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Ongoing Story· Day 2

Teva Receives FDA Approval for Monthly Schizophrenia Injection

2 developments

BizportalHealth

Teva Pharmaceuticals Stock Soars on Schizophrenia Drug Launch

Translated & summarized from Bizportal by baba

BusinessNeutral tone

Hebrew · 10 newsrooms covering

Teva Pharmaceuticals' stock rose significantly following the FDA approval and detailed launch plans for Voltroza, a new monthly schizophrenia injection. CEO Richard Francis projects combined annual sales of $1.5-$2 billion for Voltroza and Uzedy, with Voltroza priced at $3,950 per injection. The drug offers a convenient alternative to daily pills, though its success hinges on physician adoption and insurance coverage. Significant revenue is anticipated in the latter half of 2027.

The story in 6 lines · by baba

  • Teva's new schizophrenia injection, Voltroza, received FDA approval and is projected to achieve $1.5-$2 billion in annual sales with Uzedy.
  • Voltroza is priced at $3,950 per monthly injection, with significant revenue expected in the second half of 2027.
  • The drug offers a monthly injection alternative to daily oral schizophrenia medications, potentially improving patient adherence.
  • Analysts questioned Voltroza's sales potential compared to established drugs, while Teva emphasized physician education and insurance coverage.
  • Teva's stock surged approximately 5.4% following the announcement of the drug's launch details.
  • The company has established patient support systems and marketing plans to facilitate Voltroza's adoption.
Teva Pharmaceuticals Stock Soars on Schizophrenia Drug Launch
Editorial illustration generated by baba News, not a photograph of the event.

Teva Pharmaceuticals' stock surged approximately 5.4% on Wall Street following a special conference call with analysts, where significant details about its new monthly schizophrenia injection, Voltroza, were revealed. The U.S. Food and Drug Administration (FDA) approval for Voltroza was anticipated, but the call provided first-time insights into its pricing, marketing strategy, and sales potential.

CEO Richard Francis reiterated Teva's projection that Voltroza, combined with its existing schizophrenia drug, Uzedy, could achieve annual sales of $1.5 to $2 billion. This figure is substantial when compared to Teva's total projected drug sales of $16.5 to $16.85 billion for the current year. A key point of discussion was Voltroza's list price of $3,950 per injection, translating to an annual cost of $47,400 per patient. While this is a high figure, it's noted as a wholesale price, with actual revenue for Teva expected to be lower after discounts to insurers and government health programs.

Analysts questioned the drug's potential sales volume, with Michael DiFiore of Evercore asking if it could rival the past global sales of Eli Lilly's Zyprexa, which reached approximately $5 billion annually. Francis maintained the $1.5-$2 billion target for Voltroza and Uzedy combined, emphasizing the next steps involve educating doctors and patients, securing hospital formulary inclusion, and obtaining insurance coverage. The regulatory approval is just the first step; achieving substantial sales depends on physician adoption, patient transition from oral medications, and insurer willingness to pay.

Voltroza is based on olanzapine, an active ingredient familiar to physicians for decades. Its primary advantage is its monthly subcutaneous injection delivery, a simpler alternative to daily oral pills. Unlike Eli Lilly's older olanzapine injection, Voltroza does not require three hours of medical supervision post-injection due to a rare risk of adverse reactions. It also bypasses the need for special starting injections or continued oral medication during the initial treatment phase, offering a significant benefit for patients struggling with treatment adherence, which can lead to symptom relapse and hospitalization.

Eric Hughes, Teva's head of R&D, highlighted that in long-term trial follow-ups, approximately 4% of patients who stabilized on the treatment experienced a relapse, indicating about 96% maintained stability during the observed period. He noted that about 2.2 million people in the U.S. have schizophrenia, with 1.5 million receiving treatment, and roughly 20% of those on oral medications use olanzapine. Converting even a small fraction of the estimated 300,000 olanzapine pill users to Voltroza could generate significant sales, with ten thousand patients representing nearly $474 million in list price sales annually.

Questions also arose regarding the transition rate from oral medications to injections, with Francis estimating that 13-14% of the relevant antipsychotic treatment market in the U.S. currently uses long-acting injections, a figure that might be higher in Europe. While olanzapine's efficacy is known, its side effects might lead some well-balanced patients to continue their existing oral treatment. Teva is also exploring Voltroza's potential for bipolar disorder, though further research may be needed.

Regarding insurance coverage, Francis projected that about 85% of insured individuals would have coverage by the end of Voltroza's first year on the market, though this process will be gradual due to varying state regulations for Medicaid programs. While Voltroza will be available in the U.S. within weeks, initial sales will be limited, with significant revenue expected in the second half of 2027. Teva has established a patient support system similar to Uzedy's to assist with eligibility and insurance funding. The company plans to distribute Voltroza within weeks, using a system that includes kits and samples for hospitals and doctors, with initial patients likely coming from those currently using olanzapine pills but struggling with daily adherence. Teva has been preparing for this launch for over a year, including national sales training and a public advertising campaign to encourage patient-doctor discussions about the monthly treatment option.

In differentiating Voltroza from Uzedy, Hughes explained that patients already on specific oral medications might be steered towards the corresponding injectable. For instance, those on risperidone pills might be suited for Uzedy (based on the same active ingredient), while olanzapine pill users might be better candidates for Voltroza. Christine Fox, Teva's US commercial lead, added that many doctors visited for Uzedy marketing are also relevant for Voltroza, allowing the sales force to leverage existing relationships. She emphasized that both drugs are important for Teva, catering to slightly different needs and expanding the company's long-acting injectable offerings in schizophrenia treatment. Uzedy itself saw 43% revenue growth in the second quarter, reaching $77 million, with full-year projections of $270-$290 million.

Concerns about olanzapine's side effects, such as weight gain and metabolic changes, were addressed by Hughes, who stated Voltroza's side effect profile is similar to oral olanzapine. He noted that physicians are familiar with managing these effects. While the FDA approved Voltroza without requiring extended post-injection monitoring, the drug's label includes a warning about a potential risk of a rapid drug release syndrome. Regarding pricing, Fox explained that the uniform $3,950 price across all three dosages was a deliberate choice to prevent cost considerations from influencing dose selection. Teva will pay royalties to MedinCell, the developer of the extended-release technology, and incur marketing, distribution, and insurance discount costs.

Francis concluded by reaffirming Teva's strategy of focusing on growth through new drug development and launches, with Voltroza being a key outcome. The company's pipeline includes treatments for Tourette syndrome and inflammatory diseases. Key metrics for the launch's success in the coming months will include prescription numbers, sample usage, physician adoption rates, and hospital approvals. Significant revenue is expected to materialize gradually as insurance funding expands, with the second half of 2027 anticipated to be the first major commercial test.

BizportalOther · Tel Aviv

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