Amgen sales slide as copies dig into Sensipar, Neulasta

Amgen’s CGRP launch Aimovig generated $83 million during the second quarter, helping offset losses of exclusivity that cost the drugmaker. (Amgen)

Amgen is contending with some costly losses of exclusivity, and as sales for old stalwarts slide, the drugmaker is shifting its focus to a host of new launches in a bid to grow down the line.

For now, though, sharp declines for two old meds are hurting the drugmaker’s performance. Amgen posted a 3% revenue decline to $5.9 billion in second-quarter results released Tuesday. The decrease came thanks to copycat competition for white blood cell booster Neulasta and calcium reducer Sensipar, which posted quarterly sales declines of 25% and 71%, respectively.

Those drops create quite a large hurdle to growth for Amgen—even as the drugmaker has several meds on the upswing. Prolia, Repatha, Parsabiv and Aimovig prescriptions grew by double digits or better during the period, the drugmaker reported.

Sales of osteoporosis med Prolia jumped 14% to $698 million during the quarter, while Repatha’s 3% revenue increase was tempered due to a recent discount Amgen implemented. Immunology med Enbrel remains a strong performer for the company, and it chipped in a sales increase of 5% to hit $1.36 billion during the period.

Despite the overall sales decline, Amgen’s revenue haul came in above consensus analyst estimates by $175 million. Earnings per share of $3.57 also bested analyst expectations.

Amgen doesn’t plan to see its sales dip for long, though. Looking forward, the company intends to grow thanks to a host of oncology launches, plus CGRP migraine med Aimovig and other treatments. The company recently launched two biosimilars to Roche cancer blockbusters, which could start to chip in as well. Outside of the U.S., Amgen’s biosims chipped in $82 million in second-quarter sales.

Aimovig, which is early in its U.S. launch, contributed $83 million in sales during the quarter. The drug is contending with Eli Lilly’s Emgality and Teva’s Ajovy, and Lilly execs reported strong progress for their drug earlier on Tuesday.

In all, Amgen CEO Robert Bradway said the company is “well positioned to serve patients and deliver long-term growth for our shareholders” as new meds gain uptake and the drugmaker advances its pipeline.

https://www.fiercepharma.com/pharma/amgen-sales-slide-as-sensipar-neulasta-suffer-from-generic-and-biosim-attack

Lilly’s Emgality powers ahead with ‘best-in-class’ CGRP access

Emgality held 41% of new to brand market share for CGRP drugs at the end of the second quarter. (Eli Lilly)

Eli Lilly’s CGRP migraine prevention drug Emgality is in a heated market share race with Amgen’s Aimovig and Teva’s Ajovy, but in the second quarter, it gained some steam.

By the end of the period, Emgality held 41% of the new to brand market share, a 9% jump from the end of the first quarter, Lilly execs reported with the company’s quarterly results. Amgen will update on its own drug’s performance late Tuesday, but Lilly’s drug is showing strong momentum and now has “best-in-class” access, Lilly execs said.

Sales, though, are still catching up, thanks in part to an early strategy that involved distributing the drug for free. Sales reached just $34 million for the quarter, although Lilly’s leadership did report that three-fourths of Emgality prescriptions are now paid.

The Emgality launch figures bode well for Lilly as it leans on its new meds for growth. For the second quarter, Lilly’s “key growth products,” a set that includes breast cancer therapy Verzenio, anti-inflammatory drugs Olumiant and Taltz and diabetes treatment Jardiance, reached $2.4 billion in global sales, or 43% of the company’s total haul. Psoriasis and psoriatic arthritis med Taltz is powering ahead despite a new rival in AbbVie’s Skyrizi, and Type 2 diabetes drug Trulicity turned in $1 billion in quarterly sales in the face of stiff competition from Novo Nordisk. 

While Lilly is succeeding at growing volumes for many of its drugs, the company’s prices in many places around the world are suffering. Across its portfolio, prices slipped 4% in the U.S., 2% in Europe and 2% in the rest of the world. In Japan, prices stayed flat.

On the flip side, Lilly grew volumes 5% in the U.S., 8% in Europe, 4% in Japan and 14% in the rest of the world. Total revenue of $5.64 billion grew 1%, or 3% at constant exchange rates, versus last year’s second quarter.

Lilly is relying on its new meds following a big patent loss for Cialis. The drug’s sales fell 63% during the quarter to $200 million, and it wasn’t the only one in the portfolio to struggle. Lilly’s insulin Humalog, once its best-seller, continued to slide, falling 12% in the quarter to $677 million. And bone drug Forteo is hurting from lower demand and lower prices, sinking 17% to $360 million.

Overall, sales for the Indianapolis pharma giant topped analyst estimates of $5.58 billion, while earnings per share of $1.50 beat profit expectations of $1.45. Lilly’s lower-than-expected tax rate of 9.5% for the period significantly helped the earnings figure.

https://www.fiercepharma.com/pharma/emgality-s-powering-ahead-complementing-other-new-launches-at-lilly

Celgene’s new triple-combo FDA nods shift Revlimid, Pomalyst into higher gear

Celgene’s second-quarter sales show what a couple of new FDA approvals can do.

New triple-combo green lights for myeloma drugs Revlimid and Pomalyst helped drive Celgene’s 15% increase in second-quarter revenue, to $4.40 billion. And with another Revlimid combo nod on tap, the aging superstar could continue delivering the gains for Bristol-Myers Squibb when the two companies wrap up their merger later this year.

Celgene’s stalwart Revlimid jumped 11%, reaching $2.73 billion, thanks to the adoption of use in tandem with Takeda’s Velcade and dexamethasone in previously untreated multiple myeloma patients. And Pomalyst, sold as Imnovid in Europe, delivered $619 million to Celgene’s Q2 topline after growing sales by 22%, driven by its own Velcade-dexamethasone nod in the second line.

The drugs saw smaller increases in Europe compared with the U.S., though, partly because the triplet green lights only came through the European Commission mid-May—and perhaps to a lesser extent, the arrival of a generic Alvogen launched recently in some small markets.

Meanwhile, Revlimid is up for some additional sales. The Celgene drug and Roche’s Rituxan recently won FDA approval for previously treated follicular or marginal zone lymphomas, offering those patients a chemo-free option. The pair showed they could stave off tumor progression for a median of 39.4 months, versus 14.1 months Rituxan and placebo. That kind of number led to SVB Leerink’s projection of an additional $600 million in Revlimid annual haul.

However, in an asset that BMS will reluctantly let go, Otezla racked up $493 million in the second quarter. The whopping 31% year-over-year rate once again showed the pain BMS is taking to win U.S. antitrust clearance for the $74 billion megamerger. The drug also recently added an FDA nod in oral ulcers associated with the rare Behçet’s Disease, and it also awaits a label update in scalp psoriasis.

On track to about $1.9 billion in 2019 sales, per Celgene’s guidance, Otezla’s potential bodes well for the divestment process. Several groups of analysts have given the fast-growing drug a price of around $8 billion to $10 billion, depending on the fierceness of the bidding, while Bernstein analyst Ronny Gal arrived at $5.4 billion due to potential patent dispute.

Among all the potential buyers, RBC Capital analysts Brian Abrahams and Gregory Renza figured Gilead Sciences should buy the drug, given that it could use Otezla’s existing commercial infrastructure for the expected launch of its oral JAK inhibitor filgotinib as it moves closer to an FDA filing in rheumatoid arthritis.

Overall, Celgene now expects its 2019 total revenue could reach $17.2 billion to $17.4 billion, up $200 million on both ends, due to a sunnier outlook for Pomalyst and Abraxane. As for the takeover, the two parties currently expect to close it at the end of 2019 or the beginning of 2020.

https://www.fiercepharma.com/pharma/celgene-upbeat-revlimid-pomalyst-myeloma-jumps-as-bristol-myers-merger-nears

Emergent Bio: BARDA Exercises 1st Option at $261M for Anthrax Vax Stocks

Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Biomedical Advanced Research and Development Authority (BARDA) has exercised its first contract option valued at $261 million to procure doses of AV7909 (anthrax vaccine adsorbed with adjuvant) for delivery into the Strategic National Stockpile (SNS) over 12 months. This contract option was exercised under the company’s 2016 development and procurement contract with BARDA, valued at up to $1.5 billion, that includes a five-year base period of performance to develop AV7909 for post-exposure prophylaxis of anthrax disease and to deliver an initial three million doses to the SNS, as well as contract options for procurement of up to an additional 50 million doses. This exercise of the contract option through a modification is the first such option for procurement of doses to follow the initial deliveries of doses under the base contract.

https://www.marketscreener.com/EMERGENT-BIOSOLUTIONS-INC-36547/news/Emergent-BioSolutions-Announces-Exercise-by-BARDA-of-the-First-Contract-Option-Valued-at-261-Milli-28983820/

Amedisys to Acquire Home Health Regulatory Assets, Expanding in NY

Amedisys, Inc. (NASDAQ: AMED), America’s leading independent home health, hospice and personal care company, has signed a definitive agreement to acquire regulatory assets that allow the Company to conduct home health care operations in more counties in New York.

Under the terms of the agreement, expected to close in approximately six months, Amedisys will acquire the right to operate certified home health care services from Premier Home Health Care Services, Inc., in Westchester, Bronx and New York counties. The Company currently conducts business in the overlapping counties of Kings and Queens.

https://www.marketscreener.com/AMEDISYS-INC-8342/news/Amedisys-to-Acquire-Home-Health-Regulatory-Assets-Expanding-Access-in-New-York-28983671/

Iradimed Surges Following Strong Q2 Results

Iradimed Corp IRMD 33.37% shares were up after the company posted upbeat Q2 results and raised FY19 EPS guidance.

https://www.benzinga.com/news/earnings/19/07/14161677/mid-day-market-update-iradimed-surges-following-strong-q2-results-mcdermott-shares-plunge

Ironwood Pharmaceuticals EPS beats by $0.11, beats on revenue

Ironwood Pharmaceuticals (NASDAQ:IRWD): Q2 Non-GAAP EPS of $0.10 beats by $0.11; GAAP EPS of $0.08 beats by $0.15.

Revenue of $102.22M (+26.0% Y/Y) beats by $12.94M.

Shares -0.01%.

Press Release

https://seekingalpha.com/news/3483730-ironwood-pharmaceuticals-eps-beats-0_11-beats-revenue