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heard nothing
nice work guys...locked and loaded...hog
$IPCI...http://ih.advfn.com/p.php?pid=nmona&article=75217004
Intellipharmaceutics Announces Second Quarter 2017 Results
Date : 07/11/2017 @ 5:15PM
Source : GlobeNewswire Inc.
Stock : Intellipharmaceutics International Inc. (MM) (IPCI)
Quote : 2.8 0.3601 (14.76%) @ 4:47PM
Intellipharmaceutics Announces Second Quarter 2017 Results
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Intellipharmaceutics International Inc. (MM) (NASDAQ:IPCI)
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Today : Tuesday 11 July 2017
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Intellipharmaceutics International Inc. (NASDAQ:IPCI) (TSX:IPCI) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the three and six months ended May 31, 2017. All dollar amounts referenced herein are in United States dollars unless otherwise noted.
Second Quarter Key Highlights
Revenues more than tripled to $2.0 million from $0.6 million (launch of new generic Focalin XR® strengths)
Secured final FDA approval for all strengths of generic Seroquel XR®
Successfully manufactured and shipped all strengths of generic Seroquel XR® to Mallinckrodt
Mallinckrodt launched all strengths of generic Seroquel XR®
Progress on Rexista™ NDA continues with joint meeting of the FDA Advisory Committees scheduled for July 26, 2017
The CEO of Intellipharmaceutics, Dr. Isa Odidi, said, “We are pleased with the recent progress made on both the generic and NDA initiatives, having demonstrated our manufacturing capability in respect of generic Seroquel XR®, and the FDA scheduling of the Advisory Committees meeting to review our Rexista™ NDA candidate. These are welcome developments on the heels of significant revenue improvement in the second quarter, which we expect to continue into the second half.”
Corporate Developments
In June 2017, we announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States Food and Drug Administration (“FDA”) has been scheduled for July 26, 2017 to review the Company's New Drug Application (“NDA”) for Rexista™ abuse-deterrent oxycodone hydrochloride extended release tablets. The submission also includes abuse-deterrent studies conducted to support abuse-deterrent label claims, having reference to the FDA's "Abuse-Deterrent Opioids — Evaluation and Labeling" guidance published in April 2015. The abuse-deterrent properties incorporated into Rexista™ are designed to make the product unlikable and discourage or make it more difficult to manipulate for the purpose of abuse or misuse, and the Company is preparing to share its data with the Advisory Committees as a key step towards securing FDA approval of Rexista™.
In June 2017, we announced that Mallinckrodt LLC (“Mallinckrodt”), in its capacity as the Company’s marketing and distribution partner, launched all strengths of our generic Seroquel XR® (quetiapine fumarate extended-release tablets) in the U.S. This launch follows the recent final approval from the FDA for the Company's Abbreviated New Drug Application (“ANDA”) for quetiapine fumarate extended-release tablets in the 50, 150, 200, 300 and 400 mg strengths. The approved product is a generic equivalent of the corresponding strengths of the branded product Seroquel XR® sold in the U.S. by Astra Zeneca Pharmaceuticals LP. Under its license and commercial supply agreement with Mallinckrodt, the Company granted Mallinckrodt a license to market, sell and distribute in the U.S. our generic Seroquel XR® and the Company manufactures and supplies the licensed product for Mallinckrodt.
There can be no assurance that our generic Seroquel XR® product will be successfully commercialized or produce significant revenues for us. Also, there can be no assurance that we will not be required to conduct further studies for Rexista™, that the FDA will ultimately approve the NDA for the sale of Rexista™ in the U.S. market, or that it will ever be successfully commercialized, that we will be successful in submitting any additional ANDAs or NDAs with the FDA or Abbreviated New Drug Submissions (“ANDSs”) with Health Canada, that the FDA or Health Canada will approve any of our current or future product candidates for sale in the U.S. market and Canadian market, or that they will ever be successfully commercialized and produce significant revenue for us.
2017 Second Quarter Financial Results
The Company recorded revenues of $2.0 million for the three months ended May 31, 2017 versus $0.6 million for the three months ended May 31, 2016. For the three months ended May 31, 2017, we recognized licensing revenue of $2.0 million primarily from commercial sales of 15, 25, 30 and 35 mg strengths of generic Focalin XR® capsules under our license and commercialization agreement with Par Pharmaceuticals Inc. (“Par”). The increase in revenues is due to Par’s January 2017 launch of the 25 and 35 mg strengths of generic Focalin XR® capsules in the U.S. and also reflects revenue from the Company’s first shipment of generic Seroquel XR® to Mallinckrodt (subsequently launched by Mallinckrodt in June 2017). The Company’s revenues on the 25 and 35 mg strengths of generic Focalin XR® are expected to decline commencing in July 2017 when their 6 month exclusivity expires. The Company’s revenues on the 10 and 20 mg strengths of generic Focalin XR® in the second quarter of 2017 are negligible due to their launch date being late May 2017. Revenues under the Par and Mallinckrodt license agreements represents the commercial sales of the generic products in those strengths and may not be representative of future sales.
The Company recorded net loss for the three months ended May 31, 2017 of $1.8 million, or $0.06 per common share, compared with a net loss of $2.0 million, or $0.08 per common share, for the three months ended May 31, 2016. In the three months ended May 31, 2017, the lower net loss is primarily attributed to higher licensing revenues from commercial sales of generic Focalin XR® in the second quarter of 2017, partially offset by an increase in performance-based options expense and third-party research and development (“R&D”) expenditures. Revenue in the three months ended May 31, 2017 was $2.0 million versus $0.6 million in the prior period, with the increase primarily due to Par’s launch of the 25 and 35 mg strengths of its generic Focalin XR® capsules.
Expenditures for R&D for the three months ended May 31, 2017 were higher by $1.2 million compared to the three months ended May 31, 2016. The increase is primarily due to higher stock option compensation expense as a result of certain performance-based stock options vesting upon FDA approval of quetiapine fumarate extended release tablets and due to higher third party consulting fees associated with our preparation for the FDA Advisory Committee meeting in relation to our Rexista™ NDA filing. After adjusting for the stock-based compensation expenses, expenditures for R&D for the three months ended May 31, 2017 were higher by $0.4 million compared to the three months ended May 31, 2016. This is primarily due to an increase in third party R&D expenditures.
Selling, general and administrative expenses were $0.8 million for the three months ended May 31, 2017 in comparison to $0.9 million for the three months ended May 31, 2016. The decrease is primarily due to the lower expenses related to a decrease in professional fees and wages, partially offset by an increase in marketing and occupancy cost.
The Company had cash of $1.5 million as at May 31, 2017 compared to $2.4 million as at February 28, 2017. The decrease in cash during the three months ended May 31, 2017 was mainly a result of our ongoing expenditures in R&D and selling, general, and administrative expenses, which includes increased consulting fees incurred to prepare for the July 26, 2017 Advisory Committee meeting and an increase in purchases of plant and production equipment to support our generic Seroquel XR® launch, which were only partially offset by higher cash receipts from commercialized sales of our generic Focalin XR® and cash receipts provided from financing activities derived from common share sales under the Company’s at-the-market offering program.
As of July 11, 2017, our cash balance was $0.6 million. We currently expect to satisfy our operating cash requirements until September 2017 from cash on hand and quarterly profit share payments from Par and Mallinckrodt. Should our marketing and distribution partner, Mallinckrodt, soon be successful in fully commercializing our generic Seroquel XR® (all strengths of which were launched in June 2017), then we may be cash flow positive in the second half of 2017. Failing this, the Company may need to obtain additional funding prior to that time as we further the development of our product candidates and if we accelerate our product commercialization activities. There can be no assurance as to when or if Par will launch the remaining two strengths of its generic Focalin XR® and, if launched, whether they will be successfully commercialized, or if generic Seroquel XR® will be successfully commercialized. If necessary, we expect to utilize our at-the-market offering program to bridge any funding shortfall in the second half of 2017.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (some of which have received FDA approval) and product candidates in various stages of development, including ANDAs filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
$IPCI...Rexista Pain relief
PDUFA 07/26/2017
Advisory Committee Meeting July 26, 2017. PDUFA date September 25, 2017.
havent sold a share... thanks for all the hard work from all keeping the board informed, its hard for me to participate now days but my family will all benefit from this and more coming forward...just beginning...hog
you've been doing a great job here doog, i got hurt awhile back in a car accident, cant participate like i want, but follow when i can, keep up the good work
exciting times
there is a 5mg dose available...hog
$CYNA After holding the same stake for one year, Samuel Isaly raised stake by 400k to hold 1.6mln sh 13.2% as of 7/6 https://hedgemind.com/real-time-insights/stock-holdings?ticker=CYNA …
thanks. i am blessed... already made money on CYTR... little more aches and pains then usual but all is good...hog
Well guys I am back, was hit by a drunk driver Christmas Eve 2015 been on a vent and worked my way back to walking and talking, bless the er, ICU and floor staff that have given me a second chance, my stocks took a major hit, was doing so well following sheff, back to do it again, life is good with good people around you
You didn't..he misread it...hog
$CYNA...
Jason Napodano, CFAPremium Research »
Research analyst, medium-term horizon, biotech, small-cap
Profile| Send Message| Follow (5,097 followers) Performance
What To Buy Based On The Biotech Pullback
Aug. 24, 2015 10:20 AM ET | 63 comments | Includes: ABBV, ADMA, BLUE, CRBP, CUR, CYNA, JUNO, KITE, NBIX, NVIV, PIRS, POZN, TBUFF, XBI
Disclosure: I am/we are long NVIV, BLUE, JUNO, CUR. (More...)
Cynapsus Therapeutics (NASDAQ:CYNA): Now Nasdaq-listed Cynapsus is another of my top-picks. The company is progressing in its Phase 3 trial with APL-130277 for the acute rescue of OFF motor symptoms of patients with Parkinson's disease (PD-OFF). I think the stock looks like a big potential winner, and I'm not the only one who thinks that to be the case. A lot of really smart healthcare funds are loaded-up in Cynapsus. The major institutional holding list as of June 30, 2015, shows some big players with sizable stakes in the name. My article outlines why I believe APL-130277 is a better option for the treatment of PD-OFF than the current standard of care, subcutaneous apomorphine or its next-nearest competitor, Acorda's inhaled levodopa also in Phase 3 trials. I think APL-130277 has peak U.S. sales potential of nearly $700 million. The company has over $111 million in cash as of June 30 and the current Phase 3 trial, which should offer data next year, looks low-risk / high-reward in my view. I think Cynapsus is worth $30 per share, another potential double.
http://seekingalpha.com/article/3461486-what-to-buy-based-on-the-biotech-pullback?page=2
$CYNA...still holding...missed some selling opportunites but like the folks in it...Hedge Funds-News
Adage Capital, Point72 Raise Stakes In These Pharmaceutical Companies
By Prakash Pandey in Hedge Funds,News
Published: August 31, 2015 at 11:33 am
Phill Gross and Robert Atchinson of Adage Capital Partners remain bullish on Cynapsus Therapeutics Inc (NASDAQ:CYNA) according to their latest 13G filing with the SEC. In it, the hedge fund has reported ownership of 650,000 shares of the clinical-stage biopharmaceutical company, from an earlier 600,000-share position, with the current stake representing 5.36% of the company’s common shares. In a separate 13G filing, Steve Cohen’s Point72 Asset Management disclosed an updated position in Uniqure NV (NASDAQ:QURE), comprising 1.14 million shares or 5% of the outstanding common shares of the company. The hedge fund held 546,313 shares of the pharmaceutical company at the end of the second quarter.
Steven Cohen
Why are we interested in the 13F filings of a select group of hedge funds? We use these filings to determine the top 15 small-cap stocks held by these elite funds based on 16 years of research that showed their top small-cap picks are much more profitable than both their large-cap stocks and the broader market as a whole. These small-cap stocks beat the S&P 500 Total Return Index by an average of nearly one percentage point per month in our backtests, which were conducted over the period of 1999 to 2012. Moreover, since the beginning of forward testing from August 2012, the strategy worked just as our research predicted, outperforming the market every year and returning 118% over the last 36 months, which is more than 60 percentage points higher than the returns of the S&P 500 ETF (SPY) (see more details).
Phill Gross And Robert Atchinson
Phill Gross And Robert Atchinson
Adage Capital Management, $40,101,883,000
Phill Gross and Robert Atchinson go all the way back to their time working together at the Harvard Management Company. Adage Capital Management was founded under their leadership in 2001 and the investment firm manages a public equity portfolio worth $40.10 billion, as reported in its latest 13F filing. The investment firm is most heavily invested in the healthcare and information technology sectors, while its top ten stock holdings account for 13.17% of its overall equity portfolio. Apple Inc. (NASDAQ:AAPL) is the top stock bet of the hedge fund, as it has ownership of 8.85 million shares of the tech company, valued at $1.11 billion. Puma Biotechnology Inc (NYSE:PBYI) lands at number two in its equity portfolio, with the fund owning 5.69 million shares of the stock.
Cynapsus Therapeutics Inc (NASDAQ:CYNA) is a clinical-stage pharmaceutical company, working on a treatment for the OFF episodes of Parkinson’s disease. The medical company announced its second quarter financial results on August 14, reporting a net loss of $10.96 million against the prior-year loss of $2.82 million. Being a clinical-stage company, Cynapsus Therapeutics Inc (NASDAQ:CYNA) didn’t release revenue figures. The specialty pharmaceutical company announced the enrollment of the first patient into its pivotal phase 3 study of APL-130277, which is used for the treatment of OFF episodes of Parkinson’s disease. At the end of the second quarter, 12 hedge funds in our database had positions worth $69.47 million in the company. Samuel Isaly’s Orbimed Advisors was the largest shareholder of those, followed by Millennium Management, holding 1.14 million shares and 287,390 shares, respectively.
Read more at http://www.insidermonkey.com/blog/adage-capital-point72-raise-stakes-in-these-pharmaceutical-companies-368573/#UcHwFJ5tq8uAgpOp.99
I sold Fri at 0.35...hog
Nokoolaid...I think what your asking for IPCI has already shown that it's quite capable of providing when they had the FDA rescind extra Focalin XR bioequvalence requirements...
Also in this day of being politically correct having a drug for women and one men want to get approved bodes well for PTA I think...hog
So about 15 business days to move...I don't. like to hold thru rulings either...I am sure PTA is feeling the effects of the past couple of biotech bloody red days as well....at least what I am holding looks a little ugly butni hope next two weeks we see some movement...hog
Agreed doog...I don't see a phase111....and the way IPCI came back on the latest FDA decision was quite impressive....the data used to thwart FDA's previous decision to ask for more data must have been kick ass....IPCI has been connecting the dots quite nicely...haven't seen any missteps... Damn Drug mafia aka FDA needs to get busy like they were a private company not the govt bureaucracy that it is...hog
I think you have to be..what are your time frames...hog
I think you have to be..what are your time frames...hog
Prolly missed placed a zero or two but very wealthy...hog
$IPCI...another purchase...Jul 21, 2015 (filed on Jul 24, 2015)
Insider Name:Della Penna, Domenic
Ownership Type:Direct Ownership
Securities:Common Shares
Nature of Transaction:10 - Acquisition or disposition in the public market
# or value acquired/disposed of:45,000
Price:$4.81
- See more at: https://canadianinsider.com/company?menu_tickersearch=i#sthash.SEl3vfF0.dpuf
$PTN has some significant advantages with no alcohol interactions and the ability to take on demand...with approval of the privately owned drug it opens the door for PTN getting their product in much easier much like what Viagra did for its market and it's competitors... hog
Nice find...thx...hog
$APRI...got in this morn @ 1.53...hog
$APRI...interesting...a vivus/apricus marriage with Denner putting the deal together sounds very plausible...hog
Healthcare earnings cal for the week... http://www.loncarblog.com/#!july-27-healthcare-earnings-calendar/c1ss0
I'm sorry moneypenny... after posting this it will probably be deleted as our friends post was... thought I would tell tall tales as well... So easy to spew nonsense...hog
I'm not sure if I saw that exactly but I did notice we have had a 10 bagger in the past 12 months...hog
I was just going to ask if that could be stickied because I definitely will post this response elsewhere...hog
Yep very ugly day today but IPCI holding its own quite well...wish my NVIV was doing as well today...hog
Ditto....hog
Z...Google says its Jean jaucques rousseau...Aristotle sounds much better though...but I say why is patience a virtue?? Why can't hurry the 'f' up be a virtue???
$PTN finally got mine...1.01...hog
THE FDA really is the epitome of government bureaucracy's quagmire that has been created in this country...it's amazing a company can survive while waiting on the FDA to just do it's job...and people wonder why drugs cost so much...