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That's why he is not your boss.
So I was off by a few bucks. My bad.
It was only between 20-40 then
My jackass boss told everyone in 2018 to buy this at 50. Thanks god I didn’t.
New SoS post:
* * $PTLA Video Chart 01-10-2020 * *
Link to Video - click here to watch the technical chart video
PTLA -40% on soft 4Q19 Andexxa sales—consistent with yesterday’s AH session (#msg-153217853).
Why such a steep selloff? 4Q19 Andexxa sales of $28M were down 15% from 3Q19, and investors evidently aren’t buying these excuses in the PR:
A disappointing quarter!
Q4 2019 revenue are disappointing!
News: $PTLA Portola Pharmaceuticals Presents New Interim Data from Ongoing Phase 2a Study of its Oral SYK/JAK Inhibitor Cerdulatinib in Heavily Pre-Treated T-Cell Malignancies
SOUTH SAN FRANCISCO, Calif. , Dec. 8, 2019 /PRNewswire/ -- Portola Pharmaceuticals, Inc. ® (Nasdaq: PTLA) today announced new interim results from the Company's ongoing Phase 2a study of cerdulatinib, an investigational, oral SYK/JAK inhibitor, in patients with specific subtype...
Got this from PTLA - Portola Pharmaceuticals Presents New Interim Data from Ongoing Phase 2a Study of its Oral SYK/JAK Inhibitor Cerdulatinib in Heavily Pre-Treated T-Cell Malignancies
Updated Smith on Stocks Projection
https://smithonstocks.com/portola-detailed-spreadsheet-projecting-sales-and-earnings-through-4q-2021-ptla-buy-28-00/
Given this previous projections (which was fairly close to actual), I look at his numbers with some level of confidence.
Best of luck in your investments!
LOL re the Bevyxxa sales figure.
Smith on Stock August projection is close to the actual numbers.
https://smithonstocks.com/portola-andexxa-looks-to-be-a-blockbuster-ptla-30-00-buy/
SoS for Q3 2019: $34M
Actual Q3 2019: $36M
Q3 2019: $36.8M v. $14.2 M Q3 2018!
This includes $35.7 million in net product revenues from sales of Andexxa/Ondexxya [coagulation factor Xa (recombinant), inactivated-zhzo], $17,000 in revenues from Bevyxxa® (betrixaban) sales and $1.1 million in collaboration and license revenues.
EPS beats by $0.34, beats on revenue
Portola Pharmaceuticals (NASDAQ:PTLA):
* Q3 Non-GAAP EPS of -$0.53 beats by $0.34;
* GAAP EPS of -$0.68 beats by $0.20.
* Revenue of $36.8M (+159.2% Y/Y) beats by $2.16M.
https://seekingalpha.com/news/3514823-portola-pharmaceuticals-eps-beats-0_34-beats-revenue
That continues the positive trend on Andexxa and the balance sheet looks better.
Sales have started, but they're rather anemic.
How could we miss with this company? Sales have started, the US and EU. Revs growing and growing. Possible to be tested and used against ALL the thinners and not just two.
Ptla has gone lazy as of late...good earnings..good news...slow on sales numbers...sideways we travel. GLTA Here.
Nice, late on a Friday news! Monday will be volumous. Get your tickets punched early...imo. GLTA
Europe conditional Marketing Authorization for Ondexxya™
https://seekingalpha.com/pr/17490076-european-commission-grants-conditional-marketing-authorization-portola-pharmaceuticals
Buying oppurtunity? Slow drift on no news. Almost May....Glta.
Slow steady accumulation with modest rise past three weeks. May just around the corner. Possible inflection point. Imo, GLTA
Solid value for the PPS action today.
This looks like a good reaction by the Market to the CHMP nod.
Best of luck with your investments!
I agree ACTcrazy.
They have had a really good run, and given they had a positive nod and that it would be the first and only "specific reversal agent available in Europe to address life-threatening bleeding associated with the use of apixaban or rivaroxaban", I expect a CHMP approval.
Best of luck with your investments!
If all goes well in May...clear the launch pad. IMO
Thanks ACTcrazy :)
For now, a positive opinion from the CHMP!
https://seekingalpha.com/pr/17429923-european-chmp-adopts-positive-opinion-ondexxya-andexanet-alfa-portola-pharmaceuticals-factor
CHMP Aproval to market Let's call this a Gap up day. GLTA
Maybe in the morning? The time has come
I don't see any news on the CHMP decision. Do you guys?
Best of luck in your investments!
Feb 28 coming up!
investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=2380212
SoS on Andexxa ANNEX4-A Study:
https://smithonstocks.com/portola-nejm-report-on-positive-results-in-annexa-4-study-is-a-significant-positive-ptla-buy-28-89/
Best of luck with your investments!
Hi NOLA70124,
I don't look at the Short shares. For me, the focus is on the Gen 2 and the ability to move products to, at first, the 600 Tier 1 hospitals which are targeted because of their specific "Level I or Level II trauma centers or have Comprehensive Stroke designation."
When we get there, Mister Market will start to take notice.
And the 900 Tier 2 will be a great addition.
It's all about execution and sales now.
Best of luck in your investments!
H2R - There were ~17M shares short as of end of November. How do you view this short interest?
Up %14 on an above average 2.5M shares today. I think things will kick up in in January and then the sales numbers will do the talking.
Happy New Year 2019!
PTLA will target a large number of hospitals
Now that the PAS is approved, the CC comments can be taken more seriously.
"PAS" APPROVED !
http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsArticle&ID=2381753
Trading halt on pending news...
https://seekingalpha.com/news/3419790-trading-halt-portola-pharmaceuticals
Today is the PDUFA date... Wondering how it will fly.
Best of luck to investors!
PTLA getting ready for the PDUFA - December 31, 2018 for Prior Approval Supplement (PAS)-:
AMAG acquires Perosphere Pharmaceuticals—owner of FXa antidote in development:
#msg-145422756
PR from PTLA:
http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=2380212
Well, CHMP chickened out. No pop, but some questions that will take until February to decide. Most disapointing is no comments from the company.
I would not be surprised if there is an early approval.
A couple of notes from the CC:
On Finances:
"Importantly, as a result of our change in focus to prioritize Andexxa, we've been able to extend our cash runway into the first half of 2020."
On Andexxa adoption:
" We estimate that more than 4 million people in the United States are currently taking a Factor Xa inhibitor, and we expect that number to continue to grow at strong double-digit rates."
"We believe the success we are having in getting formulary approvals, orders and reorders is setting us up nicely for the anticipated launch of Gen 2 in early 2019."
"While our focus is on the Andexxa U.S. market, we continue to assess our European launch strategy as we approach the CHMP opinion date."
On PAS:
"we are on track for the December 31, 2018 PDUFA data for the anticipated approval of our Andexxa Gen 2 manufacturing process. In fact, we just received notification from the FDA that the PAS was deemed okay to file."
From the Q&A on targets:
" The tier 1 or our first set of targets are about 600 U.S. hospitals are Level I or Level II trauma centers or have Comprehensive Stroke designation. So those are the biggest institutions across the country. The next tier of about 900 additional accounts, additional hospitals were the Advanced Stroke Center designation."
Overall a very good CC in my opinion.
It will take time for the PPS to move, but it will move once revenue start pouring in.
From the PR
The key for me is the end of year PAS Date: December 31, 2018 and getting set up for the launch in 2019.
So far, it looks like the target is still relevant (and of course I'm hoping for a positive outcome). Financials are OK in view of that launch.
Third Quarter 2018 Financial Results
Total revenue for the third quarter of 2018 was $14.2 million, compared with $3.8 million for the third quarter of 2017. This includes $7.7 million in product revenue for our first full quarter of Andexxa sales and $7.0 million in collaboration and license revenues. Bevyxxa product orders remained relatively flat in the third quarter, during which we recognized a net product loss for Bevyxxa of $552 thousand. This adjustment was primarily related to potential returns of initial launch quantities provided to wholesalers.
Total operating expenses for the third quarter of 2018 were $83.3 million, compared with $84.3 million for the same period in 2017. Total operating expenses for the third quarter of 2018 included $11.4 million in stock-based compensation expense, compared with $10.1 million for the same period in 2017.
Research and development expenses were $40.2 million for the third quarter of 2018, compared with $55.3 million for the third quarter of 2017. The decrease is driven primarily by the timing of manufacturing costs for Andexxa Generation 2 campaigns. Approximately $12 million, or 30 percent, of R&D expense for the quarter and $75 million, or 45 percent, for nine months year-to-date of total R&D expense was related to Andexxa manufacturing.
Selling, general and administrative expenses for the third quarter of 2018 were $38.8 million, compared with $28.9 million for the same period in 2017, reflecting the investment in our field force and marketing for our product launches.
For the third quarter of 2018, Portola reported a net loss of $71.3 million, or $1.08 net loss per share, compared with a net loss of $82.9 million, or $1.41 net loss per share, for the same period in 2017.
Cash, cash equivalents and investments at September 30, 2018 totaled $380.9 million, compared with $534.2 million as of December 31, 2017.
2018 Annual Financial Guidance
For the fiscal year 2018, Portola is updating its guidance for GAAP operating expenses, which are now expected to be between $355 million and $365 million, a decrease from the prior guidance range of between $390 million and $430 million, both including stock-based compensation. The updated guidance reflects the Company’s narrowed focus on a group of key hospitals for the Bevyxxa launch, as well as additional cost savings for the year.
Recent Achievements and Events
Appointed industry veteran Scott Garland as president and chief executive officer.
Submitted Prior Approval Supplement (PAS) to U.S. FDA for large-scale Generation 2 Andexxa manufacturing process; assigned a PDUFA date of December 31, 2018.
Transitioned commercial focus to the ongoing Andexxa U.S. launch under the Early Supply Program.
Secured New Technology Add-on Payment (NTAP) for Andexxa, which became effective as of October 1, 2018.
Implemented new strategy for Bevyxxa U.S. launch focused on establishing 10 Centers of Excellence to provide a model for driving broader adoption.
Received Orphan Drug Designation from the U.S. FDA for cerdulatinib for the treatment of peripheral T-cell lymphoma.
Eight abstracts presented at the European Society of Cardiology (ESC) meeting.
Upcoming Milestones
Anticipated broad launch of Andexxa upon U.S. FDA approval of Generation 2 supply.
Committee for Medicinal Products for Human Use (CHMP) opinion on andexanet alfa, with potential for European approval of andexanet alfa in the first half of 2019.
End-of-Phase 2 meeting and determination of regulatory path forward for cerdulatinib in Q1 2019.
New interim Phase 2a study results for cerdulatinib to be presented in an oral session at the 60th American Society of Hematology (ASH) Annual Meeting. Also accepted for presentation: outcomes-based research on the burden of hospital readmissions for venous thromboembolism among patients with cancer (oral) and two poster presentations on andexanet alfa.
was this a key day?
I think the FDA had till today to comment on the application for the Gen 2
Drug.
I don't see any comments from the company on this.
Cerdulatinib Orphan Drug Designation
http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsArticle&ID=2368929
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