Antares Pharma, Inc. (ATRS)

[gi197845]

If ATRS could break $5, there probably wouldn't be much resistance for a while and no I'm not looking at a chart at the moment.

[TrendTrade2016]

ATRS ready to break 4.98 as the bollie ride continues!!

[TrendTrade2016]

boom ATRS first target approach at 4.98...cant slow this down!!

[H2R]

Got interrupted (you know, work) in the middle of writing my post.
Posted it and saw yours.

Best of luck with your investments mikeslife!

[H2R]

New SoS article after the Jefferies Healthcare Conference

Larry continues to be optimistic about the launch and market share for Xyosted and the EpiPen.

https://smithonstocks.com/antares-pharma-highlights-from-presentation-at-jefferies-healthcare-conference-atrs-buy-4-79/

Interesting info on his blog.

One basic takeaway:

Sales guidance for 2019 has been raised twice over the course of the year. Latest guidance for 2019 is $110 to $120 million. Sales in 2018 were $64 million.

Best of luck with your investments!

[mikeslife]

FYI
https://smithonstocks.com/antares-pharma-highlights-from-presentation-at-jefferies-healthcare-conference-atrs-buy-4-79/

[TrendTrade2016]

shaky shaky....here we go!!

[TrendTrade2016]

gap and run to target...watch the magic!!

[hyperopia]

Thanks, but it's old news - that was from last February. But being stale doesn't make it any less awesome!

[hyperopia]

Yes good news, but the major revenues will be a few years away. At the Jefferies Conference in London, Antares provided a little color on the new partnership, and they believe there is huge potential for this product. There are well established P2Y12 blockbuster products like Plavix and Brillinta already on the market for cronic use but Idorsia’s Selatogrel will be used in an emergency, acute setting at the onset of heart attack symptoms. Although terms haven’t been disclosed, Antares will supply a fully assembled product at cost plus margin, and said the royalty will be similar to their arrangements with their other partnerships which are a single to double-digit royalty on end sales. From a royalty standpoint, it could be very meaningful since the product will address a large, global population. They plan to start a phase 2 crossover (bridging) trial, and if successful, will prepare to supply a very large, global, Phase III study in early 2021. If the product is eventually approved, from a marketing standpoint, it will be the largest product for Antares to date.


This article, makes it sound like the bridging studies may have actually started back in September.

Phase 2 data of selatogrel, Idorsia’s highly-selective P2Y12 receptor antagonist, presented at ESC 2019
September 03, 2019
https://www.globenewswire.com/news-release/2019/09/03/1910237/0/en/Phase-2-data-of-selatogrel-Idorsia-s-highly-selective-P2Y12-receptor-antagonist-presented-at-ESC-2019.html

Guy Braunstein, MD and Head of Idorsia Global Clinical Development, added:
“The Phase 2 data demonstrate that subcutaneous administration of selatogrel 16mg in patients with stable CAD and patients with AMI has a rapid onset of action, within 15 minutes, with the effect extending over 4-8 hours. Based on the speed at which selatogrel takes effect, the duration of that effect, and the safety and tolerability profile, self-administration of selatogrel at the very onset of symptoms of a suspected AMI has potential as a highly innovative approach to AMI management.”
In consultation with health authorities, Idorsia is preparing a large, international, multi-center, Phase 3 study to investigate the efficacy and safety of subcutaneous self-administration of selatogrel for the treatment of a suspected AMI in patients with an history of AMI. Participating patients will be trained on when to inject and instructed on how to self-administer treatment. An integrated drug delivery device is being developed through usability and reliability studies to ensure functional efficacy can be demonstrated ahead of the Phase 3 study.

[TrendTrade2016]

ATRS rock solid trend in place riding the band to 5.31$$$

[ConstitutionNow]

THAT is AWESOME!

[mikeslife]

FYI:
https://thefly.com/landingPageNews.php?id=2868712&headline=ATRS-Antares-Pharma-upside-share-target-raised-to---at-Jefferies

[TrendTrade2016]

BOOM otta the gate...fuc this is strong!!

[TrendTrade2016]

ATRS the weekly is a work of art...a monster bio beast...hang on!!!

[TrendTrade2016]

ATRS riding the bolli like a wild bronco...so sweet!!

[ClayTrader]

* * $ATRS Video Chart 11-20-19 * *

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

[TrendTrade2016]

ATRS target approach. Just lovely.

[TrendTrade2016]

ATRS the trend is your friend

[gi197845]

Hi, I have a few questions and comments.

Based on reading positive articles about Antares, it appears that Antares will be successful for years, due to their current drugs and future FDA approvals.

However, I can't make a prediction and I'm not sure that I've done enough DD.

I like the drugs, the pipeline and the recent events. I like the fact that institutional investors own about 39% of the stock. I don't see any reverse split or stock offerings happening.

It looks like Teva could be going put of business, due to high debt and being sued for opioid addiction. Antares has 2 Teva drugs, pinephrine and Teriparatide.

Q1. If Teva goes out of business, what does that mean for Antares selling Epinephrine and Teriparatide? How does the sales/profit structure work?

Q2. Antares makes the auto-injector, drug delivery mechanism, but not the drug itself, correct?

Q3.What about future lawsuits from Lipocine regarding Xyosted? Are you guys concerned about that, at all?

I'm tempted to make an Antares investment.

Does anyone have any thoughts or comments?

Thank you.

[H2R]

SOS on ATRS: Projections


https://smithonstocks.com/antares-pharmaceuticals-projecting-very-strong-growth-in-xyosted-sales-for-2020-2021-and-2022-atrs-buy-3-89/

Key Points

In my sales and earnings model for 2020, I will be using a working estimate of $53.6 million for sales of Xyosted in 2020.

My working estimate is lower than two alternative scenarios laid out in this report. In Scenario 1, I arrive at a sales estimate of $70.3 million for 2020 and in scenario 2 it is $63.1 million.

My intuition is that the assumptions underlying both Scenarios 1 and 2 are conservative. However, we are at a very early stage in the launch and have only sketchy data so that I have “haircut” my working estimate to $53.6 million.

Quite recently, the consensus Street estimate for 2020 sales was $45 to $50 million.

My working estimate for 2021 sales is $85.8 million and for 2022 is $115.8 million.

[H2R]

Global development agreement with IDORSIA Pharmaceutical LTD.

Novel Drug Device Combination Product To Be Developed For The Treatment Of Suspected Acute Myocardial Infarction

EWING, NJ, November 19, 2019 -- Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) today announced that it has entered into a global agreement with Idorsia Pharmaceuticals Ltd. (“Idorsia”) (SIX: IDIA) to develop a novel, drug-device product combining selatogrel, Idorsia’s potent, fast-acting and highly selective P2Y12 receptor antagonist under development, with the Antares subcutaneous QuickShot® auto injector. Selatogrel, a new chemical entity (NCE), is being developed for the treatment of a suspected acute myocardial infarction (AMI) in adult patients with a history of AMI. Idorsia’s Phase 2 clinical data demonstrated that subcutaneous administration of selatogrel resulted in a potent and rapid platelet inhibition effect in patients with a history of coronary artery disease and AMI. According to Idorsia, the product was safe and well tolerated. Idorsia is now preparing for a clinical bridging study to be followed by a global Phase 3 study of a self-administered QuickShot® auto injector containing selatogrel for the pre-hospital treatment of a suspected acute myocardial infarction.

[...]

Idorsia will pay for the development of the combination product and will be responsible for applying for and obtaining global regulatory approvals for the product. The parties intend to enter into a separate commercial license and supply agreement pursuant to which Antares will provide fully assembled and labelled product to Idorsia at cost plus margin. Idorsia will then be responsible for global commercialization of the product, pending FDA or foreign approval. Antares will be entitled to receive royalties on net sales of the commercial product.

[TrendTrade2016]

ATRS can we see the 4.98 resistance next. Come to papa

[TrendTrade2016]

ATRS an just amazing little beast

[TrendTrade2016]

ATRS. Just a beautiful trend in place here

[TrendTrade2016]

ATRS outta the gate ....watch this beast bio testy play!!!

[TrendTrade2016]

ATRS is gonna be epic!!!

[TrendTrade2016]

ATRS new nasy jazzy beast play!!!

[H2R]

On a solid volume too :)
I agree, the $4 barrier break was good to see and will hopefully turn into support.
Best of luck with your investments!

[hyperopia]

Actually H2R, that’s 2 days in a row. It reached a new 52-week high yesterday at $4, then hit another new high today at $4.20. I said back in March that I expected ATRS to hit many new 52-week highs, but I was beginning to wonder how long it would take. With the accumulation since the 3rd quarter earnings announcement, it has been difficult to keep the price down. Turning the profitability corner was a very important milestone, but it looks like the large volume was waiting to see if Tlando received approval. Breaking the $4 barrier was definitely nice to see!

[H2R]

52 week high reached today.

[gi197845]

FYI, Lipocene's TLando Tbooster pill was rejected a 3rd time, today by the FDA. Thisbodes well for ATRS and its' Tbooster, so enjoy the ride up!

[H2R]

Hi Hyperopia,

Lessons in patience is definitely part of being an investor, especially with regards to biotech companies! Everything takes longer than my most conservative expectations. And yet, the reward is worth it. (At least for this company :)

Best of luck with your investments!

[hyperopia]

Yes, it was an excellent quarter! I have to admit that I was disappointed to hear that Teva expects a 2H 2020 launch for generic Forteo. I was hoping for a catalyst this fall, but all in good time I guess. We're getting a good lesson in patience with our investments huh?

[hyperopia]

Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA

https://www.prnewswire.com/news-releases/lipocine-receives-complete-response-letter-for-tlando-from-us-fda-300955195.html

SALT LAKE CITY, Nov. 11, 2019 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced today that it has received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for TLANDO™, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.

The CRL identified one deficiency stating the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations ("Cmax").  The CRL does not identify any specific issues relating to the chemistry, manufacturing and controls ("CMC") of TLANDO.

"We are disappointed by the FDA's decision and intend to request a meeting with the FDA as soon as possible to discuss a potential path forward for the approval of TLANDO," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.


I thought there was a decent chance this could happen. Only one deficiency this time. Looks like Antares will have some more time to build market share . . .

[H2R]

Hi ou71764

I hope we are going to continue on a positive EPS going forward. This may be the first of many quarters! We may well have turned that corner :)

Best of luck with your investments

[traybaby]

Wow yeeeeehaaaaa

[ou71764]

Nice quarter. It appears that we've turned the corner!

[ClayTrader]

* * $ATRS Video Chart 11-05-2019 * *

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

[H2R]

Record Quarterly Revenue of $34.3 Million – Earnings Per Share of $0.01

The Company Increases Full Year 2019 Revenue Guidance to a Range of $115.0 to $120.0 Million

EWING, NJ, November 5, 2019

Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”) today
reported operating and financial results for the third quarter ended September 30, 2019.

The Company reported revenue of $34.3 million and earnings per share of $0.01 for the quarter ended September 30, 2019. The Company also reported record nine-month year-to-date revenue of $86.0 million.

Third Quarter 2019 and Recent Highlights
? Reported third quarter 2019 revenue of $34.3 million, an increase of 92% compared to the same period last year. Generated third quarter product revenue of $24.7 million, an increase of 113% compared to the same period last year.

Third quarter royalty revenue was $8.4 million
as compared to $3.7 million reported in the same period last year, a 126% increase. Cash and cash equivalents were $41.9 million at September 30, 2019, as compared to $40.2 million at June 30, 2019.

? Reported third quarter 2019 earnings per share of $0.01. This represents the Company’s first quarterly income from ongoing operations.

? On October 28, 2019, we received the final $2.5 million payment from Ferring Pharmaceuticals in connection with the previously announced sale of the ZOMAJET™ needle free delivery system. The gain on the sale of the needle free product line was previously recorded in the
fourth quarter of 2018.

? Announced two poster presentations at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of America.

? Announced that our partner Teva Pharmaceuticals launched a generic equivalent of the EpiPen Jr®
. Teva’s generic equivalent of the EpiPen® and the EpiPen Jr® utilize the Antares Pharma VIBEX® device.

https://www.antarespharma.com/application/files/5015/7295/5631/Q3_2019_operating_and_financial_results_final.pdf

Not too shabby!

[ou71764]

Shadow,

I was talking about the 3.40 area. Toward the end of June and early July the stock price hit that area a couple of times and couldn't hold it. The stock price fell into the 2.90s in mid-July and early August.

Then later in August I thought we had broken above 3.40 once and for all - but again, we hadn't and the stock fell back under 3.20.

So I was thinking that the strong price move this past week was a breakout above the low 3.40s - and might have created a gap. I thought you might have been referencing that.

But like I said, charting really isn't my primary area. I try to be conscious of support and resistance areas when I am buying or selling. Right now I have no intention of selling. At a higher level I'll think about selling...but at a much higher level. I've been burned by betting big and then not holding on for the big move.

Once we finally break above 4.00 and hold it, I think the stock could run significantly. Double digits is my goal by the EOY 2020. And if we hit that, I wouldn't necessarily sell a lot. Depends on the news.

[ShadowSpy69]

the gap($3.77) was filled yesterday from March. If you're referring to the gap-up at $3.02 from Aug., I doubt that fills.. Not expecting it to.

[ou71764]

I don't do charting, but I am aware that it took a long time to finally break above 3.40. So it wouldn't surprise me if that we tracked back down to 3.40 - hopefully as a floor this time!

But I would rather have a break away and never fill the gap. I am aware that gaps are often filled - but not always. I think the stock is undervalued and to me, there's no reason to fill a gap that was a mispriced valuation.

I don't know what will happen but I am long.

[ShadowSpy69]

This was prior to today's open... might/could try to overshoot and gap fill. I'm betting on the sp to stall and roll back towards $3.36-40 ballpark...basically have a month +- week to ping pong turtle style until ER . Expect a ramp up $4-4.50 min. thereafter...

[ShadowSpy69]

$3.77 gap finally filled from March. It was good spot to let some shares go... look for the $3.36-40 area I'm guessing before mid Oct.

[ou71764]

I agree. I'm not trading, just letting it play out on its own time.

[ConstitutionNow]

Likely hard resistance in the 3.93 to 3.96 range...if we reach that another consolidation down to 3.50s probably in order short of any news or earnings release before moving higher. I'm not trading this this one, as with many bio's you never know when they really take off.

[ShadowSpy69]

targeting $3.77 to $4.09 after Tree Fiddy cracks! Let's GO!

[ShadowSpy69]

$ATRS Investor Update - Sept.
https://www.sec.gov/Archives/edgar/data/1016169/000156459019034467/atrs-ex991_6.htm

[ShadowSpy69]

Antares Pharma Has Been Awarded A $8.3M Supply Contract From The Department Of Veterans Affairs
https://www.fbo.gov/?s=opportunity&mode=form&id=3219648f8700584f7e37adfc7562c72a