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Excellent. Thanks so much for letting me know the terminology for that and for that court document. Much appreciated.
I figured I could count on you for clarity on that subject. Thanks for that and for referencing an earlier post.
I agree that we cannot infer imminent bullish news based solely on the timing of their option grants, but I did find the timing of before the call, rather than after, curious. Of course, it'll all be a non-issue when the call ends on Monday with no major news; but they'll have the same situation on their hands as CYTR if bullish news is released ;)
To, Dew [or any of the others who know more about employee-based stock options than I do (probably all of you on this Board)]...I would love to get your opinions on my post here (#msg-98488718) regarding NVAX. Thanks in advance.
Employee stock options
NVAX granted some new employee stock options yesterday (See the Form 4s here). I am wondering about the timing of them being granted just prior to the quarterly financial conference call, which is in two days.
My question is this:
Are insiders allowed to grant stock options with material data in hand that has not yet been released to the public.
If they are not allowed to grant options without having first made material data public, then I doubt that anything material will be released on Monday's conference call (i.e. interim RSV Phase II results in pregnant women).
On the other hand, if they are required to make material data public prior to granting employee stock options, then I would think that their timing of the options might be a bullish sign, in that they think the stock price will be heading upwards soon, potentially as soon as after the conference call.
I also wonder if these stock options had anything to do with those big purchases made EOD and A/H on Tuesday, March 4 (#msg-98249875).
Definitely agree.
Yeah, I remember the financials are coming on the 10th. You are right that some people don't want to hold through that, but with the financing PR'd recently, you'd think that'd support the share price some. Personally, I don't care so much about the financials of early stage biopharmaceutical companies because I always expect them to lose money. As long as their fundamentals haven't changed dramatically, I won't trade my position to avoid a potential near-term small loss when I think that it'll rebound back anyway. But I'm not a trader, just an investor. There are probably a lot of traders in this stock, and it could be contributing towards downward share price like you said.
I was wondering about that myself. It has dipped down the past two days.
I envision that one of three things are happening:
1. I'm hoping it's just a shakeout of weak hands by the MMs, taking out stops along the way in order to accumulate.
2. A lot of small biotechs were down around 4-5% today. Not sure why.
3. The thing that fears me the most is that whole large amount of shares that went thru EOD on Tuesday and AH. I think people are wondering what that was all about. Was it an institution selling? Was it an institution buying? Is it selling on insider info or just maybe somebody (institution) looking to take some profits? I keep telling myself that somebody may have sold all those shares, but somebody was willing to buy them, too!
After the selling the past two days, I started getting a little nervous, but then I tried to sit back and take stock of the situation. The share price has rocketed over the past handful of months. There have been days like this before and it's always gone back up. Plus, with all these financing deals PR'd about lately, I have to imagine that good things are still to come. I am expecting great Ph2 data in pregnant women; but we shall see.
Ahhh. Thanks for the info. That was very helpful. Figured it must be something like that going on.
Things definitely lining up well.
Saw those large blocks at EOD as well as A/H. I have to imagine that was some pre-arranged purchase or transfer of shares that was worked out with a market maker to accumulate those shares over some time and then sell them to an institution (or maybe it had to do with rebalancing an index fund?) because the share price didn't budget on those huge purchases, which under a normal huge market purchase like that the price would have gone up dramatically. At least those are my thoughts about that.
A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant
clinicaltrials.gov/ct2/show/NCT02078674?term=novavax&lup_s=02%2F19%2F2014&lup_d=14&show_rss=Y&sel_rss=mod14
Large blocks at end of day and after hours...wonder what that was? Accumulating shares pending some news? Or maybe institutional transfers? Not sure how all that works behind the scenes but interesting nonetheless.
Nice work on those buys. Hopefully NVAX continues to bring great returns :)
Craaaazy. I first got in at $1.89 and $2.25 (those are long gone, though, unfortunately). But I have built up a nice chunk of shares with average of $3.62. Almost at a double, overall. Have been a big believer in RSV vaccine. But NVAX is positioned well with seasonal and pandemic flu vaccines, as well as others in the pipeline. Still debating on whether to shed a few shares and take some profits just in case some unforeseen safety issue comes out of the Ph2 trial in pregnant women. I doubt that will happen, but one never knows.
Good luck to all of us NVAX longs :)
$6.99 in after hours. EOM.
Novavax Announces Extension of Contract for Advanced Development of Recombinant Influenza Products and Pandemic Preparedness with HHS-BARDA
ih.advfn.com/p.php?pid=nmona&article=61255455&symbol=NVAX
GAITHERSBURG, Md., Feb. 27, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced today the execution of a contract modification to extend the base period of performance of its current contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of Novavax' recombinant seasonal and pandemic influenza vaccines. The contract was originally awarded in February 2011, with funding of up to $97 million over an initial base period ending in February 2014. Novavax and BARDA have agreed to amend the agreement to allow Novavax to continue to access the remainder of the $97 million in base period funding through September 2014. These funds will support the upcoming Phase 2 trial for our H7N9 vaccine candidate with Matrix-M, and activities relating to our quadrivalent seasonal influenza vaccine. BARDA has the ability to dedicate up to $79 million in additional funds to support Novavax' later-stage development of these vaccines, during an option period currently anticipated to add two years to the overall performance period.
"Development of our seasonal and pandemic influenza products during the last three years under our contract with BARDA has allowed us to refine and develop influenza vaccine products while delivering important clinical trial results from our seasonal quadrivalent, avian H5N1, and most recently, avian H7N9 studies. While our original development plans anticipated utilizing the full amount of the contracted base-period funding within the three-year period, certain scope changes and development efforts resulted in delayed development timelines. Extending the base period allows us to continue to access the remaining base period budget as we initiate a pandemic H7N9 Phase 2 study early this year and prepare for additional Phase 2 and Phase 3 influenza clinical trials, which we expect would occur during the contract's option period," said Stanley C. Erck, the company's CEO and President.
About the Novavax BARDA Contract
In February 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness. Throughout the contract's base period, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. Upon satisfaction of established milestones, the contract is expected to be extended, upon execution by BARDA of an Option One period. The milestones under the Option One period would focus on completion of the pathway to product licensures from the U.S. Food and Drug Administration (FDA), including support for manufacturing scale-up. There is an additional contract option for vaccine production ($3 million).
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2012, and Form 10-Q for the period ended September 30, 2013, both filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
Another nice day with increasing share price on good volume. Four green days in a row. I emailed IR and they never said they were going to release interim data results, so it looks like we might have to wait until the trial is over to get the data on RSV vaccine in pregnant women. Hopefully the share price keeps going up nicely until then. The pop that people want in NVAX share price (assuming positive Ph2 data) will depend on the price action leading up to the data release. If the share price already has increased significantly, we might experience less of a jump on positive news; but I'm sure we'll still get a nice bump. The potential is too great.
SRPT has been moving up in pre the past two days, albeit on small volume. It held gains yesterday, though. Today up to $32 (6.51%). I think investors are expecting some news to be released on conference call this week. Chris Garabedian tends to do that. A lot of people expect that we'll get some update on their FDA minutes or any other insight on their conversations with FDA.
Some big buys really coming in today...
pSivida: Positive Roche And Regeneron Conference Calls Confirm Tehadur's Potential
seekingalpha.com/article/2025831-psivida-positive-roche-and-regeneron-conference-calls-confirm-tehadurs-potential
Assessing the Long and Short View of pSivida Corp.
Company Overview
pSivida Corp. (PSDV) is not a proof-of-concept stage biopharmaceutical company, but is a developer of a proven, sustained release drug delivery system. pSivida already has two approved products, Retisert partnered with Bausch & Lomb for the treatment of chronic noninfectious uveitis, and Iluvien partnered with Alimera Sciences (ALIM) in the treatment of Diabetic Macular Edema (DME). Iluvien is already approved in 6 EU countries and it is expected to have an FDA decision by 4Q14. pSivida is entitled to 20% royalties of both products and is developing Medidur, which is their first full commercial rights product for posterior Uveitis in Phase III trials. Importantly, pSivida will retain all earnings from Medidur, and will likely replace Retisert in the market, because it is more efficacious with fewer side effects. Importantly, pSivida has no new molecular entity risks in its commercialization strategy because they focus on partnering with larger commercial players with drugs already FDA approved to incorporate into their drug delivery devices.
While pSivida is growing its sales with these approved products, the most significant catalyst and path to large commercial success relies upon a new product called Tethadur. Tethadur is a small honeycomb structure drug delivery device that has the surface area of over two tennis courts, which is designed to carry large complex proteins and peptides such as Avastin, Lucentis, Eyelea or Herceptin. Critically, pSivida's Tethadur platform can provide sustained release of these drugs for over two years with only one dose! With over $50B of biological drugs coming off patent within the next 5 years pSivida's strategy is centered around providing a patent extension strategy for these biological drugs by reformulating them with Tethadur, thereby reducing the frequency of dosing.
Market Overview of Diabetic Macular Edema (DME)
Diabetes affects an estimated 23.6 million people, or 8% of the US population. It is the leading cause of new cases of blindness among adults aged 20-74 years, with a projected 12,000-24,000 new cases of blindness in these adults each year in the U.S.
The prevalence of DME among U.S. diabetics approaches 30% in adults who have had diabetes for 20 years or more. This would imply that close to 8 million diabetic patients would require chronic treatment for DME over the next decade.
A large meta-analysis found that 27% of type I diabetic patients develop DME within 9 years of onset and estimated that the overall prevalence of DME was 6.8%. If left untreated, 50% of patients lose 2 lines of visual acuity (VA) within 2 years. Roche/Genentech estimates that DME affects more than 560,000 Americans with the disease. In Europe, nearly 5.4% of patients with diabetes are estimated to experience visual impairment due to diabetic macular edema (DME). While in the U.K., 336,000 individuals with diabetes have diabetic macular edema.
The most important drug class in the wet AMD and DME markets is the humanized monoclonal antibodies targeting VEGF. The relative differences amongst these three biologics (Avaston, Lucentis, and Eyelea) are not well differentiated based on efficacy, but are primarily only distinguishable based on their frequency of administration by intravitreal injection. And this is where things get interesting, the current market share for Lucentis, Eyelea, and Avastin are 24%, 24%, and 52%, respectively in the wet AMD market. Regeneron (REGN) recently announced full year 2013 sales for Eyelea of $1.4 Billion. All of which, comes at the expense of Roche/Genentech's (OTCQX:RHHBY) Avastin and Lucentis losing market share driven by a more convenient dosing schedule. Eyelea is dosed at 2 mg monthly and then 2 mg dosed every two months (after 5 initial monthly injections) compared to monthly injections with Avastin or Lucentis. It is undeniable that fewer injections are a powerful differentiator within a drug class, when efficacy and safety are equivalent. Iluvien is pursuing a similar approach in the much smaller steroid segment of the DME market and expect to have similar success based upon more convenient dosing.
The available patient pool for Iluvien is likely to be restricted to 2-5% of the total DME population, limited to pseudophakic patients (those who have undergone previous cataract surgery) who have chronic diabetic macular edema (DME) and as salvage therapy for non-responders to anti-VEGF therapies. Based on the available literature, anti-VEGF non-responders are a very small segment of the treated population ~2%, however, price and insurance coverage may work in Iluvien's favor with its reduced price and with patients reluctant to receive intravitreal injections every 4-8 weeks. Although a recent physician survey provides direct evidence of marginally higher rates than what is reported in the literature at 6.25% switching from anti-VEGF therapies. Of these, one-third switched to steroid therapies or ~2% of the total. pSivida's CEO Dr. Paul Ashton proclaims "the pseudophakic DME population represents a large subgroup, as patients with DME have a far higher incidence of cataract than the overall population. In the Phase III FAME trials of ILUVIEN, over 50 percent of control patients were pseudophakic at the end of the trial." As a result, the number of pseudophakic patients will grow over time, and Iluvien's market opportunity will grow in proportion.
The current treatment landscape in the United States for DME is distributed 60%/40% between anti-VEGF and laser/steroid therapy respectively (steroids account for 5-10%). Based on a physician survey conducted by Merrill Lynch, who prescribe anti-VEGF therapies to a patient population of 7,000 wet AMD and 5,000 DME patients per month found that the rates of discontinuation of anti-VEGF therapy was approximately 6.25% or 750 patients during a three-month period. Of these patients, 31% discontinued anti-VEGF treatment, 30% switched to Lucentis, and 39% switched to Eyelea.
In April 2012, the wet AMD market share distribution for Avastin, Lucentis, and Eyelea were 57%, 32%, and 11%. But in July 2013, the market share shifted strongly toward Eyelea gaining a market share of 24%, with Avastin falling to 52%, and Lucentis falling to 24%. This is noteworthy because the survey also determined that over 65% of physicians prescribe Eyelea over other anti-VEGFs due to less frequent dosing.
(click to enlarge)
This establishes that there is strong preference in the clinic for prescribing less frequently dosed therapies, which bodes well for Iluvien.
Since Lucentis' approval in DME there has been a revival of Lucentis sales growth despite the attrition in sales in the wet AMD indication due to Eyelea. Recall, Eyelea is slated for an FDA decision in DME on August 18, 2014, upon notice of approval Lucentis sales will likely continue their decline or at best flatten. This could provide the impetus needed for Roche/Genentech to confirm a competitive initiative with pSivida's Tethadur platform with Lucentis. Lucentis is a potent VEGF inhibitor and would regain a substantial advantage over Eyelea if Lucentis could be successfully formulated with pSivida's Tethadur insert. Roche held their 4Q13 conference call on January 30th 2014, Daniel O'Day - Chief Executive Officer of Roche Molecular Diagnostics and President of Roche Molecular Diagnostics stated "In DME, we continue to gain share and do well there. I would just remind you that in the second half of the year, we expect to have competition from Eylea in this DME setting, just to raise that to your attention for the course of the year." This was an attempt to reduce 2H14 expectations of Lucentis growth in DME prior to Eyelea's PDUFA on August 18, 2014. Importantly, pSivida will be the last one to enter this market, if at all, and will garner only a small share of 1-5% of the overall DME market.
Typically, this makes a bearish case for a stock. However, pSivida is starting with really low expectations, a small market valuation, and only requires modest royalties to justify its current valuation. If global sales launch exceed $100 million in 2015 it would provide $20 million in royalties to pSivida. This would disproportionately propel shares substantially higher if coupled with a favorable outlook and forward guidance.
Reported steroid use is broken down among triamcinolone acetate, dexamethasone, and fluocinolone acetate. Unfortunately, it was not possible to ascertain what the market share is for each steroid in DME indicating that there is wide dispersion and no real preference for one over another. However, extrapolating from this physician survey and other sources there is evidence that longer duration therapies with evidence of fewer side effects would provide strong incentive for physician's preference of Iluvien over other steroids.
We could reasonably assume that after 1-2 years on the market Iluvien could reach >25% market share (equivalent to Eyelea in anti-VEGF market) of the steroid segment in the DME market which would indicate 1.25% of the total DME market. This assumption is based on its extended duration of action and its infrequent dosing. Recall, steroid/laser therapy collectively represents 40% of the overall DME market, but the steroid component has fallen from 10% to only 5-7% (see chart below) since Lucentis' approval in DME. Although, it is possible to envision that the best bull case for Iluvien could reach 50% of the steroid market in DME, this translates into 2.5-3.5% of the whole DME market. More conservatively, if Iluvien only penetrated 10% of the steroid market in 2015 it would represent 0.25-0.35% of the DME market. On August 12, 2013, Alimera reported that 30 DME patients were treated with Iluvien and $300,000 in total sales, but stated that demand from funding requests for Iluvien were 3x these numbers. On November 11, 2013, Alimera reported total sales of Iluvien of $758,000 or 323% growth within the Eurozone, and does not include any sales inside the U.K. A recent press release said they only recently shipped its first product to the U.K., in January 2014. On December 2, 2013, Iluvien received approval for reimbursement in the U.K. where there are 336,000 eligible patients to receive Iluvien. In the best-case scenario, using recent Iluvien growth metrics and reducing them 80%, we will model 68.75% average growth per quarter for 4Q13 and 2014 resulting in:
Best Case Model
Alimera
$1,279,125 4Q13
$2,158,523 1Q14
$3,642,508 2Q14
$6,146,732 3Q14
$10,372,610 4Q14
pSivida 20% royalty ~$2.06 million
But if approved in the United States sales growth could reaccelerate to at least 80% per quarter 2Q 2015:
$18,670,698 1Q15 (80% growth)
$33,607,256 2Q15
$60,493,060 3Q15
$108,887,508 4Q15
pSivida 20% royalty ~$22 million
P/S ratio of 20: $440 million market cap or $17.23/share
These growth rates are premised on the assumption that Iluvien's most recent sales data are primarily derived from 3-4 European countries and expected 2014 launches in France, Italy, and U.K. Additionally, 2015 sales growth will be supported by a United States launch that is at least 1-1.5x E.U. demand. A substantial risk to these estimates comes from the fact that Iluvien is dosed only every 2-3 years, and therefore a lack of recurring revenues. Consequently, Iluvien sales may peak relatively rapidly and trying to determine the timing is not feasible, but may occur 1.5x redosing period implying 4-5 years. Moreover, Alimera's marketing strategy in the U.S. will be paramount to its success. According to Alimera's 3Q13 press release they contracted this effort out to Quintiles Inc. (Q), a global leader and should be able to accomplish sales goals in a cost-efficient manner.
Base Case Model
The current demand for Iluvien in the EU is approximately $1-1.5 million per quarter and since it only recently started sales in the U.K., it is fair to assume similar demand, representing at least a combined $3 million in quarterly sales outside the U.S. and $12 million per annum. The United States market potential is likely to be 1.5-2x the total E.U./U.K. combined, when simply adding identical sales demand seen in the EU/UK and the U.S. this would equate to at least $24-36 million in world-wide sales providing royalties to pSivida of $4.8-7.2 million annually, producing a P/S ratio of 16-25 at its current market price, and assumes no growth in the future. The most important factor when elucidating if pSivida's stock is fairly valued or undervalued is how to model Iluvien's medium-term growth rate. If it can achieve sustainable 60-100% quarterly growth then the stock is undervalued, however if it only attains 20-40% growth there is 20-30% downside in the stock. However, as revealed during pSivida's fiscal 1Q14 conference call, they do not receive any royalties until Iluvien is at breakeven by Alimera's cost of production, distribution, and marketing in each country. Management provided no guidance as to when that threshold would be met.
Base Case
$4.8-7.2 million in 2014 sales of Iluvien
Gives a P/S ratio of ~17-25 at current market valuations
(click to enlarge)
(click to enlarge)
The cost effectiveness of Lucentis (ranibizumab) in DME was evaluated from evidence gathered in the RESTORE trial. Using a Markov model simulating a 15-year time frame for treating DME in one eye using 2010 price levels, it was found that the Lucentis monotherapy was approximately US$39,072 compared to laser monotherapy. Previous sales prices for pSivida's Retisert cost $20,000 for each implant, compared to the Ozurdex (dexamethasone insert) price of $1,600 every 6 months. When adjusting costs to Iluvien's 2-3 year dosing schedule, Ozurdex 2-3 year equivalent cost is $7,200-$10,800 per eye. An important metric that supports Iluvien from a cost-benefit perspective is that outpatient department visits for DME patients accounted for $10,557 vs. $5,353 for non-DME patients. Thus, it is reasonable to assume a 30-40% reduction in overall costs of care in DME patients treated with Iluvien as a result of fewer outpatient visits and reduced drug costs compared to anti-VEGFs. When compared to Ozurdex, however, there are some noteworthy differences on efficacy between these two ocular inserts. Ozurdex's primary outcome for efficacy in clinical trials was measuring the proportion of patients at week 8 that achieved a 3-line improvement from baseline best corrected visual acuity (BCVA). In this small study of 143 patients, 43% met the primary endpoint at week 8. In two Phase III trials consisting of over 956 patients treated with Iluvien inserts demonstrated statistical significance at 24 months with 26.8% (p value 0.029) of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 26.0% (p value of 0.034) of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline. These distinguishable qualities of Iluvien should give Iluvien an advantage and support pricing of at least $10,000 per insert in the U.S. The main disadvantage of steroids is an amelioration of its efficacy over time, but Iluvien has reasonable efficacy at the end of 2-years of follow-up.
Multiple Pathways to Commercial Success
pSivida is more akin to a medical device company than a drug company. The reality is that the agents currently being utilized with their Durasert platform are lackluster and do not provide a meaningful advantage beyond a slight benefit in diminished side effects and longer durations of response with less frequent dosing. Not to minimize this meaningful achievement or sales potential relative to its small market cap, but the drugs pSivida and its partners are utilizing with their Durasert technology significantly limits its full commercial potential.
While pSivida's ongoing development programs for Medidur in Uveitis and Iluvien in DME could provide meaningful upside to its stock price, pSivida's long-term potential and commercial success will be driven by their ability to commercialize their Tethadur platform for large biological molecules. And with that will follow their stock price. The commercial opportunity is so disproportionate in size that it diminishes Medidur and Iluvien as sideshows to the main event. Again, using Regeneron as an example, which currently trades at 15x 2013 sales, pSivida would only require $8 million in royalties in 2014, and the expectation of consistent growth greater than 50% per year through 2017 to justify its current market value.
Thus, our bogey for validating our cautious, but bullish thesis is:
Consistent sales growth of at least 60-80% per quarter.
FDA approval in the U.S.
Official announcement with a large commercial partner for Tethadur and entry into Phase I development in 2015.
The pathway to Tethadur's commercial development and approval will require a partnership with a leading ophthalmology company that will fund the development of Tethadur with a potent agent such as Lucentis for DME. Their technology for sustained delivery of drug to the site of action is an attractive modality for many indications. The question remains why they have not sought more lucrative therapeutic indications for market entry with more efficacious therapies.
Although, this is fairly speculative at this point, but additional pathways to substantial shareholder returns may come in the form of an acquisition. And would certainly be contingent on Tethadur completing Phase I/II trials successfully, which is still in the distant since it is still in preclinical testing. OPKO (OPK) stands out as one potential bidder, and has a long history of pursuing high risk high-reward acquisitions. However, any transaction would likely occur as a stock-for-stock deal. Upon successful regulatory approval of Tethadur many other of the typical large ophthalmology focused companies would surely become potential suitors as well.
As noted previously, remarks from pSivida's management at a medical conference claimed to have an ongoing feasibility study with a "…large specialty pharmaceutical company in the ophthalmic market for testing its Tethadur platform to deliver a large antibody." This was also confirmed during the 4Q13 conference call "Tethadur in certain ophthalmic applications is being evaluated under a funded evaluation agreement with a leading global biopharmaceutical company. Two other major pharmaceutical companies are evaluating our technology platforms in other ophthalmic applications under funded agreements." The upcoming Fiscal 1Q14 conference call may provide additional developmental details about Tethadur's future.
The two potential companies that immediately come into play are Genentech (Avastin and Lucentis) or Regeneron (Eyelea). However, surveying the competitive landscape and treatment trends of eye diseases over the past few years implicate Genentech as a more likely partner than Regeneron. Since the launch of Eyelea (aflibercept) Regeneron generated $838 million in 2012 during its first full year of commercial sales, and sales grew 60% in 2013 to $1.4 billion. Eyelea's commercial success is almost exclusively attributable to its more convenient dosing every 8 weeks versus Lucentis or Avastin every 4 weeks. Avastin and Lucentis remain the market leader in diabetic retinopathy (DR) and DME. However, since the launch of Eyelea Genentech has continuously lost market share to Eyelea in wet AMD. Consequently, due to the recognition that less frequent dosing translates into higher sales, it is plausible that Roche/Genentech are seeking new modalities to reassert its dominance in the DME market with pSivida's Tethadur delivery platform.
Regeneron expects its PDUFA for Eyelea in DME by August 18, 2014 and expects to file for BRVO (branch retinal vein occlusion) in 1Q14. Regeneron is seeking to develop a PDGFR-B antibody co-formulated in combination with Eyelea for DME, as well as with an ANG2 antibody. These recent moves in their late stage programs conclusively reveals their patent extension strategy for Eyelea and provide additional evidence that Genentech is the more likely partner for pSivida.
Support for this Hypothesis from both Roche's and Regeneron's Conference Call
Roche/Genentech has no patent extension strategy in development. With reported total sales for Avastin and Lucentis in eye diseases somewhere around $2 billion per annum, if formulated with pSivida's Tethadur insert and a similar royalty scheme with Alimera would result in $400 million of royalties to pSivida.
On February 11, 2014, Regeneron reported 4Q13 results that provided additional evidence of these assertions. On the conference call Regeneron provided additional long-term safety and efficacy data from its Phase III VISTA DME trial with Eyelea. These results showed that the improvement in vision compared to laser photocoagulation therapy that was seen after one year of treatment with Eyelea dosed either monthly or every other month after five initial injections was sustained after two years of treatment. In this long-term study, EYLEA dosed every other month resulted in visual acuity benefit that was similar to that achieved with monthly dosing. It is also worth noting that 43% of the patients in the VISTA study were not treated naïve and in fact had received prior anti-VEGF therapy (Lucentis/Avastin).
It stands to reason that Eyelea will continue to take market share from Lucentis/Avastin in DME, as it has already accomplished in wet AMD. This puts substantial pressure on Roche/Genentech to protect its eye disease franchise, but with only one new agent in Phase I trials in wet AMD, it appears that Roche has lost the initiative against competing Eyelea. However, something very interesting that most investors have failed to recognize (including myself) is that Roche is actively exploring a sustained delivery system for Lucentis with Novartis and ForSight Lab's VISION4 platform (see figure below courtesy of Roche), although there was immaterial information available with regard to frequency of dosing, other than a brief statement "the device is a refillable drug port delivery system (PDS) designed to release Lucentis over a period of months." The lack of recognition of this program is due to Roche's widespread development pipeline, which makes it easy to overlook small cues and their implications for smaller companies. Other important metrics to be able to determine the potential significance of this program or their long-term strategy for protecting their eye disease franchise remain unavailable and ambiguous at this time.
(click to enlarge)
According to a press release on January 13, 2012 from ForSight Labs- Genentech, a member of the Roche Group announced it entered into an agreement in December 2010 for exclusive worldwide rights for ForSight's implantable ocular device and made its first milestone payment to ForSight VISION4, Inc. on January 13, 2012. This milestone was achieved based on Genentech's decision to move forward and submit an (IND) with the FDA as part of an exclusive license agreement to develop the company's investigational drug delivery device, designed to provide sustained delivery of Lucentis (ranibizumab).
The implications of this program are confirmation that there is significant interest from global pharma companies in developing new dosing modalities to extend the duration of action of monoclonal antibodies. Furthermore, this confirmed my suspicions that Roche would more likely be identified as pSivida's undisclosed partner. While the ForSight Vision4 program would enable Roche to "catch up" to Regeneron with regard to less frequent dosing regimens, and may provide a small advantage, it is nonetheless not all that impressive. In fact, this program with such a small incremental improvement in less frequent dosing may not justify the costs to carry through full clinical development.
According to ClinicalTrials.gov, the ForSight Vision4 program has enrolled 20 patients from Latvia in a Phase I study, with primary outcome (change in retinal thickness measured by Optical Coherence Tomography) completion date in May 2012, and estimated study completion data May 2014. No study data has been released at the time of this writing.
There are important read-throughs from Roche's strategy and Regeneron's 4Q13 conference call for pSivida , specifically with regard to their Tethadur platform in preclinical development. Tethadur, which is designed to achieve sustained delivery over 2 years with Lucentis and Avastin, would offer a significant competitive advantage. This achievement, if attained would provide a strong incentive for Roche to carry Tethadur through full clinical development and would represent an additional $1-2B annual opportunity.
On the Regeneron conference call Jefferies & Co., analyst Biren Amin asked:
"on your competitors they are working at more infrequent delivery of anti-VEGFs could you may be share your thoughts on EYLEA and your efforts on -- around this, thanks."
Leonard S. Schleifer Chief Executive Officer of Regeneron responded:
"Yeah we continue to look at alternative delivery systems whether it would be through genetic approaches whether it would be through delivery devices or what have you as far we know one of our competitors had something in Phase I for quite some time now and we haven't seen that progress (Roche/Forsight4). We don't know much more than you do. And we don't have anything in the clinic as yet but I can assure you we look at this area very carefully and we'll see whether or not this combination will make a difference as well."
Eyelea's 2013 full year sales were $1.4B representing approximately 25% of the wet AMD market share, Lucentis was roughly equivalent in market share, with Avastin remaining the leader with approximately 50%. It is reasonable to assume that a new device that delivers Lucentis over 2 years would become the dominant product in wet AMD and DME, if using 2013 as a representative example, the market opportunity would be at least $1.4B (Eyelea). As described previously, the prescribing behavior of physicians in wet AMD and DME are determined from dosing convenience, when the efficacy of anti-VEGF products is equivalent. Lucentis is highly efficacious and prominently positioned to be formulated with Tethadur. pSivida is keen on the size of this opportunity focusing their preclinical development of Tethadur on Roche products. Clearly, they are trying to court Roche in some respects, and may already be working with them. Below are some in-vitro data for Tethadur using Lucentis and Avastin from pSivida presentations at medical conferences in 2013:
(click to enlarge)(click to enlarge)
(click to enlarge) (click to enlarge)
(click to enlarge)(click to enlarge)
The key points to observe from these Tethadur slides is that it appears that the "dosing and coating" process does not alter the stability of the antibodies, and that Tethadur exhibits modifiable drug delivery kinetics based on alterations of the pore size of the cylinders which alters the delivery rate of the drug.
pSivida's "dosing and coating" is an ideal approach, which simply requires adding water to lyophilized biological drugs in the vial and then drawing the liquid into a prefilled syringe containing the Tethadur insert followed by an intravitreal injection. This bypasses a complicated manufacturing process that would be required if pre-coating the Tethadur insert prior to injection, which would present significant problems in protein stability. While very early in development, the early data looks promising.
Bullish Case
The most compelling metric that supports a long bias on pSivida is the fact that its market capitalization is only $120 million. With a PDUFA (Prescription Drug User Fee Act) expected from the FDA in 4Q14, if granted marketing approval would provide pSivida a $25 million milestone payment or about 20% of its total market cap and 20% royalties on U.S. based sales and profits. Additionally, they are entitled to a similar 20% profit-sharing scheme in Europe where Iluvien is already approved in 6 countries. Their most recent cash utilization rates for fiscal year 2013/2012 was -$11.9 million and -$24.8 million respectively with no debt. Consequently, the anticipated milestone payment would fund 1-2 years of operations. At June 30, 2013, cash, cash equivalents and marketable securities totaled $10.3 million. In July 2013, the Company completed an underwritten public offering of common shares for gross proceeds of approximately $10.8 million. Significant risks exist for additional secondary offerings, pSivida has no debt and has consistently shown a strong preference for issuing equity rather than debt financing, which removes a certain element of urgency for scaling into a large long position today.
For any value oriented investor it is important to recognize that it would only require $8 to $10 million in annual sales to trade on par with other ophthalmologic oriented specialty pharmaceutical companies like Regeneron. Regeneron's market capitalization is $28.78 billion and currently has a P/S ratio of 15. Clearly Regeneron is not a fair comparison for pSivida because Regeneron had to grow into this valuation and justify its current P/S multiple. It accomplished this through flawless execution taking market share from Roche/Genentech, an established leader in eye diseases with their Avastin and Lucentis franchises. But the important framework that supported this multiple expansion stems from the following:
Consistent high double-digit to triple-digit sales growth.
Managing market expectations.
Pursuing and succeeding in gaining marketing approval with new drugs or additional indications.
The bullish case for pSivida would have to replicate similar growth metrics relative to the Eyelea franchise, not the same scale in nominal dollars, but growth rates of sales.
However, the most important component to pSivida's future prospects resides with its Tethadur platform. As stated previously, they are currently working with a "major pharma company conducting a feasibility study." For micro-cap stocks such as this, any official press release of licensing or partnering with a major and established player could provide substantial upside and would be a powerful source of momentum in its shares providing optionality not reflected in the current share price.
Bearish Case
The bearish case for pSivida is quite obvious in this case and primarily centers on three issues. First, their cash burn rate exceeds its ability to generate milestone payments or other sources of revenues exposes investors to heightened risk of shareholder dilution from additional equity offerings.
Second, fluocinolone acetate is a steroid, and even though it is efficacious in DME at reducing vision loss and edema, it is not probable that pSivida's will be successful in its efforts to decouple fluocinolone acetates innate pharmacological effects from its negative side effects, such as steroid induced glaucoma and cataract formation. These side effects are a class effect and are an innate pharmacodynamic (what the drug does to the body) property of all steroids. Thus, sales of Iluvien if approved in the U.S. are likely to be inadequate for a significant P/S multiple expansion. Regardless of these facts, steroids will forever hold a place in the DME treatment paradigm for one simple reason; they work rapidly. The problem has largely been that the duration of action with intravitreal injections are not favorable for a prolonged response. Iluvien has provided evidence that it differentiates itself amongst other steroid treatments by both prolonging its duration of action and reducing the frequency of serious adverse events due to orders of magnitude reduction in total exposure to drug. The FDA labeling will likely restrict its use to pseudophakic patients and as salvage therapy, where the risks of side effects are reduced.
Lastly, Iluvien was submitted to the FDA on 2 separate occasions previously without success and after receiving a Complete Response Letter (CRL) from the FDA with concerns about safety stating: "The risks of adverse reactions shown for Iluvien in the FAME Study were significant and were not offset by the benefits demonstrated by Iluvien in these clinical trials," and that additional Phase III clinical trials would be required for approval, but Alimera has elected not to do so. Two key adverse events tied to Iluvien caused most of the concern. First, cataract extraction had to be done in 41.1 percent of the low-dose patients, 50.9 percent of the high-dose patients and only 7 percent of the sham group; and second, more Iluvien patients require intraocular pressure-reducing interventions (8.1 percent high-dose versus 3.7 percent low-dose versus 0.5 percent sham). However, recent events should allay some of these concerns since the FDA has cancelled its Advisory Committee meeting this month and moved directly into labeling discussions. While not a guarantee of FDA approval, certainly is a positive signal. Consequently, these issues will remain and are likely to provide an overhang on shares until 4Q14.
Highlights from pSivida's Fiscal Year 2Q14 Conference Call
1Q14 Revenues $592,000 vs. $585,000
Net loss for the quarter ended December 31, 2013 was $3.5 million, or $0.13 per share, compared to a net loss of $2.6 million, or $0.11 per share
$15.7M cash (enough to fund through 1Q2015)
Quarterly burn rate highly variable
Do not know if they will or not issue a secondary offering, and if so under what terms
$1.25 million of net proceeds from sales of common stock under pSivida's at-the-market (ATM) offering program
Sold $224,000 in January using ATM facility
May sell additional under their ATM program
$1.2M from collaboration agreement
Retisert and other expected cash inflows will fund current and planned operations through calendar 1Q15 calendar including Phase III trials; excludes net profits and milestones with Alimera
Beyond 1Q15 depends significantly on successful commercialization of Iluvien in US and $25M milestone on approval, and other existing agreements
Medidur
Phase III enrollment continues as planned and expects full enrollment by this summer
December 2014 (Final data collection date for primary outcome measure)
Goal: To be as effective as Retisert, but with fewer side effects.
However, this will cannibalize Retisert sales from Bausch & Lomb
Tethadur
$50B expiring patents for Biologics over next 5 years
Funded agreement in eye disease
Looking in other indications
Data mid-year (Summer)
Tethadur great candidate for partnering (expect 4Q14/2015)
Provide leverage to go after applications outside of Eye diseases.
Critical financing needs being met.
Already received $30M in milestones for Iluvien
Iluvien
Iluvien Approved for DME and reimbursement by NICE in U.K.
FDA Cancelled Advisory Committee meeting
Ongoing labeling discussions with FDA, will file response to FDA's complete response letter by end of this 1Q14, based on completed data and recent safety data from UK and Germany
$25M milestone upon FDA approval in U.S. 4Q14
Europe: launch in France this year
UK NICE pseudophakic patients covered
Private pay already approved
Already sent product in January to NICE hospitals
No guidance on royalty scheme with partner
Has not received any royalties yet
Alimera wont commercialize Iluvien in other countries until positive cash flow on sales in first 3 EU countries.
2014 Catalysts
Phase III program Medidur (Q3/Q4'14)
Preclinical data on Tethadur (2H14) most important!
Iluvien Sales in EU (fiscal 2Q14?)
Iluvien approval in U.S. (4Q14)
$25M milestone payment may be altered to receive higher backend royalties for less upfront milestone payment, which management stated when asked by an analyst as "interesting thought, can't really comment."
Risks
The recent risk-off bias in equity markets dissuades any sense of urgency for initiating new long positions. It is important to note that the various valuation metrics used to justify valuations in BioPharma in 2013 will come under pressure if risk-off remains much longer. Investors may revert back to a trailing-twelve month valuation basis in the biopharma sector instead of forward P/S and forward P/E ratios. Key metrics to monitor for this are intra-equity correlations; ten-year U.S. treasury yields remaining below 2.8%, and Global Financial Stress Indices. These global-macro indicators at first glance seem unrelated to the sector, but micro-cap BioPharma are especially exposed to overall risk-sentiment. Sector specific indicators that are useful to measure risk-appetite are the number of biotech IPOs scheduled, but are then delayed or cancelled. 2013 was a record year for biotech IPOs and monitoring new deals coming to market will be an important metric to monitor for 2014.
As stressed previously, on July 2013, pSivida completed a secondary offering of common shares for gross proceeds of approximately $10.8 million. Significant risks exist for additional secondary offerings.
Finally, it is critical to appreciate that the clinical research and data available in DME is meager at best, especially compared to other therapeutic areas. Specifically, it was not possible to establish any reliable estimates in pseudophakic incidence and prevalence. This is problematic when forecasting Iluvien sales because it is most likely going to be the FDA approved indication and the largest source of sales in the U.K. and U.S.
Upside pressure to estimates would come from persistent triple-digit sales growth of Iluvien in the E.U./U.K., positive clinical trial results for Medidur in Uveitis, and upside headline risks of partnering Tethadur.
Price Targets
Expect an additional 20% equity dilution through 2016.
Target a P/S ratio of 15x Iluvien royalties for 2014 of $4.8-7.2 million gives a market capitalization of $72 million-108 million and a share price range $2.66-$4.
Taking the midpoint of the price range gives us a target of $3.33/share for Iluvien and would be a buyer around these levels.
These estimates assign no value to Medidur or Tethadur programs.
Look forward to hearing both Alimera and pSivida's upcoming conference calls to gain clarity on what level of sustainable growth rates for Iluvien can be reached in the E.U.
Currently, uncomfortable assigning growth levels higher than this model given that the most recent growth of 336% for Iluvien was only for one quarter, if similar growth rates are reported we would likely assign a 150% growth rate quarter-on-quarter for the remainder of 2014.
Upside price targets is based on 20x 2014 royalties of $7.2 million, giving a market capitalization of $142 million or $5.26/share.
Upside potential is only 12%
Downside potential of 29% using the midpoint target price range of $3.33/share.
Any improved clarity on Tethadur partnering and filing for an investigation new drug/device (IND) would likely be a key fundamental change that could increase shares substantially.
Tethadur could represent at least $40/share in value.
Dew, thanks so much for the reply; I appreciate your insight.
You make a good point about the commercial rights for ABT-493. Also, thanks for pointing me over to the clinicaltrials.gov website. I had forgotten that they included estimated completion times on that site. Overall, it seems like we still have a decent number of upcoming catalysts and milestones for ENTA in 2014 to look forward to.
I'm excited for ENTA's future. Hope things continue trending in the right direction.
Cheers.
ENTA questions:
Dew, I am long ENTA and have a few questions that I was hoping you (or others who feel like chiming in) might be able to help me with.
QUESTION 1:
I was wondering what you think the inherent value of ENTA's future HCV pipeline is. For example, ABT-493/ABT-530 combo; EDP-239; Cyclophilin (CYP) inhibitor; and the NS5B inhibitor. Dew, I have seen your share price valuation for ENTA (message #171343), so I know of the monetary value that you ascribe to some of ENTA's pipeline (at least for early 2015); but without really looking at a dollar amount per se and also looking a lot further down the road, which factors do you see as truly giving value to their future HCV therapies?
I have been thinking about it a little bit lately and have come up with some ideas but was wondering about your take on it. Do you see the value of their future HCV pipeline attributed to any of the below or do you assign value to it based on some other factors that I haven't been able to come up with?
1. Resistance - their future HCV treatments might be able to address future resistance to theirs or GILD's all-oral txs.
2. Answer to expiring exclusivity/emergence of generics - maybe the true value is related to this so that when ABT-450/ABT-267/ABT-333 combo OR ABT-450/ABT-267 combo loses its exclusivity, it has some new brands that will have exclusivity while they lose out to generics.
3. ? 100% SVR - maybe they can make a combo pill that has all of their mechanisms of action in it, which might be able to achieve near 100% SVR for most genotypes. For example, either their first-gen 3-DAA or 2-DAA combo OR second-gen 3-DAA or 2-DAA combo PLUS their CYP inhibitor PLUS their NS5B inhibitor.
4. Milestone payments - maybe the most value of their future HCV pipeline comes from milestones. This scenario suggests that the products won't be taken to market and stopped short at some investigational phase or ENTA gets bought out before those drugs go to market
5. Higher asking price in a buyout - maybe the true value of their future HCV pipeline goes only to fetch a higher share price buyout. Again this scenario assumes that these products won't get to market before a buyout is completed.
QUESTION 2:
What is likelihood in your mind that FDA denies GILD’s 8-week tx for non-cirrhotics based on lower SVRs and their concern it could lead to resistance? If a denial for this happens it would adversely affect GILD’s pricing/labeling strategy of using that shorter regimen to gain the cost savings that the public wants (i.e. rather than having to bring down the high cost of their 12-week tx).
QUESTION 3:
Any timeline on when PhI might be done with EDP-788?
My apologies if you or others have discussed any of the above items in earlier threads here; I have a free iHub account and can't search posts for key words.
Thanks in advance.
I've been pretty sick the past few days, but I actually just got around to responding to it about an hour and a half ago.
BioNitrogen Completes Biomass Feasibility Study for Florida Plant
ih.advfn.com/p.php?pid=nmona&article=61051450&symbol=BION
BioNitrogen Completes Biomass Feasibility Study for Florida Plant
Study Estimates Annual Feedstock Savings of About $1 Million
WEST PALM BEACH, FL--(Marketwired - Feb 13, 2014) - BioNitrogen Holdings Corp. (PINKSHEETS: BION), a cleantech company that utilizes patented technology to build environmentally-friendly plants that convert biomass into urea fertilizer, announced today that it has received the feasibility study for biomass feedstock supply to the initial BioNitrogen plant in Florida from BioResource Management, Inc. The feasibility study estimates a potential annual feedstock savings of around $1 million, more than an 11% savings on initial estimates.
"This biomass feasibility study estimates a significant annual savings to the plant for our feedstock supply cost," said Bryan Kornegay, Jr., President and CFO. "We will now be able to receive more than two times our plant needs in the haul zone at a much lower price than originally forecasted."
"We are pleased with the BioResource team and their ability to deliver a quality product on time," said Ernie Iznaga, VP of Operations. "The feasibility study validates our internal analysis and provides additional support to our funding sources about the biomass feedstock availability for the plant."
Biomass feedstock feasibility studies are a key requirement leading up to tax-free bond financing to ensure that plant sites will be sustained by local biomass supplies.
About BioResources Management Inc.
BioResource Management, Inc. (BRM) is a forestry, geography and agriculture-based firm that focuses on biomass resources -- organic material used for energy, chemicals, and agricultural uses. Its personnel bring together over forty years of experience in forestry, biomass production, agriculture, and organic materials recycling. www.bioresourcemanagement.com
About BioNitrogen Holdings Corp
BioNitrogen Holdings Corp. (PINKSHEETS: BION) is a cleantech company that utilizes patented technology to build environmentally-friendly plants that convert biomass into urea fertilizer. Our mission is to provide safe, cost effective, green solutions that are economically beneficial in locations where biomass is produced and urea is consumed. Additional information can be found at www.BioNitrogen.com
Safe Harbor Statement
The forward-looking statements contained in this document involve risks and uncertainties that may affect the Company's operations, markets, products, services, prices and other factors as discussed in filings with the Securities and Exchange Commission. These risks and uncertainties include, but are not limited to, economic, competitive, legal, governmental and technological factors. Accordingly, there is no assurance that the Company's expectations will be realized. The Company assumes no obligation to provide revisions to any forward-looking statements should circumstances change, except as otherwise required by securities and other applicable laws.
Contact
Adam Friedman
Principal
adam@adam-friedman.com
917-675-6250
Biomass does not appear to be one of the stumbling blocks for them in their endeavors, esp. in areas like Florida and Louisiana.
You mentioned sugar cane bagasse, which, in fact, is one of the main sources BioNitrogen plans to use for their biomass feedstock. Based on info from their website and previous PRs, they also plan to use tree trimmings, agricultural waste, woodchips, palm fronds, rice and peanut hulls, cotton by-products, corn leaves and stalks and virtually any other carbon-based feedstock. Additionally, there will be opportunities for more biomass due to the destructive weather patterns down in the southeastern states like FL and LA due to hurricanes. We're talking about some of the best areas for biomass, which is why their first potential plants will be built in FL and LA.
Here are some resources to help you re biomass feedstock:
BioNitrogen Bets on Biomass for Urea Production
www.agprofessional.com/agprofessional-magazine/BioNitrogen-Bets-on-Biomass-for-Urea-Production-174272011.html
BioNitrogen Corporation Announces Agreement to Purchase Biomass in Florida
www.bionitrogen.com/2012/08/10/bionitrogen-corporation-announces-agreement-to-purchase-biomass-in-florida/
BioNitrogen Corporation Signs Exclusive Agreement With CF Industries for Biomass Supply
www.bionitrogen.com/2013/02/27/bionitrogen-corporation-signs-exclusive-agreement-with-cf-industries-for-biomass-supply/
BioNitrogen Corporation Begins Collection of Woody Biomass for Hardee County Plant
www.bionitrogen.com/2013/04/10/bionitrogen-corporation-begins-collection-of-woody-biomass-for-hardee-county-plant/
BioNitrogen Commissions Biomass Feasibility Studies in Florida and Louisiana
www.bionitrogen.com/2014/01/09/bionitrogen-commissions-biomass-feasibility-studies-in-florida-and-louisiana/
Also if you haven't read these yet, these are helpful messages about actual visits with Brian Samuels of BioNitrogen:
Recap about my trip to Wauchula office and first Florida potential plant site:
message 10690
with pics here:
message 10701
And Codaras' trip to Wauchula office here:
message 11114
ALIM - Alimera Sciences Announces $37.5 Million Private Placement
online.wsj.com/article/PR-CO-20140128-905357.html
This should be nice and bullish for PSDV.
I think another reason (definitely in addition to the overall stock market decline, esp. in biotechs) is a market over-reaction or misunderstanding of Novavax's filing of the S-3ASR on 1/24/14:
www.sec.gov/Archives/edgar/data/1000694/000114420414003941/v366172_s3asr.htm
The market seemed to react negatively immediately in after-hours trading, which was when it was released that this form was filed with the SEC. It then kept scaling down in AH trading and continued to do so when trading resumed on Monday morning. It seems like NVAX was hit particularly hard b/c of the combination of this form and the overall market performance, like I said, particularly hitting bios even more.
Initially, when I saw the most recent PR about the biomass, I was a little skeptical, too, b/c it sounded so familiar to past PRs. When I went back through my saved files about the PRs, however, I became a little less doubtful and apprehensive.
The first PR about biomass was with CF industries, who works very close to the proposed first Florida plant for BioNitrogen. CF does a lot of land clearing and BION used the biomass that was a byproduct. The PR for that is linked below if people want to review:
www.bionitrogen.com/2013/02/27/bionitrogen-corporation-signs-exclusive-agreement-with-cf-industries-for-biomass-supply/
The next PR below is proof that BION started collecting the actual biomass as agreed upon in the above PR.
www.bionitrogen.com/2013/04/10/bionitrogen-corporation-begins-collection-of-woody-biomass-for-hardee-county-plant/
Some posters on this message board might remember my description of my vaca down in FL where I took the opportunity to drive and meet a BioNitrogen employee and visit the proposed site, where I happened to see some biomass being delivered. That post is linked below:
investorshub.advfn.com/boards/read_msg.aspx?message_id=87132788
with pictures here:
investorshub.advfn.com/boards/read_msg.aspx?message_id=87175385
The next PR about an agreement re biomass
www.bionitrogen.com/2013/04/04/bionitrogen-corporation-signs-agreement-with-bioresource-management-inc-for-management-logistics-of-biomass-feedstock/
is the one that sounded really familiar to me when the most recent PR just came out linked below:
www.bionitrogen.com/2014/01/09/bionitrogen-commissions-biomass-feasibility-studies-in-florida-and-louisiana/
The PRs are very similar but the difference b/w the two is the truly important piece of information. If I'm reading it correctly, the most recent PR says that BION has actually funded/commissioned/paid BioResource Management for the work; whereas, the original PR about BioResource Management just stated that the two companies had agreed to work together.
So that made me realize it wasn't just a repeat PR. One thing I am frustrated about, though, is that the feasibility study hasn't been completed yet since the agreement b/w the two companies first happened nine months ago. I am guessing the study wasn't going to commence until payment was made by BION. Frustrating that it could have already been done by now, but now we need to wait until sometime in February. Hopefully that won't see multiple delays.
We need some bonds to be sold!!
Nice increasing volume and price action over the past month...
Ah, ok. Thanks for the update.
Now that I re-read that, I think you're right. I misunderstood it upon initial reading. I thought we were expecting totally different financing since we seemed to be so far off the $4 million from the initial $2 million financing announced previously, but I guess they are just using money from that $2 mill tranche. Seems like a steep discount for Casale to come down, but if that's the case, it's great for BION.
NVAX seems to be looking quite nice in pre-market. Up to $5.44 with 42,445 shares traded so far.
Thanks for the info. I agree, the $2 million was not dilutional, but we don't know about the $340k. If it is dilutional, hopefully the conversion rate is not ridiculous.
Yes, I think that means the same thing. The estimated cost for the EPC (Engineering, Procurement and Construction) report, which is necessary prior to getting bonds sold. Although the term "estimate" in my mind leaves open the possibility that as the report is finally completed there could be extra costs not yet accounted for. Not for sure but just my best guess.
This is certainly the good news that we've been waiting for and should finally allow bonds to be sold, which should really move this stock and get the company closer to building.
I'd have to go back and look more closely, though, but didn't the EPC report cost somewhere around $4 million? See message #11054 on this board (sorry can't post link as I'm on my phone app). Like I said, I'll have to go back and look more carefully myself later.
Also, they said they got funding but not what kind exactly. Hopefully not a lot more shares issued.
I saw that, too.
In that article it says that Gladstone Institutes is reaching out to Vertex about getting access to that drug for clinical testing. If it truly looks like that failed seizure drug can lead to a new potential HIV drug, I have to imagine that Vertex would rather do the clinical trials themselves rather than letting Gladstone do it, no? Gladstone is a non-profit organization with, what I imagine, would be a lot fewer resources than Vertex. Maybe Vertex would pay Gladstone Inst. for their novel idea and then do all the research themselves. Or maybe they don't have to pay Gladstone at all? I'm not sure how that whole thing would work given it was Gladstone's idea but Vertex's drug.
That likely explains the buying and increase in share price Friday. Maybe this thing can finally run back up soon.
Anybody know if there's any truth to this? Maybe it explains the run up this week, esp. the large share volume at EOD and the large share volume after hours.
The following link is from the NVAX message board on Yahoo! and it explains Nasdaq Tech Index rebalancing.
finance.yahoo.com/mbview/threadview/?&bn=4cc3b79a-3ac0-3136-b6ba-55e126a7836d&tid=1386019520844-bfa6ec2a-dec1-4fcd-8fa8-7357ffa75762&tls=la%2Cd%2C3%2C3
The user posted this originally on Dec. 2.
Definitely. And a few $5 paint jobs so far, too.
4,585,757 shares at close.
3,827,300 share block after hours.
So far total of 4,094,284 shares sold after hours.
Lotta volume!
WOW. Huge order at close.