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Monday, January 13, 2020

Editas teams up with Sandhill Therapeutics on cancer

Editas Medicine (NASDAQ:EDIT) perks up 2% premarket on light volume in reaction to its agreement with Sandhill Therapeutics aimed at discovering, developing and manufacturing allogeneic engineered natural killer (NK) cells and non-alpha beta T cell medicines for the treatment of cancer.
The partnership will leverage EDIT’s genome editing technology with Sandhill’s Binate product process, a novel universal donor technology to extract, isolate, and expand NK cells and non-alpha beta T cells.
Under the terms of the deal, EDIT will secure an exclusive license to Sandhill’s technology for solid tumors originating within a given area of the body and an option to expand the license into two additional areas. In exchange, Sandhill will receive an upfront payment, milestones and royalties on net sales. Specific financial terms remain confidential.

Daré Biosciences higher on Bayer licensing deal

Daré Bioscience (NASDAQ:DARE+117.2% pre-market after saying it has signed a licensing agreement in which Bayer (OTCPK:BAYRY) may commercialize Daré’s Ovaprene investigational contraceptive product in the U.S. upon approval by the U.S. Food and Drug Administration.
Daré says the deal will entitle it to receive commercial milestone payments potentially totaling $310M, in addition to double digit tiered royalties on sales.
If Bayer makes payment to Daré of $20M, which Daré says it would apply to reimbursement of clinical study costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective.
Bayer says it would receive the right to obtain exclusive rights to commercialize the product in the U.S. following completion of a pivotal clinical trial being undertaken by Daré.

NuVasive expects Q4 revenue above consensus

NuVasive (NASDAQ:NUVAexpects Q4 revenue of ~$310M vs a consensus of $304.31M.
Q4 highlights: NUVA expects U.S. Spinal Hardware revenue increased ~8%; U.S. Surgical Support revenue increased ~3% and International revenue increased ~14% on a reported and constant currency basis.
#JPM20

ViewRay announces preliminary Q4 results

ViewRay (NASDAQ:VRAYannounced preliminary Q4 and FY2019 results.
Total Q4 revenue of ~$17M vs. consensus of $18.26M and $21M year ago.
Received four new orders for MRIdian systems totaling ~$21M in the quarter, compared to eight new orders totaling ~$49M in 4Q18.
FY2019 revenue of ~$88M vs. consensus of $89.83M and $81M year ago.
Total backlog was ~$227M and Cash and cash equivalents were ~$227M as of December 31, 2019.
Cash burn in the quarter was ~$3M.
Chief Commercial Officer Jim Alecxih will be leaving the company effective January 17, 2020.
#JPM20

AxoGen reports preliminary Q4 and FY 2019 revenue outlook

AxoGen (NASDAQ:AXGNannounces preliminary Q4 and FY 2019 revenue guidance.
Q4 and FY revenue is expected to be at least $28.1M and $106.6M, respectively.
Ended Q4 with 109 direct sales representatives.
Increased active accounts in Q4 to 797, up 12% from 712 in Q4 2018.
FY 2020 revenue is expected in the range of approx. $124M to $128M and number of direct sales representatives will increase to approx. 126 to 131.
Gross margin to remain above 80%.
The Company will report full, audited results for Q4 and FY 2019 on February 24, 2020.
#JPM20

GenMark Diagnostics reports 2019 operational and financial outlook

GenMark Diagnostics (GNMK -3.7%provides preliminary operational and financial results for FY 2019.
Total revenue for FY 2019 and Q4 is expected to be ~$88M, +24% Y/Y and ~$27M, respectively.
ePlex revenue for FY 2019 and Q4 of ~$60M, +59% Y/Y and ~$19M, respectively.
Gross margin is expected to be between 33% and 34% for Q4 and between 32% and 33% for FY 219.
The Company placed 48 new ePlex analyzers in Q4, for a net increase of 38 to the installed base finishing the year with 527 ePlex analyzers placed worldwide.
ePlex installed base grew 49% Y/Y.
Q4 annuity was ~$148 thousand per analyzer.
The Company expects to issue full 2019 financial results and 2020 guidance in late February.

Guardant Health teams up with Amgen to develop CDx test

Guardant Health (GH -2.2%) will collaborate with Amgen (AMGN -1%) on developing a blood-based companion diagnostic (CDx) test for candidate AMG 510.
GH will pursue regulatory approvals in the U.S., Europe and Japan for its Guardant360 CDx for this use in metastatic non-small cell lung cancer.