfolio sales include chronic hepatitis C virus, chronic hepatitis B virus and chronic hepatitis delta virus. Higher demand for chronic hepatitis delta virus products and chronic hepatitis B virus has likely boosted sales of this franchise in the first quarter.
Veklury sales continue to be highly variable. Higher COVID-related hospitalizations in the fourth quarter enabled Veklury to beat on sales. However, the trend has likely not continued in the first quarter of 2024.
Cell Therapy product sales have likely seen a slight increase in the first quarter. Yescarta sales are primarily being driven by increased demand in the second and third-line settings for relapsed or refractory (R/R) large B-cell lymphoma outside the United States.
Tecartus (brexucabtagene autoleucel) sales are being driven by increased demand in adult R/R B-cell precursor acute lymphoblastic leukemia and mantle cell lymphoma. However, sales growth in the United States continues to be slower than anticipated, while that in Europe continues to be strong.
Both the Zacks Consensus Estimate and our estimate for Cell Therapy product sales in the first quarter are pinned at $473 million.
Increased sales of Trodelvy, indicating continued solid uptake in metastatic triple-negative breast cancer, have also likely boosted sales in the first quarter. Approval of the drug in Europe is also expected to have a positive impact on sales. The Zacks Consensus Estimate and our estimate for Trodelvy sales are pinned at $323 million and $314 million, respectively.
Operating expenses are likely to have remained flat sequentially in the first quarter due to a decline in the growth of R&D and SG&A expenses.
Pipeline & Regulatory Update
Apart from the regular top and bottom-line numbers, we expect investors to focus on key pipeline updates when the company reports first-quarter results.
Gilead recently acquired a clinical-stage biopharmaceutical company, CymaBay Therapeutics, Inc., for $4.3 billion. The acquisition added CymaBay’s investigational lead product candidate, seladelpar, to Gilead’s pipeline. Seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta agonist, shown to regulate critical metabolic and liver disease pathways. A new drug application seeking approval of the candidate for the treatment of primary biliary cholangitis (PBC) was submitted to the FDA in December 2023. The FDA granted priority review to the same with a target action date of Aug 14, 2024.
Earnings Surprise History
GILD’s earnings missed estimates in three of the trailing four quarters and beat the same in one, delivering an average negative surprise of 3.64%.
Gilead’s shares have lost 17.6% year to date compared with the industry's decline of 11%.
Image Source: Zacks Investment Research
What Our Model Predicts
Our proven model does not conclusively predict an earnings beat for Gilead this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below.
Earnings ESP: Earnings ESP for GILD is -89.07% as the Zacks Consensus Estimate is currently pinned at $1.03 per share and the Most Accurate Estimate is presently pegged at 11 cents per share. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Zacks Rank: The company currently carries a Zacks Rank #3.
Stocks to Consider
Here are some drug and biotech stocks that you may want to consider, as our model shows that they have the right combination of elements to post an earnings beat this reporting cycle.
Oncolytics Biotech ONCY has an Earnings ESP of +5.88% and a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
ONCY beat on earnings in three of the trailing four quarters and missed the same in one, delivering an average surprise of 5.20%.
Omega Therapeutics OMGA has an Earnings ESP of +7.25% and a Zacks Rank #2 at present.
OMGA beat on earnings in three of the trailing four quarters and missed the same in one, delivering an average surprise of 16.04%.
Fate Therapeutics FATE has an Earnings ESP of +2.53% and a Zacks Rank #3 at present.
FATE beat on earnings in each of the trailing four quarters, delivering an average surprise of 28.86%. Shares of FATE have risen 28.1% in the past year.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Gilead (GILD) Gears Up to Report Q1 Earnings: What to Expect?

Biogen, Inc. BIIB will report first-quarter 2024 results on Apr 24, before market open. In the last reported quarter, the company delivered a negative earnings surprise of 6.65%.
Factors to Consider
Biogen’s sales in the first quarter are likely to have been hurt by lower sales of its multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri amid rising competitive pressure in the MS market. Tecfidera sales have been declining as multiple generic versions of the drug have been launched in the United States and new generic launches are ongoing in several EU countries.
The Zacks Consensus Estimate and our model estimate for first-quarter sales of Tecfidera are pegged at $224.0 million and $198.8 million, respectively.
The Zacks Consensus Estimate and our estimate for Tysabri are pegged at $434 million and $435.2 million, respectively.
Sales of another MS drug, Vumerity, are likely to have been hurt by pricing pressure and an overall contraction of the oral segment of the U.S. market.
The Zacks Consensus Estimate and our estimate for Vumerity are pegged at $138.0 million and $152.0 million, respectively.
Overall, the first quarter of 2024 is expected to have been a seasonally weaker quarter for the MS business, driven by higher discounts and allowances and some channel dynamics.
Sales growth of Biogen’s spinal muscular atrophy drug, Spinraza, is expected to have been moderate in the U.S. market. In ex-U.S. markets, pricing pressure and competition in Europe are expected to have hurt sales.
The Zacks Consensus Estimate and our estimate for Spinraza are pegged at $423.0 and $442.4 million, respectively.
Investors will be keen to know the sales numbers of Biogen’s new rare disease drug Skyclarys, which was added with the September 2023 acquisition of Reata Pharmaceuticals as well as Qalsody, which was launched for amyotrophic lateral sclerosis (ALS) in the second quarter of 2023.
In 2024, Biogen expects rare disease revenues to grow as it continues to launch Skyclarys in the United States.
Biosimilars revenues are expected to have been modest in the first quarter as the continued launch of Byooviz is likely to have made up for pricing pressure in certain markets.
Investors will be keen to know the collaboration profit-sharing revenues from Biogen’s new drug, Zurzuvae (zuranolone), which was approved for postpartum depression in August 2023 and launched in mid-December 2023. Biogen has a collaboration with Sage Therapeutics SAGE for Zurzuvae. Sage and Biogen equally share profits and losses for the commercialization of Zurzuvae in the United States, while outside U.S. markets, Biogen records product sales (excluding Japan, Taiwan and South Korea) and pays royalties to Sage.
Contract manufacturing and royalty revenues are expected to have declined in the quarter. Contract manufacturing and royalty revenues include Biogen’s 50% share of revenues (including royalties) from the collaboration with Eisai for new Alzheimer’s drug, Leqembi, and revenues from the manufacturing of Leqembi. Leqembi/lecanemab gained full approval from the FDA for early Alzheimer’s disease in the United States and broad reimbursement from Centers for Medicare & Medicaid Services in July 2023. Though Leqembi sales were slow in 2023, Biogen expects the same to start growing from 2024.
Lower cost of sales and lower operating costs due to the cost-saving initiatives are expected to have boosted profits.
Earnings Surprise History
The company’s earnings beat estimates in three of the last four quarters while missing in one. The company has a four-quarter earnings surprise of 3.47%, on average.
Biogen Inc. Price and EPS Surprise
Biogen’s stock has declined 34.4% in the past year compared with a decrease of 18% for the industry.
Image Source: Zacks Investment Research
Earnings Whispers
Our proven model does not conclusively predict an earnings beat for Biogen this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. But that is not the case here.
Earnings ESP: Biogen’s Earnings ESP is -3.19% as the Most Accurate Estimate of $3.38 is pegged lower than the Zacks Consensus Estimate of $3.49. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Biogen has a Zacks Rank #3.
Stocks to Consider
Here are some large drug/biotech stocks that have the right combination of elements to beat on earnings this time around:
Fate Therapeutics FATE has an Earnings ESP of +5.99% and a Zacks Rank #3.
Fate Therapeutics’ stock has declined 20.8% in the past year. Fate Therapeutics topped earnings estimates in each of the last four quarters. FATE has a four-quarter earnings surprise of 28.86%, on average.
Novavax NVAX has an Earnings ESP of +8.30% and a Zacks Rank #3.
Novavax’s stock has declined 56.5% in the past year. Novavax beat earnings estimates in two of the last four quarters while missing in the other two. NVAX has a four-quarter negative earnings surprise of 4.31%, on average.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Fate Therapeutics, Inc.

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