Ultragenyx up 7% after hours on positive DTX301 data

Ultragenyx (NASDAQ:RARE) announces positive results from cohort 3 and longer-term data from cohort 2 in an ongoing Phase 1/2 clinical trial evaluating gene therapy DTX301 in patients with ornithine transcarbamylase deficiency.

In cohort 3 (n=3), there were two confirmed female responders and one potential male responder (longer follow-up needed to confirm).

In cohort 2, one female patient showed a response starting at week 52 that was confirmed at week 78. Two previously reported responders in cohorts 1&2 remain clinically and metabolically stable at weeks 104 and 78, respectively.

Management will host a conference call at 4:30 pm ET to discuss the results.

Shares up 7% after hours.

https://seekingalpha.com/news/3530819-ultragenyx-up-7-after-hours-on-positive-dtx301-data

Flexion sees Zilretta sales as high as $135M for 2020

On a preliminary basis, Flexion Therapeutics (NASDAQ:FLXN) expects Q4 and 2019 revenue to be $23.7M (+149%) and $73.0M (+224%), respectively.

2020 guidance: Zilretta sales: $120M – 135M.

https://seekingalpha.com/news/3530839-flexion-sees-zilretta-sales-high-135m-this-year

Portola down after hours on weak Q4 prelim

Portola Pharmaceuticals (NASDAQ:PTLA) slumps 39% after hours in reaction to preliminary Q4 and 2019 results that are significantly below consensus.

Q4 Andexxa/Ondexxya sales will be ~$32M.

Global 2019 revenues should be ~$111M, 17% below consensus of $134M.

The company says Andexxa sales in the U.S. were negatively impacted by a $5M gross-to-net adjustment to a return reserve for short-dated product and flat demand due to an increase in utilization, mostly in tier 1 accounts.

Cash balance at year-end: $464M.

https://seekingalpha.com/news/3530833-portola-down-39-after-hours-on-weak-q4

Intuitive Surgical sees 22% growth in Q4 top line

On a preliminary basis, Intuitive (NASDAQ:ISRG) announces Q4 and 2019 results. Highlights:

Q4: Revenue: $1.278B (+22%). Da Vinci procedures up 19%, 336 system shipments (+16%).

2019: Revenue: $4.479B (+20%). Da Vinci procedures up 18%, 1,119 system shipments (+21%).

Shares are higher by 2.8% after hours.

https://seekingalpha.com/news/3530825-intuitive-sees-22-growth-in-q4-top-line-shares-rise-2_8

La Jolla Pharma sees FY 2019 Giapreza net sales as high as $23M

La Jolla Pharmaceutical (LJPC +9.5%) announces preliminary GIAPREZA (angiotensin II) net sales for the three and twelve months ended December 31, 2019.

Q4 GIAPREZA net sales were $7.2M, up 71% Y/Y. Hospital demand for vials of GIAPREZA grew 74%.

For FY 2019, GIAPREZA net sales were $23.1M, +129% Y/Y.

Net cash used in operating activities for Q4 2019 was ~$17M.

https://seekingalpha.com/news/3530706-la-jolla-pharma-sees-fy-2019-giapreza-net-sales-high-23m

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.

https://seekingalpha.com/news/3530707-si-bone-reports-4q19-and-2020-revenue-guidance

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.

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https://seekingalpha.com/news/3530711-california-mulling-private-label-generics-to-address-high-drug-costs