Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 24)

[VaJo]

Ja ich bin wieder dabei mit ein paar. So ganz ohne SPPI kann ich auch nicht sein

[vanville]

Antwort auf Beitrag Nr.: 49.321.394 von VaJo am 13.03.15 14:06:51

Hi Vajo,

schön das du da bist. Aber du hast doch nur noch 100 Stück? Also was interessierts dich noch? Na ja man kann ja bei den preisen vermutlich wieder einsteigen....?

Ich kenne mich mit business nicht aus. Was ist aussagekräftiger GAAP oder nonGAAP? Angeblich die mitte zwischen den beiden. Wenn nichts getürkt ist sind die zahlen jedenfalls akzeptabel.

Mich würde interessieren was ville zu den Eoquin Daten sagt. Jetzt scheint auf einmal (?, hatte ich zumindest noch nicht mitbekommen) ein 30-90 min. window after turbt aufgetaucht zu sein? in dem es wirksam scheint, welches genutzt werden muss. Das würde erklären warum die multi insti trials gestoppt wurden, da >90 min. wirkungslos. Die neue Studie wird dann wohl genau das definieren. Sieht somit für mich nicht mehr ganz so trostlos aus.

Ville????

Vanville

[VaJo]

HENDERSON, Nev. (AP) _ Spectrum Pharmaceuticals Inc. (SPPI) on Friday reported a loss of $3 million in its fourth quarter.

On a per-share basis, the Henderson, Nevada-based company said it had a loss of 5 cents. Earnings, adjusted for amortization costs and stock option expense, were 9 cents per share.

The results exceeded Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 17 cents per share.

Ah noch kein positive Cash flow aber verdammt nah dran

[VaJo]

SPPI is cash flow positive. Sehe ich das richtig?

[VaJo]

Antwort auf Beitrag Nr.: 49.320.395 von VaJo am 13.03.15 12:37:21

Three-Month Period Ended December 31, 2014 (All numbers are approximate)
GAAP Results
Total revenues were $51.9 million and product sales were $51.7 million in the fourth quarter of 2014. Total revenue increased 25% from $41.5 million in the fourth quarter of 2013, while product sales increased 28% from $40.5 million in the fourth quarter of 2013.
Product sales in the fourth quarter included: FUSILEV ® (levoleucovorin) net sales of $30 million, FOLOTYN ® (pralatrexate injection) net sales of $12.2 million, ZEVALIN ® (ibritumomab tiuxetan) net sales of $5 million, MARQIBO ® (vinCRIStine sulfate LIPOSOME injection) net sales of $1.6 million and BELEODAQ ® (belinostat) for Injection nets sales of $2.9 million.
Spectrum recorded net loss of $3.0 million, or ($0.05) per basic and diluted share in the three-month period ended December 31, 2014, compared to net loss of $39.4 million, or ($0.63) per basic and diluted share in the comparable period in 2013. Total research and development expenses were $14.4 million in the quarter, as compared to $10.8 million in the same period in 2013. Selling, general and administrative expenses were $24.5 million in the quarter, compared to $25.7 million in the same period in 2013.
Non-GAAP Results
Spectrum recorded non-GAAP net income of $7.5 million, or $0.12 per basic share and $0.09 per diluted share in the three-month period ended December 31, 2014, compared to non-GAAP net income of $3.5 million, or $0.06 per basic share and $0.05 per diluted share in the comparable period in 2013. Non-GAAP research and development adjustments were $0.4 million, as compared to $0.5 million in the same period of 2013. Non-GAAP selling, general and administrative adjustments were $3.1 million, as compared to $4.3 million in the same period in 2013.
Twelve-Month Period Ended December 31, 2014 (All numbers are Approximate)
GAAP Results
Consolidated revenue of $186.8 million for the twelve-month period ending December 31, 2014 was comprised of product sales of $186.5 million and $0.3 million from license fees and service revenue.

11500 S. Eastern Ave., Ste. 240 — Henderson, Nevada 89052 — Tel: [phone] — Fax: [phone] — www.sppirx.com — NASDAQ: SPPI
LOGO

Product sales in 2014 were comprised of: FUSILEV ® sales of $105.6 million, FOLOTYN ® sales of $47.5 million, ZEVALIN ® sales of $22.2 million, Marqibo ® sales of $6.3 million and BELEODAQ ® sales of $4.9 million.
The Company recorded net loss of $45.7 million, or ($0.71) per basic and diluted share in the twelve-month period ended December 31, 2014, compared to net loss of $62.1 million, or ($1.02) per basic and diluted share in 2013. Total research and development expenses were $69.7 million in 2014, as compared to $46.7 million in 2013. Selling, general and administrative expenses were $97.4 million in 2014, compared to $99.3 million in 2013.The Company had cash and equivalents and marketable securities of an aggregate $133.2 million as of December 31, 2014.
Non-GAAP Results
The Company recorded non-GAAP net income of $21.4 million, or $0.33 per basic share and $0.27 per diluted share in the twelve-month period ended December 31, 2014, compared to net loss of $5.6 million, or ($0.09) per basic and diluted share in the same period in 2013. Non-GAAP research and development adjustments were $19.6 million, as compared to $2.1 million in the same period of 2013. Non-GAAP selling, general and administrative adjustments were $12.5 million, as compared to $19.3 million in the same period of 2013.

[VaJo]

Spectrum Pharmaceuticals Reports Robust Clinical Data and Strong 2014
Financial Results
Development Highlights: 2 Near-term NDA’s and 2 Potential Blockbusters

• SPI-2012, a novel long-acting GCSF, demonstrated non-inferiority to pegfilgrastim at the 135 µg/kg dose (p= 0.002), and superiority at the 270 µg/kg dose (p= 0.023) in a randomized Phase 2 Study. Phase 3 protocols are being finalized following productive meetings with regulatory agencies in the US and Europe.

• Poziotinib, a novel pan-HER inhibitor, showed promising Phase 1 data (ORR= 60%) in heavily pretreated breast cancer patients who had failed multiple other HER2-directed therapies.

• Captisol-Enabled™ Melphalan , a propylene-glycol free formulation with improved stability, accepted for NDA review by FDA with a PDUFA action date of October 23, 2015.

• Apaziquone , a potent tumor-activated pro-drug for non-muscle invasive bladder cancer, showed statistically significant results in a post-hoc subgroup analysis of two Phase 3 studies (p=0.001); Company plans NDA submission this year.
Financial Highlights: Strong Growth in Sales and Non-GAAP Earnings

• Total product sales for the year ended December 31, 2014 were $186.5 million, a 30% increase year over year.

• Total product sales for the three months ended December 31, 2014 were $51.7 million.

• Non-GAAP diluted EPS was $0.09, and GAAP EPS was ($0.05) during the three months ended December 31, 2014.
HENDERSON, Nevada – March 13, 2015 – Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today financial results for the three-month period and year ended December 31, 2014.
“2014 was a strong year of revenue and non-GAAP earnings growth, and we now have one of the strongest pipelines in Spectrum’s history,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “SPI-2012, our lead drug being investigated for the treatment of neutropenia targets a blockbuster market and has shown impressive Phase 2 data which we are sharing at our Analyst Day today. We have recently acquired Poziotinib, a novel Pan-HER inhibitor that has shown promising efficacy in breast cancer patients who had failed multiple HER2 agents

11500 S. Eastern Ave., Ste. 240 — Henderson, Nevada 89052 — Tel: [phone] — Fax: [phone] — www.sppirx.com — NASDAQ: SPPI
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in Phase 1 studies. We believe this drug has the potential to be best in class. Further, we expect an FDA decision on our next hematology drug CE-Melphalan in October, and we expect to file an NDA for Apaziquone later this year. I am excited about the tremendous progress at Spectrum which has positioned us well for long-term growth.”

[vanville]

Antwort auf Beitrag Nr.: 49.251.605 von Ville7 am 05.03.15 17:29:58

Hallo Ville,

So langsam versteh ich aber dein "engagement" auf yahoo auch nicht mehr. Du verschwendest mit dem Zirkus wirklich nur deine Zeit! Oder du gehörst wirklich dazu, als bezahlter?

Ich mache das hier nur nebenbei aus Spass. Bist du berufsmässiger Investor?

Versteh ich nicht mehr....

Eigentlich geht es um Fakten, dafür schätze ich dich um die zu diskutieren....

Die Kindereien da drüben tue ich mir nicht an.

Vanville

[Ville7]

Antwort auf Beitrag Nr.: 49.249.997 von vanville am 05.03.15 15:42:38

Du siehst da m.E. schon richtig, vanville.

[vanville]

Poziotinib

Eigentlich sind die FGFR Inhibitoren sehr interessant. Versteh nur nicht warum Hanmi HM61713 vorantreibt (???, eigentlich sinnlos) und dann POZ verkauft obwohl poz auch die resistenzmutationen binden soll. POZ könnte auch überlegen sein da es auch auf die anderen zwei Her Rezeptoren bindet, Wenn auch nur schwach an Her4.

Das ist irgendwie fishi.

Big Pharma schmeisst sowas halt gleich in 20 P2 Studien und schaut wo sich was tut. Das kann SPPI sich nicht leisten.

Sieht somit wie Würfeln aus....., aber mal sehen was die Pozi P2s sagen....

Meinungen dazu???

[vanville]

Antwort auf Beitrag Nr.: 49.166.651 von VaJo am 25.02.15 06:47:26

H.C. Wainwright Remains Positive On Spectrum Pharmaceuticals Following Unfavorable Patent Ruling

February 23, 2015 2:35 PM EDT by Ben Mahaney, Editor in Healthcare • Insights

In a research report released Monday, H.C. Wainwright analyst Reni Benjamin reiterated a Buy rating on Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) with a $15 price target, after the US District Court in Nevada ruled last Friday that the levoleucovorin formulation used by Sandoz Inc. (private), does not infringe on Spectrum’s Fusilev intellectual property (IP), and effectively invalidated key IP covering Fusilev’s composition of matter.

Benjamin wrote, “While the company is planning to appeal the decision, in our opinion, the ruling is a clear disappointment for investors because it could accelerate the entry of generic competition. However, we remind investors that Fusilev is still protected by orphan drug exclusivity until 2018 as a treatment for patients with colorectal cancer (CRC). Even though the osteosarcoma orphan exclusivity is set to expire next month, we believe that the combination of a citizen’s petition filed to the FDA, the challenges of launching at risk during the appeal process, CRC exclusivity described above, and the strong relationships the company has been able to secure with hospitals and community physicians should keep Fusilev revenues protected into 2018.”

Therefore, “We continue to project approximately $97 MM in Fusilev sales for 2015 and remind investors that Spectrum boasts a broad portfolio, with CE-melphalan potentially joining the company’s list of marketed oncology products including Fusilev, Folotyn, Marqibo, Zevalin, and Beleodaq later this year. With a diverse pipeline of assets in clinical development, and approximately $141 MM in cash (pro forma), we believe Spectrum remains an undervalued player with significant upside for the long-term investor.”

According to TipRanks.com, which tracks and ranks over 3,500 financial analysts to gauge the performance of their past recommendations, analyst Reni Benjamin has a total average return of 2.7% and a 39.8% success rate. Benjamin has a -4.1% average return when recommending SPPI, and is ranked #1500 out of 3480 analysts.