Alexion Pharmaceuticals, Inc. ALXN posted better-than-expected results for the second quarter of 2020 and raised its revenue and adjusted earnings guidancefor 2020.
The second-quarter adjusted earnings of $3.11 per share comfortably beat the Zacks Consensus Estimate of $2.55 and grew from $2.64 in the year-ago quarter.
Moreover, revenues rose 20.1% year over year to $1.44 billion in the reported quarter and surpassed the Zacks Consensus Estimate of $1.27 billion. The negative impact of foreign currency on total revenues was 1%, inclusive of hedging activities. Revenues were driven by higher sales of Ultomiris, Strensiq and Kanuma.
Shares of Alexion have lost 3.2% in the year so far against the industry’s growth of 5.1%.
Revenues in Detail
Soliris (approved for the treatment of paroxysmal nocturnal hemoglobinuria [PNH], atypical hemolytic uremic syndrome [aHUS] and generalized myasthenia gravis [gMG]) sales were down5.4% year over year to $975.5million in the reported quarter.
Long-acting C5 complement inhibitor, Ultomiris approved for the treatment of adult patients with PNH and aHUS, generated sales of $251.1 million compared with $54.2 million in the year-ago quarter,representing a 363% increase.The company achieved its goal of establishing Ultomiris as a new standard of care in PNH, with more than 70% patient conversion from Soliris in the United States.
Strensiq revenues were $184.3 million (up 30% year over year). Kanuma contributed $33.6 million (up 28% year over year) to quarterly revenues.
In June, the European Commission approved Ultomiris for adults and children with aHUS.
Cost Summary
Adjusted research and development (R&D) expenses increased to $204.6 million from $148.7 million in the year-ago quarter.
Adjusted selling, general and administrative (SG&A) expenses were $253.6 million, down from $255.8 million in the year-ago quarter.
2020 Guidance
Alexion increased total revenues and adjusted earnings per share guidance and reducedthe operating margin guidance.
The company now expects adjusted earnings per share of $10.65-$10.95 (previous guidance:$10.45-$10.75). The company now projects revenues of $5.50-$5.60 billion (previous guidance: $5.23-$5.33 million).
Combined revenues from Soliris and Ultomiris are now estimated at $4.73-$4.76 billion (previous guidance: $4.49-$4.57 billion).
Pipeline Update
Alexion plans to initiate a phase II/III study in children and adolescents with Neuromyelitis Optica Spectrum Disorder (NMOSD) in the second half of 2020.
An application for approval of Ultomiris in aHUS is under review in Japan. A phase III study of Ultomiris in children and adolescents with aHUS is underway
Applications for approval of Ultomiris100mg/mL formulation are under review in the EU and the United States. The FDA has set an action date of Oct 11, 2020. This higher concentration formulation is designed to reduce infusion time by more than 50% to approximately 45 minutes. Alexion plans to file for regulatory approval of this formulation in Japan in the third quarter of 2020.
Recent Developments
In July 2020, Alexion announced the completion of its acquisition of Portola. The acquisition added Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] to the company’s commercial and development portfolios. Andexxa has conditional approval in the United States and the EU (marketed as Ondexxya in the EU) for the reversal of anticoagulation in patients experiencing life-threatening or uncontrolled bleeding who are treated with rivaroxaban or apixaban.
Our Take
Alexion’s second-quarter results were strong despite the COVID-19 pandemic. The company continues to take proactive measures designed to mitigate the risk of potential interruptions in supply and/or access to patients’ customary site-of-care locations. The company also witnessed accelerated conversion from Soliris to Ultomiris.
Alexion’s efforts to diversify its portfolio through prudent acquisitions are encouraging.
Zacks Rank & Key Picks
Alexion currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Emergent BioSolutions Inc. EBS, BioMarin Pharmaceutical Inc. BMRN and Applied Therapeutics Inc. APLT, all carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings per share estimates have increased from $3.14 to $4.23 for 2020 and from $3.35 to $4.63 for 2021 in the past 60 days.
BioMarin’s earnings per share estimates have increased from $1.51 to $1.57 for 2020 and from $2.46 to $2.80 for 2021 in the past 60 days.
Applied Therapeutics’ earnings per share estimates have increased from 46 cents to 47 cents for 2021 in the past 60 days.
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