Senseonics Holdings Inc (SENS)

[leemalone2k3]

Update on positions
Stock fell today on news.
This week I wrote March 4.00 calls at .42 (they peaked at .60) against my stock and against my LEAPS.
Now holding
Covered Stock
Stock price 2.25
Written calls .42
I’ll be buying theses calls back at .05 or lower which will adjust the price of the
stock down .37-.42 to 1.88-1.83 price.

LEAPS
Holding purchased 23jan 2.00 calls .72
Wrote (sold) March 4.00 calls at .42. I plan to buy these back at .05 or lower reducing the cost of the LEAPS down to .35-.30 cost

[jonny_red]

That 5.50 range is my plan as well.

[Gpheart2016]

Interesting recommendation. I have shares and options. Believe I will follow closely when FDA announcement is made and be ready to sell somewhere around $5.50. Just my guess.

[jonny_red]

My thoughts on SENS - Price Levels to Watch for Stock SENS (FDA Approval)

YouTube Link:

$SENS

[leemalone2k3]

I hope approval is soon. Best of luck.

[teifhals]

Come on buyout!

[LRD]

They keep saying that every time SENS takes a dip. Approval is coming any moment

[da_stock_analyst]

#SENS?? new SEC filing! Is FDA approval very soon? should you enter now? What are my price targets?

[nbm16yankees]

Thanks for your input.

Decided to hold my 10s.
However bot and sold some feb 2.5s and 3s.
Just bot some feb 3.5s at .26 looking to double.

Sold some mar 5s and 5.5s

I think approval is coming soon. Hopefully today

GLTA

[leemalone2k3]

Update on positions
Covered call strategy. My Jan 4.00 calls expired worthless effectively lowering the cost of my shares .40 from 2.65 to 2.25 cost basis. I’m hoping FDA approval moves the stock well. With earnings approaching coupled with FDA expectations, option prices will be highly overvalued which makes writing them very profitable with increased chances of making winning trades. I hope to be free riding all my original shares by the end of 2022 with this “hands off my shares”approach.

LEAPS
Covered half my wrote 2023 10 calls (sold at 1.30) at .40 and hope to buy back the rest today around .45. If so I will effectively lower the cost of my Jan 2023 2.00 calls to .72 from 1.60. Hoping to free ride them by writing short term calls against against them.

Also looking at purchasing Jan 2024 2.50c at 1.60

[leemalone2k3]

I bought back half of the written Jan 10 calls this week at .40 and will probably cover the rest of them today at .45. Then I’m going to wait until after the stock Runs (hopefully) then write some weekly and monthly calls against my stock and LEAPS. . I’m hoping the stock gets up around the 5.00 range again to make these trades.

I am considering adding LEAPS too but like the 2024 expiration period better they are only .40 more than the 2023 2.50c

Good luck with your positions.

[da_stock_analyst]

#SENS?? Late to enter before possible FDA APPROVAL!! When should you buy? Price target #senseonics

[nbm16yankees]

https://www.drugdeliverybusiness.com/senseonics-fda-clearance-180-day-cgm-whats-next-fran-kaufman/
With FDA clearance ‘imminent’ for Senseonics 180-day CGM, what’s next?
January 31, 2022 By Sean Whooley
Eversense CGM Senseonics The Eversense CGM [Image courtesy of Senseonics] When Dr. Fran Kaufman began her career in the late 1970s, diabetes management consisted of urine testing and animal insulin.
At that point, it had not been proven that managing glucose actually mattered, according to Kaufman, and proof didn’t come until 1992 with the conclusion of the DCCT study.
“I’ve seen a lot of innovation,” said Kaufman, chief medical officer at continuous glucose monitoring technology developer Senseonics (NYSE:SENS).
She’s been involved in innovation as well, the latest being the 180-day Senseonics Eversense continuous glucose monitor (CGM), for which FDA approval could be coming very soon.
Data presented in 2021 demonstrated strong accuracy with the 180-day sensor, as the next-generation Eversense matched performance levels compared to the current 90-day sensor available in the U.S., but with calibration reduced to essentially once per day.
In early January, the Germantown, Maryland-based company said it expected approval “in the coming weeks.”
“That approval, like everything, has been delayed and we’re so appreciative of what these agencies have done, being able to bring forth such innovation to combat [COVID-19], so we’re willing to step aside as we all have to be able to get a handle on this pandemic,” Kaufman told Drug Delivery Business News. “So, we’re waiting and we do think it should be imminent.”
An earlier version of the 180-day sensor is already available in Europe, with the same next-generation version nearing FDA clearance also under review in the EU. By doubling the duration of the current offering in the U.S., it halves the number of insertion and removal procedures while also reducing the calibration frequency after day 21 through a new calibration scheme.
Kaufman said that one of the sensor’s tests produced a mean absolute relative difference (MARD) of 8.5%, representing high accuracy.
She pointed to ease-of-use among other innovations that encompass the patient-centric efforts Senseonics has made to improve the CGM system.
“There are innovations with the reduction in calibration scheme as well as improvement in some of the user interaction and chemistry improvement,” Kaufman said. “There are all kind of things that we’re excited about.”
Once Senseonics wins FDA approval, its marketing partnership with Ascensia Diabetes Care comes into play.
“They bring forth a huge presence in the field and in marketing and commercialization,” she said. “It enables us to really focus on what we do best.”
The U.S. rollout for the 180-day Eversense CGM will show the benefits of the partnership, Kaufman said, with commercialization responsibilities falling on Ascensia and product development belonging to Senseonics, which began as an R&D company. The partnership allows Senseonics to keep future innovations within a “robust pipeline” at the forefront of its efforts, Kaufman said.
In a November report, BTIG analysts acknowledged the large market opportunity for Eversense — which, at that time, was expected to win FDA approval by the end of 2021 — but said a premium valuation wasn’t warranted “given the company’s past challenges in commercializing the product and the remaining risks related to commercial execution with its new partner.”
Next steps for Senseonics and Eversense include extending durability to one year, a mark that could be reached with the help of chemistry modifications and fundamental changes in the sensing surface itself.
The company also has plans for pushing the calibration frequency to once per week and adding a battery center that won’t increase the diameter but will marginally increase the length, allowing for the transmitter to be taken off and the device to be used as an intermittent scanning device with devices such as a smartphone.
Kaufman said the potential changes in the pipeline at Senseonics are meant to serve the entire spectrum of people managing their diabetes.
“I still think that we’ll need CGM to be sure things are working well and to understand part of our physiology better,” Kaufman said. “What better device for that in the future than an implantable one that could last a year that you could query when you want to? And when you don’t, you don’t have to get that information. I’m just excited that we’ll have something that will be meaningful through this next evolution of how we manage diabetes.”
Filed Under: Auto-injectors, Big Data, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance Tagged With: Diabetes, Eversense, FDA, Senseonics

[nbm16yankees]

leemalone2k3 covered calls strategy

Just read your post and like your ideas. Curious did you buy back the Jan 23 10's and if so what price? What are you looking to sell them again at? (if you care to share, I would much appreciate your assistance). You got a great price in April. I sold 10 of those also, but in Sept, and my average price received was .73.
Thinking of buying some Jan 23 2.50s at a dollar. What do you think?
Not adverse to risk as I just bought 5 each Feb 2 1/2s (.23) and 5 Feb 3's.(.12)

I know its speculation, but upon FDA approval (hopefully this week), do you think we will hit 5, or maybe 6 realistically?

Thanks in advance....

[leemalone2k3]

Covered call strategy is working well so far with the low historical volatility (stock staying flat) and high implied volatility (amount the stock may move). This causes the option premium to be extremely overvalued. If you sell this premium against your stock stays flat, you can pay yourself while waiting for news to move the stock.

My positions
Covered call strategy
Bought the stock at 2.65 and sold January 4.00 calls against the shares at .40. I’ll buy them back today at .05 for a .35 gain essentially lowering the cost of my stock down to 2.30. I will sell Feb calls on the next pop at resistance to continue bringing in income and lowering the cs it’s of my shares.

Long term equity appreciation strategy.
Trades made in April 2021
14 APRIL Bought 20 contracts of Jan 2023 2.00 calls at 1.60. This cost me $3200.00
22 APRIL Sold 20 contracts of Jan 2023 19.00 calls at 1.30. This paid me $2600.00.

Max risk (loss) $600.00
1.60-1.30=.30
$ 0.30 x 20 contracts = $600.00

Max Gain $ 16,000 if SENS is above 10.00 on expiration.
$10.00-$2.00= $8.00 x 20 contracts=$16,000

Breakeven SENS stock price on expiration: $2.30. There is a $20.00 increase in profit for every penny the stock is above 2.30.

I’m considering buying back the 10.00 calls soon in anticipation of a rise in stock price and selling them again at a higher price if the stock pops. They are trading .50 right now which would cost me $1000 to buy them back for a $1600 gain on those contracts.

Will continue to update the trades as they occur.
Good luck traders.

[da_stock_analyst]

#SENS ?? FDA approval expectation and swing trade idea! what is the price target for the catalyst!

[dancy]

SENS wwwwwwwwwweeeeeeeeeeeeeeeeeee

[nbm16yankees]

Senseonics Holdings Shares Spike Higher; Co Reiterates FY21 Guidance; Sees FY21 Global Net Revenue To Be In Middle Of Guidance Range Of $12M-$15M
4:48 pm ET January 4, 2022 (Benzinga) Print

Senseonics Announces Business Updates

Senseonics Holdings, Inc. (NYSE:SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced operational and financial business updates.

Operational and Financial Updates

Substantive review with the FDA for the PMA supplement for the next generation Eversense 180-day CGM system is nearing completion, all queries raised have been answered and a decision regarding approval is expected in the coming weeks

Designing plans with Ascensia Diabetes Care for a smooth transition to the 180-day system in the U.S., pending FDA approval, including:
Marketing campaigns to highlight the availability of system upgrade programs for patients and to increase overall patient awareness
Payor engagement regarding reimbursement and coverage transitions

These plans are being designed with a goal of minimizing the impact to patients, providers and sales, taking into account the expected use of existing inventory in Q1 2022 and initiating transition to the new product in Q2 2022

Reiterating 2021 financial outlook expectation for full year 2021 global net revenue to be in the middle of the revenue guidance range of $12.0 million to $15.0 million

"We understand that the FDA is at full capacity managing the backlog of COVID-19 related filings creating longer than expected review timelines. We are confident a decision regarding approval of the 180-day system will be made in the coming weeks as the FDA continues to clear out the backlog," said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. "In 2021 we integrated operations and coordination activities with our commercial collaborator Ascensia Diabetes Care. A thoughtful go-to-market strategy is being designed to target a smooth transition to the 180-day system while providing uninterrupted service for patients, providers and payors. We are excited to advance long-term solutions for people with diabetes as we continue to aim to make the new 180-day system available in the U.S.."

About Senseonics

Senseonics Holdings, Inc. is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems, Eversense® and Eversense® XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about Senseonics' expected net revenue for the full year of 2021 and the full year of 2022, the timing and outcome of the potential decision on the 180-day Eversense system from the FDA, the timing, effectiveness and readiness for launch of the 180-day Eversense system, the ability to collaborate with Ascensia Diabetes Care, the ability to smoothly transition patients, physicians and payors, the impact of existing inventory and transition timing on financial results, the ability to manage such impact, and other statements containing the words "believe," "expect," "intend," "may," "projects," "will," "planned," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties in the regulatory approval process, uncertainties inherent in the commercial launch and commercial expansion of the product, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties in the duration and severity of the COVID-19 pandemic, and such other factors as are set forth in the risk factors detailed in Senseonics' Annual Report on Form 10-K for the year ended December 31, 2020, Senseonics' Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and Senseonics' other filings with the SEC under the heading "Risk Factors." In addition, the forward-looking statements included in this press release represent Senseonics' views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics' views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics' views as of any date subsequent to the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220104006026/en/

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

[da_stock_analyst]

#SENS ?? FDA APPROVAL coming in weeks! Business update! Should you get before the FDA approval?

[Ralph11]

Total waste of time. I will dump first week of January 2022.

[leemalone2k3]

I fear you may be correct. Dilution will likely keep this one low

[Ralph11]

I appreciate the suggestion. I will wait till Jan then dump it hopefully at 4.50. I think FDA won't matter with all the shares outstanding now.

[leemalone2k3]

Have you considered selling covered call options against your shares.? Today I sold Jan 4.00 calls at .40 against my stock I bought in june at 2.65. That 4.00 ceiling seems tough to break through. Might as well take advantage of the overpriced option premium.

[Ralph11]

The way the ceo. Has increased the shares. Diluted the price I'm just looking to get out of this thing. In the $4 range. I'm So, tired of hearing about the FDA approval. Which frankly, I don't think it's going to matter. There's so, many shares out there now. Not wasting another, year on this garbage

[Melvin Capital]

Put in a order thru Etard today for 5,400 shares and it takes 14 different transactions to fill the complete. Is the A/S that slim here?

[Ralph11]

Without the FDA approval. Its not going to explode. This has been based on this for over a year.with earnings possible and it could explode. But, without that approval. This thing is just going to languish on and on and on.

[Gpheart2016]

I’ve been holding for a while but it looks like time to add shares. I see a huge breakout ready to happen. Good earning news, upcoming FDA decision……..This stock could explode!

[tavito]

“We are encouraged by the excitement demonstrated by patients and HCPs for the 180-day sensor in the US and we are pleased with the progression of the review and are hopeful the FDA will reach an approval decision in the coming months based on the positive PROMISE Study results. We look forward to launching the new system shortly after approval.”

[da_stock_analyst]

#SENS ?? Earning next Week! FDA approval and Price target! Should you buy now or wait?Price analysis??

[tavito]

So close!!

[Ralph11]

It's quite obvious that the FDA approval is being held up from one of the other diabetes companies because they don't want to see sens go up that quickly. There's no other reason this nonsense about covid holding things up is an absolute ridiculous excuse.

[Ralph11]

So you see it hitting last high 5.56? The FDA is way too slow for . since its being used in Europe already.

[georgie18]

SENS...$3.20...Bullish Harami Cross Reversal Pattern to the Upside...Back in with a starter on this Pattern...

Last move failed to Break/Hold that $5.50 Double Top...Looking for that Break/Hold on this next Upside move...imo...we shall see...

Chart... https://schrts.co/iajrANpn ...

georgie18 Saturday, 07/03/21 12:27:59 PM
Re: georgie18 post# 671 0
Post #
696
of 729
SENS...$3.51...Bullish 3 Gap Downs Reversal pattern to the Upside formed on this Overbought Retrace...

Previous $2.08 range alert saw a move to the $4.50 range...Took profit on that move and back in on this Reversal Pattern...

Break/Hold the $5.50 range Double Top takes SENS to Blue Skies Territory with No Topside Resistance...imo...we shall see...

[XenaLives]

An impressive alliance...

https://www.ascensia.com/partners/

[XenaLives]

Institutional holdings have doubled in the last year...

https://fintel.io/so/us/sens

[XenaLives]

The thingie...


https://www.ascensiadiabetes.com/eversense/eversense-cgm-system

[XenaLives]

Hmmm, not sure why the Big Boys want this to be independent...

ABOUT US

Established in 2016 through the acquisition of Bayer Diabetes Care by PHC Holdings (formerly known as Panasonic Healthcare Holdings), Ascensia Diabetes Care is a global company entirely dedicated to improving the health and lives of people with diabetes. We are home to the world renowned CONTOUR® portfolio of blood glucose monitoring systems and the exclusive global distribution partner for the Eversense® continuous glucose monitoring systems from Senseonics. And we are committed to adding more innovative and life-changing products to our portfolio.

https://www.ascensia.com/about-us/our-approach/

[XenaLives]

20 July 2021
ASCENSIA DIABETES CARE LAUNCHES PATIENT ASSISTANCE PROGRAM TO PROVIDE BROADER ACCESS TO EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Parsippany, United States

Ascensia Diabetes Care, a global diabetes company, announced it has introduced a Patient Assistance Program in the United States to reduce out-of-pocket costs associated with the Eversense® Continuous Glucose Monitoring (CGM) System.

Under the Program, which is available immediately, eligible patients starting or continuing with the Eversense CGM System will need to pay the first $100 of their out-of-pocket costs. Ascensia will then cover up to $300 of the remaining balance for each 90-day sensor. Any additional costs will be the system user’s responsibility. Overall, the Program has the potential to save eligible Eversense users up to $1,200 per year on their cumulative 90-day sensor out-of-pocket costs.

To find out more about the Program, potential and current Eversense users can go to www.ascensiadiabetes.com/eversense/patient-assistance-program-information and complete the eligibility form, after which the Ascensia team will reach out about next steps. They can also discuss with their health care provider.

Mary Puncochar, Head of Ascensia’s Region US, commented: “We hear from people living with diabetes and their healthcare providers how transformative the Eversense System can be in facilitating their diabetes management. People using the System appreciate how Eversense provides discretion with a removable transmitter, peace of mind through the on-body alerts, and the freedom that a 90-day sensor provides.

“Our fundamental goal at Ascensia is to simplify and improve the lives of people living with diabetes through technologies that facilitate better outcomes and reduce the burden of managing the condition. We therefore want to be able to offer Eversense to as many people as possible and we believe that over half of the people using insulin in the US could be eligible for our Patient Assistance Program. Our goal is to make Eversense more affordable and provide improved access to this unique and innovative diabetes management technology.”

The Eversense CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor, and a mobile app for displaying glucose values, trends and alerts. In addition to featuring the first long-term implantable CGM sensor, the System is also the first to feature a smart transmitter that provides wearers with discreet on-body vibratory alerts for high and low glucose. It can also be removed, recharged and re-attached to the skin without discarding the sensor. The sensor is inserted subcutaneously in the upper arm by a health care provider via a brief in-office procedure.

1. Christiansen, M.P. et al. (2009). A prospective multicenter evaluation of the accuracy and safety of an implanted continuous glucose sensor: the PRECISION study. Diabetes Technology & Therapeutic, 21(5), 231-237.doi:10.1089/dia.2019.0020.

2. Slattery D, Choudhary P. Clinical Use of Continuous Glucose Monitoring in Adults with Type 1 Diabetes. Diabetes Technology and Therapeutics 2017;19(2):55-61. DOI:10.1089.dia.2017.0051.

https://www.ascensia.com/press/press-releases/press-release/?id=29865981-52b1-40a9-96ce-7d3199ba6d6e

[XenaLives]

Doing some chart skimming today...

What does this company do?

News & Events
Publication
Ascensia Diabetes Care launches patient assistance program to provide broader access to Eversense Continuous Glucose Monitoring System
Publication
Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance
Publication
The PROMISE Study: An Evaluation of the Safety and Accuracy of the Next Generation 180-Day Long-term Implantable Eversense CGM System

https://www.senseonics.com/

[JJ8]

Just took a brief look on the technical (only):

1. Still the dailies are in downtrend. And strangely the weeklies remain in uptrend. Kind of a contradictory status. Yet unresolved technically.

The P&F Pattern still indicates Double Bottom Breakdown as of on 24-Sep-2021. No change in price chart patterns

I do not know about the Fundamentals of this stock. I am very much involved in my stocks and doing fine.

October could be a real challenge in the larger stock market, in general.

I understand it's not a good feeling that you have. It's a personal challenge. I hope you make your decision based on your knowledge of the company using both T/A (in the short term) and the Fundamentals for the long term.

GLTY

[Ralph11]

Any thoughts for October on thisstock.? is going to start going in the green again. cuz I took a bath for this month on this stock. I'm wondering if this is just a bunch of BS
on this company. I know that we all have been waiting for the FDA approval but, obviously they're a bunch of old people that can't find their way in the dark.

[Ralph11]

Thank you very much for the update I appreciate it immensely. I will hold it to the end of the year or when the FDA news comes out hopefully we can get a short squeeze all the way to $25 a share which would be fantastic

[JJ8]

Ralph11,

The Technical view alone shows this is not a trading stock imo.

End of August it had a golden cross and both the 50 & 200 sma are in uptrend. Looking good.

The Fundamentals appear promising. The 52 week range $0.3497 - $5.56 Today's closing price $3.59 up $0.10

The volume/price dynamic was interesting and a bit puzzling to me.

The Weeklies indicate in uptrend whereas the Dailies still indicating a downtrend, for about 2 weeks this being the third week. That seemed strange to me from a technical perspective and it coincided with the larger market downturn because of the Chinese news. A short term situation as of now.

Yet, normally the Dailies lead the Weeklies into an uptrend.

My selling was based on it only in one of my accounts. I am pursuing more attractive yet riskier stocks.

SENS share price will depend on new developments and progress with the company.

I wouldn't trade this stock based on the short term fluctuations to catch small profits at this time and at this price level.

Cheers & GLTY

[Ralph11]

I bought 1000 shares today at 3.56pps. Total of 10k shares. Any opinion on range to exit or hold till FDA announcements?

[Ralph11]

Most appricate it

[JJ8]

Ralph11,

I am following the signals and I will let you know about the timing.

I still have shares in my second account. I need to do the checking.

I think it may take some time given also that the larger market environment has challenges.

Cheers and GLTY

[Ralph11]

You were correct on dumping. Wonder when it will reverse.

[JJ8]

Dumped my SENS shares in one account as the P&F Pattern indicated today a Double Bottom Breakdown. Taking small profits only.

It appears the downtrend seems more likely for the short term.

I will wait until it changes.

GLTA

[JJ8]

Ralph11,

Technically the Dailies have been in downturn since Sept. 8th for the last 6 daily sessions of trading. That was a change since my last post.

It was disappointing to me. I also thought of selling my positions in 2 accounts.

However the Weeklies remained in uptrend even as of today. That means the Price/Volume dynamic is negative for the last 6 sessions as of now but whether that will drag the Weeklies as well appears questionable at this time.

For the upturn the Dailies must be in harmony with the Weeklies. It's the Dailies upturn in a week that leads to the Weeklies confirming the upturn.

In case the Weeklies change to a downtrend, then it may take many weeks or months to get to a change to an uptrend. The breakout in the P&F Patterns on Aug. 26, 2021 had been aborted on Sept. 8th by the Dailies.

The Dailies lead the Weeklies for a confirmation of the uptrend. Unless the Dailies bring in the Weeklies into a downturn.

We may know more which way the trend will follow soon in the short term.

We shall see.

Cheers and GLTY

[Ralph11]

We need FDA approval sooner than eoy.