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Sunday, January 12, 2020

Hologic sees FQ1 revenue of ~$851M

On a preliminary basis, Hologic (NASDAQ:HOLX) expects FQ1 revenues of ~$850.5M (+2%). Breast health and Diagnostics should account for $331.1M (+2%) and $311.5M (+5%), respectively.
Board OKs new $500M share buyback program.
It will provide updated 2020 guidance when it reports final FQ1 results.
#JPM20

Neurocrine Bio expects $238M in Q4 Ingrezza sales

On a preliminary basis, Neurocrine Biosciences (NASDAQ:NBIX) expects Ingrezza (valbenazine) sales in Q4 and 2019 to be ~$238M (+83%) and ~$753M (+84%), respectively.
Quick assets at year-end: $970M.
Q1 2020 Ingrezza sales to be negatively impacted by payer-related seasonal dynamics, gross-to-net discount increases from payers, Medicare Part D rebates and potential reduction in channel inventory.
Management does not intend to guide on 2020 Ingrezza sales.
#JPM20

Cutera announces preliminary 2019 revenue

On a preliminary basis, Cutera (NASDAQ:CUTR) expects Q4 and full-year revenue of $51M – 52M (+12 – 14%) and $180.9M – 181.9M (+11 – 12%), respectively.

GW Pharma releases preliminary 2019 results

Ahead of its JPM20 presentation, GW Pharmaceuticals (NASDAQ:GWPHannounces preliminary 2019 results:
Q4 and full-year product sales should be ~$108M and ~$309M, respectively. Epidiolex sales should be ~$104M and ~$296M, respectively.
Final results will be released on February 25.
#JPM20

Exact Sciences sees almost $300M in Q4 revenue

On a preliminary basis, Exact Sciences (NASDAQ:EXAS) expects Q4 and full-year revenue of $294M – 296M and $874.5M – 876.5M, respectively. Screening revenue should be $229M – 230M (+61%) and $809.5M – 810.5M (+78%), respectively.
Cologuard test volume: 477K (+63%) and 1.68M (+80%), respectively.
Oncotype DX test volume: 41K (+14%) and 156K (+14%), respectively.
Management will provide 2020 guidance during its Q4 earnings call next month.
#JPM20

4-Year-Old May Lose Vision After Battling Flu

Jade DeLucia, 4, of Iowa is home after a bout of the flu landed her in the intensive care unit fighting for her life and her eyesight.
Jade was flown to the University of Iowa Stead Family Children’s Hospital and diagnosed with the flu on Dec. 24, according to Jennifer Brown, PhD, a spokesperson for the Iowa City hospital.
The girl’s grandmother, Courtney Frey, told a local television station that the infection made the girl’s brain swell. On the family Facebook page to help support Jade’s fight, there was mention of eyesight problems.
She returned home on Jan. 9.
“Jade continued to improve gradually and her strength and ability to respond to commands are improving consistently. However, her vision is affected, probably at the level of brain, and she needs more diagnostic tests. She will get regular follow up visits with the neurology and ophthalmology teams as an outpatient,” said Aditya Badheka, MD, medical director of the Pediatric Intensive Care Unit at the hospital.
Jade’s mother, Amanda Phillips, talked about what happened ahead of her discharge on the Fundraiser for Jade Facebook page .
“We’re doing one final test here soon to see if her brain will react to her eyes,” Phillips wrote. “If her brain does respond then there is hope for her eyesight returning. If it doesn’t then we’ll be taking home the bravest, strongest, kindest, blind girl I will every meet.”
Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau and a professor of medicine at the Icahn School of Medicine at Mount Sinai, says the flu can cause problems in the nervous system. He did not treat Jade.
“Fortunately it isn’t very common, but it is not unheard of,” Glatt says. “Breathing problems can lead to problems in the brain,” with the lack of oxygen affecting how well the brain works.
The flu virus can also affect the eyes, experts say.
This year’s flu season is shaping up as a bad one, according to the CDC. For the week ending Dec. 28, seasonal flu activity in the U.S. is high, the CDC says, and continues to increase.
Influenza B/Victoria viruses are most common now nationally, and that is unusual for this time of year, the CDC says. Next most common are influenza A (H1N1) strains.
Five new child deaths blamed on the flu were reported during the 2019-2020 season the week of Dec. 28. The total for the season is 27 child deaths, as of Dec. 28.
Children younger than 5 years old, and in particular those younger than 2, are at high risk of getting serious flu-related problems, the CDC says. The flu vaccine is recommended each year for children 6 months and older.
Complications include pneumoniadehydration, brain problems, sinus problems, and ear infections. Since 2010, hospitalizations for children under 5 have ranged each year from 7,000 to 26,000, the CDC says.
Deaths from the flu are relatively rare in children. Since 2004-2005, the number of deaths reported annually has ranged from 37 to 187; but the CDC says the deaths may be underreported. For instance, during the 2017-2018 season, the number may have been closer to 600.

NanoString: Prelim Operating, Financial Results for Fourth Quarter and FY 2019

— FY19 Product and Service Revenue of $103.7 million, including GeoMx DSP Revenue of $10.8 million, Exceeds High End of Guidance Ranges —
— Over 90 Cumulative GeoMx DSP Orders as of Year End —
NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for translational research, today provided preliminary operational and financial results for the fourth quarter and fiscal year ended December 31, 2019.
“Last year was transformative for NanoString. The launch of the GeoMx™ Digital Spatial Profiler (DSP) accelerated our growth, with product and service revenue increasing by 24% for the full year, and by 42% during the fourth quarter. Our strategic transaction to license our nCounter® diagnostic business to Veracyte has sharpened our focus on GeoMx and other growth opportunities in our research markets,” said NanoString president and CEO, Brad Gray. “We expect this transformation to continue in 2020, as we enjoy our first full year of GeoMx revenue, and expand our addressable markets into discovery research through the launch of GeoMx compatibility with next-generation sequencers.”
“We enter 2020 with a substantially strengthened financial profile,” said Tom Bailey, chief financial officer of NanoString. “With $157 million in cash and short-term investments, we have the resources to sustain our growth in 2020 and beyond.”
Financial Highlights:
For the fourth quarter of 2019, product and service revenue is expected to be $33.6 million, an increase of 42% compared to the prior year period and exceeding the upper end of the company’s guidance range of $30 to $32 million. This includes nCounter revenue of $25.2 million and GeoMx DSP revenue of $8.4 million, as compared to prior guidance for fourth quarter nCounter revenue of $24 to $26 million and prior guidance for fourth quarter GeoMx DSP revenue of $6 million.
Product and service revenue for full year 2019 is expected to be $103.7 million, an increase of 24% compared to the prior year and exceeding the upper end of the company’s previous guidance for revenue of $100 to $102 million.
Total revenue for the fourth quarter of 2019 is expected to be approximately $36.6 million, including approximately $3 million of collaboration revenue, as compared to prior guidance for total revenue of $33 to $35 million. Total revenue for full year 2019 is expected to be approximately $125.7 million, including approximately $22 million of collaboration revenue, as compared to prior guidance of $121 to $123 million.
Cash and short-term investments totaled $157.3 million as of December 31, 2019.
Operational Highlights:
  • Generated orders for approximately 20 GeoMx DSP systems during the fourth quarter.
  • Shipped 34 GeoMx DSP systems during the fourth quarter, and completed the installation of 25 of those 34 shipped units.
  • Shipped $0.7 million in GeoMx consumables during the fourth quarter.
  • Completed 35 Technology Access Program projects during the fourth quarter, bringing the total number of completed projects to more than 200 since inception of the program.
  • Sold approximately 125 nCounter Analysis Systems in 2019, increasing our installed base to approximately 855 nCounter Analysis Systems as of December 31, 2019, an increase of approximately 17% over fiscal year 2018.
  • Licensed our nCounter-based diagnostic business to Veracyte for initial consideration of $50 million. Certain operating costs were eliminated as a result of the transaction and combining the impact of these cost savings with the impact of the supply agreement on Prosigna® revenue and gross profit results in an approximate $14 million improvement in NanoString’s 2018 operating loss on a pro forma basis and an approximate $12 million improvement in NanoString’s anticipated 2019 operating loss on an annualized pro forma basis.
Brad Gray will give a corporate update at the JP Morgan Healthcare conference at 3:00 p.m. PST on Wednesday, January 15th, 2020. A live webcast of the presentation will be available online from the investor relations page of the company’s corporate website at www.nanostring.com. After the live webcast, the presentation will remain available on the website for approximately 30 days.