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BiondVax Pharmaceuticals Ltd. (BVXV)

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  • [
    [A Blah's Blah]
    How this has stayed above $1 for so long is beyond me. Where did the pumpers go?
  • S
    While I am not actually a trained "Virologist," I do watch a lot of television and therefore believe I am fully qualified to give my opinion on such matters. Despite my impressive credential, the following is only one person's opinion.

    Regarding the soon to be released results of the recently completed U.S. phase 2 study, I believe that it will be irrelevant to the decision as to whether or not M-001 will be granted acceptance by the EMA and the FDA. It is only a 120 participant study. The U.S. study involved inoculating approximately half of the participants with M-001 and half with saline. All 120 participants received the seasonal influenza vaccine. For M-001 to demonstrate differential clinical effectiveness, it would need to show that it was more effective than the current vaccine AFTER the current vaccine's effect is taken into account. Furthermore, it would need to achieve that criterion with an exceedingly small number of cases. If, for example 15% of the general population were to contract influenza, that would mean we would expect, on average, nine people in each group to catch the flu. Partial out the effect of the seasonal vaccine on the number of participants who had the flu, and the number would fall to perhaps four or five per group. It is unlikely that any statistical test would find statistical significance with so small a number of cases, even in the presence of highly effective treatment.

    The European phase 3, on the other hand, uses more than 100 (not a typo) times the number of participants (12,463), making it far, far more likely to detect a significant difference between the two groups when, in fact, treatment is effective.

    In the European study, the first cohort is completing the second of TWO years, a capability that seasonal influenza vaccines would demonstrably fail. Recall a phase 2 study Biondvax completed in 2011 (BVX005), a study designed like current U.S. phase 2 study in which the seasonal trivalent influenza vaccine was used as adjunct to the seasonal trivalent influenza vaccine with people aged 65+. The study showed that M-001 played a significant role in adding sero-protection. However, in a follow-up with the same participants four years later, it was found that, of those who received only the trivalent flu vaccine in 2011, about ten percent were protected against an influenza virus that did not even exist in 2011. Of those who were in the group that received M-001, 60% were protected against this novel influenza virus. THAT is the strength of M-001 that no other influenza vaccine on the market today can match, and is not even addressed in the U.S. study. I missed New Year's eve with my family this year because I had the flu even though I had taken a double (geriatric) dose of the seasonal influenza vaccine less than four months earlier. Had M-001 been available, I most likely would have enjoyed that evening and would have been none the wiser about an attack on me by a strain of influenza for which the seasonal vaccine was ineffective.

    But wait ...... There's more!!!  The European phase 3 study pits M-001 against saline controls, not against a trivalent influenza vaccine, a much, much easier test to pass. A look at the first cohort, still blinded, indicates an over-all prevalence of influenza of just 3.3%, an astonishingly low number. Now, it is logically possible that the extremely low prevalence of influenza is due to the effects of saline rather than M-001, just as it is possible that the Earth will leave its orbit around the sun tonight. It just seems self evident that the chances for success are exceedingly high. A recent study out of MIT found that more than 85% of candidate vaccines already in phase 3 will not only achieve criteria for statistical significance, but will also make it to market. The fact that each and every phase 2 study of M-001 has been successful under difficult circumstances leads me to believe that the odds of success now are much greater than even the 85% estimate.

    For me, the U.S. phase 2 study results will be only of academic interest. All that matters at this point is the European phase 3 study. If it is successful, it seems clear that Biondvax will be making the world a safer place and that shareholders will be along for a very, very exciting ride.
  • S
    Valuation of Biondvax $BVXV, and why.
    Part-1 of 2
    This is for the community and specifically addressing discussions by @Sciencefan @tovtamid @A @[A Blah's Blah] @Leshiy @HanS
    I will not discuss probability of success to ph3, as I think this may be established already, I place it at 89%-93% (my personal opinion based on data published), there is a lot of data from the previous trials demonstrating safety and pointing to a high efficacy potential.
    I am not a financial advisor; my assessment is based on working in the vaccine industry. Please do your own research before investing in BVXV (don’t know why, but I felt the need to add this).

    These are the items which I use to consider the valuation, I will explain how they work into the assessment bellow:
    1. BiondFlu is a universal vaccine which protects against a broad range of flu types including newly discovered strains (potentially more than the one announced).
    2. It is good for at least 4 years of protection (may be more with more data).
    3. BiondFlu can be administered throughout the year.
    4. BiondFlu protects against pandemic flu outbreaks.
    5. Biondvax has a manufacturing facility.
    6. Biondvax has no significant sales capabilities.

    The following are gaps with current flu vaccines where BiondFlu has an advantage/solution:
    1. Efficacy of seasonal flu vaccine averages at ~40% to the general population and at only ~9% for the elderly.
    2. Adherence to flu vaccination is low.
    3. For seasonal vaccines, predicting the correct strains is tricky and sometimes manufacturers get it wrong.
    4. There is shortage of manufacturing capacity for vaccines (even pre COVID).
    5. Flu vaccine costs are very high for the governments and health insurers (mainly due to low efficacy, lack of adherence, and the HEOR not addressing the cost of the flu).

    Lastly, we need to take into consideration the following:
    • The global market is currently at ~$6B and growing at 6.5% rate (this rate may escalate due to COVID effect on policy).
    • The market is divided roughly between Sanofi (50%), Novartis (30%), and GSK (20%).
    • NITAGs, the organizations in European countries who are responsible for recommending vaccine schedule and administration, rely heavily on efficacy. The EU countries rely on these recommendation together with a heavy influence of the cost (calculated with consideration of cost of disease to the country).
    • ACIP does the same as NITAGs, but in the USA, the cost in the USA is negotiated with the insurers.

    Cost of flu vaccine for the payer/insurer:
    • BiondFlu is tested with the adult population, I am assuming NITAGs will recommend them to be the first to receive.
    • Being administered year-round allows BiondFlu to be administered during the patient’s annual visit and not have to come in for a special visit at flu season. The reduces cost for healthcare both by eliminating one more visit (although biondFlu requires two administrations, it will still be cheaper).
    The second impact of this is that most patients who do not get the seasonal flu vaccine forget to go get it or are just not motivated to take the effort. Getting the vaccine at the annual visit to the doctor will cover a bigger portion of the population, making prevention more effective and saving money to the healthcare system. This is very important for the countries in considering recommendations. BVXV may be required to conduct a post-market study to track this.
    • The overall cost of BiondFlu for the payer should be significantly lower than seasonal flu due to higher adherence, and to direct and indirect reduced healthcare costs.

    Long term immunogenicity
    • Long term Immunogenicity of at least four years also reduces costs by reducing visits and by reducing the number of patients who are not adherent to vaccinating.

    • Seasonal flu requires spikes in production. Since BiondFlu can be administered year-round, a smaller manufacturing capacity is required. This saves costs to the manufacturer, allowing it to get higher margins and transfer savings to the buyer.
    • Biondvax has developed manufacturing capabilities. I believe this may be enough to provide for only a limited launch, but nevertheless, will allow for a good launch addressing the elderly in the top paying EU countries.
    • As there is a lack of capacity available for vaccine production, BVXV’s valuation should also take into account the manufacturing facility. As context, Sanofi has invested during 2018-2019 more than EU600M for expansion of vaccine manufacturing capacity, and is still short.
    • Manufacturing is cheaper for BiondFlu compared to seasonal vaccines for the above factors and also due to length of production (2 months vs. 4-6 months).

    Pandemic flu
    • Usually contracted at lower price but provides constant revenue as the stock is partly refreshed every six months.
    • I expect more countries to stock up to pandemic flu post-COVID.

    Continue in Part-2
  • S
    Valuation of Biondvax $BVXV and why.
    Part-2 of 2

    Biondvax has no sales capabilities (as far as I know)
    • Companies at the stage where they are (ph3 data) usually have a marketing and sales leadership team in place. Following data release and up to approval is when they gradually build their field force.
    BVXV does not even have a CCO, not to mention sales, marketing, or reimbursement officers.
    • I believe BVXV will license out their vaccine while keeping the production facility.
    The big vaccine companies will probably compete on this license.
    • Given that BVXV has not yet established a commercial team, I would not be surprised if a licensing deal is already drafted and awaiting approval.

    Contracting in Europe
    • Note that each European country is different, and some may take longer to contract than others. This is not necessarily bad since it allows to safely ramp up production as one launches.
    • I expect the UK and Germany to be first to launch. Companies usually go with them first in order to establish a higher cost base, so future lower income countries have a comparative when negotiating.
    • Italy negotiates for a tender offering and requires some safeguards to ensure supply, this is a bit riskier if supply issues occur but once entered as part of the vaccine schedule, it is a lucrative country.
    • Spain takes for ages to get into schedule since there are multiple independent regions. I don’t expect BVXV to bother with Spain unless they have a partner.
    • In France vaccines are usually approved only after recommendations are complete and then begin the process, so longer to launch but lucrative country.
    • This staged launch will add valuation gradually so don’t flinch if valuation is not at maximum at approval.

    • I think valuation will come in a number of phases, as m-001 is only tested on the adults and elderly only in Europe.
    • With current capacity of up to 20M doses per year, and if licensed already by big pharma, once approved I think valuation (excluding pandemic) will be around $2B, but if not licensed I think it will be at around $1B since it will move slower to market.
    • Pandemic value should add another $0.5B, this can be managed by BVXV without a partner.
    • Once approved in the US and marketed in the US, valuation should go up to $3.5B given there will be capacity to supply.
    • If a licensing or an acquisition is announced between now and before launch (but post approval), I expect the deal to be around $2.7-$3.2B. A large pharma can take this vaccine to bring in $5B and up by 2024.

    As for why SP is not going up now if the above valuation is correct?
    I believe that investment companies are awaiting data release, I think they may be concerned as to why there is no commercial development, and they do not understand the value of a universal multi-year vaccine and how it is favored due to other HEOR items (such as adherence, non-direct cost reduction etc.).
    I also think that BVXV is very modest in its public relations and investor relation announcements, there are very limited releases and they are all very careful on what they claim. I am not worried about this as what will drive SP will be big pharma interest post data release and post approval.

    As far as I am concerned, the SP can remain $35 until approval, I am not in a rush.

    As someone who understands the data and vaccines I have high confidence on this. There is no rush on my side to see the stock at a higher price now, because once the data is published the valuation will be calculated to a specific value.

    My bottom line: I don't need the SP to be $48 or $60 now, I am waiting patiently for it to be above $100 between October and February, and above $300 in March-May.
    The potential triggers to SP as I see them are:
    1) Data release from Ph3 (by end of October)
    2) Regulatory approval and NITAGs recommendations
    3) Big Pharma acquisition (which could happen anytime in this sequence)
    4) Approval in the US and ACIP recommendations
  • H
    Investors will move from cyclicals to bios/cv related,
    Monday will open higher @24+, breaking HOYs of 25.50.
    Institutional will rush in to share the limited flow (about
    2.6m own by retailers), insiders 26% + 42% by Mr Nacht
    (Angels investment) + about 10% by institutional are not
    Tks for Zacks article ( especially, Target @81/ps, doubled
    From previous) indeed, will make BVXV greater!
    Friday AH closed @25 (high @25.50) up $1.1/+4.6% ,
    Although meanness but it was a good sign.
  • S
    Going for ATM offering is a very good signal!!!

    It means, most of all, that management are confident in ph3 results.
    ATM allows the company to offer these stocks in increments, meaning part now and part at a higher price after results are published.
    We can speculate all we want on how funds may be used (developing commercial capabilities, manufacturing, mitigating regulatory delays...) but the fact is we don't know.
    It is good practice for a company at this stage and in BVXV's situation to do so in order to be prepared for the unknown.
    If management had any doubts about ph3 data, they would have probably done an offering at below market price in order to secure funds for whatever they thought the issue may be (need for additional ph3...).

    I don't think ATM will erode SP in any way, there are buyers lined up and waiting to buy this stock.
  • H
    BVXV total O/S about 10,060,606 S
    Insiders holding about 22.93%
    Angels investment high tech (wholly owned by mr Marius Nacht) own about 42%
    Institutional own about 9.25%
    Remaining about 25.82% = about 2,597,648 shares owned by retailers.
    As insiders/Angels/institutional not selling, only about 2.597 million shares
    Owned by retailers in public for trading, which is considered as very low float.
    Any big lots of ASK could jack up sp, last week’s heavy volumes and uptrend
    Was the case. I smelled that new comers and institutional will step in before
    P3 data, they are competing and trying to grab small pie. Thus, can suggest whoever has to make sale pls put higher ASK Price, I think you can get it. However, if you want to re invest later, afraid that you have to pay higher price either.
    We have several months of non news period till P3 data, don’t think any down
    Side risks before then. I will hold on tight and wait for the fruitful result patiently.
    I invested thru broker’s recommendation about 2 weeks after IPO several years ago,
    Holding 5 figure shares at about 4.50/ps, didn’t sell at years high of about $10, and
    Held tight even sp down to low 3’s last year. I have strong confidence on the science
    Of M-001 and fundamental of the company including but not limited to the followings
    - M-001 is the only universal vaccine in the P3(Europe)/P2(USA) around the world.
    In 2015 a new “Swiss” epidemic influenza strain H3N2 emerged that did not exist
    In 2011 when BVX-005 trial took place and the participants in the BVX-005 trial were
    Exposed to the Swiss influenza strain, with results showing that greater than 60% of the M-001 vaccinated group had seroprotection against this new Swiss strain compared to only 10% of those immunized with just the seasonal vaccine. This suggests that M-001 May offer a broader long-lasting immune response not just to strain currently in existence, but to future strains that do not even exist yet. BTW had 6 successful phase studies, indeed, a great science!
    - Israeli government gave grant to the company to build manufacturing facility.
    - EIB (European Investment Bank) gave £24 (20+4) free interest loan to the company.
    Which is a great vote of confidence.
    Sp had be trading below $6 prior to last week with average volume 5,600 S, however,
    Target price was raised by analyst days ago to $44.- from previous 30-37.
    I record poster Sciencefan commented about 8 months ago “figure 1B per year sales, a 3X multiple would bring per share price to over $200/per share” ... well, anything could
    Happened especially in other bio investments, high risks and high rewards!
    Look at ARWR sp was traded around $2/ps 2 years ago but hit about 73.72 weeks ago,
    After secondary @58/ps, sp @66.46 as of Friday. Which is about 33x in 2 years.
    Furthermore, AXSM 52 week range 1.94-50.00 closed @46.79/ps Friday, again which is about 23X. Both ARWR and AXSM are in the develop stage no FDA approved drugs, same as BVXV. 24x could bring BVXV to $200/ps. Well you will never know, it could happened thou!
    I am planning to sell half of my holding prior to the p3 data/p2 (USA) @40-45/ps if reachable, remaining till NDA/BO...
    High and sound, a patient long term investor.
  • T
    The Biondvax was trading very recently on basis of very positive news releases. The science leasers are very impressive and respectful. The Shares were trading at around price of $7 for long time. With few presentations of the science leaders the shares move around $25 price. The news about completion of the Phase III move the price to above $60. In the last month the price was fluctuating down without any news to $38. There are few institutional investors that hold the lion shares of the stock, it is hard to believe that the very respectful three major investment holding, will liquidate their holding on basis of insider information that is illegal and could damage their good name. I think that there is no leakage of the test results and that the down trading is only profit taking by private holders. Investors that believe in the huge potential of the universal Flue vaccine should hold for the long term. BVXV might become a major pharma company after release of positive test result.
  • L
    I cross my fingers for BVXV success. I invested in this company many years before its come to Nasdaq. For now, beside BVXV, also keep nice stack in their warrants BVXVW. I fill confident with this investment and looking forward for good results from ongoing Phase II (by NIH, USA) and Pivotal Phase III (Europe) trials during this year.
  • S
    Let us assume the extremely unlikely scenario in which the strong, immunogenic response demonstrated in each and every one of the seven previous trials turns out - somehow - to be weak in the phase 3 and that all M-001 does is diminish severity of illness in older people. It hardly seems possible. However, even that disappointing result would still show how clearly important M-001 would be in making a real difference in saving many lives and in saving many billions of dollars in hospital related and time lost from work economic losses. There are anti-virals that diminish severity of influenza (Tamiflu is one) that are FDA approved and M-001 would offer important advantages over those. Even should this most unlikely outcome be the finding, M-001 would offer tremendous advantages that would warrant approval. I just don't see total failure as a reasonable possibility. Good luck to all longs as we enter the long-awaited latter half of September, in which results are likely to be released any day.
  • S
    At-the-market offering
    From Wikipedia, the free encyclopedia
    Jump to navigationJump to search
    An at-the-market (ATM) offering is a type of follow-on offering of stock utilized by publicly traded companies in order to raise capital over time. In an ATM offering, exchange-listed companies incrementally sell newly issued shares into the secondary trading market through a designated broker-dealer at prevailing market prices.[1] The broker-dealer sells the issuing company's shares in the open market and receives cash proceeds from the transaction. The broker-dealer then delivers the proceeds to the issuing company where the cash can be used for a variety of purposes. A higher stock price means a greater amount of money can be raised. The issuing company is able to raise this kind of capital on an as-needed basis[2] with the option to refrain from offering shares if the available prices on a particular day are unsatisfactory. ATM offerings can be started and stopped at any point, and they can also become more aggressive by selling more shares and raising more money when there is an opportunity in the market or additional need by the issuing company. ATMs can be positioned in advance of an upcoming liquidity event or major milestone to take advantage of increased liquidity and a rising stock price.[3]
  • t
    Less than 2 months to the end of the year, and to get the results of Phase 2 trail in the US.
    Could be a material event in the company's history as far as the recognition and awareness of the public - If the results will be as good as we can expect after so many positive trials.
    I really hope that this time the company will elevate the PR activities and get more traction, which could set some new records in the share price.
    In the last days the demand is increasing, and we can see 7,500, 10,000 shares in the "bid side" after manu days of only 100-300 shares in the bid side.
    Crossing my fingers to the good resolts - super bullish at the current share price.
  • S

    “We currently anticipate announcing the Phase 3 trial results in late September to the end of October this year based on the schedule of current operational activities. However, there are no assurances that this timetable will be met in the event that we encounter any delays.”

    Liked that!
  • L
    What I love about this company is that, unlike most other BioTech startups, in parallel with clinical trials, it built a rather powerful production line. This does not just say or hint - it screams with all its might that the company is confident in its product like no other. In most cases, drug development companies have only a small laboratory, and even to make a small number of products for clinical trials, they have to deal with 3rd parties contractors. And after the tests (if they are successful), to look for a partner with the opportunity to build production line. In our case, we are completely independent and ready for sales instantly with obtaining marketing approvals for this vaccine.
  • B
    Hi all.question of potential.In case that phase 3 is going well and good news will be by the end of December what do you think the stock value can reach? 2xtimes, 5 xtimes, 10 xtimes, more from its today value? and in how much tome you think it can reach it? (days? weeks?)Thanks!
  • S
    This is only my opinion but what I see is proper / smart business management.

    They have clearly stated in the past that they only had funding to get them through the phase 3 trial and to the end of 2020. With that in mind they asked to authorize another 100,000,000 common shares (2.500,000 ADS) In the shareholder meeting on September 2nd, which was approved.

    So this ATM equity offering is not unexpected. They are only seeking to raise $100M in cash, which at $40 per share they could make that goal. However I do not expect 2.5M shares to hit the open market, especially before Phase 3 results are released.

    They may place some of the shares with institutional investors before release of the Phase 3 results. Which would be a good thing for investors. As up to now the large institutional investors are either unaware or wary of such a small company as Biondvax and its one product pipeline. Maybe we will seen some real analysts coverage of the stock.

    Even with positive phase 3 results, Biondvax will need money to make the regulatory filings required to get their M-001 vaccine on the market, I would expect in Israel first followed by EU countries each of which will require approvals then later in the US. (Which may require a bridging study).

    I hope to see the share price continue to increase over the next year while these things happen, and once vaccine sales start....dividends.

    A stock split would also be beneficial as there is not enough ADS’s to go around if Phase 3 is successful.

    I believe this company is well positioned for a successful future.
  • H
    I am speechless! What a wonderful day!
    Closed @38.99 up $7.79(+21.087%), HOD/HOYs 41.64, up $14.41
    (+58.625%) from last Friday closed @24.58.
    Low float of shares will drive shorts panic, retailers and institutional
    Will rush in and paying much higher prices. I think Zacks target of
    $81 will show up in 1-2 months.
    Congrats to all! Especially, to me and Sciencefan as long term holder
    Since 2015, we are entitled to earn it on paper, so far!
    I further predict closing @45-46 tomorrow FRIDAY!
  • S
    Looking at the details of trading the past few days, although share price has fallen a few dollars, it looks to my eye that people are not really selling very many shares; that people understand the value of what they own and that most are unwilling to give away their stake in this company for a small fraction of what it is worth. Not sure why share price has dropped over the course of the past few days, but am guessing funds or people who want to invest a lot in Biondvax are trying to get in on the cheap. I think (please, if you know otherwise, correct me) that funds will be reallocating their holdings during the second week in July and Biondvax has only recently reached the market cap below which many funds are prohibited by policy to purchase shares. That, plus the $81 per share estimate by Zachs means to me that we are due for a significant increase in share price in the coming two or three weeks. A quick look at NVAX shows that their market cap is approaching $5 billion. They have a seasonal flu vaccine nearly ready for approval and are one of a good number of contenders for a corona virus vaccine. Our market cap is only ~$275 million. I remain very long in Biondvax and will continue to do so until we reach market, an event that all I know tells me is only months (not years) away. When things happen to Biondvax, they will be happening quickly. Very exciting times for Biondvax longs.
  • H
    hTo all longs
    Although always good to book profits, but don’t repeat don’t sell
    At this stage, as said when cowboys, Yankees, Vegas gamblers
    (Especially, casinos are closed) see this top winner, and find “universal
    VACCINE” (as they might not know the difference between bacteria
    And virus(Covid19)) I can expect to see buy orders flooding tomorrow
    And onward..BVXV is a real and has good potential stock, During this
    Pandemic, the whole world needs universal vaccine to prevent lose
    Of lives, even M-001 is not able to cure Covid19. I have been
    Holding since IPO 4 years ago at about $4.50, didn’t sell any at
    High of $10, 13.50 years ago.
    As a matter of fact, my portfolio was up about 18% today, as I have invested heavily in BVXV. It is the best day in my 40’s year’s investment history, I am very happy and excited.
    Lastly, I don’t want to hear any news for the time being, as it will creat “sell on news”, and stop the uptrend short term. Uncertainty will drive sp
    Either way, in BVXV case, sp will only go up till good results of p3....
    Hope I am right and can be assistant to all.
    Finally, above just IMO only, pls do your only DD.
  • H
    To whom wants to sell a good stock BVXV
    Before you place a sell order, pls think twice by reading article
    By David Bautz PHD days ago, he makes price target @81/ps
    With detailed calculations, immediately followed by Yahoo right
    After article published. Ever with 50% discount @40.50 still comes
    To 2x of current sp. Since flow is rather low, it is very easily manipulated
    By the MMs, my advice is holding tight your shares, case you need
    Cash, pls raise you ask price or use margin (against bvxv only).
    As a long term holder since ipo in 2015, can assure you our stock will
    Not drop but only hit north till/ prior to the results of P3 year end.