Lilly sees 16% non-GAAP EPS growth next year

Eli Lilly (NYSE:LLY) updates its 2019 guidance this morning and provides its 2020 outlook. Key points:

2019: Revenue: $22.0B 0 22.5B (unch); EPS: $8.57 – 8.67 from $8.59 – 8.69; non-GAAP EPS: $5.75 – 5.85 (unch).

2020: Revenue: $23.6B – 24.1B; EPS: $6.38 – 6.48; non-GAAP EPS: $6.70 – 6.80.

Revenue growth drivers: Trulicity, Taltz, Basaglar, Jardiance, Verzenio, Cyramza, Olumiant, Emgality, Baqsimi and Reyvow.

Revenue offsets: Generic encroachment on off-patent medicines, including Forteo, and an expected low single-digit net price decline in the U.S. from rebates and legislated increases to Medicare Part D cost-sharing, patient affordability programs and net price declines in China, Japan and Europe.

Management will host a conference call this morning at 9:00 ET to review guidance.

https://seekingalpha.com/news/3526686-lilly-sees-16-non-gaap-eps-growth-next-year

ImmunoGen up on accelerated pathway for mirvetuximab soravtansine

ImmunoGen (NASDAQ:IMGN) announces that the FDA has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine.

Based on this guidance, the company will initiate SORAYA, a trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab).

The  Company anticipates enrolling first patient in the study in next quarter with top-line data expected in mid-2021.

The trial will enroll approx. 100 patients. The primary endpoint is overall response rate by investigator assessment and the key secondary endpoint is duration of response.

Shares are up 27% premarket.

https://seekingalpha.com/news/3526696-immunogen-up-27-premarket-on-accelerated-pathway-for-mirvetuximab-soravtansine

Alnylam’s lumasiran successful in late-stage PH1 study

Alnylam Pharmaceuticals (NASDAQ:ALNY) is up 6% premarket on light volume in reaction to positive results from a Phase 3 clinical trial, ILLUMINATE-A, evaluating lumasiran in patients with primary hyperoxaluria type 1 (PH1), a rare inherited disorder characterized by kidney and bladder stones caused by excess levels of oxalate in the kidneys and urinary tract.

The 30-subject study met the primary and all secondary endpoints.

Results from another Phase 3, ILLUMINATE-B, should be available in mid-2020. A third Phase 3, ILLUMINATE-C, should launch in 2021.

The company plans to file a marketing applications in the U.S. and Europe in early 2020.

Lumasiran is designed to reduce oxalate in the body by reducing the levels of an enzyme called glycolate oxidase which depletes the substrate necessary for oxalate production. It has Breakthrough Therapy status in the U.S. and PRIME status in Europe for the indication.

A conference call will begin momentarily.

https://seekingalpha.com/news/3526724-alnylams-lumasiran-successful-in-late-stage-ph1-study-shares-up-6-premarket

Biohaven Pharma up 8% premarket on positive vazegepant data

Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN) is up 8% premarket on light volume in reaction to positive topline results from a Phase 2/3 clinical trial, BHV3500-201, evaluating intranasal vazegepant for the acute treatment of migraine.

The 10 mg and 20 mg dose arms met the co-primary endpoints of pain freedom and freedom from the most bothersome symptom at hour 2 compared to placebo. The 5 mg dose arm did not.

Key secondary endpoints were also met.

On the safety front, the most common adverse events were dysgeusia (distortion in sense of taste) (13.5% – 16.1% vs. 3.5% for control), and nasal discomfort (1.3 – 5.2% vs. 0.2%).

Additional data will be submitted for presentation at medical conferences in 2020.

https://seekingalpha.com/news/3526736-biohaven-pharma-up-8-premarket-on-positive-vazegepant-data

Bausch Health launches $1.25B debt offering

Bausch Health Companies (NYSE:BHC) has launched an offering of a combined $1.25B aggregate principal amount of new senior notes due 2028 and new senior notes due 2030.

Net proceeds will be used to finance amounts owed under the Company’s $1.21B settlement agreement relating to the U.S. putative securities class litigation filed; to pay transaction fees and expenses and for general corporate purposes.

https://seekingalpha.com/news/3526721-bausch-health-launches-1_25b-debt-offering

Merck begins tender offer to acquire Arqule

Merck (NYSE:MRK) commences a cash tender offer to purchase all outstanding common shares of ArQule (NASDAQ:ARQL).

Upon closing of the tender offer, stockholders of ArQule will receive $20 in cash for each common share, following which ArQule will become a wholly-owned subsidiary of Merck.

Merck will file with the SEC a tender offer statement on Schedule TO, which provides the terms of the tender offer.

The tender offer will expire on January 15, 2020.

Previously: ArQule up 101% premarket on Merck bid (Dec. 9)

https://seekingalpha.com/news/3526711-merck-begins-tender-offer-to-acquire-arqule

Purdue paid out $10.4B amid opioid crisis

As scrutiny of Purdue Pharma’s role in the opioid epidemic intensified during the past dozen years, its owners, members of the Sackler family, withdrew more than $10B from the company, NYT reports, citing a new audit commissioned by the drugmaker.

“We need full transparency into their total assets and must know whether they sheltered them in an effort to protect against creditors and victims,” New York Attorney General Letitia James declared.

Purdue filed for bankruptcy protection in September to pause thousands of lawsuits as it tries to build support for a proposed $10B settlement.

Related tickers: McKesson (NYSE:MCK), AmerisourceBergen (NYSE:ABC), Cardinal Health (NYSE:CAH), Mallinckrodt (NYSE:MNK), Endo International (NASDAQ:ENDP), Teva Pharmaceutical Industries (NYSE:TEVA), Johnson & Johnson (NYSE:JNJ).

https://seekingalpha.com/news/3526671-purdue-paid-out-10_4b-amid-opioid-crisis