[TrendVestor]

That's why he is not your boss.

[NYCPuglet]

So I was off by a few bucks. My bad.

[europtiger]

It was only between 20-40 then

[NYCPuglet]

My jackass boss told everyone in 2018 to buy this at 50. Thanks god I didn’t.

[H2R]

New SoS post:

On the conference call, management did not do a good job of explaining either the return issue or the decrease in utilization in tier one accounts. They seemed to have put the call together hastily and perhaps they are still trying to figure out what went on in the fourth quarter. At this point in time, I don’t feel that I have a good sense of the 4Q issues and how they can be addressed and I don’t know if the impact is just a one quarter phenomenon or has implications for a meaningful part of 2020. There have been continual concerns among analysts that Andexxa sales in 2019 were importantly influenced by inventory building and not actual demand. The 4Q results support this hypothesis.

I think that many investors will take a wait and see attitude on Portola until they can gain a better understanding of the 4Q issues and/or upcoming quarterly results give a meaningful indication that Andexxa sales are on track for a major increase in 2020. This might take one or more quarters of encouraging sales gains. My intuition is to add significantly now to my position, but before doing that I would like to hear what Portola management will have to say on a conference call scheduled for 10:00 AM on Tuesday January 14, 2020. I would hope for a clearer explanation of what went on in the 4Q.

More at https://smithonstocks.com/portola-my-investment-thinking-after-the-sharp-price-drop-ptla-buy-14-85/

Best of luck with your investments!

[ClayTrader]

* * $PTLA Video Chart 01-10-2020 * *

Link to Video - click here to watch the technical chart video

[DewDiligence]

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:

Fourth quarter Andexxa net sales in the U.S. were impacted primarily by two factors:

• A $5 million gross to net adjustment due to a return reserve for short-dated product. The Company expects this to be mitigated going forward by its current longer-dated, 36-month product, which began shipping in November 2019.

• Flat quarter over quarter demand due to a decrease in utilization, primarily in tier 1 accounts. While physician demand remains strong, the Company believes that in certain of these accounts, hospital pharmacies curtailed use of Andexxa following drug utilization reviews in an effort to manage pharmacy budgets. Following this reduction, re-ordering patterns are stabilizing in many of these accounts.

Even without the adjustment in the first bullet item, 4Q19 sales would’ve been only flat vs 3Q19—and well short of prior guidance.

[H2R]

A disappointing quarter!

Q4 2019 revenue are disappointing!

Q4 Andexxa/Ondexxya sales will be ~$32M.

Global 2019 revenues should be ~$111M, 17% below consensus of $134M.

https://seekingalpha.com/news/3530833-portola-down-39-after-hours-on-weak-q4


The Yahoo! Finance analysts expectations:
* Q4 2019: $43M
* 2019: $131M

https://finance.yahoo.com/quote/PTLA/analysis?p=PTLA

That bites. The market reaction was to be expected, maybe not that big of a correction though, but still.

Best of luck in your investments!

[whytestocks]

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

[H2R]

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!

[DewDiligence]

LOL re the Bevyxxa sales figure.

[H2R]

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

[H2R]

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.

[H2R]

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.

- Andexxa Now Stocked in Approximately 550 U.S. Hospitals; 76% of U.S. Sales from Reorders -
- Expanded Market Opportunity with Strong Initial Ondexxya Demand in Europe -
- Strengthened Balance Sheet; Added Net Proceeds of $245 million in Third Quarter -

A good quarter.

[DewDiligence]

Sales have started, but they're rather anemic.

[heyyou2]

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.

[ACTcrazy]

Ptla has gone lazy as of late...good earnings..good news...slow on sales numbers...sideways we travel. GLTA Here.

[ACTcrazy]

Nice, late on a Friday news! Monday will be volumous. Get your tickets punched early...imo. GLTA

[H2R]

Europe conditional Marketing Authorization for Ondexxya™

https://seekingalpha.com/pr/17490076-european-commission-grants-conditional-marketing-authorization-portola-pharmaceuticals

– Major Advance in the Treatment of European Factor Xa Inhibitor Patients Hospitalized with Life-Threatening Bleeding –

– Initial Launch in Select Countries to Begin 2H 2019 –

SOUTH SAN FRANCISCO, Calif., April 26, 2019 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (PTLA)® (Nasdaq: PTLA) today announced that the European Commission (EC) has granted conditional Marketing Authorization for Ondexxya™ (andexanet alfa). Ondexxya is the first and only antidote approved in Europe for adult patients treated with the Factor Xa inhibitor apixaban or rivaroxaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

“The medical community has been eagerly anticipating the approval of Ondexxya and the ability to rapidly reverse the anticoagulating effects of rivaroxaban or apixaban,” said Jan Beyer-Westendorf, M.D., Head of the Thrombosis Research Unit, Department of Medicine I; Division Hematology, University Hospital Dresden, Germany. “As the number of European patients prescribed these Factor Xa inhibitors continues to increase, so too does the incidence of hospital admissions related to bleeding. The approval of Ondexxya represents a significant step forward in the treatment of these patients, who previously had no approved treatment option.”

The conditional approval of Ondexxya was based on data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A) that evaluated the safety and efficacy of Ondexxya in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban or apixaban in healthy subjects, and data from the Phase 3b/4 ANNEXA-4 study that evaluated efficacy and safety data from 352 bleeding patients. Results from all three studies were published in The New England Journal of Medicine – ANNEXA-R and ANNEXA-A in 2015, and ANNEXA-4 in February 2019.

“The unmet need for a reversal agent in Europe is significant, as the number of patients taking a Factor Xa inhibitor is nearly double that of the U.S. and continuing to grow at a significant rate. To help ensure we reach as many patients as quickly as possible, our initial launch efforts will be focused on a select group of countries where Factor Xa use is among the highest,” said Scott Garland, Portola’s president and chief executive officer. “We are very proud that, in just one year, we have achieved both U.S. and European approval of this potentially life-saving medicine and look forward to continuing to expand patient access in these countries and beyond.”

The EC grants conditional authorizations to medicines that fulfill a medical need and show a potential benefit to public health, and for which additional data are required by the EC. As part of the conditional approval, Portola will provide the final study reports for both the ANNEXA-4 trial and the randomized controlled clinical trial requested by the U.S. Food and Drug Administration (FDA), as well as additional pharmacokinetic data.

Ondexxya was approved by the FDA in May 2018 and is marketed by Portola in the U.S. under the trade name Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo].

[ACTcrazy]

Buying oppurtunity? Slow drift on no news. Almost May....Glta.

[ACTcrazy]

Slow steady accumulation with modest rise past three weeks. May just around the corner. Possible inflection point. Imo, GLTA

[H2R]

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!

[H2R]

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!

[ACTcrazy]

If all goes well in May...clear the launch pad. IMO

[H2R]

And PTLA beats on revenue!

https://seekingalpha.com/news/3439056-portola-pharmaceuticals-beats-0_07-beats-revenue


and

http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsArticle&ID=2389690

Portola Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update

– Fourth Quarter Andexxa® Revenues of $14.0 Million; Third Consecutive Quarter of Strong Revenues –

– Received Positive CHMP Opinion on Ondexxya™; European Commission Decision Anticipated in Early May –

– Signed $125 Million Loan Agreement with HealthCare Royalty Partners and Athyrium Capital Management –

[...]

Total revenues for the fourth quarter of 2018 were $15.3 million, compared with $9.8 million for the fourth quarter of 2017. This includes $14.0 million in net product revenues from Andexxa sales, $35 thousand in revenues from Bevyxxa® sales and $1.2 million in collaboration and license revenues. Total revenues for the full year 2018 were $40.1 million, compared with $22.5 million for the full year 2017. Please see the tables at the end of this press release for a detailed breakdown of revenues.

They are moving!

[H2R]

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

SOUTH SAN FRANCISCO, Calif., March 01, 2019 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the marketing authorization application (MAA) for Ondexxya™ (andexanet alfa). The Committee has recommended that the European Commission (EC) grant Ondexxya conditional approval for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban or rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.

The MAA will now be reviewed by the EC, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Liechtenstein and Iceland. If approved, Ondexxya 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. The EC is expected to issue a decision in early May 2019.

Best of luck with your investments!

[ACTcrazy]

CHMP Aproval to market Let's call this a Gap up day. GLTA

[ACTcrazy]

Maybe in the morning? The time has come

[H2R]

I don't see any news on the CHMP decision. Do you guys?

Best of luck in your investments!

[H2R]

Feb 28 coming up!

investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=2380212

CHMP Extends Review Period for Portola Pharmaceuticals’ Ondexxya™ (andexanet alfa)
SOUTH SAN FRANCISCO, Calif., Dec. 11, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has extended the review period for the Company’s marketing authorization application (MAA) for Ondexxya™ (andexanet alfa), and cancelled the Oral Explanation scheduled for Wednesday, December 12, 2018. An opinion is now expected by February 28, 2019.

Best of luck with your investments!

[H2R]

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!

[H2R]

Positive Hemostasis in 82 Percent of Evaluable Patients

Portola Pharmaceuticals Announces Full Results from the ANNEXA-4 Study of the Factor Xa Inhibitor Reversal Agent Andexxa® in Patients with Life-Threatening Bleeding

Thu February 7, 2019 4:03 PM|GlobeNewswire|About: PTLA
– Excellent or Good Hemostasis Achieved in 82 Percent of Evaluable Patients –

–Thrombotic Event Rate of 9.7 Percent Across All Patients, No Thrombotic Events Observed Among Patients Who Re-started Oral Anticoagulation Therapy –

– Data Presented as a Late-Breaking Oral Presentation at the International Stroke Conference 2019 and Published in The New England Journal of Medicine –

SOUTH SAN FRANCISCO, Calif., Feb. 07, 2019 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced full results from ANNEXA-4, the Company’s Phase 3b/4 trial of its Factor Xa inhibitor antidote Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo] in patients experiencing acute major bleeding while taking a Factor Xa inhibitor. Data are being presented as a late-breaking oral presentation today at the International Stroke Conference 2019 and published simultaneously online by The New England Journal of Medicine (NEJM).

Full data from 352 patients (249 of which were evaluable for hemostatic efficacy; all 352 were evaluable for safety) showed that Andexxa rapidly and significantly reversed anti-Factor Xa activity when administered as a bolus, and sustained this reversal when followed by a 120-minute infusion. Anti-Factor Xa activity is a measure of the anticoagulant activity of apixaban, rivaroxaban, edoxaban and enoxaparin, the anticoagulants studied in ANNEXA-4. Among all 352 patients, 64 percent (n=227) were treated for intracranial hemorrhage (ICH) and 26 percent (n=90) were treated for a gastrointestinal bleed. Of those evaluated for efficacy 82 percent (n=204) achieved excellent or good hemostasis (stoppage of bleeding) over the 12-hour period following treatment with Andexxa, as determined by an independent adjudication committee.

Within 30 days of enrollment, thrombotic events occurred in 34 patients (9.7 percent) and death occurred in 49 patients (13.9 percent), consistent with previous ANNEXA-4 trial results and with the high background thrombotic risk of the enrolled patient population. The majority of thrombotic events occurred in patients who delayed or did not re-start anticoagulation therapy with a Factor Xa inhibitor during the follow-up period. Among the 100 patients who re-started oral anticoagulation therapy, no thrombotic events were observed. Two patients experienced an infusion reaction and none developed antibodies to Factor Xa or Factor X or neutralizing antibodies to Andexxa.

“The consistency of the hemostatic efficacy and safety – regardless of age, dose, type of Factor Xa inhibitor and type of bleed – confirms the potential of Andexxa to address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban or rivaroxaban,” said Truman J. Milling Jr., M.D., FACEP, Seton Dell Medical School Stroke Institute and ANNEXA-4 Executive Committee member. “We now also have new data demonstrating no observed thrombotic events after resumption of oral anticoagulation. This is a particularly significant finding given the clinical importance of re-initiating therapy as soon as possible, even in the wake of a major bleeding event.”

The worldwide use of Factor Xa inhibitors is rapidly growing because of their efficacy and safety profile compared to warfarin and enoxaparin in preventing and treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism (VTE). This growth has come with a proportional increase in the incidence of hospital admissions and deaths related to bleeding, the major complication of anticoagulation. In the U.S. alone in 2017, there were approximately 140,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding.

“The need for a specific Factor Xa inhibitor reversal agent is clear. As Factor Xa inhibitor use continues to grow, so does the prevalence of life-threatening bleeds such as an ICH, which carries a mortality rate of nearly 50 percent,” said John Curnutte, M.D., Ph.D., head of research and development at Portola. “The consistency of the ANNEXA-4 data, the strong response from the international medical societies that have already added Andexxa to their guidelines and the initial demand following the approval of Andexxa in May 2018 highlight its potential to benefit thousands of patients facing life-threatening bleeding associated with the use of rivaroxaban or apixaban.”

Andexxa received both U.S. Orphan Drug and U.S. Food and Drug Administration (FDA) Breakthrough Therapy designations, and was approved on May 3, 2018 under the FDA's Accelerated Approval pathway. Andexxa is the first and only antidote indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, and it was recently added to the 2019 AHA/ACC/HRS guidelines.

ANNEXA-4 Study Design
ANNEXA-4 is a global, single-arm, open-label clinical trial designed to evaluate andexanet alfa in patients who present with an acute major bleed while receiving apixaban, rivaroxaban, edoxaban or enoxaparin. This multi-center, prospective cohort study was not randomized and all participants received andexanet alfa given as a bolus dose over 20-30 minutes followed by a two-hour (120 minute) infusion. Patients received a low or high dose infusion depending on which Factor Xa inhibitor they received and the time since they received the last dose. Patients were evaluated for 30 days following andexanet alfa administration. The co-primary efficacy endpoints are the maximum percent reduction in anti-Factor Xa activity and assessment of hemostasis over 12 hours following the infusion. Hemostatic efficacy was assessed by an independent endpoint adjudication committee using predetermined criteria as either excellent, good or poor/none. The primary safety endpoints were death, thrombotic events and development of antibodies to Andexxa or to native Factor X and Factor Xa.

[H2R]

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!

[NOLA70124]

H2R - There were ~17M shares short as of end of November. How do you view this short interest?

[H2R]

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!

[H2R]

PTLA will target a large number of hospitals

Now that the PAS is approved, the CC comments can be taken more seriously.

So we expect that to continue next year as we target more accounts. So going into the second part of your question, in terms of the Gen 2 rollout, we're - we have multiple tiers. And we've I think discussed this a little bit previously. 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.

So those are all pretty important accounts for us. And then finally, from what we've seen in the Early Supply Program, we also want to be able to stock affiliates of these accounts too, because oftentimes patients might present to an affiliate account. That's where we want the drug to get started, if they're showing up there. And then they're transferred to the larger account. So we'll be going on next year to target as many as we can.

Scott Garland, CEO

https://seekingalpha.com/article/4219652-portola-pharmaceuticals-ptla-ceo-scott-garland-q3-2018-results-earnings-call-transcript?part=single

This is to pair up with today's PR:

Full Commercial Launch to Begin January 2019

http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsArticle&ID=2381753

I do expect a very good stock performance in 2019