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Conference call transcript - some positive things in here.
http://seekingalpha.com/article/3428626-intelgenx-technologies-igxt-ceo-horst-zerbe-on-q2-2015-results-earnings-call-transcript
I think it is worth noting they usually do not issue an 8-K announcing when they are releasing the 10-K. So, to announce the 10-K filing and also hold CC to provide an update makes it appear as if they have some new info to offer.
Royalty % for Forfivo - does anyone know or has anyone tried to get the royalty rate for Forfivo. I tried calculating it using the gross sales figures in 2013 provided in the update and the 2013 royalty revenue from the 10k for 2013. Just curious if anyone else has a figure for the %??
Movin on up! Weeeeeeee!
Trading to resume (at least in Canada) at 9:30 this morning
IntelGenx Announces Update to Settlement of U.S. Patent Litigation Related to Forfivo XL(R)BY GlobeNewswire
— 8:41 AM ET 11/26/2014
SAINT LAURENT, Quebec, Nov. 26, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (OTCQX:IGXT) ("IntelGenx") today announced that it has settled its Paragraph IV litigation with Wockhardt Bio AG related to IntelGenx (IGXT
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)' Forfivo XL® 450 mg tablets.
Under the terms of the settlement, Wockhardt has been granted the rights, with effect from January 15, 2018, to be the exclusive marketer and distributor of an authorized generic of Forfivo XL® in the U.S.
Exactly what I was thinking Gary! Makes no sense to me.
I understand Thanksgiving in the US is this week but why wait until 12/3 to announce the settlement details? Will they release the details at some point before the CC? Does any ken know if they have some sort of time limit to release the news?
I agree - very weird. I only saw info for the halt on TSX Exchange....which I have pasted below:
VANCOUVER, Nov. 25, 2014 /CNW/ - The following issues have been halted by IIROC:
Company: INTELGENX TECHNOLOGIES CORP (IGXT)
TSX-Venture Symbol: IGX
Reason: Pending Company Contact
Halt Time (ET): 9:29 AM
IIROC can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. IIROC is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada.
SOURCE Investment Industry Regulatory Organization of Canada (IIROC) - Halts/Resumptions
The PR for the lawsuit settlement states the call isn't until 12/3. Are you referring to a different call?
Trading halted. Why did they not release the decision instead of just announcing there was one?
Horst has disclosed that there is no relation.
Sales of Forfivo may increase based on IGXT investors reading the 10Q. I know it depressed me.
Forfivo Royalty Revenue:
Adding 2Q14 revenue to the list:
1Q13 - $80K
2Q13 - $14K
3Q13 - $28K
4Q13 - $49K
1Q14 - $97K
2Q14 - $82K
IntelGenx Announces Management Changes— 1:08 PM ET 07/15/2014
SAINT LAURENT, Quebec, July 15, 2014 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (IGXT
("IntelGenx") announced today that the board of directors (the "Board") of IntelGenx (IGXT) has accepted, with immediate effect, the resignation of Dr. Rajiv Khosla as President and Chief Executive Officer ("CEO") of IntelGenx (IGXT) and as a member of the Board.
Effective immediately, the Board has appointed Dr. Horst G. Zerbe to serve as IntelGenx)' interim President and CEO until a successor is found. A Search Committee has been formed by the Board to begin the search, selection and appointment of a new President and CEO.
Dr. Zerbe is the Chairman of the Board, founder, and former President and CEO of IntelGenx (IGXT). He retired from the positions of President and CEO effective December 31, 2013. However, Dr. Zerbe retained an active role in IntelGenx (IGXT)' operations throughout the past six and a half months, providing expertise in the areas of research and development, and manufacturing.
The Board thanks Dr. Khosla for his service and contributions to the company and wishes him well in his future endeavours
Coverage Initiated - BUY PT $2 - http://www.marketnewscall.com/analyst-buzz-kona-grill-inc-nasdaqkona-a10-networks-incnyseaten-2/1230918/
H.C. Wainwright initiates IntelGenx Technologies Corp.(OTCMKTS:IGXT) with a Buy and price target of $2. At the outset, the shares of IntelGenx seem to be high risk as mgmt needs to resolve issues with their current marketed product and two products that are under FDA review. However, firm considers the shares as high-risk/high-reward as it believes co has potential to receive multiple streams of revenue post 2014, and mgmt is working diligently to alleviate the current situation.
Adding 1Q14 revenue to the list:
1Q13 - $80K
2Q13 - $14K
3Q13 - $28K
4Q13 - $49K
1Q14 - $97K
Dry Powder - Man I wish I had some this morning. Once it got down to low 70's you knew the bounce was coming.
Thoughts anyone? I am a little surprised by the additional CMC data needed. Also, the following statement leads me to believe approval is further out than early summer.
The Companies believe that FDA approval of the RHB-103 NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Therefore, RedHill and IntelGenx (IGXT) continue to work with the FDA in order to submit all the data requested and will provide an update as and when applicable.
Forfivo Revenue - I tried to go back and calculate just the royalty revenue on Forfivo for the 4 quarters in 2013. Here is what I get (This is from the 10Q for Q1 thru Q3 and then I had to calculate just the revenue from Q4 as there isn't a 3 month total)
1Q13 - $80K
2Q13 - $14K
3Q13 - $28K
4Q13 - $49K
So it has increased more than 75% each of the last 2 quarters......but it is only slightly more than half of what it was in 1Q13.
Anyone have thoughts on this? We all knew sales weren't that good, but did anyone realize how much they dropped off?
It is made up of a couple of items:
$308K deferred revenue. (They record $77K per Quarter as deferred revenue from milestone payments. 4 times $77 is $308)
$171K royalty on sales of Forfivo
$13K manufacturing royalty
That gets us to $492K.
I think the deferred revenue is the confusing part.
I believe the actual royalty revenue was just short of $200k. The rest of Forfivo related revenue was defered revenue from milestone payments. Definitely room for improvement.
10-K for 2013. Don't have time to read and comment yet...but here it is.
http://archive.fast-edgar.com//20140311/AS22K22CZ225P2X222262MN2QCK7LZ22C262/
SAINT LAURENT, Quebec, March 11, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (OTCQX:IGXT) (the "Company") today announced financial results for its fiscal year ended December 31, 2013 and provided an update on operational developments. All amounts are in U.S. Dollars, unless otherwise stated.
"2013 was a challenging and exciting year for IntelGenx (IGXT
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)," said Rajiv Khosla, President and CEO of IntelGenx (IGXT
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). "We made significant progress with the filing of the NDA for our anti-migraine film and the subsequent filing of an ANDA by our partner, Par Pharmaceutical, for our opioid dependence film. Also, subsequent to the end of the year, in early January, we reached agreement with Par for the development of another two products. One of the challenges throughout 2013 was the disappointing sales performance of Forfivo XL®, our high strength anti-depressant tablet. We continue to work together with Edgemont Pharmaceuticals, our commercialization partner for this product, to address the Forfivo XL® business. At the corporate-level we successfully completed a public offering in December, raising net funds of $3.0 million, which strengthened our cash position at December 31, 2013 to $5.0 million. These funds will enable us to move forward with the next important phase of our development, which is to expand into a new facility and establish a pilot plant for VersaFilm™ manufacturing, whilst continuing to further our product portfolio."
Corporate Development Update
Product-related
Anti-depressant tablet, Forfivo XL®
Forfivo XL®, our first FDA approved product, was launched in October 2012 and is being marketed in the United States under the terms of a license agreement between us and Edgemont Pharmaceuticals. Forfivo XL® is indicated for the treatment of Major Depressive Disorder ("MDD") and is the only extended-release bupropion HCl product to provide a once-daily, 450mg dose in a single tablet. The active ingredient in Forfivo XL® is bupropion, the same active ingredient used in the well-known antidepressant product Wellbutrin XL®. Prior to the launch of Forfivo XL®, most patients in the US requiring a 450mg dose of bupropion had been taking multiple tablets to achieve their 450mg dose requirement. With Forfivo XL® now available in the US, these patients can simplify their dosing regimen to a single Forfivo XL tablet, once-daily.
The commercialization of Forfivo XL® triggered launch-related milestone payments to us of up to $4.0 million, of which $1 million was received in Q1, 2013, and additional milestones upon achieving certain sales and exclusivity targets of up to a further $23.5 million. We also receive tiered, double-digit, royalties on net sales of Forfivo XL®. We recorded total revenue for Forfivo in 2013 of approximately $492 thousand.
In August, 2013 we announced receipt of a Paragraph IV Certification Letter from Wockhardt Bio AG, advising of the submission of an ANDA to the FDA requesting authorization to manufacture and market generic versions of Forfivo XL® 450 mg capsules in the United States. We intend to vigorously enforce our intellectual property rights for Forfivo XL® and will pursue all available legal and regulatory pathways in defense of the product, which is currently protected by an issued patent listed in the FDA's Approved Drug Products List (Orange Book).
Anti-migraine Film
In March, 2013 we submitted a 505(b)(2) NDA to the FDA for our novel oral thin-film formulation of Rizatriptan, the active drug in Maxalt-MLT® orally disintegrating tablets. Maxalt-MLT® is a leading branded anti-migraine product manufactured by Merck & Co. The thin-film formulation of Rizatriptan was developed in accordance with the co-development and commercialization agreement with RedHill Biopharma Ltd. using IntelGenx (IGXT
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)' proprietary immediate release VersaFilm™ oral drug delivery technology. In December 2011, we received approval by Health Canada to conduct a pivotal bioequivalence study to determine if our product is safe and bioequivalent with the FDA approved reference product, Maxalt-MLT®. The trial was conducted in the second quarter of 2012 and was a randomized, two-period, two-way crossover study in healthy male and female subjects. The study results indicate that the product is safe, and that the 90% confidence intervals of the three relevant parameters Cmax, AUC(0-t) and AUC(0-infinity) are well within the 80 – 125 acceptance range for bioequivalency.
In June, 2013 the FDA assigned a PDUFA action date of February 3, 2014 for the review of the NDA for marketing approval.
Subsequent to the end of the year, in February, 2014 we received a Complete Response Letter ("CRL") from the FDA. A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for our anti-migraine VersaFilm™ product primarily relate to third party Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies. We believe that the majority of issues raised by the FDA were addressed in an amendment submitted by us to the FDA in January, 2014 that has yet to be reviewed.
On March 3, 2014 we announced that we submitted a response to the CRL which, we believe, addresses all the issues raised in the CRL.
Opioid dependence Film
In accordance with a co-development and commercialization agreement with Par, we developed an oral controlled-release film product based on our proprietary VersaFilm™ technology. The product is a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence. The reference listed drug is Suboxone® Sublingual Film. A bioequivalent film formulation was developed, scaled-up, and pivotal batches manufactured and tested during a subsequent pivotal clinical study. An ANDA was filed with the FDA by Par in July 2013.
In August, 2013 we learned that, in response to filing of the ANDA, we were named as a codefendant in a lawsuit pursuant to Paragraph IV litigation filed by Reckitt Benckiser Pharmaceuticals and Monosol RX in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 8,475,832 and 8,017,150, each of which relate to Suboxone®. We believe the ANDA product does not infringe those or any other patents, and will vigorously defend ourselves in this matter. In accordance with the terms of the co-development and commercialization agreement, Par is financially responsible for the costs of this defense. Since Paragraph IV litigation is a regular part of the ANDA process, we do not expect any unanticipated impact on our already planned development schedule.
Two new (undisclosed) projects
Subsequent to the end of the year, in January, 2014 we announced the signing of another development and commercialization agreement with Par Pharmaceutical, Inc. for two new products.
Under the terms of the agreement, Par has obtained certain exclusive rights to market and sell our products in the USA. In exchange we will receive upfront and milestone payments, together with a share of the profits upon commercialization. In accordance with confidentiality clauses contained in the agreement, the specifics of the product descriptions, platform technologies and financial terms remain confidential.
Corporate
Leadership succession
In April, 2013 we announced that Rajiv Khosla, RPh, PhD, MBA would assume the role of President and Chief Executive Officer, succeeding Horst G. Zerbe, PhD, with effect from January 1, 2014. Dr. Zerbe will remain as Chairman of the Board of Directors and continue to provide expertise in research and development, and manufacturing.
Dr. Khosla held the positions of Chief Operating Officer and Chief Scientific Officer throughout the transitional period of 2013 and was a member of the our Board of Directors for the previous two years. Dr. Khosla has remarkable experience and credentials including, among other senior positions, five years as Vice President of Business Development at Biovail Corporation, a Canadian pharmaceutical company operating internationally. Whilst there, he successfully led the transaction process for more than 75 deal opportunities in a variety of therapeutic areas.
Dr. Khosla holds a Ph.D. in pharmaceutical science, with a thesis on Oral Drug Delivery Technology; an Executive MBA from the Henley Business School in England, a Bachelor of Pharmacy (Honours) from the University of Nottingham, England and is a registered pharmacist in the UK.
Dr. Khosla's biography can be found on our website at http://www.intelgenx.com/aboutus/mngmt.html.
$3.5 Million Public Offering
In December, 2013 we announced the closing of a registered public offering raising gross proceeds of approximately $3.5 million.
Earlier in the same month we entered into securities purchase agreements with certain accredited investors for the issuance and sale of an aggregate of 7,920,346 shares of its common stock at $0.4419 per share. Additionally, investors received warrants to purchase up to 7,920,346 shares of common stock at an exercise price of $0.5646 per share for a term of five years.
Net proceeds, after deducting the placement agent's fee and other estimated offering expenses payable by us were approximately $3.0 million. We intend to use the net proceeds from the offering for capital investments in VersaFilm™ manufacturing equipment, leasehold improvements on a new facility, working capital and other general corporate purposes.
H.C. Wainwright & Co., LLC acted as the exclusive placement agent for the transaction.
Financial Results:
Cash on hand at December 31, 2013 increased to $5.0 million compared with the cash balance of $2.1 million as at December 31, 2012. The increase in cash on hand relates to net cash provided by financing activities of $4.5 million (2012 - $0.4 million), partly offset by net cash used in operating activities of $1.1 million (2012 - $1.6 million), net cash used in investing activities of $0.3 million (2012 - $0.3 million), and an unrealized foreign exchange loss of $0.1 million (2012 - unrealized foreign exchange gain of $0.1 million). The net cash provided by financing activities consists of approximately $3.0 million from a registered public offering that we completed in December 2013, together with approximately $1.5 million in proceeds received from the exercise of warrants and stock options.
We intend to use the net proceeds from the registered public offering for capital investments in VersaFilm™ manufacturing equipment, new facility leasehold improvements, working capital and other general corporate purposes.
Accounts receivable totaled $0.1 million as at December 31, 2013 compared with $1.3 million at December 31, 2012. The accounts receivable balance at December 31, 2012 included an amount of $1.0 million related to the launch of Forfivo XL®™ that was invoiced to our commercialization partner for Forfivo XL®, Edgemont Pharmaceuticals, in the fourth quarter of 2012. Payment against the invoice was received in February 2013.
Revenue for the year ended December 31, 2013 decreased to $0.9 million from $1.2 million in the previous year. In fiscal 2013, we recorded approximately $0.5 million of revenue related to commercial sales of Forfivo XL®, compared with a milestone of $1.0 million that was recorded as revenue in 2012 related to the launch of Forfivo XL®.
Total expenses decreased from $3.5 million in fiscal 2012 to $2.6 million in 2013, representing a reduction of $0.9 million, or 25%. The decrease is primarily attributable to a reduction in R&D expenses that we incurred in 2012 for a) the development of our buprenorphine and naloxone Sublingual Film of approximately $0.7 million, b) the technical transfer of activities in preparation for manufacturing of Forfivo XL® to our Contract Manufacturing Organization, Pillar5 Pharma, of approximately $0.3 million (of which, approximately $0.1 million were credited to us in fiscal 2013), and a Product Fee that we paid to the FDA for Forfivo XL® of approximately $0.1 million, partly offset by an increase in SG&A expenses attributable to the addition of Dr. Rajiv Khosla to our management team.
The net loss decreased from $2.3 million in fiscal 2012 to a loss of $1.6 million in 2013, and the loss per share decreased from $0.04 per share in 2012 to $0.03 per share in 2013.
RedHill filed the application I believe. We may need to wait until Tel Aviv opens for business. Not sure exactly how that has to work, if it matters at all.
I agree....no big deal. It would almost be foolish for them not to unload some at this point.
Insiders plan on selling, or already have. Could be some of the reason for the price drop today. Doesn't bother me though. Seems like a prudent move with the recent run up. Some may say it means they know something....my belief is that it is just taking some profit. If I am missing something, let me know. I am not all that familiar with Form 144
http://archive.fast-edgar.com//20140129/AP28S22CZ225S2Z2222V2WN8BBH5ZZ222262/
http://archive.fast-edgar.com//20140129/AP22S22CZ225S2Z2222K2WN8ABI4LZ222262/
Premarket bid $.83 - someone wants in!
TSX - ask price is $1.06. I know it is the TSX exchange, but I don't think I've seen an ask over $1.00.
Bid/Ask appear to have been removed. I am not showing any bids/asks on L2......Anyone ever see this during the trading day?
Did you ever just slowly say their corp name outloud? In tel gen x corporation technologies inc. Sounds more like a company in the computing/technology sector. Maybe a simple name change - throw a bio or pharma in there somewhere.
ID - interested to hear your thoughts now that PAR SAR has flipped down and MACD turned up. Thanks! Your input is highly valued.
Forfivo sales are still weak obviously, but I did notice a slight difference in the language they use to describe the situation.
From 1Q 10Q - Royalty income in the second quarter of 2013 is expected to be lower than royalty income achieved in the current quarter, as a result of lower than anticipated sales of Forfivo XL™ during the current quarter. Management is assessing this variation in sales performance with a view towards taking steps to support steady sales growth of Forfivo XL™.
From 2Q10Q - Sales levels achieved for Forfivo XL™, and related royalty income, have been lower than anticipated in the first six months of 2013. Management is actively taking steps to accelerate sales growth of Forfivo XL™.
At least they updated this to state they are actively taking steps to accelerate growth, as opposed to just "assessing this variation".
Not sure what their plan is, but we shall see.
On top of that, it would have been $90K if not for CAD currency fluctuations!
I also found this one: bullinvestor.com
That's what I get for trying to put the kids to bed and post at the same time! Just wanted to point out that your moniker is ridiculously accurate! I agree with what you are saying though
What happened to being cash flow positive? Maybe Horst was adding in the royalties for that calculation.
Well that solves the Par mystery!