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Monday, January 13, 2020

Lilly’s Tyvyt + Alimta successful in lung cancer study

Eli Lilly (NYSE:LLY) announces positive results from a China-based Phase 3 clinical trial, ORIENT-11, evaluating the combination of Tyvyt (sintilimab injection), Alimta (pemetrexed) and platinum-based chemo for the first-line treatment of advanced/recurrent nonsquamous non-small cell lung cancer (nsqNSCLC), without sensitive EGFR mutation or ALK rearrangement.
The study met the primary endpoint of progression-free survival based on an interim analysis by the Independent Data Monitoring Committee.
No new safety signals were observed.
The trial is being conducted by sentilimab development partner Innovent Biologics. A marketing application in China is next up.
Additional data will be presented at an upcoming medical conference.
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Lannett +15% premarket on NDA approval of Numbrino

The FDA has approved Lannett’s (NYSE:LCI) New Drug Application (NDA) for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the company’s branded local anesthetic product.
Product launch is expected shortly under the brand name NUMBRINO.
NUMBRINO is indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
Shares are up 15% premarket.
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Emergent Biosolutions reports prelim 2019 results and FY20 guidance

Emergent BioSolutions (NYSE:EBS) reports FY19 prelim revenue in the range of $1.1B-$1.5B against prior guidance of $1.06B-$1.14B, consensus estimate of $1.1B.
FY19 gross margin in the range of 56-58% up 200-400 bps from prior year.
FY19 net income in the range of $53M-$63M down from prior guidance of $80M-$110M.
FY19 adj. net income in the range of $150M-$160M.
FY19 adj. EBITDA in the range of $280M-$290M.
FY20 revenue in the range of $1.18B-$1.28B; adj. net income $160M-$210M; and adj. EBITDA of $300M-$360M.
#JPM20
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Organogenesis Holdings reports preliminary Q4 revenue results

Organogenesis Holdings (NASDAQ:ORGO) says it expects Q4 Net revenue to be between $72.6M to $74.6M (+14% to +17% Y/Y) vs. consensus of $70.39M, comprising of Advanced Wound Care products revenue growth of 14% to 16%; Surgical & Sports Medicine products revenue growth of 18% to 24%; PuraPly products growth of 37% to 40% and non-PuraPly commercially available products revenue growth of 14% to 18%.
For FY2019 Net revenue is expected to be in the range of $258.9M to $260.9M (+34% to +35% Y/Y), vs. consensus of $256.75M.
#JPM20
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Seeking Alpha’s JPMorgan Healthcare Conference coverage

The 38th Annual JPMorgan Healthcare Conference is underway, with plenty of deals, abstracts, test results, and operational updates.
Our news coverage of #JPM20 is here.
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Emergent Bio receives EMA agreement for chikungunya vaccine candidate

Emergent BioSolutions (NYSE:EBS) has received agreement from the European Medicines Agency (EMA) to pursue the proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate.
The company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies (SNA) as an immune correlate of protection to predict clinical benefit of the vaccine candidate.
Emergent’s CHIKV VLP vaccine candidate is currently being investigated in a Phase 2 parallel-group, dose-finding study of approx. 430 healthy adults at three U.S. sites. It is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
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Bausch Health sees cash flow ops as high as $1.6B in 2019

Highlights from Bausch Health Companies’ (NYSE:BHC) presentation at JPM20:
2019: Revenue growth should be above mid-point of guidance. Cash flow ops should be $1.5B – 1.6B (more than $1B will be used to pay down debt and/or fund “bolt-on” acquisitions).
R&D investments up ~15% versus 2018.
“Significant Seven” sales expected to about double.
2020 objectives/catalysts:
B + L:
Launch SiHy daily, enhanced enVista Toric and preloaded enVista in U.S.
EM-100 approval.
Refile Xipere application.
Salix:
Launch probiotic.
Several key data readouts.
Ortho Dermatologics:
Duobrii full-year launch.
Launch Arazlo in H1.
Launch Solodyn and BenzEFoam on dermatology.com.
Expand Thermage FLX globally.
#JPM20
https://seekingalpha.com/news/3531221-bausch-health-sees-cash-flow-ops-high-1_6b-in-2019
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