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VIVUS Inc. Message Board

atlnsider 153 posts  |  Last Activity: 4 hours ago Member since: Dec 6, 2003
  • Reply to

    Getting slightly disoriented with alxa

    by funalwayswithstocks Mar 5, 2014 4:55 PM
    atlnsider atlnsider Mar 5, 2014 6:34 PM Flag

    funalwayswithstocks;

    I can certainly understand why you would feel that way, especially considering you have been holding ALXA for over 5 years. I only bought ALXA shares just before ADASUVE was approved by the FDA, once it seemed to me that FDA & EMA approval were about to happen.

    I know that timing is everything. You invested in ALXA years before ADASUVE was approved by the FDA & EMA, and years before the Teva deal. A lot of investors, including myself, owe a big debt to you & other early investors in ALXA.

    But, at this juncture, it seems to me that an investment in ALXA has been de-risked to a large degree. The regulatory risks associated with an FDA & EMA approval has been totally removed or eliminated.

    Now there is only the risk that Teva & Grupo Ferrer will fail to have a successful ADASUVE launch in the US & EU, or ADASUVE will not sell as well as projected in the US & EU. I am not as familiar with Grupo Ferrer as I am with Teva, but I have a lot of confidence in Teva's track-record & abilities to make ADASUVE a commercial success in the US.

    There is also the risk that Alexza will not develop & commercialize any additional new Staccato based drugs in the future. But, with the Staccato System platform already being validated by both the FDA & EMA with their approvals, and the fact that the Staccato System has already being tested & proven to work with over 200 additional known drug compounds, I think that this risk is very very small.

    To use a football analogy, I feel like Alexza has fought very hard over the past few years, and they have made their way all the way down the field, and we are in the "Red Zone" now, and we are just about to finally score a touchdown. I feel like the football is inside the 5 yard line and a touchdown score by ALXA is imminent.

    For me to walk away now, after being very patient with my ALXA investment for about a year and a half, would not be a wise move to me. But, I do understand your frustration...

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 5, 2014 2:14 PM Flag

    Thanks Todzun!

    This is a very positive sign that Alexza needs to scale-up ADASUVE production in order to meet demand in the US & EU...

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 5, 2014 12:58 PM Flag

    Yawn...

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 5, 2014 11:51 AM Flag

    The actual earnings numbers from Alexza are not as important for Q4 2013. The earnings numbers will be more important starting Q2 2014 because that is when Alexza will show a full quarter of ADASUVE sales in the US.

    Prior to Q2 2014, my focus will be on seeing increasing quantities of ADASUVE shipped to Grupo Ferrer & Teva from quarter-to-quarter.

    Sentiment: Strong Buy

  • Reply to

    A Very Sad Day Indeed

    by ends_met Mar 4, 2014 8:07 PM
    atlnsider atlnsider Mar 5, 2014 10:08 AM Flag

    Dr. Zaffaroni was a pioneer in the field of novel drug delivery technology. His name is prominently displayed on most of Alexza's patents, especially the early ones.

    I too appreciate all of his contributions. My condolences to his family, friends & colleagues.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Health Net has over 5.3 million members nationwide. They are 1 of the largest Managed Care Organizations in the US. Teva continues to put everything in place for a successful launch of ADASUVE in the US.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 4, 2014 10:49 AM Flag

    Yes; you're referring to the "value proposition" related to ADASUVE compared to IM injections and oral tablets. King did talk about how ADASUVE would be a better value because the healthcare facility would not have to use restraints, or extra staff, or have to write a report because they did use restraints.

    This value propostion has always been there, even when Alexza first did their own pricing research for ADASUVE back in 2008. Alexza has always talked about the value advantages of ADASUVE & the value added by ADASUVE compared to IM injections & oral tablets. That has not changed since 2008 and the $75 per dose pricing.

    What has changed since 2008 is the total cost to develop ADASUVE & the added costs that Teva had to pay in order to license ADASUVE from Alexza (up gto $260 million), and the amount of time remaining on the ADASUVE patents for Teva to recoup the ADASUVE development & licensing costs.

    There are a lot of variables that go into pricing a new drug. I did go into a lot of detail in my article explaining why Teva's price per dose for ADASUVE would be higher than Alexza's price.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 4, 2014 10:05 AM Flag

    No, he did not. However, the price per dose for ADASUVE is completely up to Teva, not Alexza. The price that Alexza suggested per dose, was from 2008, almost 6 years ago.

    I suggest you read my Seeking Alpha article, "Teva To Price Alexza's New Drug Adasuve At $145 Per Dose In The U.S." I go into a lot of detail explaining why I believe the ADASUVE per dose price is $145.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 3, 2014 8:26 PM Flag

    Yes; you are exactly right. I would recommend that you go back & listen to the Q3 2013 earnings conference call when Alexza explained the $48 million in more detail.

    The Grupo Ferrer ADASUVE deal is not as good as the Teva deal is for Alexza. Alexza was in a much weaker negotiating position when they agreed to the Grupo Ferrer deal.

    It looks to me like that Grupo Ferrer deal boils down to $48 million in blended milestone payments, plus ongoing manufacturing profits for Alexza.

    Alexza will make a profit on every ADASUVE unit that they make for Grupo Ferrer and its sub-licensees (Meidvir AB & AOP Orphan) once Alexza is producing enough units to exceed its manufacturing costs break-even level.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 3, 2014 7:14 PM Flag

    The $48 million in future payments from Grupo Ferrer are a combination of sales milestone payments & sales royalty payments. It's a blended payment.

    Out of the total $48 million in payments from Grupo Ferrer, Alexza has received about $3 million. So, that leaves about $45 million in down-stream milestone payments remaining to be paid to Alexza. Some, or even most, of the remaining $45 million in down-stream milestone payments will be paid to Alexza after 2014.

    The only portion of this remaining down-stream milestone payments that is mostly guaranteed to be paid during 2014 will be for 1st country sales milestone payments of up to $13 million for the EU launch & 1st country sales in 9 pre-determined EU countries. Alexza has received $2.25 million to-date for the 1st country sales launch in Germany & Spain. So, that leaves about $10.75 million in 1st country milestone sales payments that should be paid to Alexza during 2014.

    In addition to the $10.75 million in 1st country sales milestone payments, Alexza still has about $10 million left on the Teva $25 million note. Alexza has already drawn down about $15 million against the $25 million Teva note.

    So, just for these 2 options, Alexza should have access to $20.75 million in additional cash to help fund their cash needs during 2014. This does not include any upfront cash payments for: ADASUVE licensing in non-USA & non-Grupo Ferrer territories, worldwide licensing fees for Staccato Alprazolam, worldwide licensing fees for all other Staccato based pipeline products.

    This also does not include any: clinical based or sales based milestone payments from Teva for its ADASUVE US license, ADASUVE manufacturing profits for producing ADASUVE units in excess of break-even volume, ADASUVE tiered royalty payments from Teva for ADASUVE sales in the US.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 3, 2014 6:29 PM Flag

    Alexza also confirmed the Medicare & Medicaid reimbursement or pass-through rate for ADASUVE of $153.70.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 3, 2014 6:22 PM Flag

    Alexza will start the Phase II Proof of Concept study for AZ-002 (Staccato Alprazolam) for the treatment of acute repetitive seizures (ARS) during Q2 2014

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 3, 2014 6:17 PM Flag

    More detailed financial & pipeline information will be disclosed on this Thursday, March 6th, during the 2013 year-end conference call.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 3, 2014 5:51 PM Flag

    We got confirmation on Items number 4 & 5. Item 4 = ADASUVE was officially launched in the US on today, but it has been available since 1/20/2014.

    Item5 = Alexza officially confirmed today that Teva has priced ADASUVE at $145 per dose in the US, and the Medicare & Medicaid reimbursement rate is $153.70.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 3, 2014 5:31 PM Flag

    Teva will be working on getting the ADASUVE label and REMS modified to allow in-home use of ADASUVE within the next 2 to 3 years.

    Sentiment: Strong Buy

  • Thomas King just confirmed the $145 per dose price in the US during his Cowen & Company presentation that is going on now.

    Sentiment: Strong Buy

  • Reply to

    What happened to AZ-001?

    by todzun Mar 3, 2014 10:34 AM
    atlnsider atlnsider Mar 3, 2014 3:57 PM Flag

    This is one reason that I am looking forward to Alexza's Staccato System pipeline update this week. I believe that a lot of the questions that most of us have regarding old & new Staccato System based pipeline drug candidates will be answered this week.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 1, 2014 6:10 PM Flag

    By the way, the biggest positive surprise that I can see would not be an earnings surprise but a Staccato System pipeline surprise. The 2 potential positive surprise possibilities that I can see regarding the Staccato System pipeline are:

    1. Alexza announces that they have entered unto a new agreement for Staccato Nicotine. As you may know, the ownership of Staccato Nicotine has reverted back to Alexza from Cypress effective December 31, 2013. As a result, Alexza was free to enter into a new agreement for the rights to Staccato Nicotine with any other interested party effective January 1, 2014. If Alexza announces that they have signed an agreement with another company for the worldwide licensing rights to Staccato Nicotine, and this agreement includes a significant upfront cash payment, this will be a very positive surprise.

    2. Alexza announces a brand new, and completely unknown, Staccato System based pipeline drug that will address an important unmet medical and patient needs in the treatment of an acute and intermittent condition. Especially if this new Staccato based drug has the chance to be a potential blockbuster drug, with annual peak sales in excess of $1.0 billion.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 1, 2014 5:36 PM Flag

    That's a good point also. At the very least, it will be interesting to see if Alexza sticks with the same stated guidance regarding their available cash, and say that they still believe that they have enough cash to last until Q3 2014, or if they change their guidance and say they believe they have enough cash until - and then move it back to Q4 2014 or move it up to Q2 2014.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 1, 2014 5:30 PM Flag

    Alexza did not provide very much financial guidance for Q4 2013. I really don't have any specific expectations regarding the numbers for Q4, other than I do expect the ADASUVE commercial sales numbers in the EU & US will continue to increase during Q4 and during every quarter thereafter.

    The number of ADASUVE units that were shipped to Grupo Ferrer during Q2 & Q3 was 13,370 & 14,405, respectively. I am expecting that the number of ADASUVE units shipped to Grupo Ferrer during Q4 will show a significant increase during Q4 because the Q4 Grupo Ferrer numbers will not only include what Grupo Ferrer needs to supply the demand in Germany, it will also include ADASUVE inventory that Grupo Ferrer needed to supply its sub-licensees, Medivir & AOP Orpan.

    AOP Orphan launched ADASUVE in Austria in October 2013. In addition to Austria, AOP Orphan sub-licensed ADASUVE rights from Grupo Ferrer for: Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Switzerland, Slovakia and Slovenia. I believe that AOP Orphan has ordered enough ADASUVE to initiate the launch of ADASUVE in these countries.

    During September 2013, Medivir signed an agreement for the exclusive rights to promote, market, sell and distribute ADASUVE in the Nordic region, including Denmark, Finland, Norway, Iceland and Sweden. My guess is that Medivir has also ordered some ADASUVE to initiate the launch of ADASUVE in these Nordic countries.

    In addition, the Q4 numbers will reflect the initial pre-launch ADASUVE inventory that was shipped to Teva for the ADASUVE launch in the US. I expect that the number of ADASUVE units shipped to Teva during Q4 will be larger than the total number of units shipped to Grupo Ferrer.

    In my view an excellent quarter would be a quarter that shows a significant increase in the number of ADASUVE units shipped. I would expect/hope for better than a 100% increase in the number of ADASUVE units shipped during Q4 compared to Q3.That would be at least 28,810+ units shipped

    Sentiment: Strong Buy

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