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Good find! What was your source? It wasn't on Yahoo Finance or in ThinkorSwim nor is it on the company website.
Kind regards,
Minding
Local biotech firm could get big boost from federal decision
This is no small thing. Take a look: http://www.bizjournals.com/sacramento/news/2015/12/02/local-biotech-firm-gets-boost-from-medicare.html
Kind regards,
Minding
S3 filed 12/1/2015: http://www.sec.gov/Archives/edgar/data/1226616/000119312515391096/d68859ds3.htm
2,000,000 Shares of Common Stock Offered by Selling Stockholders
Thanks to strange1 on ValueForum.
Kind regards,
Minding
Thanks CH.
Minding
hweb2, I owe you an apology. I was rushing before the holiday and forwarded my friend's information without verifying it. He indeed got it backwards. However it is safe to say these two stocks exhibit two different investment strategies and his is not yours so no need to compare and contrast further.
My apologies for rushing to press.
Kind regards,
Minding
TRMR-EVOL
You make a good case for EVOL. You see his for TRMR which is a more risky prospect, but he has sound reasoning for liking it and an excellent track record for deep value investing. With EVOL you're looking for a 40-80% gain. With TRMR he's aiming for > 150% gain.
Increasing revenues is one of his measures that points to a company (with a catalyst) successfully executing its strategy.
In terms of EVOL's margins, he was pointing to the most recent 3 mth (35.7% compared to 38.4% ) and 9 mth (38.1% compared to 35.5%) gross margin.
Disclosure: I own neither.
Kind regards,
Minding
KOOL's technology was used on this child.
http://us1.campaign-archive2.com/?u=513b92eb0bf6c17f06cca149d&id=243fb3653c
Leonard J. Parisi
Maxim Group LLC - Senior Vice President
405 Lexington Ave - 2nd Floor
NY, NY 10174
212-895-3512
212-895-3555 (Fax)
lparisi@maximgrp.com
AIM: lenparisi
-----------------
Kind regards,
Minding
TRMR: As a follow-up, here's the transcript for the most recent CC. I am only now looking at it.
https://finance.yahoo.com/news/edited-transcript-trmr-earnings-conference-164432510.html
Of note is increasing transparency.
Though Tremor Video (NYSE:TRMR) missed Q3 estimates, it's maintaining full-year revenue guidance of $195M-$200M (consensus is at $197M). With shares down over 80% from their $10 2013 IPO price going into today, that's being well-received.
Top-line performance: Adoption of Tremor's programmatic (automated) ad-buying offerings fueled its 26% Y/Y Q3 sales growth. Programmatic revenue rose to $17M (34.5% of total revenue) from just $3.8M a year ago. Revenue from non-programmatic proprietary higher function products (e.g. multi-screen and performance-based ads) rose to $22.4M from $17M, while revenue from non-programmatic media ad sales (a very competitive market) fell to $9.9M from $18.2M.
Financials: $22.7M worth of impairment charges were taken. Excluding the charges, GAAP operating expenses rose 16% Y/Y to $23.6M. Full-year adjusted EBITDA guidance has been revised to -$5M to -$7M from -$3M to -$7M. Tremor ended Q3 with $65.5M in cash (compares with a $111M current market cap), and no debt.
Kind regards,
Minding
hweb2, if you like EVOL, you may be interested in TRMR. A friend sent me the comment below n October.
Kind regards,
Minding
===============
EVOL is paying $10m for a company with revenue of $6 to $7m in the internet advertising sector. This is a very small acquisition in the scheme of things but it does provide a little bit of insight into how to value TRMR. TRMR has revenue per share of $3.28, cash per share of $1.33, no debt, and improving margins. The stock is really trading at about $.50 a share minus cash. This stock is dramatically underpriced and being pressured by tax loss selling. However if the company beats its expectations or even just makes them, I believe the stock could trade at least 50% higher quickly. Also the company could be a sitting duck as an acquisition candidate. If TRMR were acquired on the same basis as the EVOL acquisition, it would be priced at over $5.
EVOL is trading at over two times revenue. It just spent its cash stash on this acquisition and has declining margins.
Silver, this is an important post coming from you. I haven't found space for this kind of discussion on this forum, as it's mostly met with animosity, and have had no interest in participating in the hopes so often expressed. Investing is about assessment and reality. Yours is a good dose of both.
Kind regards,
Minding
A thought from my friend Carl:
MNOV is attempting to treat just about everything with its drugs. I have never seen any company of this size with so many irons in the fire. And they have been able to fund their trials with external sources of money.
MNOV's chart is improving. However it will take news that confirms that their drugs work in one of these research projects for a big move to take place. The market cap is about $97m so there is plenty of possible room to the upside if good news is revealed.
Kind regards,
Minding
-----------------
MediciNova initiates mid-stage study of MN-001 for elevated triglycerides in NASH patients
Nov 19 2015, 12:05 ET | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip
MediciNova (MNOV -1.9%) initiates a Phase 2a clinical trial assessing MN-001 (tipelukast) for the treatment of hypertriglyceridemia in NASH (nonalcoholic steatohepatitis) patients. The open-label, multicenter, proof-of-concept study will enroll ~20 participants. Eligible patients will have a confirmed diagnosis of NASH and serum triglyceride levels of at least 150 mg/dL (normal level is less than 150 mg/dL). Each subject will receive 250 mg of MN-001 once per day for four weeks followed by 250 mg twice per day for eight weeks.
MN-001 is under development for the treatment of NASH with fibrosis and ideopathic pulmonary fibrosis.
Tipelukast is a small molecule anti-fibrotic and anti-inflammatory compound that exerts its effects via several mechanisms, including leukotriene receptor antagonism and inhibiting enzymes known as phosphodiesterases as well as 5-lipoxygenase.
Previously: MediciNova's tipelukast Fast Track'd for ideopathic pulmonary fibrosis; shares up 17% premarket (Sept. 10)
Previously: MediciNova jumps on FDA OK of second Phase 2 protocol for MN-001 in NASH (July 27)
MediciNova Receives Notice of Allowance for New Patent Covering MN-221 (bedoradrine) for the Treatment of Irritable Bowel Syndrome in Japan
MNOV: Presentation on ALS Phase 2 Study in December?
FDA Grants Fast Track Designation for MediciNova's MN-001 (tipelukast) for the Treatment of Idiopathic Pulmonary Fibrosis
MediciNova Announces First Advanced ALS Patient Using Non-Invasive Ventilation Support Enrolled in Phase 2 Clinical Trial of MN-166 (ibudilast)
MediciNova Announces the Completion of Enrollment in Clinical Trial of MN-166 (ibudilast) in Alcohol Dependence
MediciNova Announces Randomization of 255 Subjects Completed in Phase 2b Trial of MN-166 (ibudilast) in Progressive MS
FDA Grants Fast Track Designation for MediciNova's MN-001 (tipelukast) for the Treatment of NASH with Fibrosis
Cesca’s Unique Approach to Regenerative Medicine - a Razor-Razor Blade Business Model
REDONDO BEACH, CA / ACCESSWIRE / November 19, 2015 / The regenerative medicine industry, considered by many to be the next pillar of healthcare, is projected to grow from $2.6 billion to $6.5 billion from 2013 to 2019, according to Transparency Market Research, representing an attractive 12.8% compound annual growth rate. By stimulating the body's own repair mechanisms, these technologies promise to functionally heal previously irreparable tissues or organs and are currently in late stage trials for a growing number of conditions.
Cesca Therapeutics Inc.'s (the "Company") (KOOL) core platform, SurgWerks(TM) aims to apply regenerative medicine principles to the treatment of ischemic vascular diseases, which are characterized by inadequate blood flow to an organ or part of the body. But unlike many regenerative medicine companies, Cesca's point-of-care ("POC") approach is the commercialization of an "all-in-one" clinical platform, including an innovative portable surgical workstation containing all essential equipment plus an indication specific kit with single-use disposable devices - a classic "razor-razor blade" business model applied to cell therapy.
From start to finish the procedure takes just 90 to 120 minutes; each patient's own cells are collected, processed, analyzed for QC (with companion diagnostics), and injected into the target tissue in the same procedure using a proprietary system of devices. The analytics component assures each patient, being biologically unique, receives a minimum viable cell dose, a feature missing from other autologous cell therapy platforms. Each patient simply makes a single visit to an operating room or endovascular catheterization lab for treatment, making this process one of the most efficient approaches to cellular medicine; in the words of Leonardo Da Vinci "simplicity is the ultimate sophistication."
Innovative Solution to an Unmet Need
Though the Company has a well-developed pipeline of SurgWerks applications, Cesca's most advanced clinical program targets the $2 billion critical limb ischemia ("CLI") market characterized by severe obstruction of the arteries that reduces blood flow to the extremities. CLI is a late phase of Peripheral Artery Disease ("PAD"), which is often associated with diabetes, and progresses to varying degrees of amputation due to non-healing and infected ulcers - all a result from lack of sufficient blood circulation. While medications and surgical options are available to many advanced cases of the disease, according to the think tank Sage Group, an unfortunate 70,000 or more patients are forced to undergo major amputations each year in the U.S. alone, a considerable market that is in need of a solution. The U.S. FDA has approved Cesca to initiate a pivotal clinical trial to study its unique SurgWerks-CLI(TM) platform in this no-option population. SurgWerks-CLI and the VXP System is comprised of a fully-integrated, highly-specialized protocol, single-use disposable kit, and ancillary equipment platform that enables a rapid, door-to-door, 90+ minute intraoperative treatment with the patient's own bone marrow derived cocktail, a combination of stem cells, growth factors and plasma. Once these multipotent cells and growth factors are transplanted, they may promote angiogenesis and alleviate amputation in high-risk CLI patients.
Distinctive Path to Commercialization
Cesca Therapeutics unique path differs in several important ways from its competitors. The SurgWerks System is regulated as a medical device in the United States for which Cesca, upon successful completion of the pivotal trial, will seek FDA approval under a premarket approval ("PMA") to treat CLI. This approach is in stark contrast to the rather lengthy process typical of a biologics license application ("BLA") and new drug application ("NDA") regulatory pathways that non-POC approaches must follow. These latter regulatory requirements are required by essentially all of Cesca's cell therapy peers including Athersys Inc. (NASDAQ:ATHX), and Caladrius Biosciences, Inc. (CLBS) to mention a few. The PMA pathway potentially represents a timesavings of years over BLAs & NDAs, and thus provides a recognizable advantage to Cesca over its competition.
Furthermore, Cesca's autologous approach (e.g. leveraging the patient's own stem cells) differs from allogeneic programs (use of unrelated cells) in that the safety risks associated with cellular manipulation/expansion, immune response and complications of cell cryopreservation, storage and transport are not a factor. These (and many other) allogeneic challenges continue to confront "off-the-shelf" allogeneic cell therapy models that have yet to be proven efficacious in ischemic diseases. We will continue to watch allogeneic products like Pluristem's (PSTI) PLX-PAD for advancements in ischemic applications, however, it appears that autologous cell products and not allogeneic are leading the commercial race in this area of development, particularly CLI. Currently, Cesca has very few direct competitors, the most advanced of which is Zimmer Biomet Holdings, Inc. (NYSE:ZBH), which employs a point-of-care medical device and autologous bone marrow treatment protocol; this similarity between Cesca Therapeutics and a surgical device leader like Zimmer Biomet lends a great deal of support to Cesca's approach.
The CLI space with cell therapy solutions has thinned out over the past several years, a typical phenomenon seen as trials progress towards commercialization leaving the front-runners with the lions-share of the market opportunity. Vericel Corp. (VCEL) - formerly Aastrom Biosciences, for example, appears to have shelved their CLI program leaving Cesca Therapeutics and Zimmer Biomet in good market position. While both companies share the autologous POC approach, Cesca delivers an intra-operative "smart" solution that includes all of the hardware, software, and disposable components. This solution facilitates better control of the complete process, provides real-time companion diagnostics for a consistent therapeutic dose, and closely follows the FDA's current guidance pertaining to commercialization of cellular therapies.
Critical Limb Ischemia Stem Cell Therapy ("CLIRST III") - CLI Pivotal Trial
In June, the Company received FDA IDE approval of a pivotal clinical trial for treatment of CLI in late-stage, no-option patients. The CLIRST III trial will enroll over 200 patients from sites throughout the U.S. and India, with a primary endpoint of major amputation-free survival (see www.clinicaltrials.gov, NCT02538978). The clinical trial, based on prior successful safety and early efficacy feasibility studies, according to the Company's prior public statements is expected to begin enrollment next year.
Diversified Pipeline
Cesca Therapeutics has built up a diversified clinical platform that includes indications well-beyond CLI, including cardiac ischemia. The Company's active cardiovascular programs target an aggregate $2.7 billion market opportunity. Aside from the cardiovascular market, the Company's most advanced orthopedic programs, non-union fractures and avascular necrosis, target an aggregate $6.1 billion market opportunity, while its bone marrow transplant program targets a $100 million opportunity, for a total potential market of $9 billion dollars.
By leveraging its India-based clinical research organization embedded within the Fortis network of hospitals, the Company has built a highly cost-effective approach to feasibility studies and early-stage clinical trials. The Company has also amassed data from over 500 treated patients around the world with several more applications in the pipeline to protect this intellectual property and build significant shareholder value over the long-term.
Looking Ahead
Cesca Therapeutics trades with a market capitalization of just $12 million, despite having FDA approval for a pivotal Phase III CLI clinical trial, and eight other "early but promising shots at the goal" in the pipeline. With its low-cost infrastructure and unique medical device approach, the Company differs greatly from many other regenerative medicine companies in the space - ones that are focused on higher risk allogeneic models or autologous approaches which haven't yet integrated the most advanced medical devices critical to point-of-care cell therapy.
Leonard J. Parisi
Maxim Group LLC - Senior Vice President
405 Lexington Ave - 2nd Floor
NY, NY 10174
212-895-3512
212-895-3555 (Fax)
lparisi@maximgrp.com
AIM: lenparisi
hweb2 is a bright guy:
"Surprised so many shares available around $5 after they pre-announced those strong revenues. Revenue comp looks terrific as expected. But GAAP earnings of .06/share was disappointing. I also came up with .15/share or so excluding the warrant charge. Too bad they have such a high tax rate. The continued drop in backlog is alarming. From $34M last year to $19.7M. And down sequentially from $24.8M. So they only had $1.7M in orders in the quarter vs. $6.8M in revenue?"
Minding
Did you see comments on the Savvy Trades and Investments board?
I was distracted by an company's CC and didn't get to TIK until it was already down.
Kind regards,
Minding
Flashback: My post from 4 November 2015 is coming to fruition
----------
4 November 2015
To keep my feet on the ground, I occasionally look at ELTP's two year chart, back to January-February 2014.
Certainly ELTP is in a better position today than 1 1/2 years ago. So hopefully when this move is done the price won't retrace back to its base in the low twenties.
What would keep the price up?
* The company would need to be a takeover candidate -- in its current stage of development, it's not or
* It would need a shocking amount of revenue because that's what it would take to substantially move a company with over 661M shares outstanding.
The only other possibility is anticipation of a coming event. That we have.
But no coming event will produce earnings per share that justify this kind of move. So when this move is done, I expect to see it retrace by 1/2 to 2/3.
I think we're good for another run upward after a dip in the next few days. Third time is the charm. That's when I plan to take some profit.
Since the future is unknowable I will continue to hold shares I bought long ago because I believe one day they'll be worth a good deal more. Just not today. Not now.
Kind regards,
Minding
Rockwell Medical Technologies (RIMT) Triferic Sales Not Material Enough To Even Disclose, Brean Capital Notes
Brean Capital analyst Jonathan Aschoff reiterated a Sell rating and $4 price target on Rockwell Medical Technologies (NASDAQ: RMTI) noting Triferic sales were not material enough to even disclose.
Aschoff commented, "Rockwell launched Triferic in the US in September but has not yet generated sales material enough to report separately as Triferic revenue. Rockwell admitted the sales are minimal, and prices are currently being negotiated with individual dialysis providers. We expect dismal commercial uptake for Triferic and reiterate our Sell rating and $4 TP. Rockwell claims that one of the four largest dialysis providers signed a contract with Triferic, with none of the dialysis provider information provided. We do not have any clarity on the name of the provider, the length of the contract or the timeline to disclose such information. We are quite confident, however, that describing it as "one of the top four" means that it is either US Renal Care or Dialysis Clinic Inc., both of which are far smaller than the two biggest dialysis providers. Some minor clinics have ordered Triferic, but no material sales have yet resulted. Rockwell has not set a date to discuss Triferic with the EU agencies, and we are not confident about its plan to expand into 30-40 countries worldwide. As for the generic drug Calcitriol, which was approved in June 2014, it has not even yet been launched. We believe it will not add meaningful value to Rockwell, since IV Calcitriol will be subject to bundled reimbursement and that oral Calcitriol has been approved for many years, is inexpensive and widely available, and that there are several far larger competitors, some of which have both doses of generic IV Calcitriol.:
For an analyst ratings summary and ratings history on Rockwell Medical Technologies click here. For more ratings news on Rockwell Medical Technologies click here.
Shares of Rockwell Medical Technologies closed at $11.47 yesterday.
RMTI CC transcript @ http://seekingalpha.com/article/3668686-rockwells-rmti-ceo-rob-chioini-on-q3-2015-results-earnings-call-transcript
The big (non-) news is the continuing expectation that Triferic will get a sizable % of the market. Yes there was the signing of a supply contract but no details. That's not helpful to projections.
Kind regards,
Minding
CC transcript @ http://seekingalpha.com/article/3668686-rockwells-rmti-ceo-rob-chioini-on-q3-2015-results-earnings-call-transcript
The big (non-) news is the continuing expectation that Triferic will get a sizable % of the market. Yes there was the signing of a supply contract but no details. That's not helpful to projections.
Kind regards,
Minding
Thanks for the post.
I also listened and read. I'm a little more sanguine about the pent-up demand. Not that I doubt it, but it's unclear when it will 'unpent'. Holding (though I've got enough anyway.)
Kind regards,
Minding
4:30 today, RMTI CC: http://edge.media-server.com/m/p/5fbfoyne
Kind regards,
Minding
Recognition of J-Plasma is on the slow boat.
Kind regards,
Minding
A summary reaction.
Kind regards,
Minding
================
From http://zolmax.com/investing/perma-fix-environmental-services-pesi-announces-quarterly-earnings-results/277791/
Perma-Fix Environmental Services (PESI) Announces Quarterly Earnings Results
Posted by Wayne Rhoads on Nov 4th, 2015 // No Comments
Perma-Fix Environmental Services logoPerma-Fix Environmental Services (NASDAQ:PESI) announced its earnings results on Wednesday. The company reported $0.12 EPS for the quarter, missing the consensus estimate of $0.15 by $0.03, Analyst Ratings.Net reports. The business had revenue of $17.30 million for the quarter, compared to analysts’ expectations of $18.55 million.
Several analysts have commented on the stock. Zacks cut shares of Perma-Fix Environmental Services from a “strong-buy” rating to a “hold” rating in a research note on Tuesday, August 11th. TheStreet raised shares of Perma-Fix Environmental Services from a “sell” rating to a “hold” rating in a research report on Tuesday, August 25th.
Perma-Fix Environmental Services (NASDAQ:PESI) traded down 4.2329% during trading on Wednesday, reaching $4.0701. 179,800 shares of the company’s stock were exchanged. The firm’s 50-day moving average price is $4.15 and its 200-day moving average price is $3.84. The firm has a market cap of $46.91 million and a price-to-earnings ratio of 101.7525. Perma-Fix Environmental Services has a 12 month low of $3.32 and a 12 month high of $5.01.
Perma-Fix Environmental Services, Inc. is an environmental and environmental technology know how business. The Business operates in two segments: Treatment Section as well as the Services Segment. The therapy Section comprises nuclear, low level radioactive, mixed, dangerous and non-hazardous waste treatment, processing and disposal services. The Services Segment consists of specialized services onsite waste management and nuclear services. The business is also associated with the research and development (NASDAQ:PESI) and promotion of medical isotope technology (Technetium 99 or Tc-99m) through its Perma-Fix Medical S.A subsidiary company. Its subsidiary companies are Perma-Fix of Florida, Inc., Diversified Scientific Services, Inc., East Tennessee Substances & Energy Corporation, Perma Fix Northwest, Inc., Safety and Ecology Corporation Radcon Coalition, LLC and Safety and Ecology Corporation.
To keep my feet on the ground, I occasionally look at ELTP's two year chart, back to January-February 2014.
Certainly ELTP is in a better position today than 1 1/2 years ago. So hopefully when this move is done the price won't retrace back to its base in the low twenties.
What would keep the price up?
* The company would need to be a takeover candidate -- in its current stage of development, it's not or
* It would need a shocking amount of revenue because that's what it would take to substantially move a company with over 661M shares outstanding.
The only other possibility is anticipation of a coming event. That we have.
But no coming event will produce earnings per share that justify this kind of move. So when this move is done, I expect to see it retrace by 1/2 to 2/3.
I think we're good for another run upward after a dip in the next few days. Third time is the charm. That's when I plan to take some profit.
Since the future is unknowable I will continue to hold shares I bought long ago because I believe one day they'll be worth a good deal more. Just not today. Not now.
Kind regards,
Minding
Yeah, where IS that big gov't contract?
Minding
Actually Treatment was disappointing.
Minding
As long as the Tech-99 project stay on course (and cash is ok), that aspect of the company will appear as if dormant until next year.
I'm want to see more post-sequestration business. In that regard Treatment was more disappointing.
Minding
Perma-Fix Reports Adjusted EBITDA (as Defined Below) of $2.9 Million and Net Income from Continuing Operations of $1.3 Million or $0.12 Per Share for the Third Quarter of 2015
All cylinders firing. A good enough quarter.
Kind regards,
Minding
==============
From http://finance.yahoo.com/news/perma-fix-reports-adjusted-ebitda-123000861.html
Services Segment Revenue Increases 53.4% versus the Third Quarter of 2014
ATLANTA, GA--(Marketwired - November 04, 2015) - Perma-Fix Environmental Services, Inc. (PESI) (the "Company") today announced results for the third quarter ended September 30, 2015.
Dr. Louis F. Centofanti, Chairman and Chief Executive Officer, stated, "I am pleased to report another quarter of profitability with $2.9 million of adjusted EBITDA and $1.3 million, or $0.12 per share, of net income from continuing operations. Importantly, we continue to see growth in our Services Segment, with revenue increasing 53.4% compared to the same period last year. We also experienced another solid quarter in our Treatment Segement, albeit slightly less than the same period last year due to the timing of waste shipments which is normal in our business. Looking ahead, we believe that our prior guidance of adjusted EBITDA in the range of $6 million to $7 million for 2015 can be achieved based on our estimated performance for the fourth quarter of 2015. I am especially pleased that our results are producing improved liquidity as evidenced by our cash flow from operations, working capital and debt reduction.
"We are also making continued progress advancing our new process for the production of Technetium-99m ("Tc-99m"). We recently announced that we completed another successful scale-up of our process, which confirmed our proprietary resin could withstand higher levels of radiation, up to 6 curies, while providing clinically useful doses of Tc-99m. We believe we have now overcome nearly all the technical hurdles and required validation testing related to our resin. As a result, we have received positive feedback from the industry and are actively evaluating potential industry partners, while finalizing our strategy for U.S. Food and Drug Administration ("FDA") and European Medicines Agency ("EMA") submission. We will provide additional updates on our strategy as they become available."
Financial Results
Revenue for the third quarter of 2015 was $17.3 million versus $16.9 million for the same period last year. Revenue for the Treatment Segment was $10.9 million compared to $12.7 million for the same period in 2014. In 2014, the Treatment Segment received waste which required a short processing deadline and thus produced higher revenue in the third quarter of 2014. Revenue from the Services Segment was $6.4 million versus $4.2 million for the same period in 2014.The increase in revenue was the result of increased commercial revenue.
Gross profit for the third quarter of 2015 was $4.9 million versus $5.6 million for the third quarter of 2014. Gross margin decreased to 28.6% for the three months ended September 30, 2015 from 33.0% for the same period last year primarily resulting from reduced revenue in our Treatment Segment.
Operating income for the third quarter of 2015 was $1.5 million as compared to an operating income of $2.6 million for the third quarter of 2014. Net income attributable to common stockholders for the third quarter of 2015 was $1.1 million or $0.09 per share, versus a net income of $1.9 million or $0.16 per share for the same period in 2014.
The Company's Adjusted EBITDA was $2.9 million from continuing operations for the quarter ended September 30, 2015, as compared to Adjusted EBITDA of $3.8 million for the same period of 2014. The Company defines EBITDA as earnings before interest, taxes, depreciation and amortization. Adjusted EBITDA is defined as EBITDA before research and development costs related to the Medical Isotope project and impairment charges on goodwill. Both EBITDA and Adjusted EBITDA are not measures of performance calculated in accordance with Generally Accepted Accounting Principles in the United States of America ("GAAP"), and should not be considered in isolation of, or as a substitute for, earnings as an indicator of operating performance or cash flows from operating activities as a measure of liquidity. The Company believes the presentation of EBITDA and Adjusted EBITDA is relevant and useful by enhancing the readers' ability to understand the Company's operating performance. The Company's management utilizes EBITDA and Adjusted EBITDA as a means to measure performance. The Company's measurements of EBITDA and Adjusted EBITDA may not be comparable to similar titled measures reported by other companies. The table below reconciles EBITDA and Adjusted EBITDA, both non-GAAP measures, to GAAP numbers for income (loss) from continuing operations for the three and nine months ended September 30, 2015 and 2014.
Quarter Ended Nine Months Ended
September 30, September 30,
(In thousands) 2015 2014 2015 2014
Income (loss) from continuing operations $ 1,284 $ 2,344 $ (322 ) $ (3,720 )
Adjustments:
Depreciation & amortization 912 973 2,821 3,282
Interest income (16 ) (7 ) (36 ) (20 )
Interest expense 124 138 390 505
Interest expense - financing fees 56 52 171 133
Income tax expense 53 30 124 90
EBITDA 2,413 3,530 3,148 270
Research and development costs related to Medical Isotope project 527 229 1,354 548
Impairment loss on goodwill -- -- -- 380
Adjusted EBITDA $ 2,940 $ 3,759 $ 4,502 $ 1,198
The tables below present certain unaudited financial information for the business segments, excluding allocation of corporate expenses and research and development costs related to our Medical Isotope project:
Three Months Ended Nine Months Ended
September 30, 2015 September 30, 2015
(In thousands) Treatment Services Treatment Services
Net revenues $ 10,866 $ 6,443 $ 31,702 $ 15,562
Gross profit 3,696 1,250 8,265 2,190
Segment profit 2,681 507 5,124 265
Three Months Ended Nine Months Ended
September 30, 2014 September 30, 2014
(In thousands) Treatment Services Treatment Services
Net revenues $ 12,705 $ 4,200 $ 29,773 $ 10,333
Gross profit 4,943 638 6,379 853
Segment profit (loss) 3,985 10 2,977 (1,981 )
Conference Call
Perma-Fix will host a conference call at 11:00 AM ET November 4, 2015. The call will be available on the Company's website at www.perma-fix.com, or by calling 877-407-0778 for U.S. callers, or 201-689-8565 for international callers. A webcast will also be archived on the Company's website and a telephone replay of the call will be available approximately one hour following the call, through midnight November 11, 2015, and can be accessed by calling: 877-660-6853 (U.S. callers) or 201-612-7415 (international callers) and entering conference ID: 13624187.
About Perma-Fix Environmental Services
Perma-Fix Environmental Services, Inc. is a nuclear services company and leading provider of nuclear and mixed waste management services. The Company's nuclear waste services include management and treatment of radioactive and mixed waste for hospitals, research labs and institutions, federal agencies, including the Department of Energy ("DOE"), the Department of Defense ("DOD"), and the commercial nuclear industry. The Company's nuclear services group provides project management, waste management, environmental restoration, decontamination and decommissioning, new build construction, and radiological protection, safety and industrial hygiene capability to our clients. The Company operates four nuclear waste treatment facilities and provides nuclear services at DOE, DOD, and commercial facilities, nationwide.
Through Perma-Fix Medical S.A., our majority-owned Polish subsidiary, we have also developed a new process to produce Tc-99m, a widely used medical isotope in the world. The new process is expected to solve worldwide shortages of Tc-99m as it is less expensive, does not require the use of government-subsidized, weapons-grade materials and can be easily deployed around the world.
Please visit us on the World Wide Web at http://www.perma-fix.com.
This press release contains "forward-looking statements" which are based largely on the Company's expectations and are subject to various business risks and uncertainties, certain of which are beyond the Company's control. Forward-looking statements generally are identifiable by use of the words such as "believe", "expects", "intends", "anticipate", "plans to", "estimates", "projects", and similar expressions. Forward-looking statements include, but are not limited to: adjusted EBITDA in the range of $6 million to $7 million for 2015; benefits of our Tc-99m process; and strategy for FDA and EMA approvals of our Tc-99m process. These forward-looking statements are intended to qualify for the safe harbors from liability established by the Private Securities Litigation Reform Act of 1995. While the Company believes the expectations reflected in this news release are reasonable, it can give no assurance such expectations will prove to be correct. There are a variety of factors which could cause future outcomes to differ materially from those described in this release, including, without limitation, future economic conditions; industry conditions; competitive pressures; our ability to apply and market our new technology; the government or such other party to a contract granted to us fails to abide by or comply with the contract or to deliver waste as anticipated under the contract; that Congress provides continuing funding for the DOD's and DOE's remediation projects; ability to obtain new foreign and domestic remediation contracts; commercialization of Tc-99m; and the "Risk Factors" discussed in, and the additional factors referred to under "Special Note Regarding Forward-Looking Statements" of our 2014 Form 10-K and Forms 10-Q for quarters ended March 31, 2015, June 30, 2015, and September 30, 2015. The Company makes no commitment to disclose any revisions to forward-looking statements, or any facts, events or circumstances after the date hereof that bear upon forward-looking statements.
Please visit us on the World Wide Web at http://www.perma-fix.com.
FINANCIAL TABLES FOLLOW
PERMA-FIX ENVIRONMENTAL SERVICES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three Months Ended Nine Months Ended
September 30, September 30,
(Amounts in Thousands, Except for Per Share Amounts) 2015 2014 2015 2014
Net revenues $ 17,309 $ 16,905 $ 47,264 $ 40,106
Cost of goods sold 12,363 11,324 36,809 32,874
Gross profit 4,946 5,581 10,455 7,232
Selling, general and administrative expenses 2,887 2,733 8,663 8,916
Research and development 583 253 1,500 941
Impairment loss on goodwill -- -- -- 380
Gain on disposal of property and equipment (23 ) (25 ) (23 ) (41 )
Income (loss) from operations 1,499 2,620 315 (2,964 )
Other income (expense):
Interest income 16 7 36 20
Interest expense (124 ) (138 ) (390 ) (505 )
Interest expense - financing fees (56 ) (52 ) (171 ) (133 )
Foreign currency loss (2 ) -- (7 ) --
Other 4 (63 ) 19 (48 )
Income (loss) from continuing operations before taxes 1,337 2,374 (198 ) (3,630 )
Income tax expense 53 30 124 90
Income (loss) from continuing operations, net of taxes 1,284 2,344 (322 ) (3,720 )
(Loss) income from discontinued operations, net of taxes (377 ) (473 ) (1,313 ) 1,633
Net income (loss) 907 1,871 (1,635 ) (2,087 )
Net loss attributable to non-controlling interest 163 -- 487 --
Net income (loss) attributable to Perma-Fix Environmental Services, Inc. common stockholders $ 1,070 $ 1,871 $ (1,148 ) $ (2,087 )
Net income (loss) per common share attributable to Perma-Fix Environmental Services, Inc. stockholders - basic:
Continuing operations $ .12 $ .20 $ .01 $ (.32 )
Discontinued operations (.03 ) (.04 ) (.11 ) .14
Net income (loss) per common share $ .09 $ .16 $ (.10 ) $ (.18 )
Net income (loss) per common share attributable to Perma-Fix Environmental Services, Inc. stockholders - diluted:
Continuing operations $ .12 $ .20 $ .01 $ (.32 )
Discontinued operations (.03 ) (.04 ) (.11 ) .14
Net income (loss) per common share $ .09 $ .16 $ (.10 ) $ (.18 )
Number of common shares used in computing net income (loss) per share:
Basic 11,526 11,449 11,506 11,434
Diluted 11,561 11,490 11,542 11,434
The accompanying notes are an integral part of these consolidated financial statements.
PERMA-FIX ENVIRONMENTAL SERVICES, INC.
CONSOLIDATED BALANCE SHEET
(UNAUDITED)
September 30, December 31,
(Amounts in Thousands, Except for Share and Per Share Amounts) 2015 2014
ASSETS
Current assets:
Cash and equivalents $ 2,100 $ 3,765
Account receivable, net of allowance for doubtful accounts of $1,880 and $2,170 8,462 8,272
Unbilled receivables 5,732 7,177
Other current assets 4,046 3,508
Deferred tax assets - current 385 385
Assets of discontinued operations included in current assets, net of allowance for doubtful accounts of $0 for each period 37 20
Total current assets 20,762 23,127
Net property and equipment 20,535 22,824
Property and equipment of discontinued operations, net of accumulated depreciation of $10 for each period 531 681
Intangibles and other assets 41,768 42,004
Total assets $ 83,596 $ 88,636
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 18,122 $ 20,233
Current liabilities related to discontinued operations 1,491 2,137
Total current liabilities 19,613 22,370
Long-term liabilities 16,861 19,341
Long-term liabilities related to discontinued operations 1,184 590
Total liabilities 37,658 42,301
Commitments and Contingencies
Series B Preferred Stock of subsidiary, $1.00 par value; 1,467,396 shares authorized, 1,284,730 shares issued and oustanding, liquidation value $1.00per share plus accrued and unpaid dividends of $851 and $803, respectively 1,285 1,285
Stockholders' equity:
Preferred Stock, $.001 par value; 2,000,000 shares authorized, no shares issued and outstanding -- --
Common Stock, $.001 par value; 30,000,000 shares authorized; 11,535,367 and 11,476,485 shares issued, respectively; 11,527,725 and 11,468,843shares outstanding, respectively 11 11
Additional paid-in capital 104,057 103,765
Accumulated deficit (60,906 ) (59,758 )
Accumulated other comprehensive (loss) income (81 ) 11
Less Common Stock in treasury at cost: 7,642 shares (88 ) (88 )
Total Perma-Fix Environmental Services, Inc. stockholders' equity 42,993 43,941
Non-controlling interest 1,660 1,109
Total stockholders' equity 44,653 45,050
Total liabilities and stockholders' equity $ 83,596 $ 88,636
Contact:
David K. Waldman
US Investor Relations
Crescendo Communications, LLC
(212) 671-1021
Herbert Strauss
European Investor Relations
herbert@eu-ir.com
+43 316 296 316
Perma-Fix Reports Adjusted EBITDA (as Defined Below) of $2.9 Million and Net Income from Continuing Operations of $1.3 Million or $0.12 Per Share for the Third Quarter of 2015
All cylinders firing.
Kind regards,
Minding
==============
From http://finance.yahoo.com/news/perma-fix-reports-adjusted-ebitda-123000861.html
Services Segment Revenue Increases 53.4% versus the Third Quarter of 2014
ATLANTA, GA--(Marketwired - November 04, 2015) - Perma-Fix Environmental Services, Inc. (PESI) (the "Company") today announced results for the third quarter ended September 30, 2015.
Dr. Louis F. Centofanti, Chairman and Chief Executive Officer, stated, "I am pleased to report another quarter of profitability with $2.9 million of adjusted EBITDA and $1.3 million, or $0.12 per share, of net income from continuing operations. Importantly, we continue to see growth in our Services Segment, with revenue increasing 53.4% compared to the same period last year. We also experienced another solid quarter in our Treatment Segement, albeit slightly less than the same period last year due to the timing of waste shipments which is normal in our business. Looking ahead, we believe that our prior guidance of adjusted EBITDA in the range of $6 million to $7 million for 2015 can be achieved based on our estimated performance for the fourth quarter of 2015. I am especially pleased that our results are producing improved liquidity as evidenced by our cash flow from operations, working capital and debt reduction.
"We are also making continued progress advancing our new process for the production of Technetium-99m ("Tc-99m"). We recently announced that we completed another successful scale-up of our process, which confirmed our proprietary resin could withstand higher levels of radiation, up to 6 curies, while providing clinically useful doses of Tc-99m. We believe we have now overcome nearly all the technical hurdles and required validation testing related to our resin. As a result, we have received positive feedback from the industry and are actively evaluating potential industry partners, while finalizing our strategy for U.S. Food and Drug Administration ("FDA") and European Medicines Agency ("EMA") submission. We will provide additional updates on our strategy as they become available."
Financial Results
Revenue for the third quarter of 2015 was $17.3 million versus $16.9 million for the same period last year. Revenue for the Treatment Segment was $10.9 million compared to $12.7 million for the same period in 2014. In 2014, the Treatment Segment received waste which required a short processing deadline and thus produced higher revenue in the third quarter of 2014. Revenue from the Services Segment was $6.4 million versus $4.2 million for the same period in 2014.The increase in revenue was the result of increased commercial revenue.
Gross profit for the third quarter of 2015 was $4.9 million versus $5.6 million for the third quarter of 2014. Gross margin decreased to 28.6% for the three months ended September 30, 2015 from 33.0% for the same period last year primarily resulting from reduced revenue in our Treatment Segment.
Operating income for the third quarter of 2015 was $1.5 million as compared to an operating income of $2.6 million for the third quarter of 2014. Net income attributable to common stockholders for the third quarter of 2015 was $1.1 million or $0.09 per share, versus a net income of $1.9 million or $0.16 per share for the same period in 2014.
The Company's Adjusted EBITDA was $2.9 million from continuing operations for the quarter ended September 30, 2015, as compared to Adjusted EBITDA of $3.8 million for the same period of 2014. The Company defines EBITDA as earnings before interest, taxes, depreciation and amortization. Adjusted EBITDA is defined as EBITDA before research and development costs related to the Medical Isotope project and impairment charges on goodwill. Both EBITDA and Adjusted EBITDA are not measures of performance calculated in accordance with Generally Accepted Accounting Principles in the United States of America ("GAAP"), and should not be considered in isolation of, or as a substitute for, earnings as an indicator of operating performance or cash flows from operating activities as a measure of liquidity. The Company believes the presentation of EBITDA and Adjusted EBITDA is relevant and useful by enhancing the readers' ability to understand the Company's operating performance. The Company's management utilizes EBITDA and Adjusted EBITDA as a means to measure performance. The Company's measurements of EBITDA and Adjusted EBITDA may not be comparable to similar titled measures reported by other companies. The table below reconciles EBITDA and Adjusted EBITDA, both non-GAAP measures, to GAAP numbers for income (loss) from continuing operations for the three and nine months ended September 30, 2015 and 2014.
Quarter Ended Nine Months Ended
September 30, September 30,
(In thousands) 2015 2014 2015 2014
Income (loss) from continuing operations $ 1,284 $ 2,344 $ (322 ) $ (3,720 )
Adjustments:
Depreciation & amortization 912 973 2,821 3,282
Interest income (16 ) (7 ) (36 ) (20 )
Interest expense 124 138 390 505
Interest expense - financing fees 56 52 171 133
Income tax expense 53 30 124 90
EBITDA 2,413 3,530 3,148 270
Research and development costs related to Medical Isotope project 527 229 1,354 548
Impairment loss on goodwill -- -- -- 380
Adjusted EBITDA $ 2,940 $ 3,759 $ 4,502 $ 1,198
The tables below present certain unaudited financial information for the business segments, excluding allocation of corporate expenses and research and development costs related to our Medical Isotope project:
Three Months Ended Nine Months Ended
September 30, 2015 September 30, 2015
(In thousands) Treatment Services Treatment Services
Net revenues $ 10,866 $ 6,443 $ 31,702 $ 15,562
Gross profit 3,696 1,250 8,265 2,190
Segment profit 2,681 507 5,124 265
Three Months Ended Nine Months Ended
September 30, 2014 September 30, 2014
(In thousands) Treatment Services Treatment Services
Net revenues $ 12,705 $ 4,200 $ 29,773 $ 10,333
Gross profit 4,943 638 6,379 853
Segment profit (loss) 3,985 10 2,977 (1,981 )
Conference Call
Perma-Fix will host a conference call at 11:00 AM ET November 4, 2015. The call will be available on the Company's website at www.perma-fix.com, or by calling 877-407-0778 for U.S. callers, or 201-689-8565 for international callers. A webcast will also be archived on the Company's website and a telephone replay of the call will be available approximately one hour following the call, through midnight November 11, 2015, and can be accessed by calling: 877-660-6853 (U.S. callers) or 201-612-7415 (international callers) and entering conference ID: 13624187.
About Perma-Fix Environmental Services
Perma-Fix Environmental Services, Inc. is a nuclear services company and leading provider of nuclear and mixed waste management services. The Company's nuclear waste services include management and treatment of radioactive and mixed waste for hospitals, research labs and institutions, federal agencies, including the Department of Energy ("DOE"), the Department of Defense ("DOD"), and the commercial nuclear industry. The Company's nuclear services group provides project management, waste management, environmental restoration, decontamination and decommissioning, new build construction, and radiological protection, safety and industrial hygiene capability to our clients. The Company operates four nuclear waste treatment facilities and provides nuclear services at DOE, DOD, and commercial facilities, nationwide.
Through Perma-Fix Medical S.A., our majority-owned Polish subsidiary, we have also developed a new process to produce Tc-99m, a widely used medical isotope in the world. The new process is expected to solve worldwide shortages of Tc-99m as it is less expensive, does not require the use of government-subsidized, weapons-grade materials and can be easily deployed around the world.
Please visit us on the World Wide Web at http://www.perma-fix.com.
This press release contains "forward-looking statements" which are based largely on the Company's expectations and are subject to various business risks and uncertainties, certain of which are beyond the Company's control. Forward-looking statements generally are identifiable by use of the words such as "believe", "expects", "intends", "anticipate", "plans to", "estimates", "projects", and similar expressions. Forward-looking statements include, but are not limited to: adjusted EBITDA in the range of $6 million to $7 million for 2015; benefits of our Tc-99m process; and strategy for FDA and EMA approvals of our Tc-99m process. These forward-looking statements are intended to qualify for the safe harbors from liability established by the Private Securities Litigation Reform Act of 1995. While the Company believes the expectations reflected in this news release are reasonable, it can give no assurance such expectations will prove to be correct. There are a variety of factors which could cause future outcomes to differ materially from those described in this release, including, without limitation, future economic conditions; industry conditions; competitive pressures; our ability to apply and market our new technology; the government or such other party to a contract granted to us fails to abide by or comply with the contract or to deliver waste as anticipated under the contract; that Congress provides continuing funding for the DOD's and DOE's remediation projects; ability to obtain new foreign and domestic remediation contracts; commercialization of Tc-99m; and the "Risk Factors" discussed in, and the additional factors referred to under "Special Note Regarding Forward-Looking Statements" of our 2014 Form 10-K and Forms 10-Q for quarters ended March 31, 2015, June 30, 2015, and September 30, 2015. The Company makes no commitment to disclose any revisions to forward-looking statements, or any facts, events or circumstances after the date hereof that bear upon forward-looking statements.
Please visit us on the World Wide Web at http://www.perma-fix.com.
FINANCIAL TABLES FOLLOW
PERMA-FIX ENVIRONMENTAL SERVICES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three Months Ended Nine Months Ended
September 30, September 30,
(Amounts in Thousands, Except for Per Share Amounts) 2015 2014 2015 2014
Net revenues $ 17,309 $ 16,905 $ 47,264 $ 40,106
Cost of goods sold 12,363 11,324 36,809 32,874
Gross profit 4,946 5,581 10,455 7,232
Selling, general and administrative expenses 2,887 2,733 8,663 8,916
Research and development 583 253 1,500 941
Impairment loss on goodwill -- -- -- 380
Gain on disposal of property and equipment (23 ) (25 ) (23 ) (41 )
Income (loss) from operations 1,499 2,620 315 (2,964 )
Other income (expense):
Interest income 16 7 36 20
Interest expense (124 ) (138 ) (390 ) (505 )
Interest expense - financing fees (56 ) (52 ) (171 ) (133 )
Foreign currency loss (2 ) -- (7 ) --
Other 4 (63 ) 19 (48 )
Income (loss) from continuing operations before taxes 1,337 2,374 (198 ) (3,630 )
Income tax expense 53 30 124 90
Income (loss) from continuing operations, net of taxes 1,284 2,344 (322 ) (3,720 )
(Loss) income from discontinued operations, net of taxes (377 ) (473 ) (1,313 ) 1,633
Net income (loss) 907 1,871 (1,635 ) (2,087 )
Net loss attributable to non-controlling interest 163 -- 487 --
Net income (loss) attributable to Perma-Fix Environmental Services, Inc. common stockholders $ 1,070 $ 1,871 $ (1,148 ) $ (2,087 )
Net income (loss) per common share attributable to Perma-Fix Environmental Services, Inc. stockholders - basic:
Continuing operations $ .12 $ .20 $ .01 $ (.32 )
Discontinued operations (.03 ) (.04 ) (.11 ) .14
Net income (loss) per common share $ .09 $ .16 $ (.10 ) $ (.18 )
Net income (loss) per common share attributable to Perma-Fix Environmental Services, Inc. stockholders - diluted:
Continuing operations $ .12 $ .20 $ .01 $ (.32 )
Discontinued operations (.03 ) (.04 ) (.11 ) .14
Net income (loss) per common share $ .09 $ .16 $ (.10 ) $ (.18 )
Number of common shares used in computing net income (loss) per share:
Basic 11,526 11,449 11,506 11,434
Diluted 11,561 11,490 11,542 11,434
The accompanying notes are an integral part of these consolidated financial statements.
PERMA-FIX ENVIRONMENTAL SERVICES, INC.
CONSOLIDATED BALANCE SHEET
(UNAUDITED)
September 30, December 31,
(Amounts in Thousands, Except for Share and Per Share Amounts) 2015 2014
ASSETS
Current assets:
Cash and equivalents $ 2,100 $ 3,765
Account receivable, net of allowance for doubtful accounts of $1,880 and $2,170 8,462 8,272
Unbilled receivables 5,732 7,177
Other current assets 4,046 3,508
Deferred tax assets - current 385 385
Assets of discontinued operations included in current assets, net of allowance for doubtful accounts of $0 for each period 37 20
Total current assets 20,762 23,127
Net property and equipment 20,535 22,824
Property and equipment of discontinued operations, net of accumulated depreciation of $10 for each period 531 681
Intangibles and other assets 41,768 42,004
Total assets $ 83,596 $ 88,636
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 18,122 $ 20,233
Current liabilities related to discontinued operations 1,491 2,137
Total current liabilities 19,613 22,370
Long-term liabilities 16,861 19,341
Long-term liabilities related to discontinued operations 1,184 590
Total liabilities 37,658 42,301
Commitments and Contingencies
Series B Preferred Stock of subsidiary, $1.00 par value; 1,467,396 shares authorized, 1,284,730 shares issued and oustanding, liquidation value $1.00per share plus accrued and unpaid dividends of $851 and $803, respectively 1,285 1,285
Stockholders' equity:
Preferred Stock, $.001 par value; 2,000,000 shares authorized, no shares issued and outstanding -- --
Common Stock, $.001 par value; 30,000,000 shares authorized; 11,535,367 and 11,476,485 shares issued, respectively; 11,527,725 and 11,468,843shares outstanding, respectively 11 11
Additional paid-in capital 104,057 103,765
Accumulated deficit (60,906 ) (59,758 )
Accumulated other comprehensive (loss) income (81 ) 11
Less Common Stock in treasury at cost: 7,642 shares (88 ) (88 )
Total Perma-Fix Environmental Services, Inc. stockholders' equity 42,993 43,941
Non-controlling interest 1,660 1,109
Total stockholders' equity 44,653 45,050
Total liabilities and stockholders' equity $ 83,596 $ 88,636
Contact:
David K. Waldman
US Investor Relations
Crescendo Communications, LLC
(212) 671-1021
Herbert Strauss
European Investor Relations
herbert@eu-ir.com
+43 316 296 316
Good color. Thanks.
Kind regards,
Minding
For those interested, here's the source of Aussie prices: http://www.asx.com.au/asx/markets/equityPrices.do?asxCodes=BLT&by=asxCodes
Kind regards,
Minding
One view, technical for the most part.
Kind regards,
Minding
---------------
From http://www.financialmagazin.com/what-will-happen-to-medicinova-inc-next-the-stock-just-reaches-52-week-low/
What Will Happen to MediciNova, Inc. Next? The Stock Just Reaches 52-Week Low
The stock of MediciNova, Inc. (MNOV) hit a new 52-week low and has $2.05 target or 28.00% below today’s $2.85 share price. The 8 months bearish chart indicates high risk for the $84.89 million company. The 1-year low was reported on Oct, 21 by Barchart.com. If the $2.05 price target is reached, the company will be worth $23.77M less.
The 52-week low event is an important milestone for every stock because it shows very negative momentum and is time when sellers come in. During such technical setups, fundamental investors usually stay away and are careful buying the stock. The stock is up 2.15% or $0.06 after the news, hitting $2.85 per share. About 107,871 shares traded hands or 41.33% up from the average. MediciNova, Inc. (NASDAQ:MNOV) has declined 18.42% since March 18, 2015 and is downtrending. It has underperformed by 15.15% the S&P500.
Analysts await MediciNova, Inc. (NASDAQ:MNOV) to reports earnings on October, 29. After $-0.09 actual EPS reported by MediciNova, Inc. for the previous quarter, Wall Street now forecasts 11.11% negative EPS growth.
According to Zacks, “MEDICINOVA, INC. is a publicly-traded biopharmaceutical company focused on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical need with a specific focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential and patent assets having claims of commercially adequate scope. MediciNova’s pipeline includes six clinical-stage compounds for the treatment of status asthmaticus, multiple sclerosis, asthma, interstitial cystitis, solid tumor cancers, Generalized Anxiety Disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova will seek to monetize its other product candidates at key value inflection points.”
The institutional sentiment increased to 1 in Q2 2015. Its up 0.55, from 0.45 in 2015Q1. The ratio increased, as 5 funds sold all MediciNova, Inc. shares owned while 4 reduced positions. 2 funds bought stakes while 7 increased positions. They now own 2.52 million shares or 0.18% more from 2.51 million shares in 2015Q1.
Essex Woodlands Health Ventures Inc. holds 0.83% of its portfolio in MediciNova, Inc. for 1.17 million shares. Bridgeway Capital Management Inc owns 66,592 shares or 0.01% of their US portfolio. Moreover, Bank Of America Corp De has 0% invested in the company for 3,020 shares. The United Kingdom-based Barclays Plc has invested 0% in the stock. Blackrock Fund Advisors, a California-based fund reported 60,997 shares.
COCP abstract:
http://www.aasld.org/sites/default/files/documents/2015/TLM_Abstracts/LB21.pdf
Kind regards,
Minding
We're in agreement. My original point was that, for a sea change, the conditions need to be optimum. Certainly the technology is primary, but old-wave competition has sunk many a ship. (I'm stretching the metaphor, I know.)
Kind regards,
Minding
I wish what I thought mattered in the scheme of things. I take the information from Maxim as illuminating but even they aren't consistently correct. The risk for us is that it's all in the hands of KOOL management.
Kind regards,
Minding
Bobwins, I certainly didn't mean to suggest they don't have a shot. I just meant to convey my fear that I would lose all my money in a disastrous trade! ;)
Kind regards,
Minding
Maxim continues to like them: https://maxim.bluematrix.com/sellside/EmailDocViewer?encrypt=d627eede-8368-4f6e-b2f4-69c6aed33dbe&mime=pdf&co=maxim&id=lparisi@maximgrp.com&source=mail
Latest news:
Cesca Therapeutics Clinical Laboratory Successfully Facilitates Haploidentical Bone Marrow Transplant Procedure on Unique Pediatric Patient in Need
Cesca Therapeutics Inc.
1 hour ago
GlobeNewswire
????
RANCHO CORDOVA, Calif., Oct. 19, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (KOOL), an autologous cell-based regenerative medicine company, today announced that its Clinical GMP Cell Processing Laboratory "TotipotentRX Centre for Cellular Medicine" located at Fortis Memorial Research Institute (FMRI), New Delhi, N.C.R., India, performed a specialized T-cell preparation procedure designed for a unique haploidentical transplantation case. This potentially lifesaving procedure was provided for a child suffering from both Fanconi's Anemia (non-malignant genetic disorder) and relapsed AML (malignant disorder). The patient is currently in stable condition.
Haploidentical transplantation is a treatment option gaining global acceptance as it increases the possibility of finding an acceptable donor match, known as an HLA match. With respect to HLA matching, parents are always a half-match for their children and siblings have at least a 75% chance of a match (full match and half match). Until recently closely related donor sources such as the patient's parents came with a high risk of incompatibility and a high incidence of fatal Graft versus Host disease, where donor cells attack the recipient. New protocols that involve selection or removal of specific sub- types of T lymphocytes, as used in the TotipotentRX laboratory, are now providing more options with good results for patients in need of a life-saving bone marrow transplant. Furthermore, in the case of patient relapse, a closely related donor is more likely to be available for further cell therapy.
Dr. Venkatesh Ponemone, Ph.D., Executive Director GMP Laboratory and Clinical affairs, India stated, "We are very pleased by the achievement of this clinical milestone as it highlights our routine use of cell selection technology with Haploidentical transplantation and our capability to support the needs of cutting-edge healthcare. We are one of a very exclusive group of laboratories capable of this precision work and we look forward to expanding our approach for the betterment of a huge and underserved patient population in India. I'm personally very proud of Cesca's vision and thankful for the opportunity to take part in giving many patients a second chance at life, particularly children."
Mitchel Sivilotti, Senior Vice President and Chief Biologist at Cesca Therapeutics stated, "In India, there is an acute need for transplant donors as transplant registries are yet to reach the maturity of those in the U.S. and Europe. Historically, this has left patients with limited transplant options. Dr. Ponemone and his team have adopted advanced methodologies at a quality level unsurpassed in the region they serve. We are very fortunate to have this first-mover advantage and look forward to serving patients, technology partners and clinical trial sponsors through our unique infrastructure and world-class team at TotipotentRX."
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
SurgWerks(TM); proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
Cell harvesting
Cell processing and selection
Cell diagnostics
Cell delivery
CellWerksTM; an integrated system which includes a protocol, disposables and equipment for intra-laboratory use in treatment of oncological and hematological disorders.
The AutoXpress(R) (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
The MarrowXpress(TM) (MXP); a device and disposable system based on the AutoXpress platform for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control and optical sensors and concentrates white blood cells from bone marrow to a user- defined volume in 40 minutes while retaining over 90% of mononuclear cells (MNCs).
The BioArchive(R) System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant.
Forward Looking Statement
The statements contained herein may include statements of future expectations and other forward looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements, including our ability to initiate and prosecute the pivotal CLIRST III trial, our ability to obtain efficacy consistent with prior CLI studies, continued FDA approval, Medicare reimbursement approval, timing of the Company's future submission of IDE, PMA and/or Medicare reimbursement applications, or amendments to such applications, and outcomes from such submissions. Further, clinical trial outcomes are not predictable, and results may vary from the Company's expectations, including the start of any such clinical trials, patient follow up issues, and costs associated with such trials. Further description of other risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements. Contact: Cesca Therapeutics Inc. http://www.cescatherapeutics.com. Cesca may, at its discretion, choose to publish on-going interim notifications, requests for further information as received from the FDA, Medicare or equivalent foreign agencies, but as a general policy only makes announcements regarding material or significant information, such as filing of applications, approvals, initiation of studies, and conclusions.
Contact:
Cesca Therapeutics Inc.
http://www.cescatherapeutics.com
Investor Contact: Kirin Smith, PCG Advisory Group
646-863-6519, or ir@cescatherapeutics.com
Media Contact: Sean Leous, PCG Advisory Group
646-863-8998 or sleous@pcgadvisory.com
Maxim continues to like them: https://maxim.bluematrix.com/sellside/EmailDocViewer?encrypt=d627eede-8368-4f6e-b2f4-69c6aed33dbe&mime=pdf&co=maxim&id=lparisi@maximgrp.com&source=mail
Latest news:
Cesca Therapeutics Clinical Laboratory Successfully Facilitates Haploidentical Bone Marrow Transplant Procedure on Unique Pediatric Patient in Need
Cesca Therapeutics Inc.
1 hour ago
GlobeNewswire
????
RANCHO CORDOVA, Calif., Oct. 19, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (KOOL), an autologous cell-based regenerative medicine company, today announced that its Clinical GMP Cell Processing Laboratory "TotipotentRX Centre for Cellular Medicine" located at Fortis Memorial Research Institute (FMRI), New Delhi, N.C.R., India, performed a specialized T-cell preparation procedure designed for a unique haploidentical transplantation case. This potentially lifesaving procedure was provided for a child suffering from both Fanconi's Anemia (non-malignant genetic disorder) and relapsed AML (malignant disorder). The patient is currently in stable condition.
Haploidentical transplantation is a treatment option gaining global acceptance as it increases the possibility of finding an acceptable donor match, known as an HLA match. With respect to HLA matching, parents are always a half-match for their children and siblings have at least a 75% chance of a match (full match and half match). Until recently closely related donor sources such as the patient's parents came with a high risk of incompatibility and a high incidence of fatal Graft versus Host disease, where donor cells attack the recipient. New protocols that involve selection or removal of specific sub- types of T lymphocytes, as used in the TotipotentRX laboratory, are now providing more options with good results for patients in need of a life-saving bone marrow transplant. Furthermore, in the case of patient relapse, a closely related donor is more likely to be available for further cell therapy.
Dr. Venkatesh Ponemone, Ph.D., Executive Director GMP Laboratory and Clinical affairs, India stated, "We are very pleased by the achievement of this clinical milestone as it highlights our routine use of cell selection technology with Haploidentical transplantation and our capability to support the needs of cutting-edge healthcare. We are one of a very exclusive group of laboratories capable of this precision work and we look forward to expanding our approach for the betterment of a huge and underserved patient population in India. I'm personally very proud of Cesca's vision and thankful for the opportunity to take part in giving many patients a second chance at life, particularly children."
Mitchel Sivilotti, Senior Vice President and Chief Biologist at Cesca Therapeutics stated, "In India, there is an acute need for transplant donors as transplant registries are yet to reach the maturity of those in the U.S. and Europe. Historically, this has left patients with limited transplant options. Dr. Ponemone and his team have adopted advanced methodologies at a quality level unsurpassed in the region they serve. We are very fortunate to have this first-mover advantage and look forward to serving patients, technology partners and clinical trial sponsors through our unique infrastructure and world-class team at TotipotentRX."
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
SurgWerks(TM); proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
Cell harvesting
Cell processing and selection
Cell diagnostics
Cell delivery
CellWerksTM; an integrated system which includes a protocol, disposables and equipment for intra-laboratory use in treatment of oncological and hematological disorders.
The AutoXpress(R) (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
The MarrowXpress(TM) (MXP); a device and disposable system based on the AutoXpress platform for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control and optical sensors and concentrates white blood cells from bone marrow to a user- defined volume in 40 minutes while retaining over 90% of mononuclear cells (MNCs).
The BioArchive(R) System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant.
Forward Looking Statement
The statements contained herein may include statements of future expectations and other forward looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements, including our ability to initiate and prosecute the pivotal CLIRST III trial, our ability to obtain efficacy consistent with prior CLI studies, continued FDA approval, Medicare reimbursement approval, timing of the Company's future submission of IDE, PMA and/or Medicare reimbursement applications, or amendments to such applications, and outcomes from such submissions. Further, clinical trial outcomes are not predictable, and results may vary from the Company's expectations, including the start of any such clinical trials, patient follow up issues, and costs associated with such trials. Further description of other risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements. Contact: Cesca Therapeutics Inc. http://www.cescatherapeutics.com. Cesca may, at its discretion, choose to publish on-going interim notifications, requests for further information as received from the FDA, Medicare or equivalent foreign agencies, but as a general policy only makes announcements regarding material or significant information, such as filing of applications, approvals, initiation of studies, and conclusions.
Contact:
Cesca Therapeutics Inc.
http://www.cescatherapeutics.com
Investor Contact: Kirin Smith, PCG Advisory Group
646-863-6519, or ir@cescatherapeutics.com
Media Contact: Sean Leous, PCG Advisory Group
646-863-8998 or sleous@pcgadvisory.com
The question lingering in my mind is about the competition who will reach the ground running before PESI. Yes, PESI has advantages but the timing could be a major drawback.
See http://www.xconomy.com/wisconsin/2015/10/12/shine-northstar-spar-as-medical-radioisotope-race-continues/
Kind regards,
Minding
Nasdaq gives local biomedical company a new deadline
Oct 19, 2015, 6:25am PDT
INDUSTRIES & TAGS Banking & Financial Services, Technology, Biotech, Stock Market
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Mark Anderson
Staff Writer
Sacramento Business Journal
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Cesca Therapeutics Inc. reported Friday the Nasdaq Stock Market has given it more time to get into compliance with market rules before delisting the stock from the exchange.
Cesca was warned of delisting in the spring for having its shares trade below $1 per share for more than 30 consecutive days. At that time, Cesca got a 180-day extension, which expired Sept. 28.
Robin Stracey is CEO of Cesca Therapeutics, which recently received more time to raise its stock price on the Nasdaq Stock Market.
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Robin Stracey is CEO of Cesca Therapeutics, which recently received more time to raise… more
The company sought, and was granted, another 120-day extension to bring its shares to the minimum value. Nasdaq has given the company until March 28 to bring its share price up.
The company’s stock (Nasdaq: KOOL) closed Friday at 58 cents per share.
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The Rancho Cordova-based company develops and manufactures automated blood and bone marrow processing systems and related disposable products for separating, processing and preserving blood, cell and tissue therapy products.
Cesca shares faced delisting at the end of 2013 when the company was still called ThermoGenesis Corp. The company changed its name following a merger. It got its stock out of danger of delisting last time.
Earlier this year, the company had also been facing a delisting for not having filed timely financial reports, but the company resolved that issue in June.
Mark Anderson covers technology, agriculture, banking and finance, venture capital, energy, mining and hospitality for the Sacramento Business Journal.
Good question. Stifel raised their price target to $18 back in September.
Kind regards,
Minding