Novocure has 2020 prelims, update at JPM

 Full year 2020 preliminary net revenues of $494.4 million, representing annual growth of 41 percent compared to 2019

Novocure to present at the 39th Annual J.P. Morgan Virtual Healthcare Conference at 8:20 a.m. EST on Tuesday, Jan. 12, 2021

Fourth quarter and full year 2020 financial results to be reported Thursday, Feb. 25, 2021

At December 31, 2020, on a preliminary, unaudited basis, Novocure had $235 million in cash and cash equivalents and $608 million in short-term investments, for a total balance of $843 million in cash, cash equivalents and short-term investments. This represents an increase of $608 million in cash and investments since September 30, 2020.

Anticipated clinical milestones

• Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (Q1 2021)
• Data from phase 2 pilot EF-31 trial in gastric cancer (2021)
• Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
• Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
• Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2021)
• Data from phase 3 pivotal METIS trial in brain metastases (2022)
• Data from phase 2 pilot EF-33 trial with high-intensity arrays in recurrent glioblastoma (2022)
• Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2023)
• Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2023)
• Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2023)

https://www.businesswire.com/news/home/20210111005442/en/Novocure-Announces-Fourth-Quarter-and-Full-Year-2020-Preliminary-Net-Revenues-and-Provides-Company-Update

Exelixis 2020 prelims, 2021 guidance

 – Cabozantinib Franchise Preliminary Net Product Revenue of $200 million for the Fourth Quarter 2020, and $741 million for the Full Year 2020 –

– Full Year 2021 Net Product Revenue Guidance of $950 million to $1,050 million –

– Corporate priorities for 2021 include potentially filing supplemental New Drug Applications for cabozantinib in three additional indications –

– Presentation and webcast at 2021 J.P. Morgan Healthcare Conference on Monday, January 11th at 5:20 PM EST / 2:20 PM PST –

Presentation and Webcast

Exelixis President and Chief Executive Officer Michael M. Morrissey, Ph.D., will provide a corporate overview and discuss the company’s preliminary fourth quarter and full year 2020 financial results, 2021 financial guidance, and key priorities and milestones for 2021 during the company’s presentation at the J.P. Morgan Healthcare Conference beginning at 5:20 p.m. EST / 2:20 p.m. PST on Monday, January 11, 2021.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 90 days.

https://www.businesswire.com/news/home/20210110005056/en/Exelixis-Announces-Preliminary-Fourth-Quarter-and-Full-Year-2020-Financial-Results-Provides-2021-Financial-Guidance-and-Outlines-Key-Priorities-and-Anticipated-Milestones-For-2021

Gilead Lifts Adjusted-Earnings Forecast Amid Remdesivir Demand

 Gilead Sciences  (GILD) - Get Report shares rose on Monday after the biotechnology titan increased its earnings estimate for 2020 amid demand for its remdesivir covid treatment.

The Foster City, Calif., company sharpened its GAAP earnings-per-share estimate to a range of a loss of 8 cents a share to a profit of 2 cents. The previous estimate was a range of a loss of 25 cents to a profit of 10 cents. 

It boosted its estimate of adjusted earnings to $6.98 to $7.08 a share from $6.25 to $6.60.

A survey of analysts by FactSet produced consensus estimates for 2020 of GAAP earnings of 7 cents a share, or an adjusted $6.61, on revenue of $23.71 billion.

The sales gain reflects “increased Veklury [remdesivir] sales, as hospitalization and treatment rates were higher than expected given the most recent covid-19 surge,” the company said in a statement. 

https://www.thestreet.com/investing/gilead-raises-adjusted-earnings-forecast-due-to-demand-for-remdesivir

Emergent BioSolutions 2021 Financial Guidance, Prelims for 2020

 

• Expects continued strong financial and operating momentum in 2021, forecasting total revenues of $2 billion at the midpoint and Adjusted EBITDA of $780 million at the midpoint, both increases year-over-year
• Reports preliminary 2020 total revenues of $1.55 billion at the midpoint and Adjusted EBITDA of $635 million at the midpoint, both at or above prior guidance given in November 2020

PRELIMINARY 2020 FINANCIAL RESULTS (Unaudited)

The Company is providing the following preliminary, unaudited financial results for full year 2020.

(in millions)	PRELIMINARY RESULTS (As of 1/10/2021)	PRIOR 2020 GUIDANCE (As of 11/5/2020)
Total Revenues	$1,545 - $1,555	$1,520 - $1,580
Net Income	$295 - $310	$255 - $285
Adjusted EBITDA (1)	$625 - $645	$575 - $615
Adjusted Net Income (1)	$415 - $430	$375 - $405

2021 FINANCIAL FORECAST

The Company is providing the following forecast of selected financial metrics for full year 2021.

(in millions)	FULL YEAR 2021 (As of 1/10/2021)
Total Revenues	$1,950 - $2,050
Adjusted EBITDA (1)	$750 - $810
Adjusted Net Income (1)	$475 -- $525
Product/Service Level Revenue
•  Anthrax Vaccines	$280 -- $310
•  ACAM2000	$185 -- $205
•  NARCAN® Nasal Spray	$305 -- $325
•  CDMO Services	$925 -- $965
•  Other Products and Contracts and Grants	$220 -- $240

PRESENTATION WEBCAST
The Company will provide an update on the current business and discuss preliminary 2020 financial results, the forecast and corporate goals for 2021, and long-term goals during its presentation at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021 at 8:20 AM Eastern time.

A live webcast of the presentation can be accessed through Emergent’s website. An on-demand replay of the webcast can also be accessed in the investors section after the presentation has concluded.

https://www.globenewswire.com/news-release/2021/01/10/2155868/0/en/Emergent-BioSolutions-Announces-2021-Financial-Guidance-Provides-Preliminary-2020-Results.html

PTC Updatse on R&D Pipeline, Commercial Progress at JPM

  ~$333 million preliminary unaudited 2020 total net product revenue representing 14% year-over-year growth -

- Huntington splicing program healthy volunteer data expected 1H 2021 -

- Multiple late-stage clinical programs advancing with six registration-directed trials -

- 2021 Duchenne franchise revenue guidance of $355-$375 million -

2021 Financial Guidance:

• PTC anticipates full year net product revenues for the DMD franchise to be between $355 and $375 million.
• PTC anticipates GAAP R&D and SG&A expense for the full year 2021 to be between $825 and $855 million.
• PTC anticipates Non-GAAP R&D and SG&A expense for the full year 2021 to be between $725 and $755 million, excluding estimated non-cash, stock-based compensation expense of approximately $100 million.

https://www.prnewswire.com/news-releases/ptc-therapeutics-provides-update-on-rd-pipeline-and-commercial-progress-at-39th-annual-jp-morgan-healthcare-conference-301204949.html

Editas: FDA Cleared Initiation of EDIT-301 Sickle Cell Trial

 Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced the U.S. Food and Drug Administration (FDA) has cleared the initiation of the safety phase of the Company’s EDIT-301 clinical trial, and the Company can begin dosing patients. The Company is required to develop and submit to the FDA an improved potency assay prior to enrolling the efficacy phase of the RUBY trial. EDIT-301 is an experimental, ex vivo gene editing cell medicine in development for the treatment of sickle cell disease. Previously, the Company received Rare Pediatric Disease designation from the FDA for EDIT-301. EDIT-301 is the first experimental medicine in development generated using CRISPR/Cas12a gene editing.

“The FDA’s clearance for initiation for our EDIT-301 clinical trial is an exciting moment for us and the patients we hope to serve. We look forward to bringing this potentially best-in-class, one-time, durable medicine into the clinic and to patients,” said Cindy Collins, President and Chief Executive Officer, Editas Medicine. “We know patients are counting on us, and we believe EDIT-301 has the potential to transform the lives of people living with sickle cell disease, addressing a significant unmet need.”

Editas Medicine is preparing to initiate the RUBY clinical trial, a Phase 1/2 trial designed to assess the safety and efficacy of EDIT-301 for the treatment of sickle cell disease. The Company has identified a lead principal investigator and engaged a Clinical Research Organization (CRO). Clinical trial materials are being manufactured by Editas Medicine. The Company will need to resolve a partial clinical hold prior to commencement of the efficacy portion of the RUBY trial by developing an improved potency assay after the first patients are dosed in the safety portion of the trial before collection of data to support registration.

https://www.biospace.com/article/releases/editas-medicine-announces-the-fda-has-cleared-initiation-of-the-edit-301-clinical-trialedit-301-is-in-development-as-a-best-in-class-durable-medicine-for-people-living-with-sickle-cell-disease/

Clovis Oncology Has Prelim Q4, 2020 Product Revenues

 

• Estimated $43.0M - $43.5M in Rubraca® (rucaparib) global sales for Q4 2020 and $164.2M - $164.7M for FY 2020

• Q4/FY 2020 Operating Results call planned for February 23, 2021

• Company to present at J.P. Morgan Healthcare Conference on Tuesday, January 12

 A live webcast of the presentation/Q&A session can be accessed through the investor relations section of the Company’s website at clovisoncology.com. Approximately 24 hours following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

https://finance.yahoo.com/news/clovis-oncology-announces-preliminary-product-130000512.html