Neues von TRIBY - 500 Beiträge pro Seite

[Scarlett]

Gute Nachrichten sind für den Rest des Jahes gesichert:

Neue Produkte bei TRIBY

Product Estimated Completion

CAPTIA™ Measles IgM ELISA 2nd Quarter 2000

CAPTIA™ Mumps IgM ELISA 2nd Quarter 2000

CAPTIA™ VZV IgM ELISA 2nd Quarter 2000

Uni-Gold™ Strep A POC rapid test 3rd Quarter 2000

CAPTIA™ Cancer Marker ELISA range 3rd Quarter 2000

Uni-Gold™ Chlamydia rapid test 4th Quarter 2000

CAPTIA™ Syphilis total antibody ELISA 4th Quarter 2000

http://www.trinitybiotech.com/randd.htm


Und für drei Produkte läuft das Zulassungsverfahren bei der
FDA in Amiland:

The following products have been submitted to the FDA:


UniGold™ HIV peptide Rapid Assay

CAPTIA™ ENA Profile EIA

CAPTIA™ Mycoplasma IgM EIA

Scarlett

[börsenfüxlein]

hi scarlett!

weißt du näheres über das zulassungsverfahren in den usa? zB wann die entscheidung über eine möglich zulassung/nichtzulassen der Produkte fällt?

einsichimvorhineinbedankendes
börsenfüxlein

[Scarlett]

Die FDA entscheidet auf der Grundlage der Ergebnisse von klinischen Studien, die dann von einem Gutachtergremium bewertet werden. Dabei wird auch in Betracht gezogen, ob genügend hohe Fortschritte gegenüber bereits im Markt etablierten Produkten erzielt werden.

Problematisch ist, dass die FDA, wie überhaupt alle Ami-Zulassungsstellen, die Zulassung nicht-amerikanischer Produkte nach Möglichkeit verzögert. Damit soll verhindert werden, dass sich ausländische Produkte im Ami-Markt gegenüber Ami-Produkten einen Vorsprung sichern. Da die Ami-Konkurrenz natürlich alle Zulassungsverfahren genau verfolgt, weiss sie genau. wenn ein Ausländer ein gutes Produkt ins Zulassungsverfahren bringt und kann dann noch entwicklungsmäßig reagieren.

Das ist auch eine Gefahr für TRIBY und ich denke, dass die Acquisition von US-Gesellschaften auch von der Überlegung getragen ist, in Zukunft eine Zulassung von einem amerikanischen Unternehmen aus zu starten.

Für den speichelbasierten schnellen HIV-Test von TRIBY sehe ich allerdings keine Gefahr aus einer verzögerten Zulassung.

Übrigens: Goodbody, der einzige Ami-Broker, der TRIBY verfolgt, schätzt das Q1-Ergebnis auf 0.055/share. Ich glaube eher an 0.06. Der CEO von TRIBY hat nämlich gesagt, die jüngste US-Aqcuisition wird bereits jetzt zum Gewinnwachstum von TRIBY beitragen. Kommt 0.06, so wäre das 100% über dem Q1-Ergebnis von 1999.

Die anderen Firmen in dem Sektor freuen sich, wenn ihr Verlust nicht
von -0.055 auf -0.06 oder 7 oder 8 zunimmt.

Scarlett

[Scarlett]

Keine schöne Nachricht. Dürfte Zzulassung des HIV-Tests verzögern.

TRIBY HIV test kits submitted to the FDA as of 3/3/00 are being held up do to misbranding under section 510k.
Kit samples I252748A, I252749, I252760 & I252761 are the ones on detention.
510k states that a notice or other information respecting the device was not provided to FDA, as required and the device was not found to be substantially equivalent to a predicate device.

Scarlett

[Scarlett]

Achtung, das Q1 von TRIBY ist da!

Trinity Biotech Announces Record First Quarter Profits
DUBLIN, Ireland, April 27 /PRNewswire/ -- Trinity Biotech plc (Nasdaq: TRIBY - news) today announced record results for the first quarter ended March 31, 2000.

Ronan O`Caoimh, Trinity Biotech`s Chairman and CEO, commented, ``Last quarter Trinity increased its product offering and broadened its reach in the diagnostics market place. We added these products through new FDA clearances like that for our Uni-Gold(TM) H.pylori test and the Macra® Lp(a) test, as well new technologies like the Western blot tests for detection of Lyme disease, when we acquired MarDx.`` O`Caoimh continued, ``In addition, Trinity has put itself in a strong position to take advantage of the opportunity available to it in the diagnostic market through the raising of $13 million with blue-chip Irish and UK institutional investors.``

Net profit rose 55% to US$1.401 million or $0.045 cents per share for the first quarter fiscal 2000, compared to a net profit of US$902,000 or $0.032 cents per share for the first quarter of 1999 representing earnings per share growth of 41%.

Earnings before interest, tax, depreciation and amortisation (EBITDA) rose 36% to US$1.915 million for the first quarter fiscal 2000 compared to US$1.407 million for the same period in fiscal 1999. Revenues increased by 8% from US$6.35 million for the quarter ended March 31, 1999 to US$6.85 million for first quarter of 2000.

Commenting on the results, Jonathan O`Connell, Chief Financial Officer, said, ``We are very pleased to start the new year with such a strong set of results for the first quarter. The Company continues to significantly increase its net profits, which rose 55% in the quarter to US$1.4 million. While the acquisition of MarDx had a minimal impact in the first quarter, it will contribute fully for the remaining quarters of 2000. The cash flows were also strong with EBITDA growing to US$1.9 million in the quarter. These funds generated from operations along with the US$13 million raised by the recent placing of shares puts Trinity in a healthy financial position.``

Trinity Biotech plc develops, manufactures and markets over 100 diagnostic products for the point of care, self-testing and clinical laboratory market segments of the diagnostic market. Trinity sells worldwide in over 75 countries through 130 international distributors and strategic partners.

Forward-looking statements in this release are made pursuant to the ``safe harbor`` provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialisation and technological difficulties, and other risks detailed in the Company`s periodic reports filed with the Securities and Exchange Commission.

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

Die Ergebnissteigerung ist nicht so hoch wie ich sie erwartet hatte.
Aber welcher andere Biotech-Wert bewegt sich schon in diesen Ergebnisregionen!

Scarlett

[Kappo]

Was sollte an diesen Zahlen zu bemängeln sein????????
Ich denke solche Zahlen sind mehr Wert als eine Kaufempfehlung.

[börsenfüxlein]

hallo zusammen!

gleich einmal ein dankeschön an scarlett für deine infos bezüglich FDA zulassung.

wenn man sich die zahlen einiger biotechwerte ansieht und sie denen tribys vergleicht, so sind die zahlen sensationell zu bewerten. dazu kommt das die marktkapitalisierung von triby noch sehr gering ist.

für mich ein klasklarer kauf auf diesem niveau. (bin leider zu hoch eingestiegen)

mfg
börsenfüxlein

[Scarlett]

Vielleicht hat einer von euch zeit und lust, sich das am dienstag mal anzuhören und dann hier darüber zu berichten.
Ich hab leider keine Zeit.

Trinity Biotech PIc will broadcast its quarterly earnings conference call on Tuesday, May 2, 2000 at 11:00 AM EDT. This call can be accessed at http://www.vcall.com/NASApp/VCall/EventPage?ID=18377

Scarlett

[mahatma]

heute kommt ein schöner Bericht bei juchu.de
klick doch mal rein !!!!
http://www.juchu.de/biotech/archiv/trinity/triby_7-00.htm

viel Spaß beim lesen

maha

[Scarlett]

Danke, mahatma!

Alles in der Beurteilung so, wie ich auch denke.
Aber leider, leider: Ein Unternehmen kann noch so gut sein, wenn es sich nicht um die Aktionäre und die Finanzmärkte kümmert, wird der Kurs nicht in die Gänge kommen. Hier sind nur die Naturwissenschaftler und Mediziner am Werk, aber keine gewieften Finanzleute.
Ich wart noch ein paar Monate ab, wenn sich dann immer noch nichts getan hat, bin ich weg.
Eigentlich schade! es gibt kaum was Besseres in Biotech.

Scarlett

[Balim]

Sehr gut gesprochen Scarlett !
mfg balim

[mahatma]

Hier der US-Chart:
(ich finde er sieht gut aus , ja sogar seehhhrrr guuuttttt !!!!
beide Indikatoren toll, da tut sich was nach oben hin)

maha

[Ines40]

http://quotes.nasdaq-amex.com/quote.dll?page=afterhours&mode…


after houres quotes ...

[Ines40]

Monday July 17, 10:21 am Eastern Time
Trinity Bio welcomes FDA product status
DUBLIN, July 17 (Reuters) - Irish clinical products company Trinity Biotech said on Monday the U.S. Food and Drug Administration (FDA) had given waived status to its Uni-Gold H Pylori test for use in the diagnosis of peptic ulcer disease.

``The categorisation of Trinity`s Uni-Gold H Pylori test to waived status ensures (the) product can be sold to virtually all physicians offices in the United States,`` Trinity said in a statement.

The test enables the rapid assessment of patients presenting the symptoms of gastric or duodenal ulcers and is a quick, efficient and inexpensive alternative to invasive endoscopy procedures, it added.

Trinity develops, manufactures and markets over 100 diagnostic products for the point-of-care, self-testing and clinical laboratory sectors of the diagnostic market in 75 countries worlwide.

[Ines40]

Monday July 17, 9:52 am Eastern Time
Company Press Release
SOURCE: Trinity Biotech plc

Trinity Biotech Receives CLIA-Waived Status For Uni-Gold(TM) H. Pylori Rapid Test

DUBLIN, Ireland, July 17 /PRNewswire/ -- Trinity Biotech plc (Nasdaq: TRIBY - news) today announced that the Centre for Devices and Radiological Health (CDRH) of the Food & Drug Administration (FDA) has completed its review of Trinity`s application for waived status for its Uni-Gold(TM) H. Pylori test. As a result of this review, the Trinity Uni-Gold(TM) H. Pylori test has received waived status. This waived status allows most physicians to perform the test at the point-of-care using whole blood samples.

Trinity Biotech`s Uni-Gold(TM) H. Pylori test screens for the presence of IgG antibodies to the bacterium Helicobacter Pylori (H. Pylori). H. Pylori is believed to be the causative agent in over 90% of Duodenal Ulcers, 70% of Gastric Ulcer and 60% of Gastric Cancers, and is recognized worldwide as the leading cause of Peptic Ulcer Disease.

Estimates from the Centre for Disease Control and Prevention (CDC) indicate that 25 million Americans have had a Peptic Ulcer during their lifetime, and international infection rates can exceed 80%, especially in Asia and Latin America.

Trinity Biotech`s Uni-Gold(TM) H. Pylori test facilitates the rapid assessment of patients presenting with the symptoms with Gastric or Duodenal Ulcers. It is a quick, efficient and inexpensive alternative to Endoscopy, which is invasive and requires a specialist to administer.

Trinity`s test is simple to perform and is extremely cost effective, and brings the diagnosis to the immediate point-of-care environment, thus allowing not only for diagnosis of H. Pylori infection, but also of the immediate initiation of therapy.

Brendan Farrell, Trinity Biotech`s President commented, ``The categorization of Trinity`s Uni-Gold(TM) H. Pylori test to waived status ensures that Trinity`s product can be sold to virtually all physicians offices in the United States. Uni-Gold(TM) H. Pylori adds to Trinity`s increasing range of one-step tests for the point-of-care (POC) and self-test (OTC) markets. The Uni-Gold(TM) product range includes tests for HCG, HIV, Strep A and Hepatitis B.``

Trinity Biotech develops, manufactures and markets over 100 diagnostic products for the point-of-care, self-testing and clinical laboratory segments of the diagnostic market. Trinity sells worldwide in over 75 countries, through more than 130 international distributors and strategic partners.

Forward looking statements in this release are made pursuant to the ``safe harbor`` provision of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialisation and technological difficulties, and other risks detailed in the Company`s periodic reports filed with the Securities and Exchange Commission.

For more information, please contact: investors, Mark Alvino, 212-698-1360, [e-mail], or media, Kari Rinkeviczie, 616-647-0780, [e-mail], both of Allen & Caron Inc., for Trinity Biotech plc; or Brendan K. Farrell of Trinity Biotech plc, 800-603-8076, [e-mail].

SOURCE: Trinity Biotech plc

[Falke99]

Hallo

News von Triby - interessiert dies jemanden?

Der Aktienkurs jedenfalls scheint mehr oder weniger gleichzubleiben, News hin oder her. Ich habe mich
vor einiger Zeit für Triby entschieden, weil es sich um eine kleine aber feine Firma mit guten
Wachstumsraten handelt. Gute neue Produkte sind in der Pipeline, aber ich frage mich wirklich:
Interessiert dies jemanden????

Ich warte auch die morgigen Quartalszahlen und hoffe, dass der Aktienkurs dann wenigstens um 5 % nach
oben geht.

Gruss
Falke99

[Ines40]

hallo falke,

der korrekte termin für die veröffentlichung der quartalszahlen ist der 26. Juli

Servus
Ines

[Ines40]

HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
BLOOD PRODUCTS ADVISORY COMMITTEE SIXTY-SIXTH MEETING
VOLUME I
Thursday, June 15, 2000
8:00 a.m.
Holiday Inn 8777 Georgia Avenue
Silver Spring, Maryland

Excerpts.....

FDA has been taking action to facilitate approval of rapid HIV tests. These actions include maintaining an ongoing dialogue with sponsors.

http://www.ragingbull.altavista.com/mboard/boards.cgi?board=…

[Ines40]

PHILADELPHIA--(BUSINESS WIRE)--July 25, 2000--TheStreet.com, Inc.
(Nasdaq: TSCM.O), Trinity Biotech Plc. (Nasdaq: TRIBY.O), Nanophase
Technologies Corporation (Nasdaq: NANX.O), autobytel.com inc.
(Nasdaq: ABTL.O), and ViewCast.com, Inc. (Nasdaq: VCST.O) will broadcast
their investor communication conference calls over the Internet,
Investor Broadcast Network announced.
TheStreet.com, Inc. will broadcast its quarterly results
conference call on Thursday, July 27, 2000 at 11:00 AM Eastern. This
call can be accessed at
http://www.vcall.com/NASApp/VCall/EventPage?ID=25047." target="_blank" rel="nofollow ugc noopener">http://www.vcall.com/NASApp/VCall/EventPage?ID=25047.
Trinity Biotech Plc. will broadcast its quarterly results
conference call on Thursday, July 27, 2000 at 12:00 PM Eastern. This
call can be accessed at
http://www.vcall.com/NASApp/VCall/EventPage?ID=29565." target="_blank" rel="nofollow ugc noopener">http://www.vcall.com/NASApp/VCall/EventPage?ID=29565.
Nanophase Technologies Corporation will broadcast its quarterly
results conference call on Thursday, July 27, 2000 at 11:00 AM
Eastern. This call can be accessed at
http://www.vcall.com/NASApp/VCall/EventPage?ID=25443." target="_blank" rel="nofollow ugc noopener">http://www.vcall.com/NASApp/VCall/EventPage?ID=25443.
autobytel.com inc. will broadcast its quarterly results conference
call on Thursday, July 27, 2000 at 4:30 PM Eastern. This call can be
accessed at http://www.vcall.com/NASApp/VCall/EventPage?ID=29122." target="_blank" rel="nofollow ugc noopener">http://www.vcall.com/NASApp/VCall/EventPage?ID=29122.
ViewCast.com, Inc. will broadcast its quarterly results conference
call on Thursday, July 27, 2000 at 5:00 PM Eastern. This call can be
accessed at http://www.vcall.com/NASApp/VCall/EventPage?ID=28241." target="_blank" rel="nofollow ugc noopener">http://www.vcall.com/NASApp/VCall/EventPage?ID=28241.
These events are available through Investor Broadcast Network`s
Vcall website, located at http://www.vcall.com. Listeners should go to
the website at least fifteen minutes before these events to register,
download, and install any necessary audio software. For those unable
to attend the live broadcast, a replay will be available beginning
approximately one hour after the event.
There is no charge to access any event.

[Ines40]

QUARTALSZAHLEN II - TRIBY


Wednesday July 26, 7:32 am Eastern Time
Company Press Release
SOURCE: Trinity Biotech plc
Trinity Biotech Announces 45% Increase in Second Quarter Profit to US$1.6M And 14% Revenue Growth to US$7.4M
DUBLIN, Ireland, July 26 /PRNewswire/ -- Trinity Biotech plc (Nasdaq: TRIBY - news) today announced results for the three and six months ended June 30, 2000.

Net profit rose 45% to US$1,602,000 for the second quarter ended June 30, 2000 compared to US$1,105,000 for the same period last year. Revenues grew by 14% to US$7,401,000 for the second quarter compared to US$6,502,000 for the same period last year.

During the second quarter over 5.0m new shares were issued as a result of both the capital raising exercise in April and the exercise of conversion rights by a debenture holder. As a result, earnings per share rose at a slower rate of 9% to 4.3 cents per share for the second quarter compared to 3.9 cents per share for the same period last year.

Net profit for the six months ended June 30, 2000 rose 50% to US$3,003,000 compared to US$2,008,000 for the same period last year. Revenues rose 11% to US$14,251,000 for the six month ended June 30, 2000 compared to US$12,852,000 for the same period last year. Earnings per share rose 21% to 8.7 cents per share for the six months ended June 30, 2000 compared to 7.1 cents per share for the same period last year.

Commenting on the results, Maurice Hickey, Chief Financial Officer, said ``Trinity Biotech continues to grow net profits which increased this quarter to US$1,602,000, while cash flows were also strong with EBITDA for the quarter of US$1,953,000. Selling, general and administrative expenses increased to US$1,078,000 compared to US$756,000 in the same quarter last year as a result of both the MarDx acquisition and additional investment in the sales and marketing area. As at June 30, 2000 Trinity Biotech had a strong balance sheet with cash balances of US$10,945,000 and bank debt of US$4,950,000. Furthermore, deferred consideration relating to previous acquisitions has now been repaid.``

Ronan O`Caoimh, C.E.O. commented, ``The second quarter of 2000 produced a solid trading performance during which we focused on the integration of MarDx, the California based Western Blot Business, which is trading well. We received FDA approval for both our new ENA profile test and CLIA-waived status for Uni-Gold(TM) H. Pylori rapid test. During the quarter we completed a fundraising of US$13.4m, part of which will be invested in direct sales operations in our key European markets. The Company is now well financed and strongly positioned to pursue growth both organically and through acquisition.``

Trinity Biotech develops, manufactures and markets over 100 diagnostic products for the point-of-care, self-testing and clinical laboratory segments of the diagnostic market. Trinity sells worldwide in over 75 countries, through more than 130 international distributors and strategic partners.

Forward looking statements in this release are made pursuant to the ``safe harbor`` provision of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialisation and technological difficulties, and other risks detailed in the Company`s periodic reports filed with the Securities and Exchange Commission.

CONTACT: Mark Alvino (investors), 212-698-1360, [e-mail], or Kari Rinkeviczie (media), 616-647-0780, [e-mail], both of Allen & Caron Inc., for Trinity Biotech plc; or Maurice Hickey of Trinity Biotech plc, 353-1-276-9800, [e-mail].


Trinity Biotech plc
Consolidated Statement of Operations

(US$000`s except share data)

Three Months Three Months Six Months Six Months
Ended Ended Ended Ended
June 30, June 30, June 30, June 30,
2000 1999 2000 1999
(Unaudited) (Unaudited) (Unaudited) (Unaudited)

Revenues 7,401 6,502 14,251 12,852

Cost of goods sold (3,731) (3,711) (7,257) (7,556)

3,670 2,791 6,994 5,296

Research and
development (807) (575) (1,535) (1,093)
Selling, general
& administrative
expenses (1,078) (756) (1,940) (1,483)
Amortisation (214) (200) (439) (400)

Operating profit 1,571 1,260 3,080 2,320

Interest and
other income 158 21 190 39
Interest expense (127) (176) (267) (351)

Net profit 1,602 1,105 3,003 2,008

Earnings per
ordinary share
(in cents) 4.3 3.9 8.7 7.1

Weighted average
number of
ordinary shares
outstanding 37,540,961 28,172,724 34,706,102 28,078,920

Earnings before
interest, tax,
depreciation and
amortisation
(EBITDA) 1,953 1,620 3,830 3,027


Trinity Biotech plc
Consolidated Balance Sheet

30 June 2000 31 December 1999
(Unaudited) (Audited)
US$000`s US$000`s
FIXED ASSETS
Intangible assets 24,239 20,559
Tangible assets 4,639 4,696

28,878 25,255
CURRENT ASSETS
Inventories 10,240 9,511
Debtors and prepayments 7,860 7,212
Cash at bank 10,945 3,064

29,045 19,787

CREDITORS (Amounts falling
due within one year) (7,807) (14,234)

NET CURRENT ASSETS 21,238 5,553

TOTAL ASSETS LESS CURRENT LIABILITIES 50,116 30,808

CREDITORS (Amounts falling due
after more than one year) (6,411) (8,086)

43,705 22,722

CAPITAL AND RESERVES
Called up share capital
Class `A` Ordinary shares 527 448
Class `B` Ordinary shares 12 12
Share premium account 65,583 47,864
Currency adjustment (4,685) (4,637)
Profit and loss reserve (17,732) (20,965)

Shareholders` funds -
(all equity interests) 43,705 22,722

SOURCE: Trinity Biotech plc

[mahatma]

Kommentar von juchu:

Damit unterstreicht das Unternehmen seinen Wachstumskurs. Wie bereits in unserer Analyse zu
Trinity Biotech ausgeführt, sehen wir einmal mehr eine deutliche Unterbewertung von Trinity. Mittel-
bis langfristig sollte dies durch deutlich höhere Notierungen ausgeglichen werden.
nachzulesen unter http://www.juchu.de/newsflash/biotech/news/juli-2000/trinity…

gruß maha