Wednesday, May 11, 2022

Zolgensma, Kymriah, Entresto and other new meds help Novartis tread water as its generics business stumbles

Novartis’ efforts to launch several new drugs came at a good time for the drugmaker in the first quarter. Several new meds are off and running, but its generics business stumbled. As a result, the company as a whole treaded water.

In the growth column, Novartis’ heart failure med Entresto turned in a record quarter, generating nearly $800 million. Spinal muscular atrophy drug Zolgensma posted strong growth thanks to increased uptake in Europe and emerging markets. CAR-T lymphoma med Kymriah, sickle cell disease drug Adakveo and immunology med Cosentyx all chipped in, as well.

On the flip side, sales for Novartis’ Sandoz business fell 13% at constant currencies thanks in part to a “historically weak cough and cold season” that resulted from the COVID-19 pandemic, the company said in its first-quarter earnings release

The generics outfit is additionally dealing with pricing pressure, but CEO Vas Narasimhan said Novartis expects the unit’s performance to “stabilize … after a challenging quarter.”

Entresto’s performance leapt off the sales charts Tuesday, but the med also failed a trial in patients who’ve had a heart attack. Sales-wise, the drug turned in a record quarter, growing 39% to $789 million.

RELATED: Amid impressive growth, Novartis’ blockbuster Entresto falls short in post-heart attack trial

Several developments boosted the performance, Novartis’ pharma president Marie-France Tschudin said on a conference call with analysts Tuesday. Physicians are starting to adopt the new American College of Cardiology expert consensus recommendation for Entresto use in the first line of heart failure with reduced ejection fraction. COVID-19’s negative effect on sales is becoming less of a factor, as well, she noted.

And perhaps more importantly, the drug just snagged an FDA nod to expand its use to those with preserved ejection fraction that has ventricular ejection fraction below the normal level. The U.S. label now covers 5 out of 6 patients with chronic heart failure, Tschudin said.

As a result, Entresto is seeing a spike in new-to-brand prescriptions, reaching an all-time high of over 6,200 per week in the U.S. Novartis now estimates that 3.2 million patients are being treated with Entresto today, and Tschudin believes the med still has significant room for growth.

Meanwhile, Novartis investors have also been keeping a close eye on the launch of Kesimpta, a multiple sclerosis drug that aims to challenge Roche’s market-leading Ocrevus. In the first quarter, Kesimpta brought in $50 million, doubling analysts’ consensus.

Despite Kesimpta’s more convenient dosing that allows patients to self-administer the drug at home, the drug has only snagged a 10% new-to-brand share in the U.S., Tschudin said on Tuesday’s call. She attributed the slow uptake to the pandemic affecting physicians’ prescription behavior, namely that doctors prefer to stick with therapies they know well.

RELATED: Novartis study: Nurses and MS patients give thumbs-up to Kesimpta for ease of use

Another growth driver at the Swiss pharma and its largest brand, Cosentyx, grew sales by 13% during the period to $1.05 billion. Novartis is expecting a phase 3 readout later this year for the med in hidradenitis suppurativa, a rare condition characterized by tiny, painful lumps under the skin. The addressable patient population is 400,000, Tschudin said.

Outside the pharma division, sales at the Sandoz generics department slid 9% to $2.3 billion. The lackluster performance came off a price erosion of 10 percentage points, Narasimhan noted during the call. Besides, the quarter’s being compared with an “exceptionally strong” quarter in 2020, when sales were up 11% thanks to stocking of key medicines by consumers and pharmacies in preparation for the pandemic. 

Following the first-quarter performance, 

Novartis dialed down its full-year projection for Sandoz. It now expects the unit’s sales to decline at low- to mid-single digits rather than being flat.

Overall, Novartis’ Q1 sales grew 1% year over year as reported, or declined by 2% at constant currencies, to $12.41 billion. The company maintained its groupwide sales estimate, expecting to see sales grow at low- to mid-single digits.   

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