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Thursday, January 9, 2020

SI-BONE reports 4Q19 and 2020 revenue guidance

SI-BONE (SIBN +4.3%expects Q4 revenues in the range of  $19.5M-19.8M (+25-27% Y/Y) vs. a consensus of $18.64M.
SIBN expects full year 2020 revenue to be in the range of $80M -$82M (~+19%-22%) vs. a consensus $81.46M.

California mulling private-label generics to address high drug costs

The new budget proposed by California Governor Gavin Newsom includes a plan to allow the state to contract with generic drug makers to provide medicines to all Californians. He believes that the government’s purchasing power may be sufficient to cut drug prices to the state’s 40M residents, almost 33% Medicaid enrollees.
Gov. Newsom is also in favor of authorizing the California Department of Health Care Services to negotiate drug prices for international buyers, a situation that could potentially enable the state to achieve discounts on par with Canada.
He also intends to create a new Office of Health Care Affordability which would set cost targets for a range of healthcare sectors and “financial consequences” if the targets are not met.
Last year, he signed a bill that bars branded drug makers from entering into “pay-to-delay” deals with generic drug makers, the first such law in the U.S.
Selected tickers: BIBTHWARKGBMEGRXIXJBISXLVIDNAGDNAKMEDXBIIHEPJPPFEMRKNVSAMGNBIIBGILDABBVJNJLLYTEVAMYL

Lilly launches new robotic drug discovery laboratory

Eli Lilly (LLY +1.7%), in collaboration with lab automation developer Strateos, announces a new San Diego-based robotic laboratory, called the Lilly Life Sciences Studio Lab, designed to accelerate the drug discovery process.
The 11,500 sq. ft. studio lab, operated by Strateos, physically and virtually integrates several areas of the drug discovery process—including design, synthesis, purification, analysis, sample management, and hypothesis testing—into a fully automated platform.
Strateos will use the lab’s robotic cloud platform to enable access of this remote-controlled lab to other drug discovery companies and research scientists via its secure cloud-based platform.

Amarin says no change to Vascepa status at UnitedHealth

Amarin (NASDAQ:AMRN) investor relations says there’s no indication of a change to UnitedHealthcare’s 2020 coverages of Vascepa vs. 2019.
A story yesterday based on this document said the drug had been moved to “non-preferred” status.

Kaleido Bio teams up with J&J to identify microbiome metabolic candidates

Kaleido Biosciences (KLDO -4.4%) will collaborate with Johnson & Johnson (JNJ +0.2%) unit Janssen Biotech to explore the potential of Kaleido’s Microbiome Metabolic Therapies (MMT) to prevent childhood allergies and other atopic immune and metabolic conditions via driving specific features of the microbiome that support the maturation of the infant immune system.
A primary focus will be leveraging Kaleido’s proprietary ex vivo screening platform to identify promising MMT candidates.
Financial terms are not disclosed.

Regenxbio updates on key programs; shares up

REGENXBIO (RGNX +5.5%announces key milestones/events for 2020:
RGX-314: Initiate pivotal program of subretinal delivery in wet AMD in H2. Start Phase 2 studies of suprachoroidal delivery in wet AMD in H1. File IND in H1 for suprachoroidal delivery in diabetic retinopathy followed by the launch of a Phase 2 study in H2.
RGX-121: Release additional interim data from Phase 1/2 study in MPS II this quarter. Report interim data from cohort 2 mid-year. H2: accelerated approval pathway possible, contingent on analysis interim data.
RGX-501: Release interim data on LDL-C levels from Phase 1/2 study in HoFH in H1.
Hereditary angioedema: Select lead candidate in H1.
RGX-181: IND to be filed in H2 for CLN2 disease.
Zolgensma: Regulatory decision in Europe expected this quarter and in Japan in H1. Novartis is the licensee ($175M in sales through Q3 2019).

Pharmacy chains sue Ohio doctors over role in opioid epidemic

Retail pharmacy operators Walgreens (WBA -1.5%), CVS Health (CVS +0.2%), Walmart (WMT +0.4%) and Rite Aid (RAD -2.7%) have filed litigation against over-prescribing doctors in Ohio who operated “pill mills” responsible for up to 60% of the opioids dispensed in the area. The trial is set to begin on October 13.