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Thursday, August 6, 2020

Heart-mapping Acutus Medical kicks off $158M Nasdaq IPO

The arrhythmia-focused Acutus Medical has moved forward with its IPO, with plans to raise about $158.8 million to help expand its commercial teams and complete the clinical testing of its heart-mapping catheters.
The company launched on the Nasdaq under the ticker “AFIB,” reflecting its work in atrial fibrillation. Acutus started with an offering of more than 8.8 million shares at $18 each, to more than double the $75 million it initially announced more than three weeks ago. That price rose nearly 50% after trading began, to about $26.50.
One year ago, Acutus brought in $100 million in venture capital funding through its series D round, plus $70 million in credit provided by Deerfield Management and an OrbiMed fund. With the latest IPO net proceeds, plus its existing cash and revenues, the company said in its prospectus that it expects to have enough to support both its commercial expansion and R&D activities for the next year.

This past February, the company received an FDA clearance for a real-time, 3D heart-mapping algorithm, to help electrophysiologists diagnose and treat both constant and transient arrhythmias.
The AcQMap system allows physicians to map the electrical activity of the heart’s chambers and perform an ablation, then re-check the cardiac tissue to confirm the effect. It also identifies regions of slow electrical conduction, or focal points causing irregular activity that can lead to an irregular heartbeat.

More recently, Acutus launched an electrophysiology collaboration with the German medical device maker Biotronik in May, to provide a portfolio of catheter-based mapping and ablation products in select markets such as Europe and Asia.
Another of the alliance’s goals is to link a range of devices through Biotronik’s network, to help share real-time patient monitoring data following ablation procedures.
Acutus also worked with Stereotaxis to integrate its treatments with the latter’s telerobotic support. This allowed a patient to be treated with Acutus’ AcQMap system and Stereotaxis’ magnetic navigation system—consisting of two robotically controlled magnet arms placed on either side of the patient, which control a catheter with a magnet in its tip as it moves through the body. This also lets physicians and staff remain outside the procedure room, reducing radiation exposure.

Primary care firm Oak Street shares jump in NYSE debut

Oak Street Health Inc’s shares doubled in their New York Stock Exchange debut on Thursday, after the primary care provider sold shares to investors in its $328 million initial public offering (IPO).
The stock opened at $42.50, soaring 102% above its IPO price of $21.00 per share.
Oak Street, which runs primary care centers for adults on Medicare, sold 15.6 million shares and the IPO valued the company at $5 billion.
The Chicago-based company had initially aimed to sell shares at between $19.00 and $20.00 per share.
Founded in 2012, Oak Street Health receives a per-patient-per-month payment from insurers, but also shares in the risk for patients’ healthcare costs.
The company said this month that it expects the COVID-19 pandemic to raise its medical claims expense, with about 3% of its at-risk patients at the end of May showing symptoms that suggested possible COVID-19 infection.
This has left Oak Street financially responsible for their healthcare costs.
Oak Street, however, also said limited access for its other patients to healthcare specialists such as cardiologists and orthopedists during the pandemic will result in lower healthcare costs than it would have otherwise expected.
The company currently operates more than 50 centers in the United States, with plans to expand into New York and Mississippi this year.
J.P. Morgan, Goldman Sachs & Co. LLC, Morgan Stanley, William Blair and Piper Sandler are among underwriters for the IPO.

Alteryx crashes after downside full-year view outweighs beats

For FY20, Alteryx (NYSE:AYX) sees revenue of $460-465M, below the $505.14M consensus.
For Q3, the company sees $111-115M in revenue (consensus: $119.3M) and EPS of $0.09-0.14 (consensus: $0.13).
In Q2, the company beat estimates on the top and bottom lines. ARR totaled $430M, up 40% Y/Y.
Gross margin was flat on the year at 91%.
Customers totaled 6,714 at the end of the quarter, up 27% Y/Y. The company added 271 net new customers in the quarter.

Roche misses in second late-stage study of Tecentriq in first-line breast cancer

A Phase 3 clinical trial, IMpassion131, evaluating Roche’s (OTCQX:RHHBY) Tecentriq (atezolizumab), combined with chemo agent paclitaxel, for the first-line treatment of patients with PD-L1-positive metastatic triple-negative breast cancer (TNBC) failed to met the primary endpoint of progression-free survival (PFS).
Overall survival (OS), a secondary endpoint, showed a negative trend although the data were not mature at cutoff and the study was not powered for OS.
No new safety signals were observed.
The company is reviewing the results with global health authorities. The data will be submitted for presentation at a future medical conference.
Another Phase 3, IMpassion130, testing the combination of Tecentriq and Celgene’s Abraxane (albumin-bound paclitaxel; nab-paclitaxel) in the same patient population met the PFS endpoint.

Dynavax Q2 HBV vaccine sales plummet 68%

Dynavax (NASDAQ:DVAX) Q2 results:
Total revenues: $2.7M (-67.5%); Heplisav-B sales: $2.4M (-67.5%).
Net loss: ($51.6M); loss/share: ($0.53).
Quick assets at quarter-end: $200.7M (+32.8%).
2020 expected milestones:
Final immunogenicity data on Heplisav-B in dialysis patients.
Completion of post-marketing safety follow-up on Heplisav-B.
Complete animal studies on pertussis vaccine CpG 1018.

Coherus BioSciences EPS beats by $0.52, beats on revenue

Coherus BioSciences (NASDAQ:CHRS): Q2 Non-GAAP EPS of $0.81 beats by $0.52; GAAP EPS of $0.70 beats by $0.43.
Revenue of $135.67M (+62.6% Y/Y) beats by $33.15M.

Insulet EPS beats by $0.22, beats on revenue

Insulet (NASDAQ:PODD): Q2 GAAP EPS of $0.22 beats by $0.22.
Revenue of $226.3M (+27.8% Y/Y) beats by $13.89M.