Amgen reports 3% drop in Q3 sales, as biosimilar revenue climbs; full-year forecast raised

Headline results for the third quarter:

Revenue

$5.7 billion (forecasts of $5.6 billion)

-3%

Product Sales

$5.5 billion

-1%

Profit

$2 billion

Versus $1.9 billion

Note: All changes are versus the prior-year period unless otherwise stated

 

What the company said:

CEO Robert Bradway said "Amgen continues to execute well in a dynamic environment, with many of our medicines delivering double-digit, volume-driven growth, complemented by the strong performance of our recently launched biosimilar products." The drugmaker noted that although product sales declined 1% globally, units grew by double digits or better for Prolia, Repatha, Aimovig, Parsabiv, Kyprolis and Blincyto.

 

Meanwhile, Bradway indicated that Amgen is also "pursuing external opportunities that will contribute to our long-term growth, such as our pending acquisition of Otezla."

 

Other results:

  • Enbrel: $1.4 billion, up 6%, forecasts of $1.3 billion, driven by higher net selling price, offset partially by lower unit demand
  • Neulasta: $711 million, down 32%, due to lower net selling price, plus biosimilar competition hitting unit sales
  • Prolia: $630 million, up 18%, bolstered by higher unit demand
  • Xgeva: $476 million, up10%, driven primarily by higher unit demand
  • Aranesp: $452 million, down 5%, with the impact of competition hurting unit demand
  • Kyprolis: $266 million, up 15%, led mainly by higher unit demand
  • Repatha: $168 million, up 40%, just shy of forecasts of $170.3 million, with higher unit demand partially offsetting lower net selling price; Amgen recently said the PCSK9 inhibitor would be made available only at the 60% lower list price in 2020
  • Parsabiv: $157 million, up 54%, driven by higher unit demand, offset partially by lower net selling price
  • Sensipar/Mimpara: $109 million, down 73%, hurt by continued generic competition
  • Aimovig: $66 million, up from $22 million in the year-ago period, but falling short of the $94.5 million analysts were projecting
  • Blincyto: $85 million, up 47%, fuelled by higher unit demand
  • Biosimilars (including Kanjinti, Amgevita and Mvasi): $173 million, up from $19 million in the corresponding prior-year period

 

Looking ahead:

Amgen is boosting its 2019 sales outlook to between $22.8 billion and $23 billion, versus a range of $22.4 billion to $22.9 billion previously, while full-year earnings are now projected to be from $14.20 per share to $14.45 per share, up from its earlier forecast of between $13.75 and $14.30 a share. The revised guidance excludes the impact of the Otezla acquisition, which is expected to close before the end of the fourth quarter.

 

Pipeline update:

Amgen said a Phase III study evaluating tezepelumab in adults and adolescents with severe uncontrolled asthma has completed enrollment, with the primary analysis expected late next year, while a mid-stage trial of the therapy is enrolling adult patients with moderate-to-very severe chronic obstructive pulmonary disease. Tezepelumab is being co-developed with AstraZeneca.

 

Meanwhile, a Phase II study of AMG 510 monotherapy in non-small-cell lung cancer continues to enroll patients. The company stated that an initial cohort of colorectal cancer patients has been enrolled at the target dose in a Phase II monotherapy study, and "as the data mature, [we] will determine the development path for colorectal cancer."

 

Amgen also indicated that an FDA filing for ABP 798, a biosimilar candidate to Roche and Biogen's Rituxan that it is co-developing with Allergan, is expected in the first quarter of 2020. The company noted that the recent Phase III JASMINE study in patients with CD20-positive B-cell non-Hodgkin's lymphoma had met its primary endpoint, "showing clinical equivalence" of ABP 798 with Rituxan.

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