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Flamel Technologies

WKN: 901606 / ISIN: US3384881096

Flamel Technologies (FLML) die neue Amylin !!

eröffnet am: 02.11.07 13:53 von: Chalifmann3
neuester Beitrag: 25.04.21 13:11 von: Barbarayngra
Anzahl Beiträge: 67
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davon Heute: 8

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23.02.09 18:56 #26  Tyko
Bekannt? Flamel Technologi­es SA (Nasdaq: FLML) gab heute bekannt, dass Jeffery Vick hat sich ihre Geschäftsl­eitung Team Flamel als Chief Business Officer. Herr Vick war zuvor als Chief Executive Officer von Silence Therapeuti­cs plc, einer der führenden europäisch­en Unternehme­n RNAi. Herr Vick erhielt seinen MBA von der Stanford University­, seinen MS in Chemie von der University­ of California­, San Diego, Flamel und bringt mehr als zwanzig Jahre Erfahrung in der Pharma-und­ Biotech-In­dustrie.

"Jeff's Know-how im Bereich Corporate Developmen­t, Marktforsc­hung, und Fragen des geistigen Eigentums wurde entwickelt­, sowohl in Europa als auch in den USA", sagte Stephen H. Willard, das Unternehme­n als Chief Executive Officer. "Seine Erfahrung in diesen Bereichen,­ zusammen mit seiner Geschichte­ zu tun Grundlagen­forschung in der Onkologie und seine Arbeit bei der Entwicklun­g der Biotechnol­ogie, Drug-Deliv­ery-und Genomik-Un­ternehmen,­ ist er eine ideale Ergänzung zu den Flamel Team. Meine Kollegen und ich sind sehr freuen uns auf Jeff Unterstütz­ung beim Aufbau Flamel auf die bestehende­n Beziehunge­n mit unseren Pharma-und­ Biotech-Pa­rtnern sowie bei der Entwicklun­g neuer. "

"Flamel Technologi­e-Plattfor­men sind ideal positionie­rt, um wichtige Lösungen für die Pharma-und­ Biotech-In­dustrie. Diese auf die Wirksamkei­t und Sicherheit­, sondern auch zu wichtigen Fragen in der Entwicklun­g neuer Medikament­e, wie die Stabilisie­rung und die Erweiterun­g der effektive Halbwertsz­eit, ohne die Bioaktivit­ät ", sagte Herr Vick. "Ich freue mich besonders,­ werden die Beteiligun­g an einem Unternehme­n, das sich große Wachstumsc­hancen in Verbindung­ mit einer soliden finanziell­en Grundlage.­"

Flamel Technologi­es, SA ist ein biopharmaz­eutisches Unternehme­n, hauptsächl­ich in der Entwicklun­g von zwei einzigarti­gen Polymer-ba­sierte Technologi­en für medizinisc­he Anwendunge­n. Mikropumpe­ ® ist eine kontrollie­rte Freisetzun­g und Geschmack-­Maskierung­ für die orale Verabreich­ung von kleinen Molekül Drogen. Flamel die Medusa ®-Technolo­gie ist, um kontrollie­rte Freisetzun­g Formulieru­ngen von therapeuti­schen Proteinen und Peptiden
05.03.09 16:11 #27  Chalifmann3
4th quarter and year end: Zahlen Flamel Technologi­es Announces Fourth Quarter and Year-End 2008 Results
Wednesday March 4, 4:30 pm ET

Fourth quarter highlights­ include further diversific­ation through new Medusa and Micropump partnered agreements­; significan­tly improved financial performanc­e

LYON, France--(B­USINESS WIRE)--Fla­mel Technologi­es (NASDAQ:FL­ML - News) today announced its financial results for the fourth quarter and year ended December 31, 2008. Significan­t achievemen­ts were reached during the fourth quarter:
signed two new feasibilit­y studies using the Medusa and Micropump platforms;­
continued strong progress on the existing programs in developmen­t; and
further strengthen­ed the Company’s financial position.
Stephen H. Willard, Flamel’s chief executive officer, stated, “Flamel continued its success by signing two new feasibilit­y study projects in the fourth quarter. One of these was with an existing partner to work on therapeuti­c vaccines using Medusa, while the other was with a new partner utilizing the Micropump platform for a combinatio­n product. The recent decision by Merck Serono to exercise a license for the Medusa platform marks another step forward in validating­ our business strategy and laying a foundation­ to build long-term value for our shareholde­rs. Many of our other diversifie­d feasibilit­y projects have demonstrat­ed compelling­ results that we believe may serve as catalysts for further licenses being signed for our technology­ platforms.­”

Mr. Willard continued,­ “During 2008, we maintained­ our focus on preserving­ a solid financial foundation­ for future growth. We are pleased to have finished the year with $37.1 million in cash and marketable­ securities­ compared to $41.1 million at the end of 2007. We believe that our financial strength is especially­ important as we negotiate with partners in the challengin­g current economic climate.”

Flamel’s Fourth Quarter Results

Flamel reported total revenues for the fourth quarter 2008 of $9.5 million versus total revenues of $10.6 million in the year-ago period. License and research revenue totaled $3.4 million during the fourth quarter of 2008; 2007 fourth quarter license and research revenue also totaled $3.4 million, and included receipt of a $2 million milestone payment from GlaxoSmith­Kline (GSK). Product sales and services during the period were $2.6 million versus $4.7 million during the year-ago period. Other revenues, consisting­ primarily of royalty income from GSK on the sales of Coreg CR, increased to $3.4 million during the period from $2.4 million in the fourth quarter 2007.

Total costs and expenses during the quarter were $14.4 million and included FAS 123R options-re­lated expense of $2.0 million; total costs and expenses in the fourth quarter of 2007 were $18.6 million. Costs of goods and services sold were $2.4 million in the fourth quarter of 2008 versus $4.9 million in the year-ago period. Research and developmen­t costs in the fourth quarter totaled $9.8 million versus $9.9 million in the year-ago period. Selling, general, and administra­tive costs declined from $3.8 million in the year-ago period to $2.3 million in the fourth quarter of 2008.

Net loss for the fourth quarter of 2008 was ($2.7 million) versus a net loss of ($5.9 million) in the year-ago period. Net loss per share (basic) was ($0.11) versus ($0.25) in the fourth quarter of 2007.

Flamel’s 2008 Annual Results

For the calendar year 2008, Flamel reported total revenue of $38.6 million, compared to $36.7 million in 2007. License and research revenue was $13.2 million in 2008, compared to $10.3 million in 2007. Product sales and services for the year 2008 were $13.5 million, compared to $19.8 million in the year-ago period. Other revenues, consisting­ primarily of royalty income from sales of Coreg CR by GSK, increased to $11.8 million in 2008 from $6.6 million in 2007.

Total costs and expenses in 2008 were $58.8 million and included FAS 123R non-cash compensati­on expense of $8.3 million. Total costs and expenses in 2007 totaled $77.5 million. Costs of goods and services sold were $9.6 million in 2008 versus $17.3 million in 2007. SG&A in 2008 declined to $12.9 million versus $16.6 million in 2007. Research & developmen­t expenses were $36.2 million versus $43.6 million in 2007.

The Company reported a net loss for the year 2008 of ($12.1 million) or ($0.50) per share versus a net loss in 2007 of ($37.7 million), or ($1.57) per share. Flamel signed six new agreements­ with partners in 2008 and finished 2008 with $37.1 million in cash and marketable­ securities­

MFG
Chali  
05.03.09 21:47 #28  Tyko
-10%.... sei froh den Gewinn auch realisiert­ zu haben.
IMO
10.03.09 11:45 #29  Friends
Wow seit Threaderöffnung fast 50% verloren Man bist Du ein Könner!!!!­!!

Wenn dann zock richtig oder such Dir Aktien die Substanz haben.  
16.03.09 14:58 #30  Chalifmann3
NEWS ! Flamel Technologi­es to Present at the 29th Annual Cowen and Company Healthcare­ Conference­ in Boston
Monday March 16, 2009, 9:00 am EDT
     
LYON, France--(B­USINESS WIRE)--Fla­mel Technologi­es’ (NASDAQ: FLML - News) chief executive officer, Stephen H. Willard, is scheduled to present at the 29th Annual Cowen and Company Healthcare­ Conference­ in Boston at 3:55 PM today. The presentati­on will be webcast and may be accessed at the Flamel Technologi­es website: www.flamel­.com

MFG
Chali  
06.05.09 16:48 #31  Tyko
Hallo Chalif....­.

meinetwege­n könnte mal langsam was passieren.­.....

;-))
11.05.09 15:43 #32  Chalifmann3
Flamel Technologies Announces Profitable First Qua Flamel Technologi­es Announces Profitable­ First Quarter Results; Increased Cash Levels

LYON, France—May­ 11, 2009 - Flamel Technologi­es (Nasdaq: FLML) today announced its financial results for the first quarter of 2009.
First quarter highlights­ included:

Payment by Merck Serono of a €5 million upfront fee following exercise of option to license Medusa technology­ for developmen­t of an improved formulatio­n of an already marketed therapeuti­c protein in Merck Serono's portfolio;­
Achievemen­t and recognitio­n of $4 million milestone from GlaxoSmith­Kline (GSK), payable in the second quarter;
11% growth in revenues;
Increased cash with no debt; and
Earnings of $1.2 million.
For the first quarter 2009, Flamel reported total revenues of $12.1 million versus $10.9 million in the year-ago period. License and research revenues during the quarter were $7.1 million and included a $4 million milestone from GSK; license and research revenues during the year-ago quarter were $3.5 million and included a €500,000 ($0.75 million) milestone from Merck Serono. Product sales and services, pursuant to the Company's supply contract with GlaxoSmith­Kline declined in the first quarter to $2.4 million from $4.7 million in the year-ago quarter. Other revenues in the quarter were $2.5 million, as compared to $2.6 million in the year-ago quarter.

Operationa­l expenses in the first quarter 2009 declined 22% from $15.8 million in the year-ago quarter to $12.4 million. Costs of goods and services sold were $2.1 million, as compared to $2.4 million in the first quarter of 2008. Costs and expenses of Flamel's research and developmen­t were $7.4 million, compared to $9.3 million in the first quarter of 2008. SG&A expenses during the quarter declined from $4.1 million in 2008 to $2.9 million in the first quarter 2009.

Net income for the first quarter 2009 was $1.2 million as compared to a net loss of ($3.7) million in the first quarter of 2008. Net income per share (basic) for the first quarter of 2009 was $0.05, compared to a net loss per share (basic) in the year-ago period of ($0.15). Net income per share (diluted) for the first quarter of 2009 was $0.05. Cash and marketable­ securities­ at the end of the first quarter totaled $39.1 million and did not include receipt of the $4 million milestone from GSK. Cash and marketable­ securities­ as of December 31, 2008 were $37.1 million.

Stephen H. Willard, Flamel's Chief Executive Officer, stated, "During the first quarter, we made continued progress in expanding our partnershi­p model. We are beginning to enjoy the fruits of work that we have undertaken­ over the past few years, such as with the announced license agreement with Merck Serono. There are numerous additional­ feasibilit­y studies that could serve as potential catalysts for further license agreements­. The strength of our technology­ and the success of our scientists­ in creating value for our partners are driving this process, which we believe may accelerate­ in the remainder of this year. Our financial strength is an especially­ important asset to us as we negotiate these potential license agreements­ and as we work to develop new feasibilit­y studies to fuel our future growth."

MFG
Chali  
15.05.09 09:38 #33  schilo-nrw
moin Chali "Flamel" davon habe ich gehört! Der Geldgeber war doch ein skandinavi­schen Pharmaries­e... das war doch in 2001/2 werde heute abend mal recherchie­ren! Danke für BM
18.05.09 19:16 #34  Chalifmann3
Flamel: Interleukin-2 gegen Krebs.... As a whole, interleuki­n sales totaled an estimated $213 million in 2007.
Due to toxicity issues, interleuki­ns are not approved for use in as many applicatio­ns as they theoretica­lly could be. Interleuki­n-2 (IL-2) is used for the treatment of certain types of cancer, such as renal cell carcinoma and metastatic­ melanoma, and is being studied for the treatment of acute myelogenou­s leukaemia,­ non-Hodgki­n’s lymphoma and HIV/AIDS infection.­

IL-2 is the only therapy offering complete remission for the treatment of late stage renal cancer or metastatic­ melanoma.
For IL-2 to be effective in fighting against cancer, high doses are required. This has limited the potential applicatio­ns for the compound, due to safety issues. We (Flamel) feel that a significan­t increase in the approved applicatio­ns of this compound can be achieved with a reduction of its toxicity through the use of an appropriat­e drug delivery system.

The Medusa® platform has been validated in monkey and other animal studies for this compound. Our initial studies show an increase of the response of the immune system, with an increase of CD4, CD8 and CD25 compared with Proleukin®­ (aldesleuk­in, from Chiron), a decrease of the blood concentrat­ion of the drug after injection (which limits toxicity),­ and an increase in the duration of action. This project is being developed internally­ and is available for licensing.­

Flamel Technologi­es presented at the 2006 ASCO (American Society of Clinical Oncology) Annual meeting (June 2-6, 2006) the preliminar­y results of the phase I/II of its controlled­-released formulatio­n of interleuki­n-2 (IL-2 XL)

MFG
Chali  
25.05.09 21:37 #35  schilo-nrw
Moin Chali gibt es news?
26.05.09 02:20 #36  Chalifmann3
Hi shilo Ich habe Steve willard (CEO) angemailt bezüglich einer ASCO-Teiln­ahme von flamel jetzt über Pfingsten.­Ich habe noch keine antwort erhalten ...... ?

MFG
Chali  
26.05.09 14:54 #37  Chalifmann3
ASCO Flamel nimmt an der ASCO über Pfingsten NICHT teil,habe folgende E-mail erhalten:

"Dear Sir:

We do not have plans to publish new data on our IL-2 formulatio­n at ASCO this year.  Howev­er, I would be pleased to review the program with you if care to schedule a conference­ call.  I hope to hear from you and, in the meanwhile,­ wish you all the best,

Charles Mosseri-Ma­rlio"

Director of Strategic Planning and Investor Relations

Flamel Technologi­es
33 avenue du docteur Georges Levy
69693 Venissieux­ Cedex
FRANCE
tel: + (33) (0) 472 78 3423
cell: (1) 401-480-97­29

MFG
Chali  
14.06.09 13:57 #38  Chalifmann3
Q1 2009 Earnings Call Transcript May 11, 2009 8:30 am ET

Executives­

Stephen Willard - CEO

Siân Crouzet - PFO

Analysts

Matt Kaplan - Ladenburg

Peter Butler - Glenhill Investment­s

Tom Weissenbor­n - Credit Suisse

Presentati­on


Operator


Hello, and welcome to Flamel Technologi­es' first quarter 2009 earnings conference­ call. All participan­ts will be in a listen-onl­y mode. (Operator Instructio­ns). Please note, this conference­ is being recorded.

Your host for today's call is Stephen H. Willard, Chief Executive Officer of Flamel Technologi­es. Mr. Willard, please begin your call.

Stephen Willard

Thank you very much and good morning, ladies and gentlemen.­ We open as always with the forward-lo­oking statement language, which is set out at the conclusion­ in today's press release. All statements­ made on this call are subject to a variety of future events and risk factors, including those set forth in our filings with the SEC, particular­ly our Form 20-F, which are all publicly available.­ Please review them and they are directly applicable­ to every element of this call.

Our first quarter result highlighte­d the success the company has achieved in leveraging­ its strengths to build a solid foundation­ for growth based on innovative­ technology­, a prudent partnershi­p approach that recognizes­ the advantages­ that working with leading companies confers on Flamel, the ability of our scientists­' to create valuable working relationsh­ips with their colleagues­ in these partner companies and force the stability that Flamel enjoys in terms of financial resources at a time of relative difficulty­ in the industry.

I would like to briefly review the first quarter highlights­ and then I will ask Siân to review our financial result. We were, of course, very pleased that Merck Serono exercised its option to license to Medusa technology­ for one of their already marketed therapeuti­c protein this past February. We received a EUR5 million upfront payment, that's about $6.5 million, during the quarter [personal]­ to the contract that we signed at the beginning of the project. As many of you will remember, this program was initiated in December of 2007.

During the time that we have been engaged on this project with Merck Serono, our scientists­ have forged a strong working relationsh­ip with their scientific­ counterpar­ts. We are very pleased with the results that we have generated on the project, both with respect to the product itself, but also with respect to have it relates to the Medusa platform as a whole. Our expectatio­n is that this program will serve as a strong showcase for the strength of the Medusa platform as it advances and data become public.

During the fourth quarter, we also achieved a milestone with GSK regarding COREG CR, triggering­ a $4 million payment. This payment was based on the second anniversar­y of the launch of the product and is not included in our published cash and marketable­ securities­ as of the end of Q1.

Our relationsh­ip with GSK remains strong and we believe that they have a good understand­ing of the strengths that Micropump can offer for the delivery of controlled­ release small molecule drugs. The quality of the work that we have achieved for GSK has benefited us in many ways, not least by increasing­ our visibility­ and reputation­ with other large players in the industry and small players as well for that matter.

I hope that you have all had a chance to read the press release detailing our financial results for the first quarter as went out this morning. Obviously,­ we are pleased to have increased our revenues, strengthen­ed our cash during the quarter and achieved profitabil­ity.

Siân, would you please review the first quarter results.

Siân Crouzet

Thank you, Steve, and good morning, everyone. I'm pleased to discuss quarter one results, which were highlighte­d as Steve pointed out by growth in revenues and increase in the company's cash reserves, and the profit of $1.2 million during the quarter.

The results continued and, in fact, accelerate­d certain trends that we have discussed in previous quarters. These trends are increased R&D revenues, cost prioritiza­tion, and improved earnings quality.

When we look at our revenues during the quarter, these were affected by the $4 million milestone,­ which we invoiced to GSK in March. In the year ago period, we had received a EUR0.5 milestone from Merck Serono, which was approximat­ely $750,000 at that time.

Leaving aside these items, what shown important contributi­on to our financial results, but which can make analysis more difficult with regard to underlying­ trends, we enjoyed a 53% increase in R&D research revenues year-on-ye­ar and in constant currency terms.

We highlight these revenues that they are an important leading indicator to the extent that they reflect the increased interest in our technology­ platforms.­ In effect, the price in this line item is one of the things we look at to gauge eventual license fees, milestones­, and clinical R&D revenues which we could receive if and when projects progressed­ further into the clinic.

Our operating cost during the quarter declined somewhat in constant currency terms. A decline that was magnified in dollar terms by the weakness of the dollar versus the euro year-on-ye­ar. With respect to the research and developmen­t cost, much of it declined due to timing and commitment­ of certain expenses, which we expect to reverse in future quarters. Our effort to contain non-critic­al expenditur­e has led to a decline in SG&A cost year-on-ye­ar.

The FAS 123R non-cash charge for the quarter amounted to $1.4 million. Our cash and marketable­ securities­ at the end of the quarter was $39.1 million versus $37.1 million at the end of the last quarter of 2008. This increase in cash did not include the $4 million we have invoiced to GSK, but it does includes the payment from Merck Serono for the EUR5 million as an upfront fee following the exercise of that option to the Medusa technology­.

The cash and marketable­ securities­ position is better effected by negative exchange rate variance during the quarter. As per the exchange rate effect, cash and marketable­ securities­ would have increased by $3.6 million in the quarter.

We are pleased with the success of our efforts to build the company with a diversifie­d foundation­ of multiple projects with multiple partners across different platforms and in different indication­s. It is for this reason that we are positioned­ to benefit from milestones­, such as the one from GSK and to report a profitable­ quarter.

As I began by pointing out, these results represent the continuati­on of several trends that we have pursued over the past two years. We are pleased with the progress we have made thus far, and look forward to further continuati­on of these trends as events unfold over the coming years.

With that, I would turn it back to Steve.

Stephen Willard

Thank you very much, Siân. It has been a little over two months since we last hosted a conference­ call, so I will try to be brief in my remarks hoping to leave more time for questions.­

As we mentioned,­ our Q1 cash and marketable­ securities­ number did not include the $4 million milestone that we invoiced GSK in March. That will be included in our Q2 balance sheet.

We are very pleased to have achieved profitabil­ity in the first quarter of this year, because it speaks to the strength of the work that we have done and continue to do with our partners, the commercial­ success of our platforms and the strong work that our scientists­ have achieved working together with the partners we have attracted.­ We are in a strong position where as things stand now events can push us into profitabil­ity very easily.

I would also like to point out that our fiscal responsibi­lity has extended for a significan­t period of time now. In the third quarter of 2007, when we cut back on expenses in response to COREG CR sales, which were far less than projected,­ we had $40.8 million in cash and marketable­ securities­. Today, six quarters later, our cash is $39.1 million, a decline of only $1.7 million over the six-quarte­r period. More importantl­y, during this period, we have made tremendous­ strides both with our technology­ and our relationsh­ips with new partners.

We have every reason to be confident in this regard. Recently, we have taken steps to streamline­ our feasibilit­y projects, so as to prioritize­ our work. This was necessary in order to favor those projects, which we believe have the greatest commercial­ appeal for potential license agreements­ and also to open capacity for the agreements­ that we are currently negotiatin­g.

We have updated our presentati­on accordingl­y to reflect that we have one fever vaccine project and one fever therapeuti­c protein project. Both projects were being conducted with smaller companies that faced funding constraint­s that were of concern to us.

With respect to vaccines, we still have one active partnershi­p with the Top 20 company and we are currently in discussion­s with two Top 10 companies for new vaccine programs. These companies have far greater resources to apply to vaccine developmen­t. We now know a lot more about the applicabil­ity of Medusa with respect to vaccines as a result of the work that we have completed over the past two years.

We are also negotiatin­g a number of feasibilit­y programs both for Medusa as well as Micropump.­ The negotiatio­ns are for the most part well advanced. We expect that there should be a number of updates in this regard over the coming months. With respect to our remaining ongoing studies, we are pleased with the data that our scientists­ are generation­ and expect that a number of these studies could lead to license agreements­ this year.

With respect to many of our feasibilit­y programs, the point at which a company chooses to exercise a license, is entirely at their discretion­. As a general matter, we prefer that a company develop more data using our platforms rather than less, as this favors our negotiatin­g position. Fundamenta­lly, the greater the value we are able to create for our partners, the better our position in these negotiatio­ns.

Sometimes this is a function of the molecules that we are working on as much as the strength of the platforms themselves­. Some molecules required greater functional­ity that others either because of the nature of the indication­, the nature of the molecule itself or some combinatio­n of the two. A corollary to my earlier comment is, the greater the problem, the better our position.

This is one reason that we continue to invest in creating greater comparativ­e advantage for both Medusa and Micropump.­ Some of this investment­ is being done on the standalone­ basis and other efforts are being conducted using our partner's funds. As an example of the first approach, we have worked over the past year-and-h­alf on our own to extend the duration of release for the Micropump platform.

Currently,­ Micropump has many strengths that make it, in my opinion, a best-in-cl­ass technology­. Its principal strengths are the ability to affect the controlled­ release with precise pharmacoki­netics consistent­ly for all patients using a variety of dosage formulatio­ns.

If we succeed in extending the duration of actions significan­tly beyond the competitio­n, we will create new markets for the platform. Large pharmaceut­ical companies are always interested­ in product life extension strategies­, particular­ly if there is a compelling­ therapeuti­c rationale.­ Many molecules are not commercial­ly developed because the molecules have very short half-life.­

As an example of the second approach, the one using partner funds, we are working with the Top 10 pharma company to demonstrat­e the ability of Micropump to be used in over-the-c­ounter liquid formulatio­ns, which could be administer­ed to children. This should give us further opportunit­ies to access pediatric and geriatric markets for which we have long believed Micropump was ideally suited. The over-the-c­ounter market is also very attractive­ to us. In this the time-to-ma­rket is reduced compared with prescripti­on drugs.

We are using the same two-pronge­d approach with respect to Medusa. Several of our ongoing feasibilit­y programs are for new applicatio­ns of the Medusa platform, by which I mean different modes of applicatio­n amongst others. We are pleased to be able to leverage the scientific­ and economic resources of our partners to further develop the Medusa platform.

Our partners gain potentiall­y beneficial­ terms with respect to the molecules we are working on and we are able to further develop the platform so as to extend our comparativ­e advantage and create more value-adde­d solutions in different therapeuti­c settings.

We are currently negotiatin­g with two large pharma companies to sign projects that will be based on specific knowledge we built using this approach. We are very pleased with the traction we have achieved using this approach, and that we have been able to accrue this intellectu­al property with minimal expense. It is a very efficient model.

As we look to the remainder of the year, we are encouraged­ with the progress we have made with the programs we have in developmen­t, with our backlog of projects in discussion­ and negotiatio­n, as well as of the interest that we have for our internal programs. The potential for all three of these sources of growth to contribute­ to the strength of the company over the coming year has never been greater.

With that, I would now be pleased to take your questions.­

Question-a­nd-Answer Session

Operator


(Operator Instructio­ns). Our first question comes from Matt Kaplan from Ladenburg.­ Please go ahead.

Matt Kaplan - Ladenburg


Just following up on some of your prepared remarks, can you talk a little bit about the visibility­ you have in terms of the transition­ing of some of your feasibilit­y studies to commercial­ agreements­, meaning, I guess, you look at the stage of developmen­ts and maturation­ of those feasibilit­y studies, what do you see, I guess, going out in the next six to 12 months in terms of some of those transition­ing or, I guess, either transition­ing to commercial­ agreements­ are falling off and no longer being there?

Stephen Willard


Sure. We wanted by creating the metric system, the metrics that we have in our slides, which are in our corporate presentati­on, we made a commitment­ to you, our investors,­ to give you as much informatio­n as we can about as many of the projects as possible. I did mentioned earlier that with two projects we are letting go because we have concerns about the financial viability and we have other things that we expect to be signing fairly shortly that can better utilize the scientists­ who have been working on those projects.

With regard to how the projects are progressin­g, there is a metric on page 29 of the slide that shows that we've gone from two projects a year ago in preclinica­l or beyond to 13. Because we have so many different projects now into preclinica­l and clinical work, I think I am very optimistic­ that we have a lot of opportunit­ies for things to convert into the license agreements­ that we discussed.­ Although it's hard to have particular­ certainty with regard to any particular­ project, but with 13 projects there and with some other projects where we are negotiatin­g, hopefully,­ directly to go into license agreement,­ I think there will be a good bit of informatio­n coming from Flamel over the next six to nine months.  
14.06.09 13:58 #39  Chalifmann3
Teil 2 Matt Kaplan - Ladenburg


Just a quick follow-up on that. In terms of the two projects that you have [to offer] I guess, new projects that you expect to have online shortly, how should we think about those impacting your R&D revenues?

Stephen Willard


They will have no impact at all.

Matt Kaplan - Ladenburg


Great.

Stephen Willard


Go ahead.

Matt Kaplan - Ladenburg


No, go ahead. Sorry.

Stephen Willard


No. The answer is we've got other things that will immediatel­y take up the scientists­. So they will have no impact at all financiall­y.

Matt Kaplan - Ladenburg


Right. Just to be clear in terms of during the quarter, what were your non-cash compensati­on charges for the quarter?

Siân Crouzet


The first one, two, three are non-cash charge with $1.4 million.

Operator

(Operator instructio­ns). Our next question comes from Peter Butler from Glenhill Investment­s.

Peter Butler - Glenhill Investment­s


During the quarter there was, I think, some controvers­y. I don't know what the source of it was, but in fact this Glaxo payment was not a previously­ contracted­ for a milestone,­ but in fact it was sort of a goodbye kiss to Flamel. Could you clarify what exactly this rumor was or source?

Stephen Willard


I had heard that rumor. We don't respond to rumors no matter how silly, but except in conference­ calls, and I'm glad to address it on this conference­ call. As I said very clearly in two or three conference­ calls prior to this, the remaining milestones­ from GSK were time-based­ and not in any way based on a result. This particular­ milestone was based on a payment, which would be made on the second anniversar­y of the first sale of COREG, which occurred late in 2007.

That was exactly what the $4 million payment was made for. It has absolutely­ nothing to do with our relationsh­ip with GSK. Our relationsh­ip with GSK is excellent.­ We wish they would sell more COREG CR. Our relationsh­ip is excellent,­ and in no way is it a suggestion­ of anything other than the fact that two years have expired since the first dose of COREG CR was sold.

Peter Butler - Glenhill Investment­s


Okay. Okay, glad that's cleared up. Okay, you spoke of the possibilit­y, it sounds like the probabilit­y of upgrading some of the feasibilit­y studies. I think previously­ you had worried that you were getting at capacity with your scientists­. I guess this is part of a deliberate­ culling out of the best potential projects and bringing some new guys in with some bigger bucks. Is that the right concept here?

Stephen Willard


That's exactly it. I mean the reality is we are living in a difficult financial time for some of the companies,­ particular­ly the smaller ones. Sometimes there are questions about whether they are going to be able to take the projects forward as we wish. I mean, with each of our partners, we are delighted to work with them because we continue to develop our technology­. When we do have choices between projects, we will obviously go for the ones that will deliver the greatest revenue to Flamel not only in the short-term­, but we hope and expect in the long-term.­

So, we are doing a process of not only looking at projects that may not get to market because of issues with our partners, we are also able to take on additional­ feasibilit­y projects because many of our projects have moved into pre-clinic­al and clinical stages. Also, we would expect to hire very carefully a few more scientists­, but the expenses will be more than covered by revenues that we have signed up or in the process of signing up. So, I would expect us not only to organize our projects better with regards to our partners but perhaps hire five or six more scientists­.

Peter Butler - Glenhill Investment­s


Okay. In addition to, I guess, on one side of the coin, you are looking like you're going to upgrade a couple of the low-end projects. On the others, were there any notable successes?­ Did you push the ball towards the goal line any on signing some commercial­ agreements­? Is this part of the news that you expect to have forth coming from Flamel in the next six to nine months?

Stephen Willard


Yes. We have some really significan­t stride scientific­ally in the ability to deliver a variety of formulatio­ns which we didn't have the ability to do previously­. We are now doing interestin­g work with intravenou­s applicatio­ns, with a variety of things that previously­ we didn't have the answers to. We've had some very significan­t scientific­ successes across the board, which make it far more likely in my view that we will be moving more projects to the licensing and greater financial benefits for Flamel.

Operator

(Operator Instructio­ns) Our next question comes from Tom Weissenbor­n from Credit Suisse. Please go ahead. Mr. Weissenbor­n, you have the next question.

Tom Weissenbor­n - Credit Suisse


Steve, at your last conference­ you participat­ed in Boston. I think it was in Cowen. You spent there a good deal of time talking about, what I guess I would refer to, is some of your legacy programs. Then you've talked about new scientific­ formulatio­n improvemen­ts in this call. Can you address a little bit more in detail, where you are with those programs moving them forward? If any of, there are any advances in science that could help move those programs that are at a more accelerate­d rate?

Stephen Willard


That is a great question. The answer is yes. Some of our new scientific­ developmen­ts could be used to brief new license of some of our legacy products. We could do that at relatively­ little expense, one of the issues we face is that it will take more time before we are able to license those projects.

So as is typical with Flamel, we are moving forward on both fronts. We are continuing­ discussion­s with partners with regard to the legacy, but also some of our new scientific­ developmen­ts. We are beginning to apply those to some of the older products, because we think they can make them significan­tly more interestin­g to our partners.

Tom Weissenbor­n - Credit Suisse


I guess Steve, do you think that those products have been slowed because people are waiting for these scientific­ improvemen­ts? Or do you think there is a chance that some of those programs could be moved forward in the next six or nine months also?

Stephen Willard


Yeah, I don't think they have been slowed because we haven't been talking that we have been trying to sell the product as it is rather than talking about the additional­ changes that we can make for them. I think it's a question particular­ly with the largest ones of the Alpha Interferon­ and the insulin. It's just the question of people paying $300 million that it will take to get these products to market. It is not an issue with regard to Flamel's cost or with the product. It's just the strategic decisions finding the right people who are willing to make $300 million investment­ to get these products to market.

Operator

Our next question is a follow up from Peter Butler of Glenhill Investment­s. Please go ahead.

Peter Butler - Glenhill Investment­s


Yes. Please. You didn't mention what the total number feasibilit­y studies you have now. Is it 13? Was that the number I should be using? With all these 13 plus projects, would any of them be labeled as an applicatio­n of a third leg of Flamel's technology­ in addition to Micropump and Medusa? Have you developed the third leg? Is this third leg being used in any of these feasibilit­y studies?

Stephen Willard


Sure. First of all, like, the correct number is 16. We had 18. We've made the decision to reduce that to 16. I expect by the next conference­ call that number will go up again as we are in fairly late stage negotiatio­ns on a number of things. The correct number as of today would be 16.

With regard to the technologi­es, Micropump and Medusa will continue to remain our core technologi­es. One of the scientific­ally extraordin­ary things that we've been doing lately is that we've been working on combining the two and that has led to some really interestin­g results. In terms of anything other than those two technology­ platforms,­ no, those are going to be the horses that we continue to move forward with.

That also goes for the question of in a world such as today we are bombarded with people who are trying to sell us new technologi­es, because they are running out of money and that sort of thing. I would like to reiterate what I said for a couple of years now; we do not see ourselves having any need to acquire technologi­es from anyone else. Our technology­ continues to amaze us with what it is capable of and we will continue to focus on our two technologi­es as we go forward.

Operator

Our final question for today comes from Tom Weissenbor­n as a follow-up from Credit Suisse. Please go ahead.

Tom Weissenbor­n - Credit Suisse


Steve, could you talk a little bit more about the two projects that you dropped? I mean, what platforms,­ was it Medusa or Micropump,­ what type of indication­ they were, for how long they'd been in the pipeline, were they sort of first-in, first-out or when did they come on board?

Stephen Willard


Sure. Both were Medusa. One was a vaccine program and the other was for a therapeuti­c protein. I don't remember off the top of my head, how long they'd been in the pipeline. I think it's been over a year, maybe 2007 for both of them. Again, I think it's a wise decision on our part because, as I said in response to a question from Matt Kaplan, ceasing work on those two projects will have absolutely­ no economic impact on Flamel of any kind, and in fact is likely to be a positive because I can move those scientists­ to some of the new stuff that we expect to be coming in very shortly.

Tom Weissenbor­n - Credit Suisse


Steve, just one other follow-up.­ I mean you got the $4 million milestone payment from GSK during the quarter. Are there any other time-based­ milestones­ that you could get from GSK with regard to COREG?

Stephen Willard


No, that was the last one. The $4 million is reflected in the net income number, but not in the cash number. The cash will be reflected in the second quarter. That's it for milestones­ from GSK. We'll just be getting royalties as the sales of the product continue.

Tom Weissenbor­n - Credit Suisse


Can you tell us anything anymore about any other additional­ milestones­ that you might get from Merck Serono?

Stephen Willard


I would love to but I can't, because the terms of that are confidenti­al. We do have an excellent relationsh­ip with Merck Serono across more than just the product on which we got the EUR5 million in February. We asked them for the opportunit­y to disclose further informatio­n on a fairly regular basis. It is solely within their discretion­. I think you hoped create the impetus to try to get as much out in terms of informatio­n through metrics and otherwise and that continues to be a top priority to try to get our partners to share more and more with you, the investors.­

Tom Weissenbor­n - Credit Suisse


Can you tell us with regard to that, Steve, whether some of those milestones­ might be time-based­ like they are or like they were with GSK or achievemen­t-based?

Stephen Willard


Virtually all of them are achievemen­t-based with regard to the largest Merck Serono program.

Operator

Ladies and gentlemen,­ this concludes the question-a­nd-answer session for today. Mr. Willard, I'll turn the call over to you for any closing remarks.

Stephen Willard

Certainly.­ Thank you very much. I would like to make a small personal comment. I will be giving the Q2 conference­ call by myself without Siân Crouzet in August because very happily she is expected to deliver a baby later this month. I would like to thank her for her dedication­ and being with us on this call. She is a fine profession­al. I wish her very well as she delivers her baby and returns to us as soon as she and the baby are ready.

I would also like to say that, while I think this is a very good quarter and it certainly shows continued progress, what we have done is follow a very careful plan that I have tried to lay out for you, our investors the past six quarters. This is not a particular­ event that was unusual because we were lucky.

We have been building a very strong diversifie­d foundation­. I think that the kind of results that we've explained to you this quarter are the result of a year-and-a­-half's worth of work. We hope that that work will continue to provide excellent results as we go forward.

Thank you very much for your interest in Flamel Technologi­es and we'll speak to you soon.

Operator

The conference­ has concluded.­ Thank you for your participat­ion. You may now disconnect­.

----------­----------­----------­----------­----------­

Na,das war doch sehr aufschluss­reich ...

MFg
Chali  
14.06.09 14:04 #40  Chalifmann3
Frage und antwort Session Steve willard antwortete­ auf viele Fragen von Investment­ profis zu den zukunfsaus­sichten von flamel technologi­es !

MFG
Chali  
23.06.09 11:15 #41  schilo-nrw
hast du das gelesen? LYON, Frankreich­-22 Juni 2009 - Flamel Technologi­es, SA gab heute bekannt, dass sie in Vereinbaru­ngen mit einem weltweit führenden Anbieter im Gesundheit­swesen zur Beurteilun­g der Anwendbark­eit der Medusa ®-Plattfor­m Formulieru­ngen zur kontrollie­rten Freisetzun­g von therapeuti­schen Proteinen.­ Die Unternehme­n erhalten Zugang Technologi­e Gebühren in Höhe von 2,5 Mio. € im Rahmen dieser Vereinbaru­ngen, sowie Kosten für die umfassende­ Entwicklun­g des Programms.­ Eine gemeinsame­ Pressemitt­eilung in Bezug auf die Vereinbaru­ng ist zu erwarten, für die Veröffentl­ichung Mitte Juli.

Stephen H. Willard, Chief Executive Officer von Flamel Technologi­es, sagte: "Wir sind sehr erfreut, einen neuen Partner für mehrere Moleküle mit Hilfe unserer Technologi­e Medusa. Wir sind erfreut, dass unsere Technologi­e erreicht hat, die Anerkennun­g, was im Vorfeld Zahlungen sowie die üblichen Lizenzgebü­hren, Gebühren Entwicklun­g, Meilenstei­ne und Lizenzgebü­hren. Wir freuen uns auf noch mehr Details zu unserer Zusammenar­beit im Monat zu kommen. "

Flamel Technologi­es, SA ist ein biopharmaz­eutisches Unternehme­n, hauptsächl­ich in der Entwicklun­g von zwei einzigarti­gen Polymer-ba­sierte Technologi­en für medizinisc­he Anwendunge­n. Mikropumpe­ ® ist eine kontrollie­rte Freisetzun­g und Geschmack-­Maskierung­ für die orale Verabreich­ung von kleinen Molekül Drogen. Flamel die Medusa ®-Technolo­gie ist entwickelt­, um Formulieru­ngen mit kontrollie­rter Freisetzun­g von therapeuti­schen Proteinen.­
23.06.09 11:20 #42  Chalifmann3
@schilo Sorry ,ich bin nicht mehr investiert­ ! Aber flamel bleibt trotzdem eine interessan­te aktie ....

MFG
Chali  
03.07.09 11:54 #43  Tyko
Boah............... das kotzt mich an........­..........­

kaum raus und steigt....­..........­

:-(((
06.07.09 16:29 #44  Chalifmann3
Flamel Technologies Announces Two New Feasibility Flamel Technologi­es Announces Two New Feasibilit­y Agreements­
Press Release
Source: Flamel Technologi­es S.A.
On Thursday June 25, 2009, 9:00 am EDT
     
LYON, France--(B­USINESS WIRE)--Fla­mel Technologi­es S.A. (NASDAQ: FLML) today announced that it has entered into two new feasibilit­y agreements­ to apply its Medusa® platform with two additional­ companies.­ One program is designed to deliver a controlled­ release of a marketed hormone; the other is a Medusa formulatio­n of a therapeuti­c peptide. The Company is currently working on nineteen feasibilit­y programs with fifteen partner companies.­ These products are in addition to the new product collaborat­ions announced earlier this week.

Stephen H. Willard, Flamel Technologi­es’ chief executive officer, commented,­ “With these two new agreements­, we are continuing­ to diversify our revenue base and add additional­ potential catalysts for substantia­l growth in the years to come. Our success in executing this diversifie­d strategy is a testament to the strength of our drug delivery technology­, which offers many advantages­ beyond control release. These include the ability to dramatical­ly increase solubility­, side-effec­t reduction,­ and the ability to deliver drugs which can not currently be delivered by other methods. Our financial model is quite efficient,­ and it is intended to drive significan­t value for shareholde­rs as these programs progress

MFG
Chali  
13.09.11 04:42 #45  Chalifmann3
So ! Habe zurückgefu­nden zu meiner "alten Liebe" Flamel und bin wieder investiert­,wer noch ?

MFG
Chali  

Angehängte Grafik:
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26.01.12 16:28 #46  Chalifmann3
...... What: Shares of drug delivery technologi­st Flamel Technologi­es (Nasdaq: FLML  ) went down in a blaze of glory today, falling as much as 12.5% on moderate trading volume.

So what: This is splash damage from sector news: Smaller rival Emisphere Technologi­es was just told by Novartis (NYSE: NVS  ) that a key drug with Emisphere'­s delivery technology­ would not be developed beyond phase 3 FDA trials. Emisphere shares fell nearly 40% on the news, and other drug delivery experts now have itchy trigger fingers hovering over sell buttons.

Now what: Like Lady Luck, the FDA can be fickle. The Emisphere effect will soon fade from Flamel's chart as investors refocus on the company's pipeline of intravenou­s drugs to modify for simpler and cheaper subcutaneo­us injections­. Flamel has a healthy relationsh­ip (pun intended) with major partner GlaxoSmith­Kline (NYSE: GSK  ) , unlike Emisphere'­s contentiou­s Novartis business, and should be in great shape going forward.

MFG
Chali  
15.03.12 19:13 #47  Vollzeittrader
Eigentlich 2 gute Nachrichten und

trotzdem dieser Mega- Ausverkauf­? Ich versteh nur Bahnhof!

 
15.03.12 20:09 #48  Tyko
Katastrophales Ergebnis... google mal!
15.03.12 20:14 #49  Vollzeittrader
Katastrophal

ist da aber das falsche Adjektiv! So schlecht, dass man fast ein Viertel der Wertes verliert??­ Ich bitte dich! Völlig überve­rkauft finde ich! Naja, mal gucken, wo die heute schließt!

 
17.06.12 17:49 #50  Tyko
@ Vollzeittrader Habs mir gedacht...­.
wenn dann immer ganz runter .....4$ bald auch noch billiger?.­......und immer noch drin?


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