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Pharma Stock Roundup: Q2 Earnings of MRK, PFE & Others, FDA Approvals for GSK, ABBV

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This week Pfizer PFE, Merck MRK, AstraZeneca AZN, Glaxo GSK and Sanofi SNY announced second-quarter results with most beating estimates on both counts. The FDA approved AbbVie ABBV new antibiotic injection, Dalvance (dalbavancin) for skin infections and expanded the use of Merck’s blockbuster PD-L1 inhibitor, Keytruda and Glaxo’s shingles vaccine, Shingrix and asthma drug, Nucala.

Recap of the Week’s Most Important Stories

Q2 Earnings Season in Full Swing: Pfizer’s second-quarter results were strong as it beat estimates for both earnings and sales. Pfizer raised its financial outlook for 2021 for the second time this year, mainly due to increasing revenue expectations from BNT162b2, its COVID-19 vaccine.

Merck’s second-quarter results were mixed as it missed estimates for earnings while beatingthe same for sales. Ongoing recovery from the pandemic and strong global underlying demand across its business led to improved sales in the quarter. Merck tightened its previously issued financial guidance for 2021. Merck expects revenues to be in the range of $46.4 billion to $47.4 billion in 2021 compared with $45.8 billion to $47.8 billion, expected previously.

Glaxo beat estimates for both earnings and revenues on the back of strong recovery across all segments.Glaxo maintained its previous guidance for adjusted earnings to decline in 2021 by mid- to high-single digit percentage at CER.

Sanofi’s results were strong as it beat estimates for both earnings and sales. Dupixent continued its outstanding performance in the quarter while sales recovered in the Vaccines unit. The company increased its guidance for earnings growth. It now expects earnings to grow around 12% at CER in 2021 compared to the previous projection of high single-digit range.

AstraZeneca also beat estimates on both counts. Sales rose 27% at constant exchange rate. The company’s COVID-19 vaccine added $894 million to revenues. AstraZeneca provided updated financial guidance to include the impact of the recently closed Alexion acquisition.

FDA Approves AbbVie’s New IV Antibiotic for Skin Infections: The FDA approved AbbVie’s Dalvance (dalbavancin) injection for treating acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients. Dalvance is the first and the only single-dose option administered as a 30-minute intravenous (IV) infusion to treat ABSSSI in pediatric patients from birth.

The FDA also approved a label expansion of AbbVie’s drug Botox to include eight new muscles to treat adults with upper limb spasticity.

FDA Approves Merck’s Keytruda for Early Stage TNBC: The FDA also approved Merck’s Keytruda in combination with chemotherapy as a neoadjuvant and then continued as an adjuvant therapy for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). The approval was based on data from the pivotal phase III KEYNOTE-522 study. In breast cancer, Keytruda plus chemo is presently approved to treat locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) based on results from phase III KEYNOTE-355 study. The FDA also converted this accelerated approval to a regular one based on confirmatory data from KEYNOTE-522 study.

FDA Approves Expanded Use of Glaxo’s Shingrix and Nucala: The FDA approved Glaxo’s asthma medicine Nucala for a new indication, chronic rhinosinusitis with nasal polyps (CRSwNP). Nucala, an anti-IL5 biologic, is presently marketed for eosinophil-driven diseases like severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome (HES) in the United States.

The FDA also approved Glaxo’s Shingrix for the prevention of shingles in adults aged 18 years and older in immunocompromised adults. Until now, it was approved for the prevention of shingles in adults 50 years of age or older.

FDA Grants Priority Tag to Roche’s Eye Candidate BLA: The FDA accepted Roche’s BLA seeking approval of faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME), two retinal diseases which are the leading causes of vision loss. The FDA granted priority review to the BLA. If approved for nAMD and DME, faricimab would be the first in a new class of eye medicines targeting two key pathways that drive retinal diseases that can cause vision loss.

CHMP Updates for AstraZeneca’s and Sanofi’s Drugs: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency gave a positive opinion,recommending approval for expanded use of its rare disease drug, Ultomiris for use in children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH). Ultomiris was added to AstraZeneca’s portfolio with the recent acquisition of Alexion. Ultomiris is already approved in the EU for the treatment of adults with PNH. In the United States,it was approved to treat PNH in children (one month of age and older) and adolescents in June.

The CHMP also recommended approving Sanofi’s investigational enzyme replacement therapy (ERT), avalglucosidase alfa, for the treatment of Pompe disease, a rare degenerative muscle disorder. However, the CHMP considered that avalglucosidase alfa does not qualify as a New Active Substance (NAS),which means a substance not previously authorized as a medicinal product in the EU. Sanofi plans to request a re-examination of the CHMP opinion for the NAS decision. A new drug application (NDA) seeking approval of avalglucosidase alfa is under priority review in the United States.

Sanofi’s Dupixent Succeeds in Urticaria Study: Sanofi’s phase III study evaluating its blockbuster drug, Dupixent in patients with chronic spontaneous urticaria (CSU) met its primary endpoints and all key secondary endpoints. The data showed that at 24 weeks, Dupixent, added to standard-of-care antihistamines, nearly doubled reduction in itch and urticaria activity scores in CSU patient population compared to antihistamines alone. Dupixent now is approved in the United States and the EU for three type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma and moderate-to-severe atopic dermatitis.

Lilly’s New Immuno-Oncology Deal: Lilly LLY announced a collaboration deal with Kumquat Biosciences to discover and develop novel small molecules that stimulate tumor-specific immune responses. Lilly has the option to select some novel immuno-oncology drug candidates that Kumquat discovers as part of the deal for further development and commercialization worldwide, excluding Greater China. For the deal, Lilly will make a payment of $70 million,which comprises a cash upfront payment and an equity investment while being eligible to receive over $2 billion in potential milestone payments.

The FDA broadened Lilly and Incyte’s Emergency Use Authorization for Olumiant (baricitinib) to allow it for treatment of COVID-19 in hospitalized patients with or without remdesivir. Earlier,the EUA had only allowed use in combination with remdesivir

The NYSE ARCA Pharmaceutical Index rose 1.6% 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.

In the last five trading sessions, all the stocks were in the green except AstraZeneca. Pfizer rose the most (3.2%). AstraZeneca’s stock declined 0.5%.

In the past six months, Lilly has recorded the maximum gain (20.8%) while Merck declined the most (0.5%)

(See the last pharma stock roundup here: JNJ, NVS Q2 Earnings, PFE, ABBV, LLY & MRK FDA Updates)

What's Next in the Pharma World?

Watch out for Eli Lilly, Novo Nordisk and Bayer’s Q2 earnings and regular pipeline and regulatory updates next week.


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