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Farmas USA

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Farmas USA
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#28649

Re: Farmas USA - SNTA

No he analizado los datos, que conste, pero vamos, más caída me parece imposible. Y dada nuestra diapositiva...

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#28651

Re: Farmas USA - SNTA

Es que nadie más que el Bastardo ha abierto la boca para decir que eran malos. Ah, y yo tenía apuntada que la conferencia era de 3 a 4. ¿Y a las 15.46 ya tenía el tipo un artículo de 2 páginas? Los cojones.

Edito: que conste que SNTA sigue sin gustarme.

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#28653

Re: Farmas USA

IGXT

Empresa de genéricos. Cita con la FDA para un medicamento antimigraña copia de otro de Merck el día 10 de junio. Sin deuda. Productos en el mercado.

Ocasión de entrada. Es OTC pero tiene las cuentas auditadas.

Copio los datos interesantes que tengo. Los dos puntos flacos fue a) que se aprobó hace un par de años una dilución de 100 millones, de las cuales se realizó una por la mitad en diciembre de 2012 (tienen las manos libres para ejecutar la otra mitad cuando quiera, pero, vamos, como todas); b) los datos del próximo trimestre no serán tan buenos como los de este:

Total revenue in the first three months of 2013 increased to $157 thousand, compared with $100 thousand in the same period of 2012.

Por lo demás, la empresa me parece una pasada:
Produce tecnología para la administración de fármacos. Su estrategia es copiar superventas y mejorar su absorción o distribución en el mercado. No necesitan gastar mucho en estudios porque pueden utilizar los que ya están hechos.

Tecnología:
-película: VersaFilm
-comprimido multicapa: VersaTab
-comprimido mucoadhesivo: AdVersa

Tiene varios socios que se valen de su tecnología e inversores institucionales
http://markets.ft.com/research/Markets/Tearsheets/Financials?s=IGX:CVE

12 compras insiders en el último año
Ninguna venta

Bluemont capital corp: 10%, 6.212.645 acciones (11/09/2012)

Informe de poco menos de un año. Precio objetivo: 2,5 a 18 meses:
http://www.thelifesciencesreport.com/cs/user/download/co_file/3241

Resultados anuales:
http://www.sec.gov/Archives/edgar/data/1098880/000106299313001771/f424b3_577.htm
http://www.streetinsider.com/Press+Releases/IntelGenx+Reports+2012+Annual+Results+and+Provides+Operational+Update/8193378.html

Información de interés de los informes varios:

Growth Strategy
Our primary growth strategies include: (1) identifying lifecycle management opportunities for existing market leading pharmaceutical products, (2) developing generic drugs with high barriers to entry, (3) developing products for the (non-pharmaceutical) nutritional supplement market, and (4) developing new drug delivery technologies.

Lifecycle Management Opportunities
We are seeking to position our delivery technologies as an opportunity for lifecycle management of products for which patent protection of the active ingredient is nearing expiration. While the patent for the underlying substance cannot be extended, patent protection can be obtained for a new and improved formulation by filing an application with the FDA under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Such applications, known as a “505(b)(2) NDA”, are permitted for new drug products that incorporate previously approved active ingredients, even if the proposed new drug incorporates an approved active ingredient in a novel formulation or for a new indication. A 505(b)(2) NDA may include information regarding safety and efficacy of a proposed drug that comes from studies not conducted by or for the applicant. The first formulation for a respective active ingredient filed with the FDA under a 505(b)(2) application may qualify for up to three years of market exclusivity upon approval. Based upon a review of past partnerships between third party drug delivery companies and pharmaceutical companies, management believes that drug delivery companies which possess innovative technologies to develop these special dosage formulations present an attractive opportunity to pharmaceutical companies. Accordingly, we believe “505(b)(2) products” represent a viable business opportunity for us.

Generic Drugs with High Barriers to Entry
We plan to pursue the development of generic drugs that have certain barriers to entry, e.g., where product development and manufacturing is complex and can limit the number of potential entrants into the generic market. We plan to pursue such projects only if the number of potential competitors is deemed relatively insignificant.

Nutritional Supplement Products
We plan to develop additional products for the nutritional supplement market based upon our proprietary drug delivery technologies. The market for these supplements is large, with little differentiation between products. Our proprietary technology is aimed at increasing the absorption rate of active ingredients. We believe that supplements represent attractive short-term revenue opportunities since they are not regulated as pharmaceutical products and do not require FDA approval.

Many of our competitors, including Monosol Rx, Labtec GmbH, BioDelivery Sciences International, Inc. and Skye Pharma PLC strategic alliance with LTS Lohmann Therapie-Systeme AG ("LTS") for the manufacturing of certain products developed by us using our VersaFilm™ technology. LTS is regarded as a pioneer in the development and production of transdermal and film form oral systems and has become one of the world's leading suppliers for the international pharmaceutical and
Forfivo XL™, our first FDA approved product, was launched in October 2012 under a licensing partnership with Edgemont Pharmaceuticals LLP (“Edgemont”). 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. Under the terms of the agreement with Edgemont, the commercial launch of Forfivo XL™ triggered a milestone payment of $1 million, which we invoiced to Edgemont and recognized as revenue in the fourth quarter of 2012. We expect to start receiving royalty payments from commercial sales of the product in the first quarter of 2013.

Upon entering into the licensing agreement, Edgemont paid us an upfront fee of $1 million, which we recognized as deferred license revenue. The deferred license revenue will be amortized in income over the period where sales of Forfivo XL™ are expected to be exclusive. As a result of this policy, we recognized $77 thousand in income during the fourth quarter of 2012.

Also included in revenue for the year ended December 31, 2012 is the receipt of a $100 thousand development milestone in respect of our Rizatriptan VersaFilm™ project and was related to the successful completion of the pivotal bioequivalence study. Revenue earned from our pharmaceutical partners for development milestones achieved, including non-refundable upfront license fees, were $359 thousand in the year ended December 31, 2011. The decrease is attributable to the timing related to the achievement of development milestones. We are currently negotiating with a number of potential partners related to new development projects for various drug candidates and, whilst the timing of such events is difficult to predict, we are optimistic of securing contracts in the near future.

Sales of our first commercialized product, a pre-natal multivitamin supplement, marketed in the USA as Gesticare®, were discontinued in the third quarter of 2011. We received final royalties from the sale of the product in the fourth quarter of 2011 from Azur Pharma, now part of Jazz Pharmaceuticals plc. In the year ended December 31, 2011 royalty revenues earned from Gesticare® were approximately $74 thousand.

Interest and other income of $10 thousand was recorded in the year ended December 31, 2012, compared with $7 thousand in the previous year. Interest and other income relates primarily to interest earned on deposits at banks.

In August 2010 the Company entered into a joint development and commercialization agreement with RedHill Biopharma (“RedHill”), an Israeli company, for an anti-migraine product based upon the Company’s VersaFilm™ technology. In accordance with the terms of the agreement, RedHill made up-front and milestone payments in the aggregate amount of $600 thousand, of which $100 thousand was received by the Company in 2012 upon production of pivotal batches. RedHill is required to make additional milestone payments of up to $700,000 as follows:

$200 thousand upon the filing of an NDA and acceptance of the filing by the U.S. Food and Drug Administration; and

$500 thousand upon receipt of U.S. Food and Drug Administration marketing approval for the product.
Product Sales:

The Company launched Forfivo XL™ in the USA in October 2012 under a licensing partnership with Edgemont Pharmaceuticals LLP (“Edgemont”). Under the terms of the agreement with Edgemont, the commercial launch of Forfivo XL™ triggered launch-related milestone payments for IntelGenx of up to $4.0 million, of which $1 million was invoiced by the Company to Edgemont and recognized as revenue in the fourth quarter of 2012 and the cash received in February 2013. Additional milestones of up to a further $23.5 million are payable upon achieving certain sales and exclusivity targets and the Company expects to commence receiving royalties from sales of the product in the first quarter of 2013.

Upon entering into the licensing agreement, Edgemont paid the Company an upfront fee of $1 million, which the Company recognized as deferred license revenue. The deferred license revenue will be amortized in income over the period where sales of Forfivo XL™ are expected to be exclusive. As a result of this policy, the Company has a deferred revenue balance of $923 thousand at December 31, 2012 that has not been recognized as revenue.

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™.

On March 27, 2013 we announced that, together with our co-development partner RedHill Biopharma (“RedHill”), we submitted a 505(b)(2) New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for our anti-migraine oral film product.

We had previously announced a successful pre-NDA meeting with the FDA following the successful completion of a bioequivalency study demonstrating that our oral film product is bioequivalent with Maxalt MLT®, a leading branded anti-migraine product manufactured by Merck & Co. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012. The thin-film formulation of Rizatriptan has been developed in accordance with the co-development and commercialisation agreement with RedHill.

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#28654

Re: Farmas USA

Esto es una recomendación razonada y no lo que yo hago. Gran trabajo Ana.

#28655

Re: Farmas USA

menuda paliza con SNTA.
Bueno, ya he dejado la furgo aparcada.
Si le dan otro meneo para 4.80 le meto un tiro a ver si promierdo.
Una mañana cojonuda en el DAX y alguna cosilla, para rascar unos cientos, y llega snta y me multiplica por 10 el bujero.

#28656

Re: Farmas USA

IGXT

Pues ya me dirás que te parece. Lo que pasa es que no mueve nada de volumen.

«Después de nada, o después de todo/ supe que todo no era más que nada.»

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