Friday, December 31, 2010

Tuesday, December 28, 2010

Novartis' "Ilaris" Appears to Have Application for Treating Gout Flares

According to a recent report by Deutsche bank equity analysts, Novartis already has recieved approval for its drug Ilaris. The company currently has a P3 trial underway for an additional indication for Ilaris for juvenile arthritis, but the DB analyst appears to see potential for up to $500 million in sales for this drug for

Ilaris currently is approved for CAPS (Cryopyrin-Associated Periodic Syndromes). Now, I have NEVER heard of such a thing, and I watch both "Mystery Diagnosis" on Discovery Health (about to become the Oprha Winfrey network), and I also watch House. I have also been a big watcher of ER and Chicago Hope, and that one in Seattle with all those dopey girls who can't decide which guy they like. About 12 seconds with Google, though, yields information that CAPS is a group of genetically-based autoimmune-related inflammatory "syndromes."

Oh, wait, no wonder I never heard of it! It used to be known as "Hereditary Periodic Fever Syndromes." That explains everything!

But seriously, Ilaris already has been approved and is on the market. The P3 trial for juvenile arthritis is underway, and it is yet another chink in the armor of Krystexxa.

That's it for now

aa/Jay Hains

SVNT Commences Overdue CEO Search

This afternoon after the close of the market, SVNT announced that it will search for a CEO.

In my view, this serves as the denouement (I had to check the dictionary on spelling that) for SVNT's second failed attempt to sell itself in the past two years. Sucha record should be a cause for shame among the members of the Board of Directors, in my view. I doubt that the company will EVER take publicly again about SVNT being "for sale." In my opinion, if SVNT ever does get sold, it will be a deal announced figuratively "in the dead of night."

With the company searching for a CEO, it is clear that a new direction for SVNT is in the offing, but it is a direction that has been pretty obvious to long-time SVNT-watchers ever since the humiliating announcement almost two months ago that there was no buyer "at this time."

Instead, SVNT will need to rebuild its credibility one prescription at a time. To use an automotive metaphor: "the rubber is hitting the road, now we need to wait and see if it gets an traction."

Sunday, December 26, 2010

ALIM Gets "Complete Response Letter" from FDA on Iluvien

On Christmas Eve, the FDA played the role of Grinch for ALIM And PSDV shareholders by issuing a Complete Response Letter (CRL) for ALIM's Iluvien application. It seems that both ALIM and PSDV shares will decline at least 25% on Monday when trading resumes, as it is likely to take 9-12 months for ALIM & PSDV to reach the point where an FDA decision again is imminent, as was the case for the past month or so. While this clearly is a nasty setback, it is not a "death sentence," and it cannot even be said that it was completely unexpected. Let's dissect why this is the case.

Firstly, the issuance of a CRL is not a rejection of the application. A CRL reflects a decision by the FDA that approval is not possible at the current time. The CRL also provides the company filing the application with the opportunity to remedy the issues that the FDA notes as deficient in the letter itself. The FDA's procedures provide for the company to have a meeting in person with FDA personnel within a specified period of time during which the company will get further specific information about what it must do to gain approval.

In the current case, the FDA noted manufacturing irregularities at more than one of ALIM's contract manufacturers. The FDA will, in short order, tell ALIM and those contract manufacturing organizations what it observed that must be corrected.

Secondly, the FDA decided that 24 months of trial data was insufficient to allow it to approve Iluvien at the current time. The FDA requested that the company provide 36 months of data and additional statistical analysis of the data. The company already has the 36 month data, as the 36-month timeframe ended in December 2010. The FDA did NOT request or require any additional trials to be done, an event that would have been as close to a "rejection for cause" as seemingly possible.

ALIM will hold a conference call at 8:30 a.m. tomorrow morning to discuss its way forward from this point.

The company's FDA application and "Priority Review" were two steps forward, in my view. The CRL is "one step back."

Tuesday, December 21, 2010

Breakout Move Today in PSDV; ALIM Lags

Today PSDV staged a "breakout performance" with the stock up by $0.75/share to $6.64 as I write this, a gain of more than 10%. Trading volume has swelled to almost 300,000 shares just shy of 2 p.m. (NY time), already more than 2x the average daily volume (last 50 days) of about 125,000 shares per day. The weekly chart for PSDV is a thing of beauty with a very lengthy "rounding bottom" formation (please refer to your copy of "Edwards and Magee" on that) with this week's price representing a breakout. Given the TIMING of this breakout, just before the FDA deadline for ALIM's application for Illuvien, I think it is particularly auspicious.

Interestingly, shares of ALIM are lagging, despite today's trading volume of more than 400,000 shares nearing 5x the average daily volume over the past 50 days. There are several reasons why ALIM may be lagging. One is that ALIM went public only last spring and so there are fewer money managers and portfolio managers that know about it. In my view, that is not a strong argument, however, since any PMs that know PSDV likely know the ALIM story very well, too. A second reason for ALIM's lagging share price may be that it is seen, at this point, as a "one trick pony" and any event short of approval this month by the FDA might be perceived as requiring them to raise some additional capital in the near term due to ongoing "cash burn" during the FDA review process. In my view, that isn't a great argument, either.

In my view, ALIM is being unfairly left behind here.

Readers can look back at some of the earlier posts here on the AfterSVNT blog about ALIM and PSDV to get the background story. Suffice it to say that rumors of the FDA acting on the Iluvien application prior to Christmas make alot of sense to me, since it is hard to believe that the FDA commissioners themseves are going to be in town and meeting on the day before New Year's eve.

Happy Hunting and best wishes to my readers and fellow investors/speculators.

aa/Jay Hains

Wednesday, December 15, 2010

Sparton Also Bags Another Large Defense R&D contract

Sparton has been getting quite a few good looking sonobuoy R&D contracts lately. Check out the press releases on the company's web site or under Yahoo! Finance's new section.

Today, the combination of the news on the real estate sale and the new R&D contract seemed to give the stock quite a pop of volume and the stock moved up nicely.

Jay Hains/aa

Tuesday, December 14, 2010

Sparton (SPA) Bags $4.5 Million in Real Estate Sale

SPA management continues to execute on those things that are within its ability to control. The sale of the company's last piece of unused real estate (in New Mexico) for $4.5 million is another example of this. As a result of this sale, it seems to me that SPA's cash balance for 11FQ2 (ends December 31) could well be back above the $30 million level (almost exactly $3.00 per share) after internally-generated FCF is included. That would compare to $27.3 million (Bloomberg basis) in 11FQ1. There is also some "restricted cash" related to environmental liabilities that either is or will soon be available to count as cash on hand.

Meanwhile, the current quarter has seen several nice sonobuoy R&D contracts let by the Defense Department. This should provide a solid backlog level going forward for the company's defense segment.

Given the economic environment, though, the company's operations are not without headwinds. The Medical Division had a weak performance in the September quarter, in my view, given the additional revenue gained from the August 2010 acquisition of Delphi. In addition, the EMS division continues to struggle with margin issues in what is without a doubt a naturally tough business even in good times. Nevertheless, decent performance at those divisions should allow SPA to generate a very nice amount of FCF given my expectation of continued strong results at the defense division.

On the 11FQ1 earnings conference call, management reiterated that it continues to look at many potential acquisitions, but that thew company intends to remain very disciplined in deploying the company's very hard-earned cash and capital resources.

With the stock at $8 currently, and cash likely at around $3.00 per share, the business is available for the equivalent of about $5.00 per share. By comparison, I expect the company to be generating on the order of $0.80 per share in FCF in the current fiscal year, with the potential to generate $1.00 per share in FCF in FY2012 (ends June 30, 2012) visible before long. That leaves the stock at its current level still quite cheap, in my view.

Jay Hains/aa

Monday, December 13, 2010

From the Division of Market Insanity Department

Take a look at the chart on tiny New Energy Technologies (NENE) on the OTC Bulletin Board.

It is a six bagger from the $0.50 level a couple of months ago.

The company claims to have invented a technology that allows for a photo-voltaic solar thin film to be sprayed onto regular glass at room temperature thereby converting the glass into a generator of electricity, even if only exposed to artificial lighting.

This brings back memories of Paul McCartney and Wings performing "Maybe I'm Amazed."

Friday, December 10, 2010

Alimera: Less Than 2 Weeks Until PDUFA Date of December 30

Apparently, there will be no Advisory Committee meeting for Alimera's Iluvien retinal insert treatment for diabetic macular edema, the leading cause of blindness among diabetes sufferers. This is encouraging for approval by the full FDA on December 30th.

The fact that Alimera's application was granted "Priority Review" status on August 30th, shortening the review period by 4 months (from 10 months to 6 months) is encouraging for approval.

The fact that Bausch & Lomb already has gained approval for Retisert, a retinal insert using the same steroidal treatment in the same dose as Ilubien for a related condition, uveitis, provides additional comfort that Iluvien will gain approval from the full FDA on December 30th.

According to the company, 50% of people that suffer DME need treatment bilaterally (i.e. both eyes). The company estimates that about 250,000 diabetes patients per year in the United States alone develop DME.

Analysts at CS estimate that treatment with Iluvien will be priced at approximately $6,000 per eye.

If Alimera's Iluvien can capture a 20% share of a 250,000/year market that's 50,000 patients per year needing 75,000 procedures per year (remember, half the people need both eyes treated). At $6,000 per treatment, then Illuvien can generate $450 million annually in revenue.

Assuming an 85% gross margin, ALIM would earn $382.5 million in gross profit. After deducting $62.5 million for SG&A expenses, ALIM would be left with $320 million in "operating profits."

As best as I can determine, ALIM's technology source, NASDAQ-traded Psivida (PSDV) is entitled to 20% of ALIM's pretax profitability. The scenario noted above would divert about $64 million per year from ALIM to PSDV, leaving ALIM with $256 million in pretax income. That leaves ALIM with about $70 million in after-tax income.

Currently, ALIM's market capitalization is less than 2x this potential level if profitability.

PSDV's $100 million market cap also is less than 2x its potential pretax royalty stream.

Apparently, the market believes either that the probability of approval is low or that the product is unlikely to gain wide acceptance by retina specialists and patients in the process of losing their vision.

Am I missing something?

Saturday, December 4, 2010

Atrion (ATRI) Mentioned as Buffet-style stock in Barron's Online Article

In its "Stocks to Watch" column (click on the title of this post to go to the article: you likely will need a password to Barron's), Barron's online highlighted the musings of Credit Suisse strategist Victor Lin, as he sought to divine what Warren Buffet would buy in the current market if building a portfolio from the ground up. I have, though, reproduced the article on the Yahoo! message board for Atrion which is populated by a very intelligent group of long-timers

Without further comment about any of the names chosen, the article listed Atrion (ATRI) as one of those stocks, including it properly in the Healthcare sector. The methodology focuses on each company's earnings record, management, and return on invested capital.

As a side note, ATRI this week declared a special dividend of $3 a share to supplement the company's regular $0.42/share quarterly dividend. The shares are trading hands these days in the upper $160s, having traded this past week at over $170. ATRI's $3 special dividend comes on top of the $6 special dividend paid early in 2010 which was declared in late 2009. ATRI paid in excess of $10 in cash dividends per share in 2010 but remains debt free and cash-rich.

I expect ATRI earnings to slightly exceed $10 a share in 2010, as full diluted e.p.s. for the first nine months of 2010 were $7.65 per share. In 2011 I anticipate earnings in the $11.50-$11.75/share range.

The thinly-traded shares have been one of the past decade's great performers, backed by consistently superior operating and financial performance and shareholder-friendly activities.

Tuesday, November 30, 2010

SVNT Prices Krystexxa at $59,800/Year; Stock Declines Further

**Something is Rotten in New Brunswick**

After collapsing on the news that no buyer for the company could be enticed to make an offer, SVNT shares fell further upon announcing that the pricing for the company's biologic Krystexxa for "refractory gout" would be well above the most bullish street estimates of $50,000 per year. The company announced that the price would be $2,300 per treatment, with a one-year course of treatment encompassing 26 infusions at a cost of $59,800.

The company confirmed that the product would ship immediately to specialty pharmaceutical distributors for use by patients getting prescriptions for the new-fangled treatment, which is disease modifying in nature.

It appears to the market as if only patients without any insurance coverage will ever choose to be infused, leaving SVNT (and its ever-patient shareholders) once again holding the proverbial bag.

To review the current pricing, an annual Rx load of 20,000 patient years per year would generate revenue of almost $1.2 billion annually. Assuming that SVNT could achieve net revenue (before royalty payments) of $30,000/patient year, revenue of $600 million would result from 20,000 patient/year's worth of prescriptions.

OK, let's assume they get only 10,000 patient/years of prescriptions per year at $30,000 net to SVNT per year. That's $300 million in revenue. After 22% for royalties and COGS, that would leave $234 million. After subtracting $84 million for SG&A expenses, SVNT would net $150 million/year before taxes, and about $100 million a year after taxes. If we figure the company must sell another approximately 10 million shares in order to capitalize the product rollout, that would be e.p.s. of $1.25/year on FD shares of 80 million.

The stock trades at less than 10x this scalped (not just "crew-cut," we are talking SCALPED estimate of the market dynamics) earnings run rate.

What are the OTS's (Old Time Savienters) missing?

Jay Hains/aa

Sunday, November 28, 2010

Coming SVNT Events

SVNT is scheduled to announce the pricing for Krystexxa on Tuesday, November 30th.

Estimates appear to range from as low as $20,000 for a year's treatment to $50,000 for a year's treatment.

With treatment bi-weekly, a year's treatment would include 26 intravenous administrations of Krystexxa.

I am tending to expect a "headline" price near or even above the high end of the analyst range for two main reasons: It will maximize the amount that is reimbursed by insurers and Medicare/Medicade/VA, and it will tend to maximize the bid level if they get a takeover offer.

Why sell yourself short?

SHIPMENT of Krystexxa will begin on November 30th, and the drug will be available for prescription on December 1.

Many Savienters have been waiting for this day for many years....

Good luck to SVNT employees and its shareholders

Wednesday, November 24, 2010

ALIM Breaks Out to New All-time High Today

Shares of ALIM are trading at $12.11 this morning, after hitting a new all-time high yesterday of $12.24. The company's IPO was in April 2010 at $11 per share, and the stock sagged as low as $6.30 on July 15th.

I started my position in the name yesterday, having spent the past several weeks engaged in due diligence and trying to get a better feel for "how the stock trades."

I also started a position in PSDV of about equal dollar size, as that name also is very, very modestly valued relative to a potential year-end approval of Iluvien.

These are simply starter, or monitoring positions, designed to force me to focus more closely on the name and I will continue to be doing additional work. It appears that the trigger for the move in both stocks is the passage on the calender of the T-minus six weeks mark. Apparently, the FDA notifies applicants of its intent to hold an Advisory Committee meeting at least six weeks prior to PDUFA dates, which in this case, appears to be December 29, 2010. With no AC meeting scheduled, it appears that investors believe the probability of approval has increased. I previously noted the expectation of Credit Suisse's analyst of a 75% approval probability.

Based on my own due diligence regarding Iluvien relative to Retisert, I now believe the probability of approval for Iluvien is greater than 90%.

Monday, November 22, 2010

An Excellent Blogticle on ALIM/PSDV's Iluview

I have read the article linked to in the title of this post and it is better than most of the sell-side research I have reviewed on ALIM/PSDV. I suggest you take a look at it, too.

Jay Hains/aa

Thursday, November 18, 2010

Tuesday, November 16, 2010

So, Dear Readers, What Are Some of YOUR Ideas?

Leave a comment with a short story for your favorite name.

Doesn't have to be a Biotech;
Doesn't have to be a Microcap;
Doesn't have to have a High FCF Yielder;
Doesn't have to be a Turnaround

Sunday, November 14, 2010

A New Name: Planar Systems (PLNR): A Pure Value Opportunity

Recently, Planar (PLNR) reported a profit for the quarter ended September 30th, its fourth fiscal quarter. Click on the title of this post to visit the company's home page.....

With about 20 million shares outstanding (I am rounding up for simplicity, the earnings report gave 19.4 million as the FD figure) and a share price of $2.10, PLNR has an equity market capitalization of about $42 million. This debt-free company has almost $32 million of cash on its balance sheet, about $1 million more than a year earlier. The company's cash position means that a buyer of the company at its current price would recoup all but $10 million of its investment just from the company's current cash position. Of course, the company needs some cash to operate.

The company reported Total Current Assets of $96 million compared to Total Current Liabilities of $39 million. The differential of $57 million is just shy of $3 per share, and was approximately unchanged compared to a year earlier. The company indicated that its tangible book value was $3.20 per share.

PLNR generated revenue of about $175.7 million in the fiscal year ended September 30, 2010, compared to $174.9 million in the prior fiscal year. For the recently-completed year, PLNR posted pretax operating income excluding amortization of intangibles of about $1 million, compared to approximately a break-even performance in the prior fiscal year.

So what does PLNR do?

PLNR manufactures specialty displays for multiple markets including military and space, utility and transportation hubs, shopping centers, banks, government agencies, and home theater applications. When you watch CNBC on TV, you probably are looking at some displays made by PLNR. When you see footage from the TV commercial for the Air Force that shows their cyberwarfare exercises on large displays, you probably are looking at PLNR products. A recent contract has PLNR supplying screens that will be used for railroad track inspection on specialty rail cars in China.

Try the web site: www.planar.com

The company has been a poor performer for many years and I am involved in trading/owning the shares in a significant way for the first time this year, despite having "monitored" the company for more than a decade. Why? Management has exited some businesses where they could not compete. The company's shares seem overly punished compared to its robust cash and working capital position. In addition, management appears recently to have been successful in reducing expenses. The growth business opportunity appears to be the in-store retail display business.

Recently, the stock has pulled back modestly after the 10FQ4 earnings report, as management indicated the company would post a loss of a single-digit cents per share in the December quarter, and refused, blaming a lack of visibility, to make a projection for the new full fiscal year ending September 2011. With the stock at $2.10, the company not shedding cash on an operating basis, and tangible book value of $3.20 per share, I think PLNR could well have upside of 30-40% from here to a range that approaches $3.00.

Jay Hains/aa

Wednesday, November 10, 2010

Sparton Corp Follow Up

The first new idea I presented AfterSVNT was Sparton Corp., a diversified electronics manufacturer engaged in defense, medical, and electronics manufacturing services operations.

I am happy to report that this pick has been a smashing success...so far. (There is ALWAYS a "so-far" when it comes to investing, as long-time "Savienters" must by now realize).

I first posted about SPA on September 21 and the stock closed that day at $5.50. I will use the following days close to measure "performance" for this pick, and SPA rose $0.25 a share the next day, closing on 9/22 at $5.75 per share. As this is written, SPA is trading at $7.75 per share, up almost 35% in about 6 weeks or so. A nice pick, but probably not representative of my long-term ability, otherwise I would have (almost) as much cash as Warren Buffet rather than writing this blog!

Yesterday, SPA reported 11FQ1 earnings for the quarter ended September 30, 2010. The company reported an "adjusted" operating earnings figure of $0.16 a share for the quarter. GAAP e.p.s. was $0.40 per share and included a $0.24/share "gain on acquisition." Revenues would have been down considerably were it not for the revenues acquired via the acquisition of Delphi Medical.

On August 6, SPA closed on the acquisition of the assets of Delphi Medical for a price that the company's management states was less than the fair value of the assets acquired. As a result, their accountants decided that the difference between those figures represents a gain that should go through the income statement. Now, I don't have a CPA, but I do have an MBA, and I dissect financial statements for a living (my day job). I must say that I cannot recall having seen something exactly like this, and frankly, it does not smell 100% kosher to me, accounting-wise. Maybe one of you guys out there with a CPA can set me straight on this issue!

All of which brings me back to SVNT. Justaguy will remember this event, as he was around, and SVNT was still named Bio-Technology General. For several years, BTGC carried an item on its balance sheet listed as "Negative Goodwill." Eventually, they were forced to restate their results to eliminate the "Negative Goodwill" since such an accounting entity does not meet GAAP requirements. I suppose this is a reason why SPA decided to put it through the income statement instead of putting it on the balance sheet where it does not belong.

In any case, SPA remains virtually debt free, with about $2.75 a share in cash on its books, and earnings somewhere in the neighborhood of $0.75 a share as a representative run rate over the past year.

Management has turned its sights from restructuring both operations and finances to restoring growth and searching for acquisitions that can add to profits and cash flow.

I still think the stock is cheap here, but it has had a substantial move over a relatively short period of time and is entitled to a pullback of some sort.

Jay Hains/aa

Tuesday, November 9, 2010

Discussion on Failure to Consummate a Deal

I'm curious as to others thoughts on why no deal (to date)?

I'm thinking that the 2 big issues are (1) market size potential (2) pricing. The discrepancy between what SVNT says (170K) and the FDA number (90K) is significant. Pricing becomes clearer on 11/30.

I also wonder if BMY, NVS or anyone else felt SVNT needs us more than we need them (for now). In other words, let SVNT twist in the wind a bit knowing the only other alternative is launch on their own. And then they play a game of watch and see what unfolds? Is the drug widely accepted? Do revenues ramp up quickly?

I also faxed the following to Paul Hamelin -- in part to release the frustration with this company and inability to get a deal done.

Mr. Hamelin:


Like many shareholders I was disappointed that no sale of the company has happened to date. A similar experience occurred in fall 2008, when Mr. Clement led shareholders to believe a strategic transaction would occur in Q3 of that year.


I am forwarding to you something I sent to Brian Hayden, ex-CFO of Savient, back in 2008 after the supposed deal for the sale of the company fell through.


Please give some thought to a multiple paypoint buyout of the company. For example, with FDA approval you determine that $15/share (as an example) is fair valuation. Then you set subsequent goals that reward shareholders over time. Perhaps filing the EU application is worth $1/share. And EU approval is worth another $6/share. By the time Krystexxa is (hopefully) approved in the EU there should be at least a year of sales in the US where an additional payment might result. Such an approach to a possible acquisition allows the buyer to not put 100% of the ultimate purchase price at risk upfront.

There is obviously disagreement between what SVNT sees as the TFG US market size (170K) and what the FDA sees (90K). I'm a bit surprised that you have chosen to not go into detail as to how the studies arrived at these numbers. Analysts and institutions seem skeptical of your estimates. And revenue estimates are also varied making fair valuation of the company more challenging.


Last, allow me to share some of the disappointments as a longer term shareholder.


  • In 2006 Savient stated they expected to file the Puricase BLA in late 2007. It was finally successfully filed in 2010, a 2 ½ year delay.

  • The 2004 FDA approval of Nuflexxa should have allowed for Savient to establish sales in the US and pave the way for Krystexxa. But Savient relinquished those rights and paid almost $18 million to Ferring.

  • Savient Pharmaceuticals Enters Co-Promotion Agreement with Ferring for Nuflexxa; Savient to Establish Sales Force Targeting Rheumatologists Upon Sale of Global Biologics Manufacturing Business.
    Business Wire

  • The lack of a sales force today (that would have existed w/ Nuflexxa) has clearly weakened your negotiating ability for a sale of the company.

  • Two stock offerings in the past 1 ½ years has diluted shareholders almost 30%

  • Five (5) years of restated financials and the possibility of delisting a few years ago

  • Disaster after the 2008 ACR Conference

  • Savient being a revolving door of CFO's (around 8 in the past decade)

  • Chris Clement liquidating essentially all of Savient (BTGC plant & associated drugs, Rosemont, etc.)

  • Mr. Clement, Hayden, Lamm and Horowitz all leaving the company and receiving considerable compensation



I fully agree with the Board of Directors that the sale of the company will maximize shareholder value. And I trust that you, the Board, along with Lazard and JP Morgan are exploring all strategies. I am surprised that you've been unable to consummate a deal given the revenue problems big pharma faces in the coming years with generic competition. I do hope you consider a multi-paypoint approach as a possible way to successfully sell Savient to a larger company who can maximize sales both in the US and worldwide. I know there are many creative ways to reach the desired end result and I trust you will.


Respectfully,

Monday, November 8, 2010

SVNT: Cashless Warrant Exercise

Contributor Michael posted the following as a comment, but I think it deserves its own thread, so here it is...

Michael said...

I researched cashless exercise of stock warrants. The holder of the warrant has two options to exercise the warrant. In the most logical case, the holder pays the exercise price to the company to obtain the warrants which is based upon the price set when they were distributed. We had two dilutions with different prices. I believe $5.23 and around $10.

In the cashless case, the holder can immediately sell the stock on the open market and pocket the difference between excise price and stock price but it is my understanding that the company would still receive the excise price in return. The other option is to receive the equivalent shares of stock represented by the difference between the stock price and the warrant exercise price thereby reducing the amount of stock issued by the company not receiving any money for the stock issued.

Therefore, it is difficult to state how many warrants were issued cashless vs. bought outright via exercise of stock. I assume all warrants have been exercised now (not 100% sure of this). In any case, stock outstanding increased from 54.7 million in 12/2008 to 66.9 Million in 12/2009 to 70.3 million shares on 11/1/2010 or approximately 15.6 million share increase which equates to 28.5% dilution. They may not all be from warrants since stock options have been exercised in this time frame also.
November 8, 2010 9:24 AM

Sunday, November 7, 2010

Have Any of You Guys Looked at ALIM/PSDV?

This name seems to be a replay of the SVNT story: a great unmet need story with a low valuation. I'd love to see if you take a look at one of their recent conference call presentations what you have to say about it

Friday, November 5, 2010

SVNT Revenue Build

If the company acquires 750 new patients per month at an annual revenue level of $36,000 per year, and the patients complete an 18 month course of treatment SVNT will reach an annual revenue run rate of $281.25 million.

We should keep in mind that the company is likely to set the initial price for the treatment VERY high for the simple reason that DRUG PRICES NEVER GO UP, THEY ONLY GO DOWN. Thus, the cumulative revenues will be maximized by the highest price, it seems.

If I haircut revenue by ~10% to an annual revenue run rate of $250 million, apply a 75% gross margin to account for manufacturing and royalties, subtract $60 million for SG&A expenses and apply a 37.5% tax rate, I get net income of ~$80 million, or about $1.15 per share.

Savient 10Q3 Earnings Conference Call Notes

This thread is designed to contain discussion of the SVNT 10Q3 earnings conference call. If you have posting privileges, feel free to "post." If you do not have posting privileges, please let me know and for now use the "comment" facility.

Thanks

JH/aa

Thursday, November 4, 2010

Alimera: Correction to Earlier Post

Rather than simply correcting my earlier post on Alimera, I will note the correction here AND correct via editing, the prior post.

In my original post on Alimera, I stated that the royalty due to PSDV was 20% of revenue. This is incorrect. The 20% royalty rate applies, essentially, to pre-tax profits earned from sale of Iluvien. Thus, it is essentially a split of operating profits rather than a royalty payment.

This actually makes a substantial difference when doing a "back-of-the-envelope" estimation of ALIM's potential profitability, since royalties are not coming right off the top, but from somewhere in the middle of the income stream.

Jonathan Hains/alexalekhine

Atrion (ATRI): A Stock I Must Comment Upon

I have been following Atrion Corp. for more than 10 years. This Texas-based outfit manufactures medical products and components used in fluid delivery, cardiovascular, and ophthalmic. There is an "Other" segment that makes valves for self-inflating rafts and for life vests.

The company grows like clockwork. In the recent quarter, the company's gross profit margin reached 47.8% (a record) and the net profit margin after taxes reached 19.9%.

There are only 2 million shares outstanding and the market cap is around $325 million at the recent price in excess of $160/share. Management owns a considerable chunk approaching 20% of the shares, which trade daily in small numbers with a bid/ask spread that frequently is several points.

The company does not court Wall Street at all, and has manufacturing facilities in Texas and Florida that are owned outright. The Florida facility was built for on the order of $25 million several years ago and paid for with a combination of cash on hand, free cash flow, and a line of credit.

I welcome questions from my readers and fellow investors about this company after you guys have done a modicum of DD.

Jay Hains/alexalekhine

Link to Recent Alimera Sciences Confernce Presentation

I recommend checking out this presentation in order to understand the basics of this company's product and opportunity.

Jay Hains/alexalekhine

Tuesday, November 2, 2010

ALIM Working toward New High Territory Since IPO

I should add that ALIM only went public in April of this year in an offering underwritten by Citi and Credit Suisse via an offering of 6.55 million shares at $11.

The company's lockup expired on October 18th of 2010.

ALIM has a presentation scheduled for 3:55 p.m. today at the Oppenheimer 21st Annual Heath Care Conference in NYC.

Another conference presentation is scheduled for 11/10 at the Credit Suisse 2010 Healthcare Conference in Scottsdale, AZ at 6 p.m. eastern time.

Finally, a third presentation is scheduled for November 17, 2010 at the Citi 7th annual Small/Mid Cap Conference in Las Vegas at 2:35 p.m. eastern time.

I have been unable to develop real conviction about this name for a number of reasons, one being that I have not followed this company for very long. Issues related to patents seem like a potential pitfall, and the shares confront an almost completely "binary event" in the form of the expected FDA meeting in December. There are no options trading on ALIM.

The "realted stock" Psividia (PSVD) which holds a royalty interest in ALIM's product, does have options that trade, but they are extremely illiquid.

Also, there is the issue of just how much improvement in vision is provided by treatment with Iluvien and how that will be evaluated by the FDA. Competitive concerns round out my list of pitfalls: I simply am not familiar enough with alternative treatments.

Finally, there still is the potential that the FDA may schedule an advisory committee meeting relative to Iluvien. I am not even certain that the FDA has these for devices (as opposed to drug or biological products for which they certainly sometimes do schedule Advisory Committee meetings).

That leaves the intrepid stock trader with two simple concepts:

1) trade with the technicals; It seems unlikely that bad news will emerge prior to the scheduled FDA date other than the scheduling of an advisory committee meeting.

2) Honor the time-tested maxim of "buy the rumor, sell the news." The corollary of that advice is to "Buy the sizzle, sell the steak." A trader operating on that basis might try to trade the stock based on technicals and price action, then take out the capital invested, leaving a core position equivalent to the profits to ride on the FDA decision. Admittedly this is a whimpy strategy, but it is one that allows the trader to "live and trade another day" in the event of an adverse outcome.

aa

Wednesday, October 27, 2010

SVNT

Reply to Dooby that would not post (after 12 tries) on Yahoo

Dooby:

I'd assume a 55% dropout rate - that's off the top of my head based on trial results. Infusion reactions, non-responders, etc. As far as market size see my earlier post on Hamelin numbers vs. FDA. Going forward I'd use FDA and think SVNT would do well to capture 30K patients. Pricing? A premium to TNF Alpha is suggested. I'm not in the camp of $30K to $50K. Conservatively I say $25K. That would mean 30K x $25K = $750 million US revenues. They say EU is larger market. But IMO pricing over in EU will be weaker so I'm using $450 million EU revs. So we're at $1.2 billion. I don't buy the 3 to 7 times revenue multiplier to get a fair valuation. SVNT isn't in that strong of a negotiating position. I'm using a factor of 2. So we get $2.4 billion valuation with 68 million shares out. NOw we need to discount this back to get some NPV since peak sales are likely 5 years out (more in EU as drug won't reach patients until 2012). I come up with an estimate of $1.8 billion today. That's $26+/share. I'm backing out another $1 to $2/share due to the position SVNT is in. Now, had they pursued sales of Euflexxa a few years ago in the US they'd have an established sales force in rheumatology, and going it alone would be a more serious consideration. But that decision to not sell in the US - and pay Ferring $18 million to back out, was another blunder on the part of mgt. IMO.

I have no clue as to what kind of chaos is going on in NJ and/or with the board. Whether they're scrambling to revive any buyout interest or are considering partnering proposals (which they likely didn't solicit recently as they did 2 years ago). So partnering may be a long shot also.

If they go it alone I'd like to see Hamelin & Yachmetz pushed aside. I think they're both liabilities at this time. Use them for a transition period while a seasoned CEO, with launch experience, gets up to speed. I'm fine with a new guy getting options, a big salary and incentives to make this successful. I'm much less confident the current mgt. team can succeed. Past execution being my primary reason for being skeptical.

Another Blog Discovers Sparton Corp.'s Attractions

http://www.valueuncovered.com/sparton-corp-spa-turnaround-team-returns-micro-cap-manufacturer-to-profitability

Sunday, October 24, 2010

A Little Info on ALIM (Alimera Sciences)

I looked recently at a CS equity research report on ALIM published subsequent to the company getting "Priority Review" designation for its NDA (New Device Application) for Iluvien in the treatment of Diabetic Macular Edema from the FDA.

The CS report provided estimates for several important metrics including market size, pricing, percentage of patients needing treatment for both eyes, the percentage patients that can benefit from laser treatment, gross margins, and earnings.

Essentially, the report gives Iluvien a 75% probability of being approved by the FDA by around the end of this year, though no date has been set for a potential FDA meeting date on the application.

The report did not indicate the likelihood of a "panel" meeting ahead of the FDA vote. it seems likely that news about the scheduling of a panel meeting should be available soon of there is to be one.

The CS analysts anticipate approval of Iluvien and expect AALIM to turn profitable on an annual basis immediately in 2011, with e.p.s. growing rapidly to more than $5 per share by 2015.

It will be at least three years before the market will begin discounting 2015 earnings, and there still is a binary event (FDA Vote) as an upcoming hurdle.

I would recommend discounting the earnings projection back at a 25% rate for three years then applying a reasonable P/E multiple to that figure. Applying a 15x multiple to the discounted earnings of $2.50 per share generates a potential price target for ALIM of $37.50 per share. CS is maintaining, I believe, a $48 price target.

CS believes the company needs about 40 sales people to cover the market for retina specialists.

In sum, diabetes is a large and rapidly-growing market and ALIM has a unique treatment for what appears to be an unmet medical need.

Jay/AlexAlekhine

Saturday, October 16, 2010

Preliminary Idea: Alimera Sciences (ALIM)

Alimera Sciences (ALIM) is a development-stage company that has completed a Phase 3 study of Iluvien, its investigational device for the treatment of DME (Diabetic Macular Edema). Currently, patients with DME have an "unmet medical need."

Here is a link to the slide deck from a recent conference presentation:

http://files.shareholder.com/downloads/ABEA-4IAIIR/1039523696x0x402653/b9516ee7-fc7f-423c-8ef8-7d379993baa7/ALIM%20Presentation%2009.2010.pdf

DME is a swelling of the macular region of the retina which results in a loss of eyesight. The company's product is inserted into the back of the eye where it releases a constant low-dose stream of a steroid. In the P3 trial, the device was shown to result in a measurable restoration of vision within 3 weeks. Patients continued to experience vision improvement for the next 24 months.

ALIM will be presenting data from its P3 trial of Iluvien at the American Academy of Opthamology today, October 16th.

On August 30, 2010 ALIM received "Priority Review" for Iluvien. With the NDA for Iluvien having been filed June 29, 2010 the company now expects action on its NDA by the end of the current year.

Another interesting way to play the potential approval of Iluvien may be through PSDV, pSivida. PSDV will earn a 20% split of operating profits from the sale of Iluvien, and also will receive a $25 million "milestone payment" from ALIM upon FDA approval of Iluvien.

The equity market cap of PSDV currently is about $100 million and the company recently had balance sheet cash of $17.5 million not counting the milestone payment.

The equity market cap of ALIM is around $300 million. ALIM last week obtained a $32.5 million credit line, presumably in order to make the $25 million milestone payment to PSDV.

Currently, I do not know much about the intended pricing for Iluvien. However, the market opportunity appears to be large and growing rapidly, as it is related to the number of cases of diabetes.

I am hoping some of you Savientors can help on this idea.

Friday, September 24, 2010

What are YOUR Ideas?

The purpose of this blog is to allow the cooperative community of SVNT board posters to identify new ideas and to discuss them. Hopefully, those discussion will allow those who are interested in a particular name discussed here to migrate to the Yahoo! board of that particular company, while still continuing to participate here. In that way, this sort of could become a "clearinghouse" for ideas.

I intended my post about SPA to be a "model" of the kind of writeup that I would encourage here.

I am open to giving those of you (and you know who you are!), the ability to make not just comments here, but to post your own ideas and opinions directly.

One other person already has the ability to do that, and I have invited a few others whose email address was provided by them, but they have not yet responded. As we used to say at the beach: Jump right in, the water's fine.

Jay (aka AA)

Wednesday, September 22, 2010

Link to Lawndale's Seeking Alpha Blog including Sparton

http://seekingalpha.com/author/andrew-shapiro

a

http://seekingalpha.com/instablog/36551-andrew-shapiro/91918-sparton-delphi-medical-acquisition-hits-the-sweet-spot-should-be-highly-accretive





This blog has a lot of material on Sparton as well as some of Lawndale's other investments.

Corrections & Amplifications

The previous blog post has been re-posted with corrections and amplifications.

Regards

JH

Tuesday, September 21, 2010

My First Idea AfterSVNT is SPA - Sparton Corp.

OK, I am going to kick us off with my first proposal for the AfterSVNT blog. Justaguy and I have discussed it a little bit in the comments to a prior post.

My pick is Sparton Corp., a more than 100-year old manufacturing company trading at about the $5.75 level with 10 million shares outstanding and about a $58 million market cap.

This company currently is virtually debt free and had about $30 million of cash on its balance sheet at June 30th. In addition, the company has a piece of unused real estate in New Mexico for sale, with an original asking price about $6.5 million. In 10FQ4 (June 30th) the company took a charge to write down the property to its net realizable value. There are four manufacturing facilities: one in OH, two in FL, and one in Vietnam. In addition, there are tax loss carryforwards that can shelter about $15 million of future pretax income from taxes. This loss carryforward is not yet assigned any balance sheet value because the company has not yet experienced a long enough period of consistent profitability. However, the company's restricted cash is likely to become available to it as its profitability will qualify those funds (earmarked for future environmental remediation spending)

There are three divisions, with by far the most important (on an operating profit basis) being the Defense & Security Segment (DSS). This division makes "sonobuoys," disposable electronic devices used to track the comings and goings of submarines. These devices are deployed from anti-submarine warfare aircraft and helicopters, used once, and never recovered. There are two manufacturers, but they operate as a joint venture and split annual two-year orders from the US Navy. Typically, there also are orders from friendly foreign navies. It is supposed that China's ongoing construction of a modern submarine fleet is likely to result in an increase in orders over the next 5 to 10 years at least from foreign navies. This timeframe is a bit far out for me, investment-wise, but comforting nonetheless.

A second segment produces medical devices, primarily on a contract design/manufacturing basis, while the third is a contract electronics manufacturing operation (think Flextronics or Sanmina but much, much smaller).

The company suffered a lengthy period of mismanagement beginning in the late 1990s, after the departure of the management team that had taken control of the company shortly after the end of World War 2. In 2008, agitation by investors that included hedge fund Lawndale Capital Management (current owner of 9.5% of the stock, 968,616 share according to Bloomberg) resulted in the appointment of a new, outside CEO practically at the height of the post-Lehman financial crisis. A new management team began to take action in early 2009, effectively saving the company from a bankruptcy filing that many believe was only weeks, if not months away. Only successful negotiation with a large number of third parties including bankers, customers, and the Defense Department provided Sparton with the cash needed to regain a semblance of financial health. Since that time, a classic financial and operational turnaround has increasingly become evident.

The turnaround included major cost cutting, the liquidation of excess inventory, collection of excessive levels of Accounts Receivable, and the "firing" of unprofitable customers. Basically, the new management team did everything they could to stem the bleeding and right the ship. That included shutting down multiple underutilized manufacturing facilities including the former Headquarters facility in the company's home town of Jackson, MI and one in Canada. Employees also were let go and the company's cost structure was rationalized. Cash raised was used to eliminate debt and to raise the company's cash position.

More recently, improved profitability has been at least in part a result of significantly improved rejection rates at the sonobuoy operation, as scrap and rework costs were cut sharply.

As of now, the company has posted 4 consecutive profitable quarters despite the lower sales base that resulted from letting customers go. Offsetting the lower sales is the cost cutting as well as the elimination of unprofitable revenue. In the current quarter (11FQ1) SPA completed the acquisition of Delphi Medical Systems for approximately $8 million. In addition to $10 million of inventories, SPA acquired 2 facilities. The deal includes a potentially favorable inventory valuation adjustment, and should quickly (though not immediately) be additive to earnings and cash flow. The operations acquired add to the company's customer base and should result in about $32 million in sales that go into the Medical division (not the EMS division as stated in an earlier version of this article.)

With $2.25 a share in cash (after subtracting out the $8 million acquisition, but not including the restricted cash balance), and a solid core defense segment, I believe SPA is in a position to generate nearly $1 a share in cash flow (about $10 million) in its FY2011 (ends June 30th).

Management indicated on the most recent conference call that the company would increase its spending on R&D and would pursue acquisitions that promise rapid incremental profitability using a combination of existing cash and ongoing free cash flow. In a recent conference presentation, management announced a target of $500 million of revenue for its FY 2015. This is an ambitious growth rate of better than 20% CAGR for revenues over 5 years.

If Sparton were to be successful in achieving its objective of $500 million in annual revenue and could earn a relatively modest 5% net income margin after taxes without increasing the share base appreciably, earnings could approach $2.50/share. There is quite a bit of blue sky between that objective and the company's present condition, but a stretch goal such as that surely is designed at least in part to be inspirational.

Trading in the stock is thin, about 22,500 shares per day on average over the past three months, and this is not a day trading opportunity. Care needs to be taken in accumulating a position, and I recommend that investors build their position over time as they learn more and grow more comfortable with the company and its prospects.

In sum, I think SPA is now a solid, profitable company with a large cash cushion and a new management team that has made near miraculous progress in getting the company back on track after a long period of decline. if SPA can achieve $1 a share in cash flow, I can easily see this as an $8 stock. That makes it more and more attractive as it drops below the $5.50 level (which would equate to 50% upside). This $1 per share in cash flow is essentially the same level of profitability that I figured about a year ago when I first began looking at Sparton after having had it "on the back burner" for more than 10 years.

I know more, but this is certainly sufficient for now.

Jay (aka AA)

Monday, September 20, 2010

Welcome MBusser!

Hi Bob!

Welcome Husky, Justa!:

It has certainly been a "long, strange trip" with SVNT as Jerry G would say.

I have a number of what I consider "value" plays that I have followed for quite a while, but all of them are up quite a bit right now.

Probably the most interesting name on a pullback is SPA, which is just emerging from a turnaround after a near-bankruptcy and a management change. They are now debt free with $3 a share in cash and selling for under $6. There is a Yahoo! board that is reasonably informative, though there are a bunch of somewhat sour former employees.......

I think it can be $10 in 12-18 months. Not a SVNT, but neither is it a SVNT timeline or risk profile.

Any ideas?

AA, TraderJay

PS -- I think I have to "enable" you individually to let you start your own posts. Give me a couple of days to get it set up, otherwise use the comment section for now. I'm not a master at this stuff and pretty busy.

Friday, September 17, 2010

This is the AfterSVNT Blog

This Blog is open to "approved" posters from the SVNT Yahoo! message board who have shared a lengthy and (hopefully for all) rewarding experience investing in and trading shares of SVNT over the past many years.

On that message board, I believe we became a community, and have, despite our anonymity, developed strong relationships. We have the ability to criticize each other with rancor that is within acceptable limits, developing and improving information that has led to our mutual success.

The purpose of this blog is to provide those users with an easy to use forum that allows us to discuss our investment ideas, get criticism of them from our peers, and share information and opinion about a wider group of opportunities.

I am your moderator, Jay, and I Yahoo with the handle AlexAlekhine