MEI Pharma, Inc., a clinical-stage pharmaceutical company, focuses on the development and commercialization of various therapies for the treatment of cancer. The company develops Zandelisib, an oral phosphatidylinositol 3-kinase delta inhibitor for the treatment of patients with relapsed/refractory follicular lymphoma; and Voruciclib, an oral cyclin-dependent kinase 9 inhibitor, which is in Phase I clinical trial for acute myeloid leukemia and B-cell malignancies. It also develops ME-344, a mitochondrial inhibitor targeting the oxidative phosphorylation complex which has completed Phase I clinical trial for the treatment of human epidermal growth factor receptor 2 negative breast cancer. MEI Pharma, Inc. has a license agreement with Presage Biosciences, Inc. The company was formerly known as Marshall Edwards, Inc. and changed its name to MEI Pharma, Inc. in July 2012. MEI Pharma, Inc. was incorporated in 2000 and is headquartered in San Diego, California.

MEI Pharma, Inc.

Health care stocks advanced in late Monday afternoon trading, with the NYSE Health Care Index adding 0.7% and the Health Care Select Sector SPDR Fund (XLV) up 0.5%.
The iShares Biotechnology ETF (IBB) climbed 1.4%.
In corporate news, Hepion Pharmaceuticals (HEPA) shares tumbled nearly 21% after the company agreed to merge with Pharma Two B.
Mira Pharmaceuticals (MIRA) shares skyrocketed 627% after the company outlined more "promising" results on potential advantages of Ketamir-2 to treat neurological and neuropsychiatric disorders.
IQVIA (IQV) shares jumped almost 10% after the company reported higher Q2 adjusted earnings and revenue.
MEI Pharma (MEIP) shares surged nearly 24% after the firm said that it's evaluating strategic alternatives, including potential deals as well as an orderly wind down of the company, if appropriate, to maximize the value of its assets for stockholders.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Sector Update: Health Care Stocks Rise Late Afternoon

Nektar Therapeutics NKTR reported an adjusted loss of 19 cents per share for the third quarter of 2023, which was wider than the Zacks Consensus Estimate of a loss of 18 cents. In the year-ago quarter, the loss was 24 cents per share.
Total revenues increased 2.1% year over year to $24.1 million during the third quarter. Revenues beat the Zacks Consensus Estimate of $21 million.
Quarter in Detail
In the third quarter, product sales increased around 16% from the year-ago quarter’s levels to $5.8 million. Product revenues beat our model estimate of $3.5 million.
Non-cash royalty revenues were $18.2 million, down 0.5% from the year-ago quarter. Non-cash royalty revenues were better than our model estimate of $16.4 million.
License, collaboration and other revenues were $0.2 million in the reported quarter compared with $0.3 million reported in the year-ago quarter.
Research and development (R&D) expenses declined 28.5% to $24 million due to the winding down of the development of bempegaldesleukin (bempeg). NKTR stopped all clinical studies on bempeg in April 2022.
General and administrative (G&A) expenses declined 6.2% year over year to $21.1 million due to the discontinuation of the development of bempeg.
Cash and investments in marketable securities as of Sep 30, 2023 were $372.7 million compared with $409.4 million as of Jun 30, 2023.
Shares of Nektar have plunged 75.8% in the year-to-date period compared with the industry’s decline of 15.1%.
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2023 Guidance
Nektar continues to expect revenues in the range of $80-$90 million, which includes $65-$70 million in non-cash royalties and $15-$20 million in product sales.
R&D costs are expected to range between $105 million and $115 million, unchanged from the previous expectation. G&A costs are now expected to be between $80 million and $85 million compared with the earlier projection of $75-$80 million. Nektar expects to end 2023 with at least $320 million in cash and investments, higher than the prior projection of $315 million.
Pipeline Update
Nektar has two key candidates in its pipeline, rezpegaldesleukin (rezpeg) and NKTR-255.
The company regained full rights to rezpeg from Eli Lily LLY in April 2023 and took charge of its clinical development. Rezpeg was earlier developed in collaboration with Eli Lilly for several autoimmune indications.
Rezpeg is now a wholly owned asset of Nektar, and the latter owes no royalty payments to LLY.
In October 2023, Nektar initiated a phase IIb study of rezpeg in biologic-naïve patients with moderate-to-severe atopic dermatitis (AD), also called eczema.
Data from this study on the primary endpoint of EASI reduction over the 16-week induction period is expected in the first half of 2025. EASI is a validated and widely used standard measurement for AD studies.
Nektar also expects to begin a phase IIb study on rezpeg for treating patients with alopecia areata by early 2024.
In September 2023, Nektar entered into a partnership with Cellular Biomedicine to develop NKTR-255 as a combination therapy for advanced non-small cell lung cancer (NSCLC) patients who are relapsed or refractory to anti-PD-1 therapy.
The study will investigate NKTR-255 in combination with Cellular Biomedicine’s C-TIL051 — a tumor-infiltrating lymphocyte therapy for the given indication.
NKTR-255 is also being evaluated in two separate mid-stage studies in combination with cell therapies and immunotherapy. Along with partner Merck KGaA, Nektar is evaluating NKTR-255 in a phase II study in combination with cell therapies and the phase II JAVELIN Bladder Medley study.
Nektar Therapeutics Price, Consensus and EPS Surprise
Zacks Rank & Stocks to Consider
Nektar currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Dynavax Technologies Corporation DVAX and MEI Pharma, Inc. MEIP. Each stock presently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 15 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 12 cents. Year to date, shares of DVAX have rallied 25.3%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 25.78%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 52.7%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP delivered a four-quarter earnings surprise of 53.58%.
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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.

Nektar Therapeutics (NKTR) Incurs Wider-Than-Expected Q3 Loss

Biogen BIIB reported third-quarter 2023 adjusted earnings per share (EPS) of $4.36, beating the Zacks Consensus Estimate of $3.99. Earnings, however, declined 9% year over year due to higher R&D costs. On a constant currency basis, earnings were flat.
Sales came in at $2.53 billion, up 1% on a reported basis (3% on a constant-currency basis) from the year-ago quarter, as lower sales of multiple sclerosis (MS) drugs like Tecfidera and Tysabri were partially offset by improved revenues from spinal muscular atrophy drug, Spinraza. Sales beat the Zacks Consensus Estimate of $2.39 billion.
Product sales in the quarter were $1.81 billion, down 8% year over year. Revenues from anti-CD20 therapeutic programs rose 1% to $421.0 million. The revenues include royalties on sales of Roche’s RHHBY Ocrevus and Biogen’s share of Roche’s drugs, Rituxan, Gazyva and Lunsumio. Contract manufacturing and royalty revenues rose 135% in the quarter to $304.0 million. Contract manufacturing and royalty revenues include Biogen’s 50% share of revenues (including royalties) from the Leqembi collaboration with Eisai and revenues from the manufacturing of Leqembi. Eisai recorded $2 million in sales from the new Alzheimer's drug, Leqembi, in the third quarter.
Leqembi gained full approval from the FDA for early Alzheimer’s disease in the United States and broad reimbursement from the Centers for Medicare & Medicaid Services (CMS) in July. Regulatory applications seeking approval of Leqembi are under review in China and Europe, and some other countries, while it was approved in Japan in September.
Multiple Sclerosis Revenues
Biogen’s MS revenues were $1.16 billion in the reporter quarter, down 14% on a reported basis and 12% on a constant currency basis year over year.
Tecfidera sales declined 29.4% to $239.5 million as multiple generic versions of the drug have been launched in the United States and new generic launches are ongoing in several EU countries. Tecfidera sales missed the Zacks Consensus Estimate of $245 million.
Vumerity recorded $165.5 million in sales, up 20%. Vumerity sales beat the Zacks Consensus Estimate of $157.0 million and our model estimate of $160.6 million.
Tysabri sales declined 9.7% year over year to $456.3 million, which missed the Zacks Consensus Estimate as well as our estimate of $474 million and $475.1 million, respectively. Tysabri sales are being hurt by increased competition and higher discounts.
Combined interferon revenues (Avonex and Plegridy) in the quarter were $277.7 million, down 17.4%, hurt by a continued shift from the injectable platform to oral or high-efficacy therapies.
Other Products
Sales of Spinraza rose 4% on a reported basis and 7% on a constant currency basis to $448.2 million. Spinraza sales were slightly better than the Zacks Consensus Estimate of 432 million but missed our estimate of $452.4 million.
In the quarter, biosimilar revenues rose 4% on a reported basis and 7% on a constant currency basis year over year to $194 million. A biosimilar of Roche’s Actemra called Tofidence was approved by the FDA in September.
Research and development expenses were $539.0 million, down 2% year over year. Adjusted selling, general and administrative expenses declined 2% year over year to $553.0 million, driven by the company’s cost-saving initiatives.
2023 Guidance Updated
Total revenues are expected to decline by a low-single-digit percentage in 2023 from the 2022 level. Earlier, the company expected revenues to decline by a mid-single-digit percentage.
Adjusted earnings are expected in the range of $14.50 to $15.00, down from the prior expectation of $15.00 to $16.00 per share, reflecting 75 cents dilution from the acquisition of Reata Pharmaceuticals, which closed in September. The acquisition added Reata’s newly approved rare disease drug, Skyclarys, for the treatment of Friedreich’s ataxia to Biogen’s portfolio.
Our Take
Biogen’s third-quarter results were better than expected as it beat estimates on both counts. While it raised its revenue guidance, it lowered its EPS range to include the impact of dilution from the Reata acquisition.
Biogen’s shares were up around 1% in pre-market trading due to a better-than-expected performance in the third quarter and an increase in revenue outlook.
Biogen’s stock has declined 11.2% year to date compared with a decline of 21.3% for the industry.
Image Source: Zacks Investment Research
While most of Biogen’s key drugs are facing declining sales due to intense competitive pressure, Biogen’s new products, such as Leqembi for Alzheimer’s disease, Qalsody for amyotrophic lateral sclerosis with SOD1 mutations and Zurzuvae for depression, could help revive growth. Zurzuvae (zuranolone) was approved by the FDA to treat women with postpartum depression in August and is expected to be launched by the end of 2023. Biogen believes Leqembi has the potential to generate blockbuster sales following its traditional approval and broader CMS coverage in the United States. Biogen expects sales of Leqembi to start growing from 2024.
With its focus shifting to Leqembi, Biogen announced a new restructuring program (called the Fit for Growth initiative) in July, which is expected to result in a headcount reduction of approximately 1,000 employees. The program is expected to generate approximately $1 billion in gross cost savings. Out of these savings, around $300 million are expected to be re-invested in new product launches and R&D activities, which should further save $700 million in costs by 2025.
Zacks Rank & Stocks to Consider
Biogen currently has a Zacks Rank #3 (Hold).
Biogen Inc. Price and Consensus
Some better-ranked stocks in the healthcare sector are Dynavax Technologies Corporation DVAX and MEI Pharma, Inc. MEIP, sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 25.3%.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 52.7%.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2023. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
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Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free 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.

Biogen (BIIB) Beats on Q3 Earnings & Sales, Cuts EPS View

AstraZeneca PLC AZN announced that the FDA has accepted for review its supplemental new drug application (sNDA), seeking expanded use for its blockbuster drug Tagrisso (osimertinib) as a combination treatment in advanced lung cancer.
The company is looking to get approval for Tagrisso in combination with chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the first quarter of 2024.
The FDA generally grants a priority review to drugs with the potential to treat a serious condition. These, if approved, would substantially improve safety or effectiveness.
Currently, Tagrisso is already approved as a monotherapy for treating EFGR-mutated NSCLC.
The latest sNDA was based on data from the phase III FLAURA-2 study.
Data from the study showed that treatment with the Tagrisso+chemotherapy combination reduced the risk of disease progression or death by 38%. The study data also suggested that the Tagrisso+chemotherapy combination extended median progression-free survival by nearly nine and a half months.
Shares of AstraZeneca failed to deliver any returns to investors in the year-to-date period compared with the industry’s increase of 8.5%.
Image Source: Zacks Investment Research
Tagrisso has been one of the key revenue drivers for AstraZeneca. In the first six months of 2023, Tagrisso generated sales worth $2.9 billion, reflecting an increase of 12% year over year at constant exchange rates (“CER”). If approved for the new indication, sales of the drug are likely to rise further as it will be able to address a broader patient population.
AstraZeneca remains focused on strengthening its oncology product portfolio through label expansions of existing products. The company’s oncology franchise clocked sales worth $8.3 billion during the first half of 2023, increasing 21% year over year at CER.
AstraZeneca’s oncology business is now annualizing at almost $15 billion. Constant label expansion for key cancer drugs is likely to boost sales further in the days ahead.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Neurocrine Biosciences, Inc. NBIX, Sarepta Therapeutics, Inc. SRPT and MEI Pharma, Inc. MEIP, sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Neurocrine Biosciences’ 2023 earnings per share have risen from $2.17 to $2.19. During the same period, estimates for 2024 have risen from $4.77 to $4.86 per share. Year to date, shares of NBIX have lost 4.9%.
Earnings of Neurocrine Biosciences beat estimates in one of the last four quarters and missed the same on the other three occasions. NBIX delivered a four-quarter negative average earnings surprise of 105.45%.
In the past 60 days, estimates for Sarepta’s 2023 loss per share have improved from $9.73 to $9.19. During the same period, loss per share estimates for 2024 have narrowed from $1.66 to $1.00. Year to date, shares of SRPT have declined 9.3%.
Earnings of Sarepta Therapeutics beat estimates in three of the trailing four quarters and missed the mark on the other occasion. On average, SRPT delivered a negative earnings surprise of 5.15% in the last four quarters.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 40.4%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with an average four-quarter earnings surprise of 53.58%.
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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.

MEI Pharma, Inc.

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