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VIVUS Inc. Message Board

atlnsider 154 posts  |  Last Activity: Apr 18, 2014 12:24 PM Member since: Dec 6, 2003
  • I tweeted the link @ATLnsider

    This new patent application was published on 3/6/2014 by the USPTO. Once this new patent is approved, it will provide Alexza's proprietary Staccato System platform technology additional patent protection at least until the year 2034.

    This will make ADASUVE an even more valuable asset to both Alexza & Teva.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 13, 2014 7:02 PM Flag

    ends_met;

    If it was just Alexza by themselves trying to commercialize ADASUVE in the USA and the rest of world, I would be more concerned about Alexza's past. The Teva ADASUVE partnership deal in the USA was the most important catalyst for Alexza in Alexza's history.

    Teva is en exceptional partner for Alexza. Teva has decades of experience marketing & selling neuro-psych drugs that treat patients who are suffering from schizophrenia and/or bipolar disorder.

    I have a lot of confidence in Teva. Teva knows what they are doing. Teva has done extensive research on ADASUVE and they are confident that they will make it a commercial success in the USA. Teva has a very successful track-record with its Special Drug Brands. ADASUVE will be one of Teva's Specialty Drug Brands.

    I have a lot of confidence in Teva based upon their decades of experience marketing & selling neuro-psych drugs like ADASUVE. Teva has done meticulous & expensive research on ADASUVE as an NTE, and they believe that annual ADASUVE sales will meet or exceed the average for all of their NTEs, which is $250 million.

    Even more importantly, Teva believes in Alexza's Staccato System platform. The Staccato System Platform has been proven to work with over 200 known drug compounds. Many of which are already being produced by Teva in a generic form.

    ADASUVE is just the start. It is just the first of many, many potential new Staccato based NTE drug products for Alexza & Teva.

    The question is:

    "will I trust Teva, or will I trust ends_met (cancerfighter2011)"?

    I will trust Teva, if you don't mind...

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    This new patent application was published on 3/6/2014 by the USPTO. Once this new patent is approved, it will provide Alexza's proprietary Staccato System platform technology additional patent protection at least until the year 2034.

    This will make Alexza's proprietary Staccato System platform inhalation technology even more valuable to a large pharma acquirer like Teva.

    Teva is looking for a sustainable platform delivery technology that will help them to develop 10 to 15 new NTE drugs per year.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 13, 2014 1:07 PM Flag

    You are right. Alexza has not been giving shareholders regular updates of its business development activities, ADASUVE commercialization activities, or it's Staccato System pipeline new drug candidates (except for Staccato Alprazolam). We still do not know what's going on with Staccato Nicotine, and what other Staccato based drugs will be developed next in Alexza's pipeline.

    I don't really focus on the day-to-day fluctuations in ALXA's share price whether it's up or down. I don't get excited by an ALXA stock price move of a few pennies, nickels, or dimes, whether it's up or down. I try to stay focused on the time when ALXA stock price will be at least 3 to 5 times higher than it is now. I will continue to buy, hold & accumulate ALXA shares on any weakness, like today.

    I am looking forward to Alexza filing its full annual report for 2013 (Form 10-K ) with the SEC. It will have a lot more detailed information compared to the Q4 2013 press release that Alexza issued last week.

    An investment in ALXA will require a lot of patience, a strong conviction, and a long-term outlook. I have a lot of patience & I have a long-term outlook. There are posters on this board (ends_met, cancerfighter2011, elfsysop, kingcatts, etc.) who love to talk about past Alexza set-backs & failures that happened 7 years ago, or in 2010, 2011, or 2012. But, my focus has been Alexza's excellent execution of its business & strategic plans since I became a shareholder in October 2012:

    1. ADASUVE was approved by the FDA on 12/21/2012
    2. ADASUVE was approved by the EMA on 2/12/2013
    3. Alexza signed a commercial sales partnershhip with Teva ob 5/8/2013
    4. ADASUVE was launched in Germany during July 2013
    5. ADASUVE was launched in Austria during October 2013
    6. ADASUVE was launched in Spain in January 2014
    7. ADASUVE was launched in the USA on March 3, 2014
    8. ADASUVE was launched in Romania today, March 13, 2014

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Teva continues to do a very good job of getting both public (Medicare & Medicaid) and private insurers across the US to provide prescription drug coverage for ADASUVE.

    Everything is coming together for a successful commercial sales launch of ADASUVE in the US. This is very good news for patient long-term ALXA investors.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Teva continues to add more and more health insurers to the list of payers that will help patients cover the cost of being treated with ADASUVE.

    Sentiment: Strong Buy

  • Reply to

    adasuve launched in Romania

    by sawsbaws1 Mar 13, 2014 9:21 AM
    atlnsider atlnsider Mar 13, 2014 9:32 AM Flag

    Thanks sawsbaws1!

    The global roll-out of ADASUVE is progressing nicely.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Teva continues to put everything in place to ensure that a lot of both public & private payers will provide coverage for ADASUVE. This will help to make the commercial sales launch of ADASUVE in the US a success.

    Sentiment: Strong Buy

  • Reply to

    USD158.00 @2007 March Miracle

    by moonckm Mar 8, 2014 1:33 AM
    atlnsider atlnsider Mar 8, 2014 5:41 PM Flag

    So you are saying that because Alexza had some setbacks in the past, that means Teva will fail with their commercial ADASUVE launch in the US?

    In other words, you are saying that Alexza's past is a good predictor of Teva's future?

    Yeah, that's the ticket...(lol)

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Alexza has already gotten a trademark for ADASUVE in Japan. This is in preparation for expanding the ADASUVE & Staccato brands to the country of Japan.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Alexza has already gotten a trademark for ADASUVE & Staccato in China. This is in preparation for expanding the ADASUVE & Staccato brands to the country of China.

    According to Alexza yesterday, they are currently & actively pursuing a 2-pronged strategy of expanding ADASUVE to Asia, including China, Japan, South Korea, Maylasia, Indonesia, Australia & New Zealand. Alexza will choose either a large multi-national (like Teva) who can take the whole Asian-Pacific region, or they will partner with regional pharmaceutical companies that will take each Asian country separately.

    I would expect that Alexza will negotiate an ADASUVE deal similar to the Teva deal for the US rights, which will include:

    1. A large or significant upfront cash payment.

    2. Ongoing tiered royalty payments based on net sales

    5. Significant sales & clinical based milestone payments

    These partnership & licensing deals will be a way for Alexza to raise some additional cash to meet its cash needs beyond Q3 2014.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Teva continues to do a very good job of getting both public (Medicare & Medicaid) and private insurers across the US to provide prescription drug coverage for ADASUVE.

    Everything is coming together for a successful commercial sales launch of ADASUVE in the US. This is very good news for patient long-term ALXA investors.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 7, 2014 12:36 PM Flag

    So far, Alexza has answered questions: 1, 2, 4, 5, 7 & 8. I would still like more information regarding questions: 3, & 6.

    I am hoping that the Roth Capital investor presentation on Monday, March 10th, will give us more detailed information regarding the Staccato System pipeline, and maybe more information about the EU launch.

    Also, I am waiting for the 2013 Annual Report (10-K) to be filed with the SEC. I am sure that there will be a lot of additional information in the full year-end report.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 6, 2014 9:17 PM Flag

    Thanks!

    The next few weeks should be very interesting...

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 6, 2014 6:59 PM Flag

    You are correct about Teva already working on getting in-home use of ADASUVE approved by the FDA.

    In fact, Alexza is already recognizing some income on its financial statement to reflect the probable income expected from the sNDA that Teva will submit to the FDA. My guess is that the sNDA will include in-home use of ADASUVE, plus the expansion of the ADASUVE label to treat adolescents (ages 13 to 17).

    It will all depend on the results of the Phase 4 studies, and if the efficacy & safety data does support the FDA approving the sNDA & expanding the ADASUVE label.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 6, 2014 6:51 PM Flag

    Alexza will make a manufacturing profit because it is selling each ADASUVE unit to Teva at a pre-determined price that include a fully-loaded manufacturing cost + a manufacturing profit for each unit.

    Also, Alexza will earn tiered royalty payments from Teva, ranging from the low teens to the mid-twenties percent of net sales 0f ADASUVE units.

    I would suggest that you go back & read my Seeking Alpha article: "Valuing Alexza After the Teva Deal". This will give you some good background information.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 6, 2014 6:12 PM Flag

    The $400 million per year is top-line sales for Teva. It's not just the Alexza share.

    So, fredpaete2000 is right about how many ADASUVE units it will take for Teva to reach $400 million in annual sales.

    Sentiment: Strong Buy

  • That's because the ADASUVE per unit sales price is $145 instead of $75 per dose.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 6, 2014 4:30 PM Flag

    They came in at a loss of -$0.33. This is much better than consensus, but I was a little disappointed by the number of ADASUVE units shipped. They shipped a total of 21,170 units in Q4, compared to 14,405 units in Q3.

    This was an increase in units shipped of about 47%, but I was hoping for at least a 100% increase. My guess is that most of the new Teva units were shipped during this quarter, Q1 2014 instead of Q4 2013.

    Sentiment: Strong Buy

  • atlnsider atlnsider Mar 6, 2014 3:46 PM Flag

    The consensus analysts EPS estimates that I have seen for ALXA for Q4 2013 are in the range of a loss of -$0.71 to a loss of -$0.76.

    Has anyone found any different estimates?

    Sentiment: Strong Buy

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