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Pharma Stock Roundup: BAYRY Mixed Q1 Results, AZN, RHHBY Regulatory/Pipeline Updates

The first-quarter earnings season came to an end this week. Bayer BAYRY was the last large drugmaker to report its first-quarter results. AstraZeneca’s AZN Ultomiris received approval for a new rare disease indication in the European Union (EU). The FDA accepted Roche’s RHHBY regulatory application seeking approval of eye drug, Vabysmo for a third retinal condition.

Recap of the Week’s Most Important Stories

Bayer’s Mixed Q1 Results: Bayer announced mixed results for the first quarter, beating estimates for earnings while missing the same for sales. Sales in the Crop Science unit declined 1.1% (Fx & portfolio adjusted), mainly weighed down by the poor performance of the glyphosate-based products. Revenues in the Pharmaceuticals segment were down 3.1% year over year while Consumer Health sales rose 4.1%.

Bayer reaffirmed its previously issued financial guidance for 2023. The company expects to generate currency-adjusted sales of €51-€52 billion in 2023. Core earnings per share are projected in the range of €7.20-€7.40 on a currency-adjusted basis. However, Bayer expects target attainment to come in at the lower end of the guidance.

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Bayer announced a collaboration with Bicycle Therapeutics BCYC for the discovery and development of novel targeted radionuclide therapies for multiple oncology targets leveraging Bicycle’s peptide technology. For the deal, Bayer will make an upfront payment of $45 million to Bicycle Therapeutics, with the latter also being entitled to potential future development and commercial-based milestones, up to a total of $1.7 billion, plus tiered commercial royalties.

Bayer also initiated a phase III study to evaluate aflibercept 8 mg for the treatment of macular edema secondary to retinal vein occlusion (RVO). The study called QUASAR will evaluate the efficacy and safety of aflibercept 8 mg dosed at extended treatment intervals compared to the standard of care, Eylea, and is expected to enroll around 800 patients in 27 countries.

Regulatory applications have already been filed for aflibercept 8 mg for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) in the United States, Europe and Japan.

AstraZeneca’s Ultomiris Gets Approval for New Indication: AstraZeneca announced that the European Commission has granted approval to its long-acting C5 complement inhibitor, Ultomiris, for a new rare disease indication in the EU.

The approval is for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). With the approval, Ultomiris became the only drug approved for the treatment of AQP4 Ab+ NMOSD, a rare and debilitating autoimmune disease, in the EU. The approval was based on data from the CHAMPION-NMOSD phase III study. Ultomiris is also under review in the United States for the treatment of NMOSD. Ultomiris is approved for treating three indications, generalized myasthenia gravis, paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome in certain patients in some countries.

FDA Accepts Roche’s Vabysmo sBLA for Third Indication: The FDA accepted Roche’s supplemental biologics license application (sBLA) seeking approval of eye drug, Vabysmo for the treatment of RVO. Vabysmo is already approved for treating two retinal conditions, nAMD and DME. If approved by the FDA, RVO would be the third indication for the drug. The sBLA was based on data from two phase III studies, BALATON and COMINO, which showed that treatment with Vabysmo led to early and sustained vision improvement, meeting the primary endpoint of non-inferiority compared to aflibercept.

The NYSE ARCA Pharmaceutical Index rose 0.4% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the last five trading sessions.

Zacks Investment Research
Zacks Investment Research


Image Source: Zacks Investment Research

In the last five trading sessions, Lilly rose the most (up 1.7%), while Pfizer declined the most (1.7%).

In the past six months, Novartis has risen the most (23.9%), while Pfizer has declined the most (23.7%).

(See the last pharma stock roundup here: MRK & Others Post Q1 Results, LLY Drug Shines in Obesity Study)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report

Roche Holding AG (RHHBY) : Free Stock Analysis Report

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Bicycle Therapeutics PLC Sponsored ADR (BCYC) : Free Stock Analysis Report

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