Are Investors Undervaluing ANI Pharmaceuticals (ANIP) Right Now?

Zacks

Here at Zacks, we focus on our proven ranking system, which places an emphasis on earnings estimates and estimate revisions, to find winning stocks. But we also understand that investors develop their own strategies, so we are constantly looking at the latest trends in value, growth, and momentum to find strong companies for our readers.

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 a variety of methods, including tried-and-true valuation metrics, to find these stocks.

In addition to the Zacks Rank, investors looking for stocks with specific traits can utilize our Style Scores system. Of course, value investors will be most interested in the system's "Value" category. Stocks with "A" grades for Value and high Zacks Ranks are among the best value stocks available at any given moment.

One stock to keep an eye on is ANI Pharmaceuticals (ANIP). ANIP is currently holding a Zacks Rank of #1 (Strong Buy) and a Value grade of A.

Investors should also recognize that ANIP has a P/B ratio of 3.16. Investors use the P/B ratio to look at a stock's market value versus its book value, which is defined as total assets minus total liabilities. This stock's P/B looks solid versus its industry's average P/B of 3.91. ANIP's P/B has been as high as 3.30 and as low as 2.31, with a median of 2.87, over the past year.

Value investors also love the P/S ratio, which is calculated by simply dividing a stock's price with the company's sales. This is a popular metric because sales are harder to manipulate on an income statement, so they are often considered a better performance indicator. ANIP has a P/S ratio of 2.27. This compares to its industry's average P/S of 6.74.

These are only a few of the key metrics included in ANI Pharmaceuticals's strong Value grade, but they help show that the stock is likely undervalued right now. When factoring in the strength of its earnings outlook, ANIP looks like an impressive value stock at the moment.

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FATE Q3 Earnings Beat on Higher Revenues, Pipeline in Focus

Zacks

Fate Therapeutics FATE reported a loss of 40 cents per share in the third quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 42 cents. The company reported a loss of 46 cents per share in the year-ago period.

The loss narrowed year over year due to higher collaboration revenues.

The company earned collaboration revenues of $3.1 million, which beat the Zacks Consensus Estimate of $1 million. The figure also increased from $1.9 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.

R&D expenses increased 1.1% to $34.6 million. G&A expenses increased 9.8% to $20.8 million.

Cash, cash equivalents and investments as of Sept. 30, 2024, totaled $330.5 million.

Shares of Fate have lost 36.3% year to date compared with the industry’s decline of 3.7%.

Find the latest EPS estimates and surprises on Zacks Earnings Calendar.

FATE's 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 first three patients, all of whom were suffering from active lupus nephritis (LN) despite having been treated with multiple standard-of-care therapies, received fludarabine-free conditioning consisting of either bendamustine or cyclophosphamide alone, followed by a single dose of FT819 at 360 million cells. All three patients continue to be on study. FATE did not observe dose-limiting toxicities (DLTs) or any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD).

The first patient treated in the ongoing phase I autoimmunity study on FT819 was a 27-year-old woman diagnosed with lupus nephritis (over ten years ago). She received fludarabine-free conditioning chemotherapy followed by a single dose of FT819 at 360 million cells. The patient remains on study.

FATE also amended the clinical protocol of its phase I autoimmunity study on FT819 to include a second treatment arm (Regimen B) 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.

Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate, with ONO Pharmaceutical. The company 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.

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.

Enrollment is ongoing at the second dose level of 300 million cells as monotherapy and at the first dose level of 100 million cells combined with epidermal growth factor receptor (EGFR)-targeted monoclonal antibody therapy.

A phase I study of FT522 in patients with relapsed/refractory B-cell lymphoma is ongoing. FATE is enrolling patients in the second three-dose cohort at 900 million cells per dose with conditioning chemotherapy (Regimen A) and in the first three-dose cohort at 300 million cells per dose without conditioning chemotherapy (Regimen B). No DLT or event of any grade of CRS, ICANS, or GvHD was reported in the phase I study.

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).

Zacks Rank & Stocks to Consider

FATE 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 frame. Year to date, shares of IMCR have lost 49.3%.

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 increased from $4.82 to $5.65 during the same time.

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 frame. CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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Axsome's Q3 Earnings Beat, Auvelity Drives Sales Growth, Stock Up

Zacks

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%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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SpringWorks' Q3 Loss Narrower Than Expected, Revenues Miss Mark

Zacks

SpringWorks Therapeutics

+5.30%

ANI Pharmaceuticals

-1.54%

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%.

ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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Mirum's Q3 Earnings Beat Estimates, 2024 Revenue View Raised

Zacks

Immunocore

-4.54%

Mirum Pharmaceuticals

Mirum Pharmaceuticals, Inc. MIRM incurred a loss of 30 cents per share in third-quarter 2024, much narrower than the Zacks Consensus Estimate of a loss of 45 cents. The company had reported a loss of 57 cents per share in the year-ago quarter.

Revenues in the third quarter totaled $90.3 million, up 89% year over year. The figure also beat the Zacks Consensus Estimate of $82 million. The top line comprised Livmarli (maralixibat) sales, newly acquired Cholbam and Chenodal sales, and minimal license and other revenues.

Mirum acquired Travere Therapeutics’ bile acid products in August 2023, which added the latter’s Cholbam capsules and Chenodal tablets to its portfolio of commercialized drugs.

Shares of Mirum were up in pre-market trading on Nov. 12 owing to better-than-expected results and increased guidance for 2024. The stock has rallied 40.9% so far this year against the industry’s decline of 1.2%.

Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.

More on MIRM's Q3 Results

Livmarli’s net product sales were $59.1 million in the third quarter, reflecting an increase of almost 52.7% year over year.

Net product sales of newly acquired Cholbam and Chenodal were $31.2 million.

License and other revenues were $0.07 million in the reported quarter. The company did not record any such revenues in the year-ago quarter.

Research and development expenses increased 21.5% year over year to $31.7 million.

Selling, general and administrative expenses totaled $50.5 million, up almost 38.3% from the year-ago quarter’s level.

As of Sept. 30, 2024, Mirum had cash, cash equivalents and marketable securities worth $293.8 million compared with $295.4 million as of June 30, 2024.

2024 Guidance

Mirum increased its financial guidance for 2024. The company now expects revenues in the range of $330-$335 million compared with the earlier projection of $310-$320 million.

MIRM's Recent Updates

Along with the earnings release, the company announced that it has initiated the phase III EXPAND study, which is a label expansion opportunity for Livmarli in additional settings of cholestatic pruritus.

The European Commission approved Livmarli oral solution for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged three months and above in July 2024. PFIC is a rare genetic disorder that causes liver failure.

The FDA approved a label expansion for Livmarli oral solution to include the treatment of cholestatic pruritus in patients aged five years and older with PFIC in March. Livmarli is also approved for treating cholestatic pruritus in PFIC patients aged 12 months and above in the United States.

In June 2024, the new drug application for chenodiol for treating cerebrotendinous xanthomatosis patients was filed in the United States. The FDA has set a target action date of Dec. 28, 2024.

Mirum’s pipeline candidate, volixibat, is currently being evaluated in two phase IIb studies for treating patients with primary biliary cholangitis (the VANTAGE study) and primary sclerosing cholangitis (the VISTAS study).

Last month, the FDA granted a Breakthrough Therapy designation to volixibat as a potential treatment for cholestatic pruritus in patients with primary biliary cholangitis.

Along with the earnings release, Mirum announced that it has in-licensed a PDE4D inhibitor, MRM-3379, for treating Fragile X syndrome, a rare neurocognitive disorder. A phase II study on the same is expected to begin in 2025.

Mirum Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

Mirum Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Mirum Pharmaceuticals, Inc. Quote

MIRM's Zacks Rank & Key Picks

Mirum currently carries a Zacks Rank #4 (Sell).

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 49.3%.

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%.

ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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ANI Pharmaceuticals Price Target Maintained With a $94.00/Share by HC Wainwright & Co.

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-1.54%

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Ani Pharmaceuticals Inc : Guggenheim Raises Target Price To $84 From $83

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Are Investors Undervaluing ANI Pharmaceuticals (ANIP) Right Now?

FATE Q3 Earnings Beat on Higher Revenues, Pipeline in Focus

Axsome's Q3 Earnings Beat, Auvelity Drives Sales Growth, Stock Up

SpringWorks' Q3 Loss Narrower Than Expected, Revenues Miss Mark

Mirum's Q3 Earnings Beat Estimates, 2024 Revenue View Raised

ANI Pharmaceuticals Price Target Maintained With a $94.00/Share by HC Wainwright & Co.

Ani Pharmaceuticals Inc : Guggenheim Raises Target Price To $84 From $83

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