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Bio,
A handful of other funds bought recently and that outweigh the Vanguard sale. Give Jack a call and he would be happy to fill you in. He did with me. Index funds are constantly rebalancing their portfolios.
Thanks Ryman! I didn't have time to search yet for that patent and wanted to take a look at it, so thanks for posting.
zacki,
6 items are on the voting agenda for shareholders.
1. To elect two directors to Class III of the Company’s Board of Directors for a term of three years and one director to Class I of the Company’s Board of Directors for a term of one year.
2. To approve an amendment and restatement of the Company’s 2008 Equity Compensation Plan to increase the maximum number of shares authorized for issuance under the plan from 13,500,000 to 15,000,000.
3. To approve and adopt an amendment to the Company’s Certificate of Incorporation to increase the number of authorized shares of common stock, par value $0.01 per share, of the Company from 150,000,000 shares to 200,000,000 shares.
4. To hold an advisory vote on our executive compensation programs as disclosed in this proxy statement.
5. To ratify the appointment of KPMG LLP as our independent registered public accounting firm for our fiscal year ending December 31, 2013.
6. To transact other business that may properly come before the meeting.
Item 3 garners the most interest I believe.
My take on this proxy vote is on the big question of a POTENTIAL ability for Antares to bring to market additional shares (50M). A yes vote (majority yea's) will provide Antares with a green light to issue these additional shares at some point in the future. It does not mean they will, but it provides the capacity to have behind them the approval(s), should they determine that they have a need.
Now the big question is, what's behind this item being up for a vote?
Are they just being prudent given this is the time to try to get approval or do they have something specific in mind? My guess is they are trying to get an upfront ahead of time approval for issuing additional shares as a "just in case" deal. Just in case, they need to raise additional funds AND I suspect the just in case would be the ability to pull the trigger on this at some point after Otrexup approval and after they start marketing it and after early revenues start to come in. At that point (Jan, Feb or even March 2014) they feel the revenues aren't just quite where they want them to be AND because of the 'cost to market' for Otrexup, then clincial trial(s) cost for QS Testosterone AND QS M for a Neurological indication, they may need to pull the trigger. But if what I just mentioned shapes up well with respect to their current war chest of funds AND with potential and anticipated milestone payments (from TEVA, Pfizer, Watson, etc) and all components in their strategic plan are getting executed (appropriately funded), then sans the need for the additional 50M shares.
That's one veiw anyway. And I'm sure others could come up with some others (acquisition(s), etc).
The other thing I'll mention is that as an investor, its our job, right and duty, to vote in a manner that you believe lies in the best interest of the company and its future. Some will argue to vote out of trust and to trust they have our best interest at heart. So, bottom line and it goes without saying, if you read the 6 items and don't agree with what they are asking, vote no. If you agree, then vote yes.
A subject worth revisiting from the 4th Q yr end CC (from SA transcripts) read just how TEVA is talked about.
Aaron Hartley
If you don't mind, we have another one for you. Could you give us a little more detail on the new sumatriptan agreement?
Apple:
Yes, I think sumatriptan was originally VIBEX 2. And what -- Teva came to us and realized that we've been doing much more on our own with methotrexate and products like QS T, so they wanted to have us do more of the development work further downstream. And so what the agreement is currently is that Teva will make the sumatriptan in a prefilled syringe and send that to our manufacturers where we will make the device, assemble the device with the prefilled syringe and do the final packaging, all on our equipment. And so it's truly taking us all the way down to the commercial supply of the product, which is very different than our other agreements with Teva where we typically just supply them with the devices and then they do everything after that. So we felt that was a real positive step in our relationship in providing them the flexibility to have us complete the product development for them. Once the product is completed, we will ship it to Teva and they will distribute it into the retail marketplace. Obviously, sumatriptan is -- we believe, it's an ANDA and we will believe it'll be AB rated for substitutability to IMITREX. And that once the product is sold, it's basically net sales minus cost of goods and then we split the profits. I think it's a great opportunity for us to get, like I said, further down the commercial stream with them.
Wotton -
Yes. I think it's also a reflection of how far we've come as a company because as a result of our taking charge of our own destiny with methotrexate and now testosterone, we've been able to grow the infrastructure, get the right people in place to enable the downstream development of these type of programs.
Apple:
Yes, and we're going to be doing all this with the same equipment that we're using in methotrexate, and that were doing all the methotrexate manufacturing and commercial packaging on. And so there's a real synergy from a capital standpoint to be able to do this.
http://www.medicaretoday.org/MT2013/pdfs/Meds%20in%20Development%20for%20Older%20Americans%202013.pdf
Loko posted about this - go to page 12.
Do I remember correctly (cause sometimes I have CRS disease), but did someone from Antares on a call or conference say with respect to EU, they are leaning towards waiting for FDA approval which then would make it easier and potentially more profitable when seeking partnerships? Or did someone from the board say that?
Here's my feeble attempt from Louis Rukeyser:
"What I've tried to teach is no big secret: Buy good stocks. And don't get spooked every time the market panics. It sounds dull, but it's worked."
I happen to believe Antares is not only a good stock, but a burgeoning stock that has tremendous upside potential.
Thanks Ryman.
I think SA author "Smith on Stocks" story is a good one to review in light of recent debates.
http://seekingalpha.com/article/537111-antares-settlement-of-epipen-litigation-is-a-positive
Bio -
I should have written it is "typically" not a forum for Q&A. I honestly don't know if the mgmt attendees will have the time to a Q&A session. The agenda for the shareholder meeting is to vote on the items indicated in Schedule 14A. It's not a conference. To be clear, Jack said ALL shareholders are invited. In fact, he said, "any shareholder can come".
My purpose in my post you responded to was to relay to anyone that will attend that they need to be prepared to prove who they are and that they are a shareholder. Then I asked him about individual shareholders showing up. He said in his experience, shareholders don't. Then I asked, if they do, is there any kind of Q&A time for shareholders that show up. He said, typically not because nobody shows up, given the limited time and the specific agenda to vote on. He made no statement in any way that shareholders were not welcome in fact he said, again, any shareholder is invited. I guess from direct conversation to posting a note on the board, much is lost when trying to note highlights and leaving things out.
I think the official shareholder welcome wagon has already stated:
"Dear Stockholder:
You are cordially invited to attend the 2013 Annual Meeting of Stockholders of Antares Pharma, Inc., to be held at 10:00 a.m., local time, on Wednesday, May 22, 2013, at the offices of Morgan, Lewis & Bockius LLP, 1701 Market Street, Philadelphia, PA 19103.
The Notice of Annual Meeting and the Proxy Statement that appear on the following pages describe the matters scheduled to come before the meeting. At the meeting, I will report on our Company’s performance during the past year, as well as other current items of interest to our stockholders. In addition, certain members of our Board of Directors and management team, as well as representatives of KPMG LLP, our independent registered public accounting firm, will be available to answer your questions.
I hope you will join us at the Annual Meeting of Stockholders
Ahh, but Gordon does has a soft underbelly at the end of the show.
Okay then, its Paula Dean! But being from Chi-town, how about Rick Bayless?
d44, I hope you and others saw the humor in my last paragraph with "RAG Inc" to illustrate my point. Now if you are Gordon Ramsey, you can be the CEO of RAG Inc.
Another thing I'll mention during my conversation with Jack about the share price, he said (to paraphrase him) the price level and small fluctuations are frustrating, frustrating for all of us..." but we can't do anything about the day to day trading but to continue to execute against our strategic plan and we ARE doing that. Investors need to look at our 'phenomenal' growth since early 2009. And that growth is ongoing. The share price will take care of itself.
I asked him about the TEVA epi orders and if he could comment on or characterize the quantity of the order. Not really, he said. Then commented that it was large enough to be considered a "material event" and the news release that came out this morn.
On a personal level, the share price of Antares frustrates the ba-geezus out of me. And does so because I don't believe for a New York minute that it reflects the true value, let alone the future value of Antares. But and without Jack saying the share price will correct itself, I'm on board with their business plan, what they have done to date and what they will do. And I see no reason why they will not meet, expand and grow their business plan that will (this time next year) give us all cause to look back and say, "I made the right investment."
Two items:
1. I spoke with Jack this morning about the upcoming shareholder meeting which confirmed my thoughts as well. So this is an fyi for any of those who would like to go next May. The meeting (as noted) is at the attorneys office in downtown Philly. There IS a specific agenda for this meeting (as noted in the Sch 14) link provided by ryman. The meeting typically lasts only about 15-20 minutes to get through the agenda. Usually, or it is rare, that individual shareholders show up, not because they are not invited or wanted, but usually because it is easier to vote by proxy statement as opposed to show up and vote (travel, timing, etc). The votes are taken and basically the meeting is over, as everyone has work to get back to. If you do show up to vote, you must be prepared to prove who you are AND that you are a shareholder. Lastly, this is not a forum for any kind of audience (shareholder Q&A) session.
Number 2 is a post I made on the ymb regarding the Schedule 14A and potential additional shares the BOD is recommending a "yea" vote on:
The purposes to increase the share count are for flexibility related to the following:
• to acquire and/or license proprietary rights to products;
• to acquire and/or license proprietary rights to promising candidates for development into commercially successful pharmaceutical products and technologies;
• to attract and retain the services of qualified persons to assist in the development of such pharmaceutical products and technologies; and
• in connection with any future equity financings of the Company.
And to do so, without the expense and delay associated with obtaining stockholder approval of an amendment to the Company’s Certificate of Incorporation at the time of such action.
I think there is too much emphasis being put on the separate follow up paragraph regarding what the additional shares would NOT be used for but is included as ‘boilerplate’ language. But the ‘proposed increase’ COULD enable the BOD to make it more difficult or discourage an attempt by someone or entity to gain CONTROL of the Company. To me this is simply a potential “firewall” that could be used. They are covering all their bases. To clarify the “intended” use of more shares further, they again say what the intent is NOT for and that is for “an anti-takover-related purpose OR “to frustrate” an attempt.
“The increase in the number of authorized shares of common stock has not, however, been proposed for an anti-takeover-related purpose and we have no knowledge of any current efforts to obtain control of the Company or to effect large accumulations of our common stock. This Proposal No. 3 is not part of any plan by the Company to adopt a series of amendments to its Certificate of Incorporation or Bylaws so as to render the takeover of the Company more difficult. Moreover, we are not submitting this Proposal No. 3 to enable us to frustrate any efforts by another party to acquire a controlling interest or to seek representation on the Board of Directors.
Lets say that we all pool our shares together and form an S Corp and call it “Retail Antares Group, (RAG Inc)”. And by so doing, we realize we have enough shares to gain a controlling interest and what to put someone on the BOD to influence how things are done. And we would want to do that because we think we can influence the decisions and run the company better than the current Phd’s, Doctors, Executives with years of pharmaceutical experience under their belts. We would rather have plumbers, electricians, chefs, landscapers, engineers, nurses, real estate brokers, barbers and hair stylists run the show. THAT’S what I interpret when I read ‘no present intention’ but ‘could enable the BOD’ to issue more shares to prevent RAG Inc from trying to screw things up.
Jab9
Joeblack, Never had an original philly cheese steak but I'll break bread with any shareholder that is there. I recall seeing an episode of "diners, drive-ins and dives" with Guy Fieri showcasing philly cheese steaks.
tdpeterson, I think all firewall options are being looked at.
I might go to the meeting, not sure yet.
jab9
and a little more color from rymans Schedule 14A post with respect to item #3.
jab9
"Although the Board of Directors has no present intention of issuing such additional shares for such purposes, the proposed increase in the number of authorized shares of our common stock could enable the Board of Directors to render more difficult or discourage an attempt by another person or entity to obtain control of the Company. Such additional shares could be issued by the Board of Directors in a public or private sale, merger or similar transaction, increasing the number of outstanding shares of the Company’s capital stock and thereby diluting the equity interest and voting power of a party attempting to obtain control of the Company. The increase in the number of authorized shares of common stock has not, however, been proposed for an anti-takeover-related purpose and we have no knowledge of any current efforts to obtain control of the Company or to effect large accumulations of our common stock. This Proposal No. 3 is not part of any plan by the Company to adopt a series of amendments to its Certificate of Incorporation or Bylaws so as to render the takeover of the Company more difficult. Moreover, we are not submitting this Proposal No. 3 to enable us to frustrate any efforts by another party to acquire a controlling interest or to seek representation on the Board of Directors."
Many regulars have had their id copied. As ryman noted before, something like, "the birth of another idiot" - when you check their "birth" id of when the alias was created. My guess is it is one person who is/has been bent on disrupting that board and there is really nothing I know of that can be done about it. Once the pps share gets going, that board should see less and less of the present day crapola posts from those (or that) particular retarded one.
It takes a "special" kind of person not to be bothered by all the nonsensical posts - like 'stockwaun' where nothing will get in the way of his agenda.
During this time of waiting on a next development or announcement of some kind from Antares, I'm relatively glad that during this time, the pps has NOT vaulted lower on heavy downside volume. The fact that it has "held up" during this lull speaks to the sound fundamentals, pipeline, management and pays only slight to no homage to the companies future prospects. When I state "held up" I mean it hasn't collapsed. That's my 2 cents anyway.
I hope everyone had a nice Easter holiday!
jab9
http://seekingalpha.com/author/ali-yasar
Ali has a Phd and is with Barclays - seems legit. Stocklasar was/is out for himself and nobody else.
I'd be shocked and surprised if Ali is stocklasar.
I just wrote a response to the article.
{An excellent "deep diving" article Mr.Yasar! Very well thought out, researched and presented. Personally, I'm on the fence about a Pfizer buyout given CEO Wotton's recent statement that they "are not for sale." As far as buyout l, I could argue that perhaps Antares would be open to sell off their 'Gel' side drug delivery platform while maintaining their expanding, revenue producing injector platform.
As you state and for all the right reasons, the future (starting with the route switch delivery to subcutaneous and self administration via Otrexup) ,is their injector technology platform with the delivery of well known drugs (methotrexate and testosterone) and eventually add on biologics and biosimilars which are slated to replace 70% of chemical drugs per GaBi Journal. And as you are aware, the abbreviated pathway for biosimilars per the Affordable Care Act that was signed into law in 2010 sets the stage for Antares to eventually secure their own market niche.}
jab9
Hope to see and read more articles from you.
jab9
bsav88,
I recall your past post on that subject of UNIS and I personally don't think UNIS devices come close to what Antares currently has and will have. When I first saw the article title, I thought Antares would for sure be mentioned but alas, it was focused around UNIS. But the key field points in the article certainly have Antares in its crosshairs when talking about injector device product differentiation, etc.
I sent the article to Jack this morning as well and he replied (about UNIS) in much the same vein.
jab9
Interesting article in the latest "Drug Development and Delivery" magazine. This article is framed and written around "Unilife's" devices - but it relates to the delivery method(s)via injectors and what the market place and companies are looking for. I've posted the link to the article and also some of the key points.
jab9
http://www.drug-dev.com/ME2/dirmod.asp?sid=&nm=&type=Publishing&mod=Publications%3A%3AArticle&mid=8F3A7027421841978F18BE895F87F791&tier=4&id=4522F169ED94482CB202FBA462D63EDC
Issue Date: March 2013, Posted On: 3/13/2013
The New Industry Paradigm for Prefilled Success
INTRODUCTION
The prefilled syringe turns 40 next year. Since the filing of the first patents for a glass ready-to-fill syringe in 1974, this device class has attained an unrivaled position as the preferred choice for the delivery of parenteral drugs and vaccines. After a period of relative industry stability defined by peripheral innovation, a converging series of external and internal forces are set to reshape the prefilled syringe industry so that it will better serve the emerging needs of pharmaceutical companies, patients, and other stakeholders across the continuum of care.
More than 2 billion prefilled syringes are used worldwide each year. At least 60 drugs and vaccines are available in a prefilled format for use across more than a dozen therapeutic classes. These branded, generic, and biosimilar injectable therapies, collectively made by a who’s who of pharmaceutical companies, generate combined annual revenues in excess of $50 billion.
In speaking with many pharmaceutical companies, it is apparent that five trends are now converging together to redefine not only the composition of a prefilled syringe, but the entire industry landscape.
These five emerging or unmet market needs for the delivery of prefilled therapies are 1) Device Customization, 2) Lifecycle Management, 3) Needlestick Safety, 4) Brand Differentiation, and 5) Combination Therapies.
Device Customization
Another key requirement for prefilled customization relates to the growing importance of human factors engineering. With prefilled therapies increasingly being targeted for self-administration by specific patient populations, the external design and functionality of the device must be tailored to specific user needs.
During the clinical development or lifecycle management of injectable therapies, drug and device companies must conduct user studies with the target patient group. Human factors that can be measured for patient acceptability include initiation force, glide force, and the activation force for a safety mechanism, the ergonomic design of finger flange, overall ease-of-use, and convenience of disposal.
Lifecycle Management
Traditionally, a pharmaceutical company would launch its therapy lyophilized in a vial, then transition a few years later into a liquid-stable format with a standard prefilled syringe, and then perhaps later add an auto-injector. The lifecycle management of Copaxone by Teva is an excellent example of lifecycle management in process. Today, however, the launch of an injectable therapy in a standard prefilled syringe is considered to be the absolute bare minimum required to compete.
With the standard prefilled syringe now widely acknowledged as a status-quo device, pharmaceutical companies are seeking access to best-in-class delivery systems that can improve therapy compliance and drive preference rates amongst patients and prescribers.
Potential may also exist for prefilled syringes to extend the commercial lifecycle of mature therapies. The conversion of a drug from a standard prefilled syringe into an enhanced, market-leading delivery system may allow the pharmaceutical company to retain some level of market share that would otherwise be lost to incoming generic or biosimilar rivals.
Needlestick Safety
OSHA, the FDA, and many healthcare associations cite a preference amongst healthcare workers for the selection and use of devices with automatic (passive) and integrated safety features that can minimize the risk of harm and best comply with routine injection procedures. Pharmaceutical companies that select such prefilled devices with automatic, integrated safety features will be in a strong position to leverage these protective and functionality benefits to build user preference rates and optimize market share.
Brand Differentiation
Devices that are differentiated and offer true benefits to the patient can be leveraged by pharmaceutical companies to optimize the commercial value of their injectable therapies.
An elegant, sleek, and attractive device that is devoid of unsightly springs, compact in size, and has an external form factor that can be customized to specific drug brand or patient needs can generate powerful levels of differentiation. User opportunities for differentiation may include a more intuitive device that offers fewer steps of use, an unobstructed view of the drug, or the use of audible, tactile, and visual indicators to signal delivery of the full dose. Pharmaceutical companies that are able to access prefilled devices that can be customized to address the specific therapy needs and create the safest, simplest possible injection experience for the patient will have the best opportunities to generate powerful brand differentiation within competitive markets.
Combination Therapies
Prefilled syringes with dual or multichamber configurations that can efficiently contain a combination of liquid or dry drug combinations in a system that is ready for efficient reconstitution or mixing at the point of delivery have significant potential to transform the treatment of countless chronic or acute conditions. Only a few such dual-chamber prefilled syringes are now available to pharmaceutical companies.
FUTURE OUTLOOK
A number of internal and external forces have led the prefilled syringe industry to a state where it is primed for change. In the future, the prefilled syringe is set to transition from being an off-theshelf commodity device, to one in which component materials, functionality, and branding are fully customizable.
To succeed in this new environment, device manufacturers must follow a new paradigm for market success. They must be committed to serving pharmaceutical companies under long-term partnerships throughout the clinical development and commercial lifecycle of the drug-device combination. They must have the right balance between operational capabilities and business agility to ensure they are responsive and adaptable to emerging customer needs. They must have quality standards that exceed the industry benchmark and instill confidence and reliability into the pharmaceutical supply chain.
Device manufacturers must also possess management depth with strong levels of technical expertise so that their knowledge base can rival, and in some cases exceed, those of pharmaceutical companies. They must have a broad portfolio of flexible, differentiated device technologies that are platform-based instead of being rigid products. And they must be fully committed to working with their customers to enhance or enable the commercial success of their injectable therapies.
Among the fine responses by tdpeterson, shadow, ryman and bio pete below I'll post directly from CEO Paul Wotton during the RBC Healthcare conference the other month:
"The thing to remember here is that MTX is an already approved drug and the challenge here was being able to convert an approved drug that’s given by intramuscular injection which usually requires a professional to administer it – converting it to an easy to use subcutaneous route of administration which can be given at home. So we switched the route. We will be the first company to have a subcutaneous route approval for MTX and that’s really the opportunity and all the work we did in the studies supported that conclusion."
jab9
Oops, you guys knew what I meant.
"There exists a divergence in the growth / trend line of the company which is northEAST, to the pps trend line which lately has been southEAST. I ask rhetorically, which trend line is the true representation? Which one is sustainable and real? Which one is going to go through a correction?"
And there are now 60 identified drug products for potential use with Antares Vibex technology platform. This is up from the previously reported 40 drugs. The 60 drugs statement is in the new Form 10-K filing. I thought that maybe and since CEO Wotton just recently mentioned 40 during RBC HCC, that it was a typo or mistake, but I verified the number with Jack.
Pandora's box has been opened but what potentially comes out is in a good way.
As Ryman's post noted also from the 10-K:
"Recently a trend has emerged where companies are now focusing on “branded generics” wherein an established drug is coupled with a device technology in order to improve the drug utility to the patient or improve the ease of use of an injectable drug. This concept is the basis of our OTREXUP™ and Vibex™ QS T products and potentially provides the pharmaceutical company a high value branded product."
Antares is going to capitalize on this and in my opinion in a big way. Why? Well, because they have identified this niche or trend and they have the wherewithal to make it happen.
These trading days of fickle market reaction to missing expected earnings by one penny and the ensuing fall out from that are an unfortunate misrepresentation of what the company has done, is doing and what will get done. The market place that reacts to news is inherently irrelevant to the companies future value but yet is relevant only to its trading reaction on any given day. Some people live and exist in those day to day emasciations and that's the market that long investors have to contend with in the meantime.
There exists a divergence in the growth / trend line of the company which is northwest, to the pps trend line which lately has been southwest. I ask rhetorically, which trend line is the true representation? Which one is sustainable and real? Which one is going to go through a correction?
jab9
fyi, This is from Antares 10-K filed yesterday:
Competition in the U.S. testosterone replacement market includes Abbvie’s Androgel® and Androgel® 1.62%, Lilly’s Axiron®, Endo Pharmaceuticals’ Fortesta® and Delatestryl®, Pfizer’s Depo®-Testosterone, Actavis’ Androderm®, Auxillium’s Testim®, Actient’s Striant® and Testopel® and several generic testosterone in oil products sold by Actavis, Sandoz, Mylan, Bedford Labs, Teva and others. In addition, at least three additional treatments for low testosterone levels are in development. Endo Pharmaceuticals has also filed for U.S. FDA approval of testosterone undecanoate injection, Aveed™. Endo licensed testosterone undecanoate injection from Bayer, which markets the product as Nebido® in Europe and elsewhere. Clarus Labs is developing an oral formulation of testosterone undecanoate, CLR-610, announcing positive Phase III clinical study results in September 2012. Trimel Pharmaceuticals is developing an intra-nasal testosterone formulation, CompleoTRT™, announcing positive Phase III clinical study results in December 2012.
jab9
Bio_pete,
You had success getting through to someone regarding posting on the yahoo board - mind telling me what that address is?
Thx,
jab9
My thoughts for what its worth:
Did today's trading respect the positive CC? Not at all! What does that say? Did today's CC report that Antares strategic plan was failing? Nope, just the opposite is true. Then why the pps share trading pain? In my book, it's due in large part because of the transparency of the company in that they have clearly laid out the strategy of when they will become a sustainably profitable company. And until then the trading will reflect a back and forth, up and down as the wind blows mentality. And in the meantime, institutions will be buying shares that are being offered up for sale and do it rather quietly, then more boldly as Antares gets closer to bottomline producing revenues that truly foot to the bottom line and that are not royalty based but 100% organically derived.
I posted this on the ymb:
Well, that was a pretty ugly trading day wasn't it! A lot of turnover to the downside for sure. Given my long term investment horizon I was extremely pleased with this mornings report. The company is being very transparent regarding laying out their strategic plan for the future.
Apple said it: " As I stated earlier today, our results this year are representative of company evolving from a drug delivery model to a commercially focused specialty pharmaceutical company."
Wotton said it: "In 2013, we will continue to transition from a royalty-driven business model to a product revenue-generating business model."
And earlier during the CC Wotton said: "the bigger picture is the progress we've made on our internal pipeline as we shift this company towards a specialty pharmaceutical company that controls its own development destiny with products such as OTREXUP and QS T."
FDA acceptance of Antares Otrexup was just that - an acceptance and not approval as we all know. That in itself was and is not transformational. The real transformational kick start will be the PDUFA when that comes in October or perhaps even earlier. Per Wotton: "This was an important milestone in the company's history, and given the timing of the filing, keeps us on track for an early 2014 launch, if not sooner." Again it was hit on by Leroux Jooste: "Later in the year, we will continue to expand our internal capabilities as we gear up to launch early 2014 or potentially sooner, as Paul had said."
Between now and the PDUFA approval, (and sans any other unforeseen event, partnership, deal etc) the pps may very well drift back and forth as investors rotate in and out based on the transparency of the strategic plan. And that transparency works both ways if you catch my drift. Much can happen within the market noise between now and the end of the year. Until then, this shareholder will act like an insty fund and hold onto his shares for the LR to get SR. (Low Risk = Sustainable Reward)
I've talked with Jack a number of times and I would not characterize him as a jerk, but someone who is a no-nonsense individual that has a wealth of experience at what he does. And from what he has told me (and not told me) he is above board with his dealings with everyone. I don't think you get as far as he has in this business without being above board.
When people first talk with him, I can see how some people would characterize him as "arrogant", then as you get to know him, the word I would use is "confident" when engaging him in meaningful dialogue. He does have little use for people that call him and try to instruct how Antares should do this or do that or to demand and outright reveal insider information because "you have to tell, I'm a shareholder".
Bio_pete wrote "His job is to find new institutional support when the stock is oversold." He mentioned to me last time I talked with him, that he is looking forward to when the institutions reveal and report their Antares holdings in May.
jab9
"aging male population" that is....
jab9
Personally, I do not underestimate any testosterone market, particularly its penetration. Meaning, I don't underestimate the again male population and their desire to maintain. Every time I bring up the internet, I see on the right side of my screen some add showing a pretty girl with the heading, got low testosterone? And I hear plenty of "on-air" commercials on Cable these days.
Silly analogy, but forgive me for a second, what's more testosterone manly than injecting yourself in the friendly confines of your bathroom - safely and conveniently and subcutaneously or with a potion that you rub on?
Regarding the current injectables - I'm not that schooled in that subject. But aren't the current injectables intramuscular? QS-T would be Subcutaneous, so QS-T would be another route switch.
jab9
On the "other" board, I speculated "M" could stand for the indication as in Migraine, as "T" stands for the indication of low testosterone.
It somewhat intriguing to me that even though the new, what I believe to be an in-house program, QS-M has made it onto the "Investor Presentation", that not much in the way of fanfare has been made of it. Barely a mention of it during the RBC and Cowen HCC's. Is this by design because the focus is on Otrexup and pushing that through, then QS-T?
Regarding another post pertaining to earnings, I'm in the camp with the analysts on the -0.02 just because they seem to be more right than wrong. Plus I wonder how much Antares is spending for the manufacturing of the Otrexup pen given Wotton hit on this during the RBC conference when he referred to a manufacturing facility in Massachusetts. They must feel confident with FDA approval given they are currently fabricating the pens. The plus side to this is that once they gain approval, they hit the ground running with the sales force they will have in place.
jab9
Hi Ryman,
All very true. However in the US, there is NO OTC Ibuprofen gel available and this would be the first of its kind - question is which Antares delivery system will be used.
Tappy mentioned the clinical trials capital expense by PFE as $30 million. I have also heard the same number (from an unnamed, reliable, double secret undisclosed source). I'm curious as to what that could translate to, as far as fees for a partner. Albeit, as biopete noted, Antares is not doing the heavy lifting, but their delivery technology is behind it - or to put it another way, making it possible.
Also, shadowplay mentioned something that I've thought about as well, and that's the "end" of the known agreement language of 3yrs post launch. What happens after that? This could be a two tranche agreement in the wings, a renegotiation when sales, etc are determinable. The first tranche, we know exists. Is there a second? Entirely possible. Or if not, then given the 3 yr lifespan, what's the size of the final payment upon successful conclusion to compensate Antares for use of their delivery system for infinity?
jab9
Biopete:
"not a big fan of the Pfizer deal".....
You are, of course, talking about the 'undisclosed' deal and as such us outsiders do not know of any of the details. Knowing you the way I do know you (from the historical posting relationship) I suspect you would say the same thing for any pharma deal where the details are undisclosded. At least you are consistent from my perspective.
To me, from the last available disclosure on the subject, it looks like they are making investors aware of the 3 year time frame.
EWING, N.J. (AP) -- Antares Pharma Inc. said Tuesday it received a $750,000 milestone payment from its partner Pfizer Inc.
Antares said the payment was related to the development of an undisclosed consumer health care product. In December 2011 Antares licensed drug delivery technology to Pfizer. Pfizer agreed to give Antares an upfront payment and milestone payments related to development and sales of the product, as well as royalties on any sales made in the first three years after product approval.
Shares of Antares Pharma rose 12 cents, or 2.8 percent, to $4.40 on Tuesday.
CEO Wotton might even agree with you with respect to the big picture. But these deals, while we don't know the true financial impact, all help fund the in-house, come to mama revenue generators.
jab9
No time line exists that I know of, as the approval in in the hands of the FDA and the Dept of Justice. It's a generic epi-pen version of the standard in prevalent use today, so the approval itself is taking a long time. Teva (nor Antares) can give any timeline for its approval. The only certainty, is that with approval, there is the date certain launch of June 2015. But in the meantime and per agreement between Teva and Antares, is the pre-launch pen orders this year and next. And kudos for Antares for fashioning this (money in their pockets) agreement for the orders prior to launch. Win-win for Teva and Antares as with approval and court ordered launch date, they will hit the ground running.
jab9
Tappy (and all),
Ymb topic, then a blurb on Antares.
It looks like nobody is safe from the ongoing and now pervasive highjacking of id's. Whogo, Loko and now even piece2frog. It looks like they can do so with anyone's id now. I'm sure I won't be sparred even though someone has come with with the similar id to mine as you mentioned. And yahoo "oversight" is non-existent, ineffective and useless as teats on a boar.
I'm not 100% sure just yet whether I say I'll never post on the board until they clean it up, but what I won't do (and I suggest to anyone else) is to never, NEVER, respond directly to "their" posts. I have in the past and I believe that is a big mistake. This is what they want - responses to their outrageous posts. Doing so, keeps their post at top and continues the off-topic, distraction and distortion they want.
I don't know if this is happening on other boards, but the ATRS ymb has been hit hard. Maybe it is because "they" see the board as one of the best boards with some of the best educated, brightest posters around - or maybe its because of a high level of fear on their part - driven to disrupt as much as is humanly and technological possible. Sometimes, I think if anyones posts anything, it should be on a new topic and if necessary, pick out one of your own best posts on ATRS and regurgitate it. But again, never engaged "them" directly.
By the way, I heard on CNBC today a statement (can't remember on what segment or by who) but I liked it because it parallels my own investment philosophy in Antares, it was, "buy stocks that you believe will deliver future revenues". Isn't that true not matter what stock it is! No matter at what price per share the stock is trading as well! I believe Antares, while they are currently have a rev stream and are building revs, those bottom line future revs are the organic, sustainable kind built on a solid strategic business plan.
jab9
Tappy:
And all that spells "sustainability" when in the world of conducting whatever business your in - including this Pharma concern. And that is what is at the core of the Antares culture in my opinion. Plus, I believe this is also what Koufax (through today's posting on the ymb with you) eludes to when the "markets" have some catching up to do. We are just ahead of the curve.
By the way, it is such a pleasure having you as a friend as well as others on this civilized venue! Good company, good board, good people.
Have a great weekend all.
Forward your thinking with a forward integrating company!
jab9
Bsav:
With all those "XXX's" in your post (email) I thought I was reading a SEC "CT Order" for Antares.
Green today and that spells V I C T O R Y. And one has to know how to take and celebrate the victories when you get em!
jab9
SP1 and anyone who cares to listen:
My last purchase of ATRS shares was in August 2012 at the price of $4.12. I'm not stating this for any other reason than an fyi. Am I happy with that purchase when I look at today's price per share?
Yes, I'm okay with it. Not ecstatic mind you, but I'm okay with it because in the sense that I truly believe my "higher" purchase was based on a thorough due diligence that began many years ago and that continues today and that I will ultimately prove my purchases to be at the right time. I'm also not in the camp of second guessing my purchases whether they be higher than today's price or lower.
These purchases are an intimate exercise and are all personal for each of us. My reasons for buying and holding are not universally accepted and I understand that. My intimacy and relationship with Antares is one I choose and I believe my choice is the best for me.
Just my 2 cents.
And per d44, wtfdik.
jab9
P.S. The yahoo mb now seems to allow people to highjack others id's and then to post links to porn sites. There's nobody home there at the switch. It's now officially a cesspool of dung.
Revised and expanded February 28:
My recap of the RBC Healthcare Conference, Wednesday February 27, 2013
Jab9
CEO PW: It’s a great day for us to be presenting to day. Last nite we revd our NDA acceptance letter for our Otrexup, so we hit a big milestone four ourselves yesterday and a natural fact this is just another step in the transition of the company.
Antares is a company that has world leading injectable technology platforms and we r using those platforms to develop pharmaceutical products and Otrexup was our first pipeline product that we r developing ourselves and we have historically worked with companies like Teva, Pfizer, Ferring, Meda, etc.
• We have 5 products with Teva
• Partnership strategy has been very successful and going forward we are pursuing a
• Forward integrating focus
• Focusing on drugs that can be taken out to very specialized segment
• Home setting for drugs
• Re-engineer existing drugs with Antares devices
• October 14, 2013 PDUFA date for Otrexup
• Will be seeking international partners.
Moderator Q: Currently to date your business model is still royalty driven and you talked about partnerships with companies like Teva, so can you talk in more detail of the partnership with Teva and the products you are working on and also how we should think about the revenue breakdown over the next 3 to 5 years as you develop you own products.
PW: Just to be clear, we generate revenues today but we are not an earnings story just yet, so the launch of Otrexup is really the lead into with what we expect to be substantial revenue growth after 2014 but right now the path we are on is to launch Otrexup within the next 12 months. Teva has been an important partner for us. I mentioned the products on the market today, human growth hormone needle free, generic version of epi-pen which is currently with the FDA, Sumatriptan which we also developed with Teva with the autoinjector platform and 2 pen programs in development.
And the partnership with Ferring over in Europe for HgH needle free is important. Part of the importance of those relationships is its help us learn about this complex area for our combination drug device development area which got us kick started and enabled us to really move the Otrexup product thru the pipeline pretty quickly, so fyi, Otrexup took 18 months start to finish on the development program and we are anticipating the Testosterone program is going to be doing the same and we filled them as a 5052B NDA’s so we’ve got this brand new product strategy using a technology platform that has a very strong IP behind it to protect the product.
And Leroux, who just joined us 9 months ago is responsible for taking Otrexup out to the market .
Moderator: So can u talk about the market and why there’s a need for the product and then how you anticipate positioning it especially given the size market as well?
LeRoux J:
• 1 ½ million people with RA most of them are not diagnosed and treated
• Estimates are between 400 and 750k patients actually drug treated in the U.S.
• It’s a huge market, the biologics made a big impact.
• I personally launched Enbrel in the U.S. in 1999 – its interesting for me now to go back and revisit MTX because it is the cornerstone, go to, gold standard DMARD that Rheumatologists go to once they’ve diagnosed RA.
• Patients tend to be treated with DMARD, with DMARD MTX being the DMARD of choice to a point where they have an inadequate response – referred to as a failure to response. You can treat the patient symptomatically with cortisone but that doesn’t stop the disease from progressing. So what they do is to move on to the biologics or they add a biologic.
• Most patients, more than 90% of them, will progress to a MTX treatment period and at that point, either switch to a biologic.
• Here’s where Otrexup comes in, it is an easy to use subcutaneous self administration so yes, there’s a need for a convenient self administration MTX.
• There’s 2 big opportunities:
1. “Braun” study which showed because of the satural limitations of MTX, the ability for the stomach to actually absorb more than 15mg is jeopardized in most patients. If u look at the pharmacokinetic studies, the bioavailability of Subcu MTX gives u almost a dose response linear increase in systemic availability. Once you get to about 15mg, it plateaus off. So if you give 20 or 25mg the body still only gets about 15mg in the blood. However, with Otrexup you give 20mg you get 20mg. You give 25mg you get 25mg – so there’s an extended clinical utility which continues to provide a satisfactory and durable response for treatment so the patients remain symptomatic free. Studies show that when patients are symptom free, their disease is not progressing. So at that point, it could be 6 months, it could b 6 years for some patients, they would switch to a biologic and that’s where the second opportunity comes in and that is ….
2. Financials. Its billions of dollars that payers are putting out for biologics. If you can extend the adequate response by one month, on average a plan may save $1k for 1 patient for 1 month.
PW comment: The other piece of this is that there’s a lot of clinical experience with parenteral MTX coming out of Europe with hundreds of patients and studies and we are using that to support our application. The thing to remember here is that MTX is an already approved drug and the challenge here was being able to convert an approved drug that’s given by intramuscular injection which usually requires a professional to administer it – converting it to an easy to use Subcu route of administration which can be given at home. So we switched the route. We will be the first company to have a Subcu route approval for MTX and that’s really the opportunity and all the work we did in the studies supported that conclusion.
Moderator Q: Can you talk about the manufacturing side of the product because sometimes that comes up as an issue later on.
PW: We’ve got that covered. We actually have, we actually manufacture our prebuilt syringes containing MTX drug solution. The components are manufactured for us by a company up in Massachusetts and they do a lot of this work for other drug companies like Lilly and then the final assembly and packaging is done in a facility down in Pennsylvania. So we already have the supply chain worked out.
Moderator Q: Is this a product you are looking to market on your own or are you looking for a partner?
PW: We will be seeking partners for certainly international opportunities. Right now LeRoux is building up a strategic group within Antares. We are working with Quintiles to provide the beat on the street initially for the product and we’ve got a launch plan for Q1 of next year.
LeRoux what do you think the peak oppty for a product like this would be?
LJ: Our estimates right now based on interviews with Rheumatologists and payers (and we’ve not finalized pricing yet) but its somewhere between 100 – 200 million dollars.
PW: And that’s just for RA – we haven’t factored in any additional sales we might obtain from psoriasis for example which we will also get as an indication from the agency. The development plan we used for RA will enable us to make that claim for psoriasis as well.
LeRoux Jooste:
• MTX is the gold standard as a DMARD
• Stand alone DMARD or with a biologic (see my post titled Formula: MTX + Medi-Jet = delivery of Biologics)
• MTX(Otrexup) revs between $100 - $200 million peak sales potential which DOES NOT include potential sales of another indication like psoriasis.
• I suggest listening to his very detailed segment on the replay!
CEO PW:
• On QS-T: Testosterone replacement therapy is a $2 billion dollar market – highly viscous drug – oily drug
• Potential is a much larger opportunity for Antares than MTX
• Other molecules for VIBEX – 40 drugs we have identified that could be applicable
• We are active on the patent front
• We want to develop drugs that people want to buy
IP question regarding ability to protect both injector and drug (Vibex)
• We’ve protected the platform and you can protect things like the speed of delivery out of the device, the strength of the spring, the lbs / sq in., the design of the devices, all the way thru to what is called the QS system.
• We’ve adopted it for highly viscous material and what we’ve done is we’ve applied that patent base to classes of drugs.
• We have a patent filing called Hazardous Agent filing which we filed 4 yrs ago which will protect Otrexup.
• We are building on that data that’s coming out of clinical trials on the project specific applications of the device
Epi-Pen discussion:
• June 2015 product lauch
• We are manufacturing devices right now
• Market oppty is significant – by the time 2015 comes along this product will be a $ 1 Billion dollar product, even Mylan estimates the projected sales, we could be looking somewhere between 25-40%
• It’s a very important product for us but its less than important product for us in terms of rev than it use to be because of the impact of Otrexup and now Testosterone as well.
• Pipeline snap shot is 2014 – Otrexup
• 2015 Generic Epi-pen
• 2016 QS T
• I believe the real opportunity for epinephrine injection lies in the substitutable product because the epi pen is such a well known brand that the substitutable angle of that cant be ignored
• Pursuing AB rating and not the 505B2
Moderator question regarding regulatory agency approval of epi pen
• You’ll have to ask Teva about that as I’m not privy to their regulatory sheet dialogue, all I’ll say is we’ve got a date in 2015 when we are expecting to launch.
• Teva and ourselves are committing all our efforts on manufacturing expertise of our devices for the launch so you can read between the lines.
Question regading being acquired, staying an independent pharma concern etc.
• First of all, we are not for sale
• The reality is you are dead on with this platform
• We have I think the best devices on the market when you look at other devices on the market they are not as good as ours.
• The applicability of that technology to drugs is quite large and as a company like ours it would be difficult to develop 40 drugs on our own so we will be continuing to seek partnerships
• And of course what happens when you file an NDA with your own product, we’ve been inundated with business development inquires since December when we filed that NDA on Otrexup
• I would anticipate we see more agreements with pharmaceutical companies coming down the road.
Question regarding Valuation:
• This year we are focused on getting approval on Otrexup
• Expect another filing out of Teva pipeline coming along……Moderator: can u tell which one?.......ATRS: NO! (laughter)
Okay, SP1, I just looked at my past notes and I'm not sure what numbers you are referring to as I note the 100-200m as being the benchmark numbers for about a year now.
jab9