Investor Relations (IR) Questions: IntelGenx Technologies IGXT
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Research Updated: June 2013
BACKGROUND
IntelGenx is in the business of drug delivery. The Company has centered it's business model on examining existing FDA approved compounds/drugs and finding better methods of delivering them. IntelGenex's technology platform includes; oral film, mucoadhesive, and multilayer tablet technologies.
VersaFilm, the Company's oral film has been approved by the FDA for use in food, pharmaceutical and cosmetic products. The Company believes that VersaFilm's instant delivery renders it a more desirable delivery method compared to fast dissolving oral tablets for indications that demand quick relief such as migraines, erectile dysfunction, motion sickness, etc.
AdVersa, the Company's mucoadhesive technology comes in the form of a flat tablet. Programmable adhesive properties keep the tablet close to the mucosal surface. Predetermined drug release patterns are a key advantage of mucoadhesive technology over oral films. Mucoadhesive technology can also be the desired delivery method in situations where the drug acts as an irritant on the GI tract or the active ingredient is poorly soluble.
VersaTab is the Company's multilayer tablet. IntelGenx believes that its multilayer tablet technology has advantages that make it a more desirable option than the traditional single layered tablet. One of the advantages is VersaTab's ability to release the active ingredient in a more linear fashion than single layer tablets.
PARTNERSHIPS: IntelGenx has partnerships with Edgemont Pharmaceuticals LLC, RedHill Biopharma, Dava Pharmaceuticals Inc, and Par Pharmaceutical, Inc.
-1- When is the last time IGXT raised cash through an offering (diluted)?
-a- On June 11, 2011 the IGXT “closed private placement offerings totaling approximately 4.8 million shares (the "Shares") of common stock (the "Common Stock") at a per share purchase price of US$0.67, and three-year warrants (the "Warrants") to purchase up to approximately 2.4 million shares of Common Stock at an exercise price of US$0.74 per share, for aggregate gross proceeds of approximately US$3.2 million.”
-2- How much cash (not cash equivalents) does IGXT have?
-b- The Company reported cash at $2.2 million as of March 31, 2013.
-3- What and approximately when is the next known catalyst?
IntelGenx has multiple partnerships, technologies, and one product, Forfivo already on the market. The company is also actively seeking new partnerships to advance its pipe line. New milestones could be reached and announced by the Company at any time...
-c- However, the next major date stamped catalyst is the February 3, 2014 PDUFA date assigned by the FDA for review of the Company's NDA for the marketing approval of the Company's anti-migraine oral film product based on VersaFilm technology.
-c- “The Company had announced on March 27, 2013 that, together with its co-development partner RedHill Biopharma Ltd ("RedHill"), it had submitted a 505(b)(2) NDA to the FDA for the Company's anti-migraine oral film product. The product is a novel, oral thin-film formulation, based on IntelGenx' proprietary VersaFilm™ technology containing Rizatriptan, the active drug in Merck & Co ("Merck") Maxalt-MLT® orally disintegrating tablets. The FDA confirmed that IntelGenx' application is sufficiently complete to permit a substantive review in accordance with the FDA's "standard" classification process.”
-4- What is IGXT's quarterly cash burn?
-b- For the first quarter of 2013, total expenses were $600,000. Total expenses for the same quarter in 2012 were $700,000.
-d- Expenses for the first quarter of 2013 were consistent with the response given by the Company in the original #IRQ in January 2013.
-5- Does IGXT have an existing line of credit and if so how much can they draw against it?
-d- The Company does not have an existing credit line/facility.
A complete archive of this and additional #IRQ research and IR responses can be found athttp://www.biotechduediligence.com/ir-questions.html.
The original January 2013 #IRQ-IR response with answers provided by IGXT can be found athttp://www.biotechduediligence.com/igxt-irq.html.
RESOURSES:
Background and Partnerships: http://www.intelgenx.com/
-a- IGXT PR 06/22/11 http://www.intelgenx.com/investors/pressreleases/2011/2011-06-22.html
-b- IGXT PR 05/14/13 http://www.intelgenx.com/investors/pressreleases/2013/2013-05-14.html
-c- IGXT PR 06/18/13 http://www.intelgenx.com/investors/pressreleases/2013/2013-06-18.html
-d- IGXT IRQ 01/2013 http://www.biotechduediligence.com/igxt-irq.html
BACKGROUND
IntelGenx is in the business of drug delivery. The Company has centered it's business model on examining existing FDA approved compounds/drugs and finding better methods of delivering them. IntelGenex's technology platform includes; oral film, mucoadhesive, and multilayer tablet technologies.
VersaFilm, the Company's oral film has been approved by the FDA for use in food, pharmaceutical and cosmetic products. The Company believes that VersaFilm's instant delivery renders it a more desirable delivery method compared to fast dissolving oral tablets for indications that demand quick relief such as migraines, erectile dysfunction, motion sickness, etc.
AdVersa, the Company's mucoadhesive technology comes in the form of a flat tablet. Programmable adhesive properties keep the tablet close to the mucosal surface. Predetermined drug release patterns are a key advantage of mucoadhesive technology over oral films. Mucoadhesive technology can also be the desired delivery method in situations where the drug acts as an irritant on the GI tract or the active ingredient is poorly soluble.
VersaTab is the Company's multilayer tablet. IntelGenx believes that its multilayer tablet technology has advantages that make it a more desirable option than the traditional single layered tablet. One of the advantages is VersaTab's ability to release the active ingredient in a more linear fashion than single layer tablets.
PARTNERSHIPS: IntelGenx has partnerships with Edgemont Pharmaceuticals LLC, RedHill Biopharma, Dava Pharmaceuticals Inc, and Par Pharmaceutical, Inc.
-1- When is the last time IGXT raised cash through an offering (diluted)?
-a- On June 11, 2011 the IGXT “closed private placement offerings totaling approximately 4.8 million shares (the "Shares") of common stock (the "Common Stock") at a per share purchase price of US$0.67, and three-year warrants (the "Warrants") to purchase up to approximately 2.4 million shares of Common Stock at an exercise price of US$0.74 per share, for aggregate gross proceeds of approximately US$3.2 million.”
-2- How much cash (not cash equivalents) does IGXT have?
-b- The Company reported cash at $2.2 million as of March 31, 2013.
-3- What and approximately when is the next known catalyst?
IntelGenx has multiple partnerships, technologies, and one product, Forfivo already on the market. The company is also actively seeking new partnerships to advance its pipe line. New milestones could be reached and announced by the Company at any time...
-c- However, the next major date stamped catalyst is the February 3, 2014 PDUFA date assigned by the FDA for review of the Company's NDA for the marketing approval of the Company's anti-migraine oral film product based on VersaFilm technology.
-c- “The Company had announced on March 27, 2013 that, together with its co-development partner RedHill Biopharma Ltd ("RedHill"), it had submitted a 505(b)(2) NDA to the FDA for the Company's anti-migraine oral film product. The product is a novel, oral thin-film formulation, based on IntelGenx' proprietary VersaFilm™ technology containing Rizatriptan, the active drug in Merck & Co ("Merck") Maxalt-MLT® orally disintegrating tablets. The FDA confirmed that IntelGenx' application is sufficiently complete to permit a substantive review in accordance with the FDA's "standard" classification process.”
-4- What is IGXT's quarterly cash burn?
-b- For the first quarter of 2013, total expenses were $600,000. Total expenses for the same quarter in 2012 were $700,000.
-d- Expenses for the first quarter of 2013 were consistent with the response given by the Company in the original #IRQ in January 2013.
-5- Does IGXT have an existing line of credit and if so how much can they draw against it?
-d- The Company does not have an existing credit line/facility.
A complete archive of this and additional #IRQ research and IR responses can be found athttp://www.biotechduediligence.com/ir-questions.html.
The original January 2013 #IRQ-IR response with answers provided by IGXT can be found athttp://www.biotechduediligence.com/igxt-irq.html.
RESOURSES:
Background and Partnerships: http://www.intelgenx.com/
-a- IGXT PR 06/22/11 http://www.intelgenx.com/investors/pressreleases/2011/2011-06-22.html
-b- IGXT PR 05/14/13 http://www.intelgenx.com/investors/pressreleases/2013/2013-05-14.html
-c- IGXT PR 06/18/13 http://www.intelgenx.com/investors/pressreleases/2013/2013-06-18.html
-d- IGXT IRQ 01/2013 http://www.biotechduediligence.com/igxt-irq.html
Answers received: January 2013
1) When is the last time IGXT raised cash through an offering (diluted)?
They last raised cash in June 2011. The company raised gross proceeds of $3.2 million through the issuance of 4.8 million units. The unit comprised of one common share priced at $0.67 and a half warrant priced at $0.74. The warrants have a 3 year term.
2) How much cash (not cash equivalents) does IGXT have?
As of their last quarter reported September 2012, the company had $2.8M in cash.
3) What and approximately when is the next known catalyst?
The next known catalyst will be IGXT's NDA submission for it's migraine thin film. It is expected to occur this quarter.
4) What is IGXT's quarterly cash burn?
The company burns approximately $600K per quarter, but is expecting to begin reporting sales for it's first FDA approved product, ForFivo, imminently.
5) Does IGXT have an existing line of credit and if so how much can they draw against it?
No the company does not have an equity line of credit.
Hope this helps. I have just started using Twitter myself. I will definitely begin following you and the broader biotech community you follow.
All the best...........Hogan Mullally (Twitter @hoganmullally)
1) When is the last time IGXT raised cash through an offering (diluted)?
They last raised cash in June 2011. The company raised gross proceeds of $3.2 million through the issuance of 4.8 million units. The unit comprised of one common share priced at $0.67 and a half warrant priced at $0.74. The warrants have a 3 year term.
2) How much cash (not cash equivalents) does IGXT have?
As of their last quarter reported September 2012, the company had $2.8M in cash.
3) What and approximately when is the next known catalyst?
The next known catalyst will be IGXT's NDA submission for it's migraine thin film. It is expected to occur this quarter.
4) What is IGXT's quarterly cash burn?
The company burns approximately $600K per quarter, but is expecting to begin reporting sales for it's first FDA approved product, ForFivo, imminently.
5) Does IGXT have an existing line of credit and if so how much can they draw against it?
No the company does not have an equity line of credit.
Hope this helps. I have just started using Twitter myself. I will definitely begin following you and the broader biotech community you follow.
All the best...........Hogan Mullally (Twitter @hoganmullally)