1. SPPI has over a $200 million annual run rate based on Q4 14.
2. SPPI is valued lower than all other biotechs with equal or greater revenues.
3. SPPI is cash flow breakeven from an operations standpoint (excluding one-time charges) as evidenced by the non-GAAP financials.
4. SPPI has an NDA filed for CE Melphalan and has indicated that it intends to file an NDA for Apaz in 2H 15.
5. SPI-2012 will be beginning Phase 3 this year and is for a $5 to $6 Billion plus market and Phase 2 indicated it is a bioequivalent if not superior.
6. The HANMI breast cancer drug P Phase 1 indicated exceptional results and is also in a blockbuster market.
7. APAZ is in the bladder cancer area which has not had a new drug approved in approximately 40 years.
8. APAZ has been estimated to have peak revenues of approximately $200 million or more.
9. SPPI has about $130 million plus in cash on had.
10. SPPI has Orphan Drug exclusivity for Fusilev for colorectal cancer until April 2018.
11. SPI-1620 s another potential blockbuster for SPPI.
12. SPPI owns 20% of CASI which is opening the China market for SPPI's drugs and CASI also owns all rights to a liver cancer drug which has a blockbuster potential in its own right.
13. SPPI has a strong relationship with HANMI in Korea as well as several Japan companies.
14. SPPI has offices in India and Japan as well as the United States.
15. SPPI management is lase focused on expanding the Company's global footprint. A Genzyme in the making.
racemic leucovorin injection VS. FUSILEV. If equivalent, why all the "generic" attempts to still try to INFRINGE on FUSILEV. Why?
Because: They are NOT equivalent. Facts speak for themselves. Raj was right. They have shet racemic drug and feed it to poor hospital patients.
Not worried at all. Just enjoying the intellectual chess match watching and analyzing how one third of all issued and outstanding shares can be purchased to cover by Shorts who need 20 million shares. If I were on the management team, I would lay the cord wood and cut them off at their knees. I am sure SPPI will when the time comes. Revenues and blockbusters will take care of that.
Update on the D.C. District Court case:
Sandoz and the shorts “have their hands completely full” on this front as well. Next week on May 18th is the Hearing on both the Preliminary Injunction request by SPPI and the trial on the Merits of the Case.
Sandoz had requested an extension of time for the May 18th Hearing date (i.e. delay, delay, delay) based upon, among other things, Sandoz’s purported need to go through over 2000 pages of FDA correspondence related to the matter. Spectrum opposed the Motion and attached a “Proposed Order Denying the Motion”.
The Judge not only ruled in SPPI’s favor but also used the "exact" Order Form proposed by SPPI and merely struck through the word “Proposed” and filed it. I would also like to point out that SPPI has an “All Ivy League and All Female” Litigation Team in this case which appears to be awesome. Their backgrounds are extremely impressive and their written briefs and motions are equally persuasive and impressive.
If Sandoz loses this case, it effectively should only be able to sell 50 mg vials of Fusilev which is limited to the dosage for the 1% bone cancer market and NOT the 175 mg and 250 mg dosages required for the Colorectal Cancer Orphan Drug exclusivity market. Thus, if SPPI wins this case one would think that SPPI’s Fusilev revenues may remain largely unimpaired until May 2018 regardless of the final outcome of the Patent case.
It may only get worse for the shorts. And soon.
1. Cash Increases Up to $144 million;
2. Positive Cash flow generating above operating expenses;
3. Revenues continue to increase quarter over quarter;
4. CE Melph NDA is upcoming before year-end which means before 12.15 due to Holidays;
5. SPI-2012 must be "the real deal".
6. SGA expenses down.
7. On prowl for more drug opportunities.
You think SPPI is going to announce earnings in NEW YORK during Trading Hours and bring in a panel of third party experts, including one of the leading bladder cancer experts in the World, to explain APAZ, SPI-2012 and the rest of the pipeline, business development and multi-billion dollar market opportunities if it is not off the chart positive?
No, you actually just confirmed that you are who I knew you were. A complete idiot.
1. The Federal Circuit Appeal ruling will be NEXT YEAR. The Federal Circuit Court of Appeals generally takes approximately 10.5 months on average to rule on any appeals. So sit tight until 2016 unless expedited by the parties in which case it could be earlier.
2. The only upcoming decision is SPPI's request for a temporary injunction.
3. SPPI has orphan drug status on colorectal cancer until April 2018. Not sure exactly how Sandoz can make and sell into that market at all without infringing. Good luck on that. Oh I know, Docs will just "out of thin air" prescribe for it off label without Sandoz doing anything. LMAO
4. Fusilev has had generic competition for years and still sales by SPPI are $100 million. Sandoz' proposed version is unstable anyway.
5. Don't talk before you know what you are talking about.
Spectrum just held a 2 hour Analysts Day with Four World Level Physicians to review Spectrum's pipeline opportunities along with the Company's Financials.
Not sure what you guys want. Ridiculous! eom
Agree 100%. In fact, even if Sandoz took $30 million of the Fusilev revenues that is really no material in the big picture with the Billion dollar blockbusters in play all of which are serious gamechangers including Apaz which is probably a $200 million plus annual revenue generator if approved. Multiple shots on goal with big result opportunities.
Another future acquisition by SPPI to expand its China footprint in the march to become another Genzyme. Gain 19/9% now with royalties and board presence. Let CASI begin the expansion of drugs to China. SPPI retains all of its cash for its own Pipeline development.
If and when the time is right, roll CASI up into SPPI.
Thank you. Very informative as to SPPI’s comparative metrics. I would appreciate your general thoughts regarding the following. Assume that:
1. Current Revenues. SPPI has an existing approximate $200 million run rate in 2015 and that the Fusilev patent is upheld or revenues are otherwise unimpaired in any significant way due to clinic contracts, orphan drug exclusivity etc.
2. CE Melphalan. Assume CE Melph is approved by the FDA in late 2015 and that it will add around $100 million of additional revenues within a reasonable period thereafter together with other drug expansions and indications such as Marqibo, Belinostat etc. resulting in an overall SPPI $300 million revenue run rate on the near horizon.
3. SPI-2012. SPPI announces the SPI-2012 data in May 2015 and the data clearly indicates that SPI-2012 is at least a Bioequivalent and may be a Biobetter in the $5 to $6 billion market.
What would a Reasonable type valuation range be for SPPI at that point during 2016 with $300 million to presumably a $1 Billion Revenue run rate on the horizon with the shortened SPI -2012 Phase III period?
Of course, this is without Apaziquone and the rest of the Pipeline.
Institutional ownership is continuing to increase. Most of the note holders and institutions who are short are, in fact, long shareholders in reality.
Thus, I would expect that at some point in the future there will come a day when SPPI's PPS is comparable to other similarly situated biotech companies which have market caps of 8 to 20 times Revenues?
I know you believe that there will be a significant reversal. However, when this occurs do you also expect that whatever SPPI's revenue and pipeline profile may be, that SPPI's valuation will also be in line with other biotech's too?
17. Two potential Blockbusters with P in Phase II and SPI 2012 in Phase III upcoming this summer.
18. Seeking flexible repayment approval to repay noteholders in cash at June 2015 annual meeting.
19. Presently expanding marketing staff and hiring.
20. Appeal of Nevada patent decision on Fusilev to Federal Appeals Court. Docketed 3.3.15 Generally approximately 10.5 months unless expedited by parties' request.
21. SPPI has TRO on any Sandoz sales in interim and has requested Injunction which should be announced anytime. SPPI generally needs to establish (i) reasonably likely to prevail on appeal and (ii) irreparable harm which cannot reasonably be satisfied with monetary damages from Sandoz. SPPI has Orphan Drug Exclusivity until 2018 for colorectal cancer.
imo, will continue Increasing year after year after year until BOOM, BOOM. $1 Billion +++++
2015 will exceed 2014.
2016 will exceed 2015
2017 will exceed 2016
Watch and learn. Do your own dd. Then, BOOM, BOOM, BOOM.
A little over 5 weeks ago. Iome, get a grip. I hope you find happiness in life. Another analysts day will be in 6 months or a year. That is customary.
Management is focused on generating revenues and building the pipeline rather than giving you a Kleenex every time you sneeze.
"GCSF SPI-2012 is the hidden gem in Spectrum pipeline from data analysis of medical and biopharmaceuticals experts. The genuine concerns of Sandoz Pharmaceuticals’ legal victory over Spectrum to commercialize its generic version of levleucovorin (Fusilev) is a non-issue in the grand scheme of things.
The aforesaid court decision will not make dent, comparing to the real pressure Fusilev has been facing with generic leucovorin for years: That is the real threat not Sandoz.
The unlocked-gargantuan value of Spectrum resides in its developing pipeline’s GCSF SPI-2012 rather than Fusilev.
Prudent corporate action in advancing global Phase 3 development program for its novel and powerful drug GCSF, SPI-2012: The firm correspondingly met with the EMA and FDA in in October and December last year.
Field research and data analysis revealed that GCSF SPI-2012 is highly likely to become a powerful oncology blockbuster, to cut into market shares of Neulasta.
Despite genuine concerns regarding Fusilev and pricing pressure from generic leucovorin, Spectrum is still posting earnings increase."
The proper answer is “Thank you Joe for your valuable information. Very helpful.” Once again, you speak before you do any due diligence and have no clue as to what you are talking about.
There a multiple lawsuits. I will ignore the Delaware cases for now. The primary cases are as follows:
1. Patent Case – Federal Circuit Court of Appeals.
The Nevada District Court ruled the patents were invalid. That decision has been appealed to the Federal Circuit which hears all patent appeals. As RAJ accurately stated, the hearing is in August.
2. Orphan Drug Case – DC District Court.
Sandoz is using 175 mg and 250 mg vials which are the Colorectal Cancer dosages even though SPPI has orphan drug exclusivity until May 2018. Bone cancer is all Sandoz is entitled to market Fusilev for and only requires 50 mg dosages. Thus, Sandoz is “back dooring” Spectrum’s statutory rights. This is a huge case. As I accurately stated, the hearing is May 18th.
You are welcome. Next time, do your own due diligence.
The only Facts that MATTER are present facts. History almost 2 years ago is basically irrelevant, just like the NASDAQ at 5000 over a Decade ago or the NIKKEI over 40,000 in 1980. Kind of completely irrelevant to say the least.
Present Facts are:
1. SPPI wearing out upro and S&P since 7/31.
2. Piddly stupid 2 x's EXISTING Revenues.
3. CE Melph NDA any moment which should add $100 Million in Revenues with Belenodaq.
4. SPI-2012 is a Potential Blockbuster in a $6 Billion Market with Data to be released in early 2015 from Phase II after Phase III starts right away.
5. APAZ NDA in early 2015 for Bladder Cancer where no new drugs have been developed in over 20 years.
6. 14 drug DEEP Pipeline with multiple blockbuster potentials.
7. Over $100 Million in Cash.
8. Owns 20% of CASI and now starting to develop China market. Laying the foundation.
9. Breakeven on Non-GAAP earnings and cash flow from operations today.
ETC. ETC. Those are CURRENT FACTS.
Annual Revenues will likely Exceed Fusilev's annual revenues and, together with Beleodaq, take SPPI to a $300 million/year annual revenue run rate. A NEW RECORD.
2012 was $267 million. With CE Melphalan, SPPI should move to a New Record of approximately $300 Million per Year and WITH:
Home Run Batters upcoming subject to approval,
1. Apaz - $200 to $300 million annually;
2. SPI-2012 - $600 to $1.5 Billion annually depending on whether Bioequivalent OR Biobetter; and
3. SPI-1620 - Billion(s) as directs blood flow to tumors to enhance positive responses from cancer drug treatments and reduces adverse toxicity on other organs.
Please give my $10 to shortshet. He threw a "hissy fit" this week and had his panties in a wad and needs a few replacements. Does not like everyone to know that he is who we thought he was.
Bought another 10,000 shares yesterday. imho, a Ridiculous buying opportunity. Happy Holidays to all!