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Thursday, August 6, 2020

Ontrak Announces 2020 Second Quarter Financial Results

Ontrak, Inc. (NASDAQ: OTRK) (“Ontrak” or the “Company”), a leading AI-powered and telehealth enabled, virtualized outpatient healthcare treatment company, today reported its financial results for the second quarter ended June 30, 2020.
  • Record Quarterly Revenue of $17.2 Million in Q2 2020, up 124% Year over Year and up 40% from Q1 2020
  • Record Number of Enrolled Members of 11,989, up 203% Year over Year and 39% from Q1 2020, and 13,200 as of the date of this release, up 10% since the end of Q2 2020
  • Record Quarterly Net New Enrollment increase of 3,389 in Q2 2020, up 309% Year over Year and up 111% from Q1 2020
  • Company Reiterates 2020 Revenue Guidance of $90 Million
  • Company to Host Conference Call at 4:30 pm ET. Investors, analysts, employees and the general public can access the call by dialing (800) 708-4539 for U.S. participants or (847) 619-6396 for international participants, and referencing conference ID #49844295, or via live audio webcast available at https://edge.media-server.com/mmc/p/664yvwtz.

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Novo Nordisk A/S tweaks outlook higher after pandemic sales hit

Diabetes drug maker Novo Nordisk raised its full-year earnings outlook slightly on Thursday as it managed to offset stagnant sales with cost cuts during the coronavirus crisis.

The Danish company, whose shares rose 1%, said second quarter sales were hit by fewer patients starting treatments as well as coronavirus-related destocking, after its first quarter was boosted by a surge in demand for medicines.
“Despite COVID-19, we are satisfied by the performance in the first half of 2020 and by the progress made on our strategic aspirations,” CEO Lars Fruergaard Jorgensen said in a statement.
Novo said it now expects annual operating profit growth in the range of 2%-5%, up from an earlier estimate of 1%-5% growth.
Novo’s operating profit was 13.8 billion Danish crowns ($2.19 billion), compared to an average 13.31 billion expected by analysts.
This was helped by lower costs, chief financial officer Karsten Munk Knudsen told reporters, which were achieved through less travel and promotional expenses, netting Novo savings of around 1 billion crowns.
But Knudsen said reversals of bulked up inventories, worth 2 billion crowns, would continue into 2021.
At 30 billion crowns, Novo’s sales were flat compared to the same period last year and were below analyst estimates of 30.7 billion crowns. They dropped from 33.9 billion reported for the first quarter of 2020.
Sales in the U.S., Novo’s largest single market, grew 1% compared to 12% in the rest of the world. Novo hopes to gradually replace its U.S. insulin business with its new GLP-1 diabetes drugs, which imitate an intestinal hormone that stimulates the production of insulin.
“The weight of U.S. insulin becomes smaller and smaller in our business, so gradually we’ll also expect to get back to growth in the U.S.” Jorgensen said.
Sales of GLP-1 products in the first half of 2020 rose by 30% globally, while insulin sales slid 3%.

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Mylan squeezes guidance range; Q2 top-line drops 4%

Mylan (MYL -1.1%) Q2 results:
Revenues: $2,731.2M (-4.2%).
Net Income: $39.4M (-123.4%); EPS: $0.08 (-124.2%); non-GAAP Net Income: $574.3M (+7.8%); non-GAAP EPS: $1.11.
Non-GAAP EBITDA: $878.6M (+3.7%).
CF Ops (3 months): $379.5M (-43.3%).
2020 Guidance: Total Revenues: $11.5B – 12.0B from $11.5B – 12.5B; non-GAAP EBITDA: $3.3B – 3.7B from $3.2B – 3.9B.


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Biocept rallies 15% on COVID-19 test development deal

Biocept (BIOC +15.2%) and Aegea Biotechnologies agree to develop a highly sensitive PCR-based assay designed by Aegea for detecting the COVID-19 virus.
The collaboration will leverage Biocept’s experience in developing high-performance assays based on the Switch-Blocker technology.
“This agreement provides Biocept with new incremental revenue for R&D development services and, if successfully developed, an option to expand our COVID-19 testing capabilities with a next-generation COVID-19 PCR assay, having competitive advantages.” said Michael Nall, President and CEO of Biocept.

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Intellia Therapeutics advances pipeline, rallies on potential Editas/Beam deal

For Q2, Intellia Therapeutics (NTLA +6.0%) reported cash, equivalents and marketable securities $436.8M vs. $284.5M as of December 31, 2019;
Collaboration revenue of $16.26M (+46.2% Y/Y) beats consensus by $6.74M; driven by $8.4M one-time cumulative catch-up adjustment related to the extension of the Regeneron collaboration.
Expanded Regeneron collaboration, receiving $100M through upfront cash and equity investment and agreeing to co-develop treatments for hemophilia A and B using CRISPR-mediated targeted transgene insertion technology.
Established research collaborations and license agreements with TeneoBio and GEMoaB GmbH to develop engineered cell therapies for immuno-oncology and autoimmune diseases
Net loss of $32.4M vs. $25.7M; GAAP EPS of -$0.61 beats consensus by $0.09.
“We are very pleased to announce our first regulatory submission to initiate a Phase 1 study of NTLA-2001, which is an important milestone as we deliver on our mission to develop curative, CRISPR/Cas9-based treatments for severe diseases,” president & CEO John Leonard, M.D. commented.
In June 2020, Intellia closed an underwritten public offering of 6.3M shares for gross proceeds of ~$115M.
Intellia indicates pipeline progression, ATTR: Plan to dose first patient by end of 2020; AML: Submit an IND or IND-equivalent for NTLA-5001 in 1H21; HAE: Submit an IND or IND-equivalent for NTLA-2002 in 2H21.

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Aditxt Introduces AditxtScore™ for COVID-19

Company Plans to file for an Emergency Use Authorization (EUA) and 510(k) Application in the Current Quarter (Q3, 2020)
Aditxt Therapeutics, Inc. (Aditxt) (the “Company”) (Nasdaq: ADTX), a life sciences company developing technologies focused on improving the health of the immune system through immune monitoring and reprogramming, today introduced AditxtScore™ for COVID-19 to be used in detecting antibodies against SARS-CoV-2 antigens, as validated in studies performed by Stanford Blood Center, headquartered in Palo Alto, California.
AditxtScore™ for COVID-19 is a double-multiplex assay that can be used to detect and differentiate various antibody isotypes (IgG, IgM, IgA) against multiple SARS-CoV-2 antigens (e.g. RBD, S1, NP) simultaneously in a single reaction. Currently, one of the most widely used platforms, ELISA, can only detect one antibody isotype against one antigen at a time. AditxtScore™ for COVID-19 increases the resolution of results obtained for each antibody isotype thereby enhancing sensitivity for monitoring changes in these values over time. Due to the enhanced specificity and sensitivity of this comprehensive antibody profiling system, false positive and false negative results have proven to be significantly reduced when testing for the antibodies produced to SARS-CoV-2, thereby expanding its utility beyond a tool used in epidemiology. Therefore, and importantly, AditxtScore™ for COVID-19 can serve as a valuable tool to evaluate immune responses to SARS-CoV-2 vaccines in clinical settings.
Aditxt plans to file for an Emergency Use Authorization (EUA) followed by a 510(K) application with the U.S. Food and Drug Administration by the end of the current quarter (Q3, 2020). Additionally, Aditxt is planning its operational capabilities in anticipation of beginning pilot programs utilizing AditxtScore™ for COVID-19 in Q4, 2020, with the goal of making AditxtScore™ commercially available starting in Q1, 2021.

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Denali soars after Biogen investment and collaboration

Shares of Denali Therapeutics Inc. DNLI, 38.43% rocketed 29% into record territory in premarket trading Thursday, after Biogen Inc. BIIB, -0.32% announced a $465 million equity investment as part of a collaboration on Denali’s treatment for Parkinson’s disease. Biogen’s stock was little changed ahead of the open. Under terms of the collaboration, Biogen will make an upfront payment of $560 million, as well as the equity investment from the purchase of 13.3 million newly issued shares, representing about 11% of the shares outstanding, at $34.94 per share, which is 50% above Wednesday’s closing price of $23.24. Denali will also be eligible to receive up to $1.125 billion in potential milestone payments depending on the achievement of certain development and commercial milestones. Biogen and Denali will co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s, and Biogen will receive exclusive options to license two preclinical programs from Denali’s transport vehicle (TV) technology platform. Denali’s stock, which was on track to open above the June 3 record close of $28.82, has rallied 33.4% year to date through Wednesday, while Biogen shares have lost 6.9% and the S&P 500 SPX, -0.04% has gained 3.0%.

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