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Ahead of World Diabetes Day, Doctors Without Borders/Médecins Sans Frontières (MSF) called for all insulin manufacturers to provide injection pen devices at $1 per pen.

The humanitarian organization emphasized that this would help ensure access to life-saving treatment for millions in low- and middle-income countries, where many struggle to afford diabetes care.

MSF highlighted that Eli Lilly And Co , Novo Nordisk A/S , and Sanofi SA , which dominate the global insulin market, have the power to set high prices that restrict access.

Also Read: Bristol-Myers Squibb Leads Biopharma Recovery With Almost 25% Growth In Market Cap, But Novo Nordisk And Lilly Suffer Market Setbacks

According to MSF, data published in JAMA Network Open shows that insulin pens could be produced for as little as $0.94 per unit and remain profitable, yet current prices far exceed this figure.

For instance, a pen costs $1.99 in South Africa, $5.77 in India, $14.00 in the Philippines, and $90.69 in the U.S.

Dr. Helen Bygrave, an advisor for MSF's Access Campaign, underscored the disparity by recalling the initial intentions of the scientists who discovered insulin. "Over 100 years ago, they sold the patent for just $1 to ensure global access. Now, only about half of those who need insulin can access it," she said.

She stated that the corporate control by Eli Lilly, Novo Nordisk, and Sanofi has led to a "double standard" that hinders equitable diabetes treatment.

In July, the FDA rejected Novo Nordisk's BLA filing for the once-weekly insulin icodec.

Insulin pens, known for their dosing accuracy and user-friendly design, have been preferred by 82% of surveyed diabetes patients due to their convenience and less invasive administration compared to vials and syringes.

Recently, Novo Nordisk decided to cease insulin pen production to prioritize its GLP-1 medications for diabetes and obesity, like Ozempic and Wegovy.

This shift, motivated by profit margins in wealthier markets, could force many patients back to using syringes and vials.

South Africa, which transitioned to insulin pens in its public sector in 2014, recently faced a shortage that led to rationing when Novo Nordisk paused the supply of human insulin pens to the government.

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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.

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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.

Prothena Corporation PRTA reported a loss per share of $1.10 per share in the third quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of $1.18.

In the year-ago quarter, the company posted earnings of 38 cents per share, driven by higher revenues.

Third-quarter 2024 revenues totaled $1 million, which missed the Zacks Consensus Estimate of $2 million. PRTA recorded revenues of $85 million in the third quarter of 2023 on the back of collaboration revenues from partner Bristol Myers Squibb BMY.

The company’s shares have lost 52.2% year to date compared with the industry’s decline of 0.9%.

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PRTA's Q3 Results in Detail

Research and development (R&D) expenses decreased 12.4% year over year to $50.7 million, primarily due to lower manufacturing expenses.

General and administrative expenses amounted to $16.8 million, up from $16.6 million in the year-ago quarter, primarily due to higher personnel-related expenses.

As of Sept. 30, 2024, Prothena had $520.1 million in cash, cash equivalents and restricted cash, and no debt.

Pipeline Updates from PRTA

Prothena is evaluating PRX012 — a wholly owned investigational next-generation subcutaneous, single-injection once-monthly antibody delivered subcutaneously targeting a key epitope at the N-terminus of amyloid beta (Aβ) — for treating Alzheimer’s Disease (AD).

Initial phase I single ascending dose and multiple ascending dose data support once-monthly subcutaneous administration and ongoing evaluation in MAD cohorts.

PRTA has enrolled approximately 260 patients in the ongoing ASCENT clinical studies on PRX012. Prothena expects to report multiple clinical readouts starting in mid-2025.

PRTA is advancing an early-stage pipeline of programs for several potential neurological indications with BMY.

BMS-986446 (formerly PRX005) is designed to be a best-in-class anti-tau, MTBR-specific antibody for the potential treatment of AD.

Bristol Myers continues to enroll in the ongoing phase II study on BMS-986446 in approximately 475 patients with early AD. The study is expected to be completed in 2027.

BMY is responsible for all development, manufacturing and commercialization of BMS-986446.

PRX019, a potential treatment of neurodegenerative diseases with an undisclosed target, is also being developed in collaboration with BMY. PRTA has initiated a phase I first-in-human clinical trial on PRX019 to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of single ascending and multiple doses in healthy adults.

Prothena is also developing a dual Aβ-Tau vaccine, PRX123, a potential prevention and treatment for AD. It is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau, designed to promote amyloid clearance and block the transmission of pathogenic tau. The FDA cleared an investigational new drug application.

The regulatory body granted Fast Track designation to PRX123 for the treatment of AD. Prothena expects to update plans for the phase I study in 2025.

The company is evaluating prasinezumab, in collaboration with Roche RHHBY, for the treatment of Parkinson’s disease (PD).

A phase II study, PASADENA, is being conducted by Roche in patients with early PD. Data from the study showed that patients taking prasinezumab continued to show reduced motor and functional progression compared with real-world data after four years.

Top-line results from the phase IIb PADOVA study, which has completed enrollment, are expected in the ongoing quarter.

Prothena is also evaluating birtamimab, a wholly-owned potential treatment for AL amyloidosis. PRTA reached a Special Protocol Assessment agreement with the FDA and initiated a confirmatory phase III AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis. Top-line results from the study are expected in the first half of 2025.

Novo Nordisk NVO acquired Prothena’s clinical-stage antibody, Coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy.

NVO is conducting an ongoing phase II study in patients with ATTR cardiomyopathy. The study has completed enrollment of approximately 99 patients and top-line data from the same is expected in the first half of 2025.

PRTA Reiterates 2024 Guidance

The company expects 2024 net cash burn from operating and investing activities to be in the range of $148-$160 million. Prothena expects year-end cash, cash equivalents and restricted cash midpoint to be approximately $468 million. Net loss for 2024 is projected to be in the $120-$135 million range.

PRTA currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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