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Amgen Stock Up This Year So Far: Will the Rally Continue?
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Amgen, Inc.’s (AMGN - Free Report) stock is up 13.5% this year so far against 6.6% decrease of its industry.
Its strong quarterly results and positive pipeline and regulatory updates have all contributed to the upside.
Strong Quarterly Results
Amgen performed well in the first two quarters of 2018, beating estimates on both occasions. In the first half of 2018, earnings per share increased 14% year over year driven by higher product sales, a lower tax rate and lower share count. Total revenues increased 3% in the first half as increasing demand for newer products like Prolia, Kyprolis, Xgeva, Repatha and Blincyto was partially offset by lower sales of mature brands like Enbrel, Aranesp, Epogen, Neulasta and Neupogen due to competitive pressure.
On the second-quarter conference call, the biotech giant raised its sales and earnings guidance for 2018. Better-than-expected second-quarter results and an optimistic outlook for the rest of the year led to the increase in the earnings guidance.
Pipeline & Regulatory Successes
In the first half, Amgen made rapid progress with its pipeline and line extensions.
Aimovig/erenumab for prevention of migraine was approved and launched in the United States in second quarter of 2018. Aimovig is the first FDA-approved treatment, specifically developed to treat migraine by blocking calcitonin gene-related peptide (CGRP). Aimovig was approved in the EU in July. Amgen has developed Aimovig in partnership with Novartis (NVS - Free Report) .
Amgen also gained approval for several line extensions this year. In the first half of 2018, Xgeva was approved in both the United States and EU for the prevention of skeletal-related events in patients with multiple myeloma; Prolia was approved for a new indication, glucocorticoid-induced osteoporosis, in both the United States and EU, and Blincyto was approved in the United States for a new indication, minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (“ALL”).
The line extensions can expand the eligible patient populations of these drugs and drive their sales higher in future quarters. Also, in 2017/early 2018, Amgen gained regulatory approvals to include overall survival data from key studies in the labels for Kyprolis and Blincyto, which can drive sales of these products.
Amgen has also delivered on its biosimilars pipeline this year, which represents significant growth opportunity. Amgen has a collaboration agreement with Allergan for the worldwide development and commercialization of four oncology antibody biosimilars. Amgen/Allergan’s biosimilar version of Roche’s (RHHBY - Free Report) Avastin, Mvasi, was approved in the United States in September 2017 and in the EU in January this year. Meanwhile, the biosimilar versionof Roche’s another cancer drug Herceptin, Kanjinti was launched in the EU last month while it is under review in the United States. A biosimilar of Rituxan (ABP 798) is in phase III development.
What to Expect in the Second Half?
Amgen’s newer drugs – Prolia, Xgeva, Blincyto, Repatha, Kyprolis – are performing well. The trend is expected to continue in the second half, which should drive sales. Besides this, Amgen’s restructuring plan is making it leaner and more cost efficient, which is likely to lend support to the bottom line.
Meanwhile, several pivotal data readouts and regulatory milestones are expected in the second half.
However, there are some challenges for the company in the second half as well. These include a continued decline in sales of mature drugs like Enbrel, Aranesp and Neulasta, which are facing an array of branded and generic competitors. While Neupogen is already facing U.S. biosimilar competition, Neulasta, Epogen and Sensipar could start facing the same in the second half. Mylan’s biosimilar version of Neulasta, Fulphila, which is priced at a discount of 33% to Neulasta’s list price, was approved by the FDA in June and launched in July. This could hurt sales of Neulasta in the second half of 2018.
Other biosimilar versions of Neulasta may also receive approval in the second half of 2018. A biosimilar version of Epogen was also approved in the second quarter of 2018 and may be launched soon. Sensipar lost patent exclusivity in March 2018 and generics are expected to be launched this year.
Also, competitive pressure on newly launched Aimovig will rise in the second half. Lilly and Teva’s CGRP antibodies for migraine prevention, Emgality/galcanezumab and fremanezumab, respectively could be approved and launched in the United States in the second half.
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Amgen Stock Up This Year So Far: Will the Rally Continue?
Amgen, Inc.’s (AMGN - Free Report) stock is up 13.5% this year so far against 6.6% decrease of its industry.
Its strong quarterly results and positive pipeline and regulatory updates have all contributed to the upside.
Strong Quarterly Results
Amgen performed well in the first two quarters of 2018, beating estimates on both occasions. In the first half of 2018, earnings per share increased 14% year over year driven by higher product sales, a lower tax rate and lower share count. Total revenues increased 3% in the first half as increasing demand for newer products like Prolia, Kyprolis, Xgeva, Repatha and Blincyto was partially offset by lower sales of mature brands like Enbrel, Aranesp, Epogen, Neulasta and Neupogen due to competitive pressure.
On the second-quarter conference call, the biotech giant raised its sales and earnings guidance for 2018. Better-than-expected second-quarter results and an optimistic outlook for the rest of the year led to the increase in the earnings guidance.
Pipeline & Regulatory Successes
In the first half, Amgen made rapid progress with its pipeline and line extensions.
Aimovig/erenumab for prevention of migraine was approved and launched in the United States in second quarter of 2018. Aimovig is the first FDA-approved treatment, specifically developed to treat migraine by blocking calcitonin gene-related peptide (CGRP). Aimovig was approved in the EU in July. Amgen has developed Aimovig in partnership with Novartis (NVS - Free Report) .
Amgen also gained approval for several line extensions this year. In the first half of 2018, Xgeva was approved in both the United States and EU for the prevention of skeletal-related events in patients with multiple myeloma; Prolia was approved for a new indication, glucocorticoid-induced osteoporosis, in both the United States and EU, and Blincyto was approved in the United States for a new indication, minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (“ALL”).
The line extensions can expand the eligible patient populations of these drugs and drive their sales higher in future quarters. Also, in 2017/early 2018, Amgen gained regulatory approvals to include overall survival data from key studies in the labels for Kyprolis and Blincyto, which can drive sales of these products.
Amgen has also delivered on its biosimilars pipeline this year, which represents significant growth opportunity. Amgen has a collaboration agreement with Allergan for the worldwide development and commercialization of four oncology antibody biosimilars. Amgen/Allergan’s biosimilar version of Roche’s (RHHBY - Free Report) Avastin, Mvasi, was approved in the United States in September 2017 and in the EU in January this year. Meanwhile, the biosimilar versionof Roche’s another cancer drug Herceptin, Kanjinti was launched in the EU last month while it is under review in the United States. A biosimilar of Rituxan (ABP 798) is in phase III development.
What to Expect in the Second Half?
Amgen’s newer drugs – Prolia, Xgeva, Blincyto, Repatha, Kyprolis – are performing well. The trend is expected to continue in the second half, which should drive sales. Besides this, Amgen’s restructuring plan is making it leaner and more cost efficient, which is likely to lend support to the bottom line.
Meanwhile, several pivotal data readouts and regulatory milestones are expected in the second half.
However, there are some challenges for the company in the second half as well. These include a continued decline in sales of mature drugs like Enbrel, Aranesp and Neulasta, which are facing an array of branded and generic competitors. While Neupogen is already facing U.S. biosimilar competition, Neulasta, Epogen and Sensipar could start facing the same in the second half. Mylan’s biosimilar version of Neulasta, Fulphila, which is priced at a discount of 33% to Neulasta’s list price, was approved by the FDA in June and launched in July. This could hurt sales of Neulasta in the second half of 2018.
Other biosimilar versions of Neulasta may also receive approval in the second half of 2018. A biosimilar version of Epogen was also approved in the second quarter of 2018 and may be launched soon. Sensipar lost patent exclusivity in March 2018 and generics are expected to be launched this year.
Also, competitive pressure on newly launched Aimovig will rise in the second half. Lilly and Teva’s CGRP antibodies for migraine prevention, Emgality/galcanezumab and fremanezumab, respectively could be approved and launched in the United States in the second half.
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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