Annexon, Inc. ANNX, a clinical-stage company, is focused on developing novel therapies to treat patients suffering from serious complement-mediated autoimmune, neurodegenerative and ophthalmic disorders.
Annexon is expected to report first-quarter 2024 results soon. Having no commercialized product in its portfolio or any ongoing collaboration agreements, the company currently does not generate any revenues. The Zacks Consensus Estimate is pegged at a loss of 32 cents per share, indicating an increase of 38.5% year over year.
Let’s see how things might have shaped up for the quarter to be reported.
Factors to Consider
In the absence of a marketed product, investors will mostly focus on progress updates regarding the company’s pipeline candidates.
Annexon has channeled its resources to prioritize three flagship development programs in its clinical-stage pipeline, such as ANX005 for Guillain-Barré syndrome (GBS), ANX007 for geographic atrophy (GA) and first-in-kind oral complement small molecule, and ANX1502 for several autoimmune indications.
In the fourth quarter of 2024, the company reported that it had completed enrollment in the phase III study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of its lead candidate, ANX005, a monoclonal antibody, in patients with GBS. Top-line data readout from this late-stage study is expected in the second quarter of 2024.
Also, during the fourth quarter, Annexon initiated a real-world evidence comparability protocol to establish comparability of the GBS patient population in its phase III study with patients from the International Guillain-Barré Syndrome Outcomes Study data from this comparison cohort is expected in the first half of 2025, potentially supporting a regulatory filing for ANX005 for GBS.
Last year, Annexon reached alignment with the FDA regarding a planned late-stage study’s (ARCHER II) primary endpoint, which will evaluate ANX007, a fragment antigen-binding antibody, for GA.
The alignment includes using, for the first time, the prevention of ≥15-letter loss of best corrected visual acuity as the primary outcome measure, followed by a head-to-head comparison (ARROW study) of ANX007 with Syfovre (pegcetacoplan injection).
ANNX expects to begin enrollment in the phase III ARCHER II study in mid-2024, followed by ARROW in late 2024. Positive results from both these studies will provide the basis for a regulatory filing for ANX007 to treat GA.
The company is also gearing up to initiate a proof-of-concept study to evaluate the safety and efficacy of orally administered ANX1502 in patients with cold agglutinin disease (CAD) in the first half of 2024. Data from the CAD study is expected in the second half of 2024. Updates regarding the same are also expected in the upcoming earnings release.
The company is likely to have recorded lower operating expenses in the to-be-reported quarter, primarily due to its strategic decision to prioritize the GBS, GA and ANX1502 development programs.
Earnings Surprise History
The company beat estimates in three of the trailing four quarters and matched on one occasion, delivering an average earnings surprise of 11.74%. In the last reported quarter, the company came up with an earnings surprise of 20.00%.
Shares of Annexon have gained 0.2% in the year-to-date period against the industry’s decline of 9.6%.
Image Source: Zacks Investment Research
Earnings Whispers
Our proven model does not conclusively predict an earnings beat for Annexon 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. Unfortunately, that is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Earnings ESP: Annexon has an Earnings ESP of 0.00% as the Most Accurate Estimate and the Zacks Consensus Estimate are both pinned at a loss of 32 cents.
Zacks Rank: ANNX currently carries a Zacks Rank #2.
Annexon, Inc. Price and EPS Surprise
Annexon, Inc. price-eps-surprise | Annexon, Inc. Quote
Stocks to Consider
Here are some stocks worth considering from the same industry, as our model shows that they have the right combination of elements to beat on earnings this reporting cycle.
Atara Biotherapeutics, Inc. ATRA has an Earnings ESP of +11.61% and a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Atara Biotherapeutics have gained 34.6% in the year-to-date period. ATRA beat estimates in one of the last four quarters and missed the same on the remaining three occasions, delivering a negative earnings surprise of 20.30%.
Alnylam Pharmaceuticals ALNY has an Earnings ESP of +5.87% and a Zacks Rank #3 at present.
Shares of Alnylam have plunged 24.8% year to date. ALNY beat earnings estimates in three of the last four quarters while missing the mark on one occasion, delivering an average surprise of 45.05%. The company is slated to report first-quarter 2024 results on May 2, before the opening bell.
Argenx ARGX has an Earnings ESP of +10.00% and a Zacks Rank #3 at present.
Shares of Argenx have lost 1.3% year to date. ARGX beat earnings estimates in two of the last four quarters and missed the mark on one occasion while meeting on another, delivering an average surprise of 14.18%. The company is set to report first-quarter 2024 results on May 9.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>
Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report
Atara Biotherapeutics, Inc. (ATRA) : Free Stock Analysis Report
argenex SE (ARGX) : Free Stock Analysis Report
Annexon, Inc. (ANNX) : Free Stock Analysis Report
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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.
