Opko Health: Following Tesla's Formula For A Market Take-Off

Investors are always on the prowl for the next big company capable of providing significant returns in a limited amount of time. Yet in this short-sighted perspective of the market, this popular mindset often boils down to a dependency on shifting market sentiments rather than tangible operational success. After all, enterprises take time to develop and the short-handed impact of rapid market gains aren't often dependent on the cash-generating business changes implemented overnight. Indeed, it is through the proliferation of investor optimism that a company's stock accelerates on the backbone of momentum.

This article takes a look at two particular companies that now find themselves following part of a formula for rapid stock appreciation. These companies are Tesla Motors, Inc. (TSLA) and OPKO Health, Inc. (OPK). In each of these instances, the companies have developed a solid innovation pipeline, the support of a strong financial backer, an unusually large short-interest, and a catalyst for demand. Combined, these attributes appear to design a formula that can lead to rapid stock price appreciation.

TSLA data by YCharts

Tesla Motors

As a company that has already appreciated in a short amount of time, it remains ideal to look at Tesla as a model. Tesla Motors is a premier innovator behind electric vehicle technology. Outlasting its private company peers such as Fisker Automotive and Coda Holdings, Tesla has made its high-end electric vehicles the envy of the automotive industry. The company has very quickly shown its ability to succeed in its target market where larger public companies such as General Motors (GM) and Ford (F) have failed to gain momentum with their own electric vehicle lines.

Tesla's most popular financial backer remains the company CEO himself. As a co-founder for the company, CEO Elon Musk helped to create a valuation premium through his own financial support. Musk owes fortune as the former founder of PayPal. In June 2011, Musk purchased $40.7 million worth of company shares. In May 2013, Musk reinvigorated investor confidence by putting another $100 million into Tesla despite the fact that the company's stock had already appreciated more than 150% in the two months prior.

Although it would ultimately be seen as a crutch to the company, the Department of Energy also played heavy role in supporting Tesla. In 2010, the company received a $465 million loan to help foster the development of advanced-technology vehicles. The catalyst for Tesla would ultimately come in two noteworthy waves. First, Tesla exceeded sales expectations even as its industry peers failed to impress. Second, the company paid back early its loan from U.S. Government while Musk significantly added to his holdings at a much higher price.

In the last 6 months, Tesla has seen its stock rise 382%. Throughout this time, Tesla's short interest remained unusually high. At the end of March, the company's short interest was 31.3 million shares, reflecting a short ratio of 22.91. Based on an average daily volume of 1.37 million shares, it would take roughly 23 days for investors that were short to cover their positions in an environment in which the company's stock was appreciating. Such artificial selling pressure allowed for a stronger acceleration when the stock began to find momentum.

OPKO Health

While being in a truly different industry than Tesla, OPKO Health still carries several unique similarities to the automotive company. Although it may easily be passed off as a mere pharmaceutical and diagnostics company now under development, OPKO Health has maintained an aggressive acquisition strategy that distinguishes it from its peers. The company's management team has brought together a very large suite of products under development, many of which provide unique synergies and address a diverse range of specialty markets.

In the last year alone, OPKO has conducted six strategic acquisitions. Most of these utilized the company's stock as either a partial or full payment for the acquisitions. The company's pipeline is now looking to address markets ranging from chronic kidney disease, to prostate cancer, to growth hormone deficiency, and even to depression. Seeking Alpha contributor Josh Ginsburg breaks down the possible multi-billion dollar markets the company can address over the short- and long-term in his article found here.

As was the case with Tesla, the company's strong financial backer happens to be the company's Chief Executive Officer. CEO Dr. Phillip Frost also serves as the Chairman of Teva Pharmaceuticals (TEVA), a position he eventually acquired after gaining his fortune in Teva's $7.4 billion acquisition of IVAX Corporation in 2005. Frost had founded IVAX and had served as its CEO.

As a result of his newfound wealth, the entrepreneur was quick to reinvest his money into OPKO Health after being appointed the company's CEO in 2007. On a near daily basis since 2007, Frost purchased company stock. Part of this can be seen in the graphic below. According to the latest Form 4 found here, the CEO indirectly owned 142,453,591 shares of OPKO, a position now worth $1.32 billion according to the last share price of $9.24 as of August 30.

(click to enlarge)

On August 30, OPKO Health rose 8.83% on more than four times the average daily volume in a rather unexpected swing. What made the climb unique was that shares had traded more than 2% down until the last half hour of the day. At that time, the company rapidly climbed more than 15% at one point to eventually settle down for an 8.83% gain. The apparent catalyst appeared to be a delayed reaction to the finalization of the company's all-stock acquisition of PROLOR Biotech. The announcement was made the day before. The acquisition greatly diversifies OPKO's potential but was initially met with skepticism in light of Frost's conflict of interest. According to the Form 4 found here, Frost owned 9.8 million shares of PROLOR, which accounted for roughly 15% of the shares outstanding.

(click to enlarge)

What likely contributed to the stock's high volatility is the heavy short interest that now surrounds OPKO Health. As of August 15, there were 31.38 million shares short. With an average 1.91 million shares traded daily, this leads to a short ratio of 16.4 for OPKO. Another catalyst which was sure to complicate the issue was the announcement by OPKO that the conversion right for the company's 3.0% Convertible Senior Notes had been triggered. Because of this trigger, it remains likely that an influx of new share demand set off a wave of investors seeking to cover their short positions.

A Look At The Financial Picture

OPKO Health now trades with a $3.11 billion market capitalization based on its last stock price of $9.24. The company carries a high price-to-sales ratio of 34.35 as its valuation is largely dependent on its future revenue potential. Likewise, the company carried a price-to-book ratio of 9.09. Neglecting its pipeline potential, OPKO may appear overvalued. After all, the company only carries a total shareholder equity of $314.48 million.

However, like Tesla, OPKO has shown no sign of slowing down on the market in light of its future potential. Over the last five years, the company's stock has risen 327%. Above all, it remains adequately capitalized. In all of 2012, the company had a cash outflow from operating activities of only $25.42 million. As of June 30, the company carried roughly $169 million in cash and short-term investments.

The company's markets also remain large and near to being addressed. Some of OPKO's diagnostic products are expected to make an impact this year and the company's pipeline carries multiple Phase 3 products. Seeking Alpha contributor John Ford notes that OPKO's 4KScore diagnostic test could generate over $1.8 billion annually just by addressing the prostate cancer test market alone. This is based on the estimates of outside consultants when asked to determine a fair price for the diagnostics test. Such reoccurring revenue significantly overwhelms the mere $47 million the company realized in 2012 as it continued to develop its existing pipeline.

(click to enlarge)

Conclusion

When we use Tesla Motors as a model case study for rapid stock price appreciation, there are several distinct similarities that stick out about OPKO Health as well. Both companies are led by well-known individuals in their respective markets. Both CEOs have accumulated a large fortune and have willingly been propping up their company's stock. Both companies have found niche and valuable industries in which they are staged to make a significant impact. Additionally, each of these companies have been accumulating a rather large short-interest despite the fact their share prices have been rising.

Most importantly, each company appears to have found a catalyst that can ignite the demand for stock. For Tesla Motors, this was the sales expectations beat along with the early payment of a federal loan. For OPKO, the completion of its most ambitious acquisition also coincided with the triggered conversion right for its largest long-term debt obligation. By releasing the artificial selling pressure created by a large short interest, these companies are proving the power of shifting market sentiments prior to true operational success.

Disclosure: I am long OPK, TEVA. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

View the original article here

Rockwell Medical Inc: SFP's Market Potential

Introduction

On September 4th, Rockwell Medical (RMTI) reported CRUISE-2 results which were practically identical to CRUISE-1 results, opening the door for an NDA submission within 6 months.

Treating anemia in CKD patients requires the use of ESAs and supplemental iron. The first step is to increase the number of red blood cells in the body which is done by injecting ESAs. However, this process falters when the patient becomes iron-deficient, and so supplemental iron is provided to maintain hemoglobin levels. An additional benefit of supplemental iron is that it leads to a reduction in the needed dosing of ESAs.

IV Iron Therapy vs ESAs

There has been an ongoing debate in the dialysis industry about whether or not more IV iron therapy is preferred to a higher ESA dosing. A solution is only determinable with a long-term, large-scale, randomized trial where 1 arm is permitted IV iron, and the other isn't. Such a trial would be very costly due to the size and duration, unethical due to the restriction against IV iron use in the ESA-only arm, and produce confounding results. Regardless, what ESA or IV iron producer is going to finance this study if they aren't sure they would come out on top? What non-producer has the financial ability to execute such a grand trial?

The market cannot determine the right answer, which means that the choice between higher ESA dosing and more IV iron therapy will continue to be left to the judgment of dialysis providers. If a patient is susceptible to more risks, or in need of the additional benefits, of either ESAs or IV iron, then providers will act accordingly.

Consider this: When a provider is dealing with an issue in a patient, who hasn't taken IV iron before, what might be the more responsible solution? Introduce an entirely new drug along with its own associated risks, or simply increase the dosing of the already applied ESAs? Probably the latter, and the low use of IV iron therapy in the CKD demographic seems to support this reality.

For the most part, IV iron is used as a weapon of last resort, which is greatly hindering the market potential of current IV iron therapies. Recently, such drugs, along with ESAs, have been under-fire by the FDA due to increasing safety concerns.

The Solution for Dialysis Centers

Is there a drug that can perform the functions of supplemental iron without the safety concerns of current IV iron therapies, while still reducing ESA dosing? Yes, it's called SFP, and it has showcased superb clinical results this year.

The chemical properties of SFP make it safer than current IV iron therapies, while still retaining the functions of supplemental iron. Here is an excellent video that compares SFP with current IV iron therapies. The video goes into detail with regards to the advantages of SFP over current IV iron therapies. From recent clinical results, we know that continuous use of SFP does not lead to tissue iron overload or cause TSAT levels to exceed normal ranges. In addition, SFP has been shown to maintain or slow down the reduction in group ferritin levels, and maintain CHr levels. These endpoints have been crucial in distinguishing SFP's superiority over current IV iron therapies. The trials have confirmed SFP's ability to be continuously applied in the targeted demographic without concerning doctors with whether or not patients are being overloaded with iron. Using current IV iron therapies can lead to tissue iron overload, and to dangerous increases in TSAT and ferritin levels... They simply cannot be continuously applied.

With the results of the PRIME study, combined with the results for the primary endpoints of the CRUISE studies, SFP has proven that it will significantly reduce ESA dosages by 37.1%, while maintaining hemoglobin levels. Doing the PRIME study was quite a shrewd tactical move by management which will allow them to better negotiate with dialysis providers.

In conclusion, SFP is providing the benefits of supplemental iron without the risks that come with current IV iron therapies. SFP's convincing efficacy and safety data will encourage dialysis providers to use SFP across the board, since it's a low-risk method of consistently reducing their own operational costs.

Market potential for SFP

Rockwell Medical will be paid an approximate percentage of the savings associated with the reduction in ESA costs for dialysis centers. Since SFP can be applied continuously and consistently for any anemic CKD patient, the pricing scheme will be quite simple. Current IV iron therapies cannot operate in this stream-lined fashion due to their inconsistent application and risks associated with continuous use. As a result, using the market size of the current IV iron therapies does not provide an appropriate base for which we can estimate potential SFP sales. A better method would be to determine the percentage of expected savings dialysis providers will achieve if they use SFP.

Approximately 436k chronic kidney disease patients in the US are being treated for anemia with ESAs that cost around $8.5k/yr. This places the domestic market size of the ESA market for anemia at about $3.7B. Since SFP can reduce dosing by 37.1%, Rockwell Medical could save dialysis providers $1.37B each year in ESA costs. If we assume they share the savings 50/50 with the dialysis center, then that leaves SFP with potential domestic sales of $690M per year. Currently, Rockwell Medical has an established working relationship with DaVita (DVA) which owns a third of domestic dialysis centers. As a result of this partnership, Rockwell Medical already has access to potential sales of $227M/yr.

Miscellanious

Earlier this year, Rockwell Medical's stock price was negatively impacted from a depleting cash supply and dwindling profits from their base products. They have since raised money with dilutive and non-dilutive financing, and, in addition, the base revenues have bounced from their lows and look to be returning to previous highs.

After the successful CRUISE-1 results, short interest more than doubled, and, given post-CRUISE-2 price action, it's likely to only keep increasing. The shorts have done their best to keep price down despite the fair value being far higher. Clearly the shorts are expecting an imminent financing, but the company is not going to do a poorly-priced financing in the near-term.

The cash balance at the end of the 13Q2 was $42M, with a net loss of $11.9M/qt. At this rate they would deplete their cash reserves before the second half of 2014. However, during the second quarter both CRUISE trials were on-going. Management has guided that R&D expenses will drop as the clinical programs wrap up during the 13Q3-Q4 period. This will extend the life expectancy of the current cash supply to well into the second half of 2014, and perhaps to 14Q4. By then Calcitriol and increasing base product profits should start reducing the quarterly net loss to the point that the cash supply shouldn't dry up before Rockwell Medical starts operating at a net profit. This doesn't mean financing won't happen, only that if it does it will not be at a meaningful discount because Rockwell Medical will be raising from a position of strength, unlike earlier this year. If the company feels that they can get a fairly priced financing in the near-future, they may be motivated towards canceling their Hercule's debt which burdens the company with interest expenses. Financing or not, shorts are not going to be saved by a repeat March 2013 financing.

Finally, institutional ownership doubled during the second quarter of 2013, which suggests smart money believes Rockwell Medical will become a profitable enterprise in the near future with the launch of SFP and Calcitriol.

Company Valuation

Assumptions

Current base revenue will peak at $60M with 20% profit marginsCalcitriol is approved this quarter (very unlikely it isn't), leading to $25M in peak sales (<7% market capture) with 55% profit marginsSFP revenue operating at a 90% profit marginInitial revenue growth for SFP is dramatic given the pre-existing network with DaVitaAssuming initial Calcitriol sales underperform, no more than 5M additional shares will be added in second half of 2014.Overlap in marketing and commercialization costs between the 3 distinct revenue streamsDrastic reduction in R&D expenses due to ended CRUISE 1 & 2 trials.Rockwell Medical does not expand SFP outside of DaVita's domestic dialysis market (Quite unreasonable, especially considering Keryx (KERX) is trading as if it will tap into the entire market with their phosphate binder)

Price Targets

Near-term target: $11 (Calcitriol approval)6 month target: $15 (NDA submission and safety trial results)12 month target $20 (Initial Calcitriol sales and SFP approval)24 month target: $25

The day after CRUISE-2 results, Summer Street raised their price target from $20 to $25. It seems clear to us that they did not limit their projections by assuming Rockwell Medical does not expand outside of DaVita's market. Thus, our price targets should be considered conservative.

Note: Most of this article, including this price target section, was written while the stock was still trading at $6.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in RMTI over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

View the original article here

Regeneron Pipeline Worth Tens Of Billions In Market Capitalization

I tend to shy away from stocks that are high on momentum and carry high P/E (price to earnings) ratios. A flattening of revenue or profit growth can lead to P/E reductions that bring big losses, at least short-term, to investors. Yet occasionally a P/E can seem high, but the stock price still does not begin to reflect the long-term profit potential of the company. In looking at the biotechnology companies in the Nasdaq 100, I believe that Regeneron Pharmaceuticals (REGN) is such a stock. Of course there are caveats, which I will discuss.

Regeneron currently has one big money maker, Eylea (aflibercept), which is currently used to treat wet AMD (Macular Degeneration), a disease that can lead to blindness. Eylea was approved by the FDA in late 2011. In Q2 2013 Regeneron reported revenue of $330 million from Eylea sales. Eylea is a large protein molecule (biologic), monoclonal antibody that works by inhibiting vascular endothelial growth factor (VEGF), which can cause excessive blood vessel growth. In the AMD market it competes mainly with Lucentis. Both drugs are injected into the eye. Since Eylea works well when injected into the eye less often, every 1.7 months vs. 1 month for Lucentis, it has tended to gain market share since its introduction. The other competitor is Avastin, which has not been approved by the FDA for AMD (but it is approved for treating a variety of cancers). However, Avastin is a VEGF inhibitor, it works, and it is much cheaper.

Looking at the usual factors in Regeneron's stock price (September 6, 2013 close of $267.57), Q2 total revenue was $457.6 million, up 50% from $304.4 million in Q2 2012. GAAP diluted Earnings Per Share (EPS) was $0.79, up 13% from $0.70 year-earlier. Non-GAAP EPS was $1.73 per share, down sequentially from $1.78, but up 92% from $0.90 per diluted share year-earlier.

That is pretty astonishing y/y growth, but it comes from the usual nature of the ramping a new drug in by a company that had little or no prior revenue. The growth rate could justify a high P/E, but only if the revenue and profit ramp will continue. Regeneron's trailing non-GAAP P/E is 35.7 (a rule of thumb is any P/E above 20 indicates expectations of at least moderate profit growth; there are formulas that give exact numbers, but they rely on assumptions about the average rate of return on investments and guesses about future profits, so good rules of thumb are more practical). GAAP trailing earnings are $4.63, so trailing GAAP P/E is 57.8, even higher.

On the negative side, after hitting $1.72 in Q3 2012, GAAP EPS has dropped sequentially each quarter. Non-GAAP EPS was $2.29 in Q3 2012, so it has also been declining, but more gradually. Usually companies with stocks with a history of decline have P/Es of 15 or under. Revenue was $428 million, which means the sequential increase from Q2 2012 to Q3 2012 brought most of the revenue growth in the last year. The main reason for the declining earnings despite rising revenue is in expenses, which were (GAAP) $225 million in Q3 2012 but had risen to almost $300 million in Q2 2013. In particular, R&D expense rose $29 million and SG&A (administration) expenses rose $25.6 million.

But here the difference between the short term and the long term makes a big difference. To optimize short term profits Regeneron would have cut the R&D budget to as close to zero as possible. To optimize long term profits more drugs have to be developed, and even Eylea needed to get approved by the FDA for indications other than AMD.

Future Eylea revenue alone might justify the extraordinarily high P/E because it has just begun its international expansion. The pipeline of other drugs, of course, should be treated with a reasonable degree of caution. Not every drug will be approved by the FDA, and of approved drugs some may not sell well due to competition.

Eylea is a pipeline unto itself. Improperly regulated VEGF, it turns out, plays a role in a number of diseases, including solid cancers, where growth is dependent on the formation of new blood vessels (recall Avastin, a cancer therapy, has the same mode of action). A second eye-related indication, CRVO (Macular Edema following Central Retinal Vein Occlusion), was approved by the FDA in September 2012, where again its chief rival is Lucentis, and was approved in Europe on August 29. A variation on Eylea, ziv-aflibercet or Zaltrap, was approved in August 2012 for second-line colorectal cancer in a collaboration with Sanofi (SNY). There are also European approvals for these indications. On August 6 positive Phase III data for Eylea for diabetic macular edema (DME) was reported and Regeneron is planning to submit the drug to the FDA for approval later this year. That means a likely new revenue ramp in the second half of 2014, as DME is a problem for well over one-half million Americans, and can become a problem for any of the 25 million Americans with diabetes.

Finally, Eylea is also in Phase III trials for Macular Edema following Branch Retinal Vein Occlusion. Also in Phase III and looking likely is Sarilumab for rheumatoid arthritis, which if approved could have a very large addressable market, but will be in competition with a large number of therapies including older generics. Alirocumab (PCSK9 Antibody) for lowering cholesterol (LDL, the bad kind) is also in Phase III. While it is entering a crowded market, it can be administered (if approved) at two-week or even one-month intervals.

In Phase II we have Dupilumab (IL-4R) antibody for eosinophilic asthma and atopic dermatitis; it reported positive Phase IIa data in May. Fasinumab (NGF Antibody) for pain from osteoarthritis has been on clinical hold since in late 2010, but not because of anything seen in its trial. Another company's anti-NGF therapy has a serious adverse event, so all anti-NGF trials are on hold until the issue is sorted out. [This is the type of thing that can come up even after FDA approval, which is why I like to use conservative probabilities to calculate future values of pipeline candidates.]

Regeneron has 8 monoclonal antibodies in Phase 1 (safety trials), mainly targeted at advanced metastatic cancers.

One early stage candidate was pulled from development recently for not meeting expectations. Probably the single most valuable asset of Regeneron, in the long run, is its ability to generate a practically unlimited series of monoclonal antibodies in house which can be put into the pipeline. Of course all of this requires R&D dollars, so it will happen gradually. Management, as a result, does not have to hang onto marginal candidates that may flop in Phase II or Phase III. Regeneron can kill a marginal candidate in pre-clinical or Phase I trials, saving the company a lot of money that would be wasted if a therapy failed to reach commercialization.

In short, long-term Regeneron looks like a biotechnology gold mine. It looks to me like it will be worth tens of billions in market capitalization over the next decade. (Current market capitalization is $26.4 billion.)

So the various analysts and others who have been hyping Regeneron, as far as I can tell, are right. That does not mean the stock will go up in a straight line. Its high P/E indicates somewhere between a year and two years of EPS growth are already priced into the stock. A number of factors could depress the price in the short run: failure or delay of a therapy that is expected to get FDA approval; pricing pressures; increased competition resulting in lost market share; a general decline in the stock market, or just profit-taking by investors who got into REGN early and want to spend some of their gains.

I don't see, however, a significant likelihood that Regeneron will be under $300 per share two years from now. More likely, with new revenue and profits, and with a pipelines where candidates are continuing to progress, any decrease in the P/E would be more than compensated for by increased earnings.

I don't think it is a good idea for me to put out a specific number for, say 2016 EPS or a stock target, given the many events and likely variances (including, particularly, pricing of new therapies) ahead. However, I would buy Regeneron today, with good (but of course not 100%) confidence that it will be one of the stocks that will have me and a lot of investors far richer by, say 2020. Most people can't think that far ahead, which is why the stock is bargain-priced today.

However, I said I would not make this new biotech investment round without going through the full process and sharing it with my readers and friends. Next up, the last of my Nasdaq 100 biotechnology checklist companies, Vertex Pharmaceuticals (VRTX). After that I will research and write about perhaps 10 to 15 smaller companies before wrapping up this round.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

View the original article here

Targeting An Untapped Female Sexual Dysfunction Drug Market

(Editors' Note: This article discusses micro-cap stocks. Please be aware of the risks associated with these stocks.)

The pharmaceutical industry remains extremely interested in female sexual dysfunction, primarily due to the enormous revenues that could be generated from this untapped US market.

From our last note on FSD (link):

Female Sexual Dysfunction (FSD) is often overshadowed by the more prominent erectile dysfunction market. While companies like Pfizer (NYSE: PFE) recruit the likes of Bob Dole and other prominent celebrities to help push Viagra, the attention on FSD has been lacking to say the least. This obscures an analysis of a National Health and Social Life Survey performed six years before initial FDA approval of Viagra which estimated that 43% of women suffer from symptoms of FSD. This and other studies imply that there is indeed a vast and significant unmet need for FSD treatments that needs to be addressed to improve the wellbeing of millions of women. In addition to this, there is a huge and untapped therapeutic market that offers a multi-billion opportunity (mimicking the size and scope of the Viagra/Cialis market) for drug developers and their investors.

Although generic competition has arrived, we can say that the Viagra/Cialis market is at least $2 B in size. $3-4 B may be more appropriate, heavily depending on the pricing of any mainstream FSD therapies that could be approved in the United States.

For now testosterone treatment for FDS can be available off-label, but progress towards an FDA-approved FSD testosterone product has been weak:

Recall the transdermal testosterone patch Intrinsa, was not successful at obtaining FDA approval after successful clinical development. Intrinsa did not have efficacy problems, although the FDA was very against its approval due to abuse potential and other safety concerns.

Also recall the testosterone product called Libigel, which was being developed by BioSante Pharmaceuticals (its ticker was "BPAX") until the product failed to achieve statistically significant improvements in Phase III trials. The results of this trial were quite upsetting and controversial for most investors, largely part due to the surprisingly positive performance in the placebo arm. Note that this, plus multiple investor lawsuits, eventually led to Biosante's merger with generic manufacturer ANI Pharmaceuticals (ANIP).

Testosterone products are approved in other countries for FSD, although it seems that non-hormonal therapy may be the first to officially hit the United States. Current non-hormonal drug developers targeting FSD are also "under-the-radar" for the time being, making them interesting considerations for special situation and value investors.

Osphena - Shionogi

Osphena (Ospemifene) is a selective estrogen receptor modulator (SERM) drug developed by Japanese pharmaceutical company Shionogi & Co (SGIOF) that was approved earlier this year, although it is specifically used for women who experience pain during sex (dyspareunia). This is an effect of vaginal dryness, which is frequent in menopausal women who have lower estrogen levels. Osphena helps to rebuild the actual thickness of the vaginal wall without direct use of estrogen, which is novel.

Although it is efficacious, Osphena has some major drawbacks with regards to its safety and use. Uncommon and possible side effects of the drug include stroke, blood clots, and endometrial cancer (cancer of the uterus). Common side effects include hot flashes, discharge, muscle spams, and increased sweating. While this therapy may replace standard estrogen therapy, it is dangerous. In addition, it is far from an equivalent to "female Viagra".

Flibanserin - Sprout

The original attempt at female Viagra was with Flibanserin by Boehringer Ingelheim. The drug failed from an efficacy standpoint, and is now controlled by a very new private entity called Sprout Pharmaceuticals (an offshoot of Slate Pharmaceuticals). The company has already submitted an NDA, and expects a response before the end of 2013.

Bremelanotide - Palatin

Palatin (PTN) recently completed end-of-phase II meetings with the FDA, and has reached preliminary agreement on key aspects of the Phase III pivotal trial. This includes the FSD patient population, the primary and key secondary efficacy endpoints, design, dosing, and safety monitoring. Since the FDA has been hard on efficacy data presented for the FSD indication, it's encouraging to hear their close involvement with the design of bremelanotide's pivotal trial.

Phase II data and discussion from a previous note (link):

The Company is testing bremelanotide, a peptide melanocortin receptor agonist, in patients with FSD. Bremalanotide works via activation of melanocortin receptors in the central nervous system, and is intended for on-demand use approximately an hour prior to anticipated sexual activity. In the first quarter of 2013, Palatin released top-line data for their Phase IIb, at-home clinical trial in patients with female sexual dysfunction.

The trial hit on the primary and key secondary endpoints, a major success, demonstrating a good safety profile for bremalanotide and statistically significant increases in the number of Satisfying Sexual Events (SSE) versus placebo. The most common adverse reactions with incidence over 5% among bremalanotide users at any dose included nausea, flushing, and headache. The FDA approved a Phase III trial design with bremalanotide, and the Company could start the trial as early as Q4 2013.

The drug's safety and tolerability has been adequate up to this point, and should be adequate for approval after the trial. This is because the cardiovascular risk concerns will be studied closely through patient blood pressure monitoring.

The FDA is expected to finalize the design of the trial before the end of the year. Patient screening is also expected to start before the end of the year. Official estimates for interim data aren't available, although the conclusion of the enrollment process should give us a lot more to work with. Investor attention is expected to increase significantly as we approach potential data releases for the pivotal trials, since they will be major catalysts for shares of PTN.

Femprox - Apricus

Femprox is a Prostaglandin Ei (alprostadil) cream being developed by Apricus Biosciences (APRI) that passed its first Phase III trial and has yet to start its pivotal Phase III trial. The first Phase III trial consisted of over 400 patients in China, and application of the cream was not performed in the clinic. Primary and secondary efficacy endpoints were achieved with statistical significance. A foreign trial may mean these data may be deemed less reliable when the FDA performs its review. This may put more weight on the pivotal trial, which investors are eagerly anticipating.

Notes on Biotech Risk:

Investors should realize that unprofitable biotechnology companies in the development stage experience particularly high volatility, are speculative, and do hold significant risk for loss of wealth. Investors believe that the company's valuation will increase more over time than the rate at which the company will burn cash, which is why the high risks are taken.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

View the original article here

Opko Health: Following Tesla's Formula For A Market Take-Off

Investors are always on the prowl for the next big company capable of providing significant returns in a limited amount of time. Yet in this short-sighted perspective of the market, this popular mindset often boils down to a dependency on shifting market sentiments rather than tangible operational success. After all, enterprises take time to develop and the short-handed impact of rapid market gains aren't often dependent on the cash-generating business changes implemented overnight. Indeed, it is through the proliferation of investor optimism that a company's stock accelerates on the backbone of momentum.

This article takes a look at two particular companies that now find themselves following part of a formula for rapid stock appreciation. These companies are Tesla Motors, Inc. (TSLA) and OPKO Health, Inc. (OPK). In each of these instances, the companies have developed a solid innovation pipeline, the support of a strong financial backer, an unusually large short-interest, and a catalyst for demand. Combined, these attributes appear to design a formula that can lead to rapid stock price appreciation.

TSLA data by YCharts

Tesla Motors

As a company that has already appreciated in a short amount of time, it remains ideal to look at Tesla as a model. Tesla Motors is a premier innovator behind electric vehicle technology. Outlasting its private company peers such as Fisker Automotive and Coda Holdings, Tesla has made its high-end electric vehicles the envy of the automotive industry. The company has very quickly shown its ability to succeed in its target market where larger public companies such as General Motors (GM) and Ford (F) have failed to gain momentum with their own electric vehicle lines.

Tesla's most popular financial backer remains the company CEO himself. As a co-founder for the company, CEO Elon Musk helped to create a valuation premium through his own financial support. Musk owes fortune as the former founder of PayPal. In June 2011, Musk purchased $40.7 million worth of company shares. In May 2013, Musk reinvigorated investor confidence by putting another $100 million into Tesla despite the fact that the company's stock had already appreciated more than 150% in the two months prior.

Although it would ultimately be seen as a crutch to the company, the Department of Energy also played heavy role in supporting Tesla. In 2010, the company received a $465 million loan to help foster the development of advanced-technology vehicles. The catalyst for Tesla would ultimately come in two noteworthy waves. First, Tesla exceeded sales expectations even as its industry peers failed to impress. Second, the company paid back early its loan from U.S. Government while Musk significantly added to his holdings at a much higher price.

In the last 6 months, Tesla has seen its stock rise 382%. Throughout this time, Tesla's short interest remained unusually high. At the end of March, the company's short interest was 31.3 million shares, reflecting a short ratio of 22.91. Based on an average daily volume of 1.37 million shares, it would take roughly 23 days for investors that were short to cover their positions in an environment in which the company's stock was appreciating. Such artificial selling pressure allowed for a stronger acceleration when the stock began to find momentum.

OPKO Health

While being in a truly different industry than Tesla, OPKO Health still carries several unique similarities to the automotive company. Although it may easily be passed off as a mere pharmaceutical and diagnostics company now under development, OPKO Health has maintained an aggressive acquisition strategy that distinguishes it from its peers. The company's management team has brought together a very large suite of products under development, many of which provide unique synergies and address a diverse range of specialty markets.

In the last year alone, OPKO has conducted six strategic acquisitions. Most of these utilized the company's stock as either a partial or full payment for the acquisitions. The company's pipeline is now looking to address markets ranging from chronic kidney disease, to prostate cancer, to growth hormone deficiency, and even to depression. Seeking Alpha contributor Josh Ginsburg breaks down the possible multi-billion dollar markets the company can address over the short- and long-term in his article found here.

As was the case with Tesla, the company's strong financial backer happens to be the company's Chief Executive Officer. CEO Dr. Phillip Frost also serves as the Chairman of Teva Pharmaceuticals (TEVA), a position he eventually acquired after gaining his fortune in Teva's $7.4 billion acquisition of IVAX Corporation in 2005. Frost had founded IVAX and had served as its CEO.

As a result of his newfound wealth, the entrepreneur was quick to reinvest his money into OPKO Health after being appointed the company's CEO in 2007. On a near daily basis since 2007, Frost purchased company stock. Part of this can be seen in the graphic below. According to the latest Form 4 found here, the CEO indirectly owned 142,453,591 shares of OPKO, a position now worth $1.32 billion according to the last share price of $9.24 as of August 30.

(click to enlarge)

On August 30, OPKO Health rose 8.83% on more than four times the average daily volume in a rather unexpected swing. What made the climb unique was that shares had traded more than 2% down until the last half hour of the day. At that time, the company rapidly climbed more than 15% at one point to eventually settle down for an 8.83% gain. The apparent catalyst appeared to be a delayed reaction to the finalization of the company's all-stock acquisition of PROLOR Biotech. The announcement was made the day before. The acquisition greatly diversifies OPKO's potential but was initially met with skepticism in light of Frost's conflict of interest. According to the Form 4 found here, Frost owned 9.8 million shares of PROLOR, which accounted for roughly 15% of the shares outstanding.

(click to enlarge)

What likely contributed to the stock's high volatility is the heavy short interest that now surrounds OPKO Health. As of August 15, there were 31.38 million shares short. With an average 1.91 million shares traded daily, this leads to a short ratio of 16.4 for OPKO. Another catalyst which was sure to complicate the issue was the announcement by OPKO that the conversion right for the company's 3.0% Convertible Senior Notes had been triggered. Because of this trigger, it remains likely that an influx of new share demand set off a wave of investors seeking to cover their short positions.

A Look At The Financial Picture

OPKO Health now trades with a $3.11 billion market capitalization based on its last stock price of $9.24. The company carries a high price-to-sales ratio of 34.35 as its valuation is largely dependent on its future revenue potential. Likewise, the company carried a price-to-book ratio of 9.09. Neglecting its pipeline potential, OPKO may appear overvalued. After all, the company only carries a total shareholder equity of $314.48 million.

However, like Tesla, OPKO has shown no sign of slowing down on the market in light of its future potential. Over the last five years, the company's stock has risen 327%. Above all, it remains adequately capitalized. In all of 2012, the company had a cash outflow from operating activities of only $25.42 million. As of June 30, the company carried roughly $169 million in cash and short-term investments.

The company's markets also remain large and near to being addressed. Some of OPKO's diagnostic products are expected to make an impact this year and the company's pipeline carries multiple Phase 3 products. Seeking Alpha contributor John Ford notes that OPKO's 4KScore diagnostic test could generate over $1.8 billion annually just by addressing the prostate cancer test market alone. This is based on the estimates of outside consultants when asked to determine a fair price for the diagnostics test. Such reoccurring revenue significantly overwhelms the mere $47 million the company realized in 2012 as it continued to develop its existing pipeline.

(click to enlarge)

Conclusion

When we use Tesla Motors as a model case study for rapid stock price appreciation, there are several distinct similarities that stick out about OPKO Health as well. Both companies are led by well-known individuals in their respective markets. Both CEOs have accumulated a large fortune and have willingly been propping up their company's stock. Both companies have found niche and valuable industries in which they are staged to make a significant impact. Additionally, each of these companies have been accumulating a rather large short-interest despite the fact their share prices have been rising.

Most importantly, each company appears to have found a catalyst that can ignite the demand for stock. For Tesla Motors, this was the sales expectations beat along with the early payment of a federal loan. For OPKO, the completion of its most ambitious acquisition also coincided with the triggered conversion right for its largest long-term debt obligation. By releasing the artificial selling pressure created by a large short interest, these companies are proving the power of shifting market sentiments prior to true operational success.

Disclosure: I am long OPK, TEVA. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

View the original article here

Abbott Labs And The Peripheral Stent Market

In July, Abbott Laboratories (ABT) acquired Idev, a Texas-based privately held company for $310 million. Idev makes a stent to treat blockages in leg arteries.

As demand and prices for heart stents continue to tumble, the $500 million market for peripheral artery disease market looks better every day as the next target. A blockage in the leg arteries affects about 27 million people in the U.S. and Europe, and it is fueled by rising obesity and diabetes rates.

Supera Veritas

Idev's Supera Veritas is a different class of stent. It is characterized by great flexibility and strength, a resistance to fracture and the ability to truly support the anatomy.

Veritas' design is based on biomimetic principles: attempting to mimic the body's natural movement to promote blood flow in the treated area while offering strength and flexibility. These properties are especially important in the treatment of blockages of the blood vessels in the thigh and knee where rapid and frequent movement occurs with daily activities like walking, sitting and standing.

The Veritas is a self-expanding nitinol stent built with six pairs of closed end interwoven nitinol wires with a closed cell geometry.

Supera Veritas is already approved in Europe for use in the legs. In the U.S., it is cleared for treatment of biliary strictures (narrowing of a bile duct) related to cancer. For other uses, it is still under FDA review.

In October 2012 during a VIVA (Vascular Interventional Advances) conference in Las Vegas, Kenneth Rosenfield, MD, presented findings from the Superb study.

264 subjects were enrolled in 34 sites. The mean lesion length was 8 cm, with 73 percent of the lesions having moderate to severe calcification.

Dr. Rosenfield reported that freedom from target lesion revascularization (TLR) and restenosis (a narrowing of a blood vessel), at 12 months was achieved in 79 percent of patients, easily exceeding the performance goal of 66 percent.

The primary safety endpoint was composite of all death, TLR, or any amputation of the index limb to 30 days, which was achieved in 99.6 percent of subjects, a significantly higher rate than the goal of 88 percent.

Independent core lab review of x-rays showed a stent fracture rate of 0 percent. Responses from Peripheral Artery Quality-of-Life Questionnaires showed a positive impact on the quality-of-life for patients treated with Veritas stents.

Market

The increasing prevalence of PAD is expected to place a heavy economic burden on the healthcare system. In patients with PAD, fatty deposits accumulate on the inner wall of the artery, causing blockages that reduce the flow of blood to lower parts of the leg. Patients with PAD can experience leg pain when walking and, if untreated, the disease can progress with severe consequences such as critical limb ischemia and amputation.

PAD usually affects men over age 50 and women over 65. Smoking and diabetes add to the risk. About eight million Americans have PAD, many of whom are not even aware they have the condition.

Many PAD patients aren't aware they have the disease because they may initially overlook the most common symptom, leg or foot pain while walking. In advanced stages, PAD carries a threat of amputation and even death.

Because leg arteries are subject to different physical forces than coronary arteries, some treatments derived from heart disease aren't as effective when applied to PAD.

Beyond the advice to quit smoking and eat healthy foods, there are three main treatment options for PAD patients: a drug called cilostazol (manufactured by Otsuka Pharmaceutical Co. under the trade name Pletal), the only medication specifically approved for the condition; a supervised exercise program; and procedures to clear arterial blockages, or to create a bypass around the blockages, to improve blood flow to lower legs and feet. Most patients also get drugs to lower cholesterol and blood pressure to reduce overall cardiovascular risk.

Few devices are available for treating PAD and doctors sometimes have little choice. The Wall Street Journal quotes a doctor as saying:

"Sixty to seventy percent of what we do in the vascular territory is off-label use."

The strategies for treating PAD are just emerging and their benefits remain to be proven with further study, he also said.

Zilver

With only one drug-coated peripheral stent approved in the U.S., and subsequently recalled, a bare metal device like Supera Veritas could help Abbott carve out a niche.

In April, 2013, a recall was issued for Cook Medical, Inc.'s Zilver PTX Drug-Eluting Peripheral Stent, including all sizes, diameters, and lot numbers manufactured or distributed starting December 1, 2012.

Complaints focused on the separation of the tip and inner catheter, which could impose additional surgery on patients to remove the catheter tip. Failure to do so can create thrombosis, amputation, possible cardiac arrest, and death.

In Europe, Zilver PTX has been available since September 2009. Cook is a private company and does not release sales figures, but Zilver PTX has met with success in clinical trials and uptake ought to have been good.

Cook had huge hopes for the product and the recall was a disaster.

Cook says it has altered its manufacturing process to fix the problem, but it will take time to get the FDA to sign off on the new system.

One factor in Cook's favor is the paucity of alternatives. The other possible options for treating the peripheral arterial disease include balloon angioplasty, bare-metal stents, drug therapy or surgical bypass. Medtronic (MDT) and C. R. Bard (BCR) are developing drug-coated balloons for peripheral arterial disease, but no other drug-eluting stents are likely to reach the U.S. for many years.

Balloons

An up and coming idea is the use of drug-coated balloons without stents.

Newer-generation balloons include a carrier designed to ensure that the drug remains attached to the balloon until it has been inflated and facilitates penetration into the tissue. Studies show that paclitaxel (the drug used in coating) remains in the tissue for days or weeks, even months, thereby producing a long-term effect. No hardware is left in the body.

So far, all the balloons to reach the market employ paclitaxel to guard against the vessel re-narrowing.

In coronary stents paclitaxel has been largely replaced as a coating material by the more effective 'limus mTOR inhibitors, (sirolimus, everolimus and novolimus). The reason that the mTOR inhibitors have not made a quick transition to the drug coated balloons is that, unlike paclitaxel, they are not absorbed quickly enough by the vessel wall.

Drug-coated balloons will have a good shot at the U.S. market. The leading balloon, Medtronic's IN.PACT Admiral, is slated for U.S. approval for peripheral artery disease in 2015. By that time Zilver PTX stent probably will have returned to the market, but the recall may have left a bad taste about the technology among doctors.

Competition

The delay between European and U.S. approval of medical devices is notorious and it is called the "device lag." No such lag exists in the approval of drugs.

The lag averages around three to five years. Zilver PTX, for example, saw a three-year delay, but with drug-coated balloons, it will probably be a lot more.

Analysts at Goldman Sachs say that by 2017, Medtronic and CR Bard will hold leadership positions in drug-coated balloons, with 39 percent each of the worldwide market, which will then be worth $500 million. This is a small change compared to the drug-coated stent market, which already stands at $4.5 billion and is growing.

In the peripheral arena drug-coated balloons could do well, better than in coronary artery disease where the competition is heated and the field is crowded.

Investors' summary

Analysts at Cowen point out that greater emphasis on peripheral vascular opportunities is key to Abbott's growth. The company has launched a version of Xience called Xience Prime BTK (below the knee) for critical limb ischemia in Europe, and is also pursuing CE mark for a below the knee version of the Absorb, its dissolving drug-coated stent.

Abbott's vascular products had a worldwide market share of 32 percent in 2010, according to analysts at Trefis, but this declined to around 26 percent in 2012. The company must know that the Idev acquisition alone cannot reverse this trend, though it will presumably improve it a little.

In the second quarter Abbott's total sales were $5.45 billion. Excluding currency impacts, mostly the effect of a weaker yen versus the U.S. dollar, sales grew 4.2 percent.

Abbott Labs reported a profit of $476 million and the operating margin rose to 11.5 percent from 10.6 percent.

The company's largest business is nutritional products, which includes baby formula and adult drinks marketed under the Ensure brand. Excluding currency impacts, nutrition sales rose 8.4 percent, while the company's diagnostics business reported sales growth of 7.6 percent.

Abbott's device business badly needs new directions and innovations and this must have been the thinking behind the Idev purchase. Further actions in the same direction are needed and presumably coming.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

View the original article here

There’s a Black Market for Botox & Other Things to Know Before Getting Injected

Botox might take years off your appearance, but before requesting your own injectable Fountain of Youth, make sure you know exactly what you're doing

By Kristin Booker - July 5, 2013

Botox Might Not Do What You Want It to
Many people confuse what Botox actually does with other age-fighting beauty injectables. “[Botox's] only benefit is to render a muscle weaker for 3-4 months. It doesn't fill lines, it just makes it harder to make the muscle contraction that creates the lines,” explains board-certified dermatologist Dr. Misbah Khan, owner of M. Khan Dermatology in New York City. So will it work on those wrinkles around the mouth? “No. If you have smile lines [the parentheses around the mouth], you'll need a filler [like Restylane] to erase them.”

There's a Black Market
Many coupon services run deals for cheap series of Botox, and they’re probably all too good to be true. Before you buy into anything, know who and what you’re dealing with. “Do not look for the better deal. Make sure you know what’s going in your face. If it's too cheap, it may be acquired on the black market, or the Botox they’re using might be expired or about to expire," warns Dr. Khan.

You Could Have an Allergic Reaction
You may know that Botox is derived from the same bacteria as the toxin botulism, and while you absolutely cannot catch botulism from the use of Botox, there is a small chance that you could have an allergic reaction to preservatives and ingredients used. "Some reactions that have been reported include itching, rash, welts, asthma symptoms or feeling faint,” says Dr. Dennis Gross, founder of 900 5th Dermatology and creator of Dr. Dennis Gross Skincare. If you do have a reaction, call your doctor right away.

An Unskilled Injector Might Leave You Lopsided
“If the Botox is injected wrong in any part of your face, you may have a lopsided appearance,” says Dr. Gross. “Just remember that there is an artistry involved in the technique, so be sure your physician is highly experienced and skilled at administering it.”

Overdoing It Could Lead to Drooping—or Worse
“Drooping of the eyebrows can happen even in the best of hands; it can occur if too much is injected in one place,” says Dr. Khan. And if you’re already using Botox, over-application could make it worse. “Overuse of Botox can cause the muscles to become so weak that they can't support the flesh.” The results can look unnatural, and even worse, be painful. “If too much Botox is applied during a neck rejuvenation, it can cause the side of the face to droop, or in some cases the muscles that hold the neck up weaken to the point where you can't swallow or hold your head up."

Speaking Up Can Divert Disaster
You might think that you really, really want Botox no matter the small risks, but the pursuit of beauty is never worth harming your health. As with any other procedure, you should always disclose your full medical history before sitting in the chair. “Make sure to tell your doctor about all of your muscle or nerve conditions, as you may have an increased risk of serious side-effects, including difficulty swallowing and/or breathing,” cautions Dr. Gross. “Also, inform your doctor of any surgery plans, weakness of forehead muscles, recent injections, or medicines you are currently taking.” Dr. Gervaise Gerstner, L’Oréal Paris Consulting Dermatologist adds one more caution to that list: “Be sure to disclose any autoimmune neuromotor disease like myasenthia gravis.”

Results Are Not Instant
“It takes about three to seven days to show the full effect, and results will last about four months,” says Dr. Gross. And those results vary, depending on the depth of your wrinkles. “If you start Botox treatments just as fine lines are beginning to appear and continue them as you age, you can prevent select expression lines from forming at all,” advises Dr. Gross. Patients who already have pronounced lines may see benefits in a bit more time, “It takes a few days to see results, and a full two weeks to see the full effects of a Botox treatment,” explains Dr. Khan.

Botox is Not Painless
Although getting Botox is not particularly painful for most patients, since there are needles involved, you can’t expect to feel absolutely nothing when getting injected. “During the procedure, you can expect a slight pinch from the needle. There are numbing creams available in topical and aesthetic forms,” says Dr. Gross. Dr. Khan is also known to use ice to numb the area for people who have a low tolerance or phobia of needles.

Aspirin and Fish Oil Don't Mix With Botox
“We tell our patients to stop using aspirin products up to a week before a treatment because they are blood thinners,” cautions Dr. Gross. "Discontinuing the use of aspirin the week before will help to keep bruising down. Also, we tell our patients to stop using fish oils a week beforehand because they also promote bruising for the same blood thinning reason.” Of course, always discuss changing the dosage of medicine with your primary physician beforehand.

Hair-Drying Is Off Limits Right After the Procedure
“There’s no lowering of the head for two hours post-procedure,” says Dr. Gerstner. “No yoga, no bending over, no blow drying your hair, no tight hats, no napping. In other words, heads up!”

It Might Cure More Than Wrinkles
If you have excessive underarm or palm sweating or suffer from serious migraines, talk to your doctor about using Botox to cure these ills. It's been proven to diminish or stop excessive sweating, called hyperhidrosis, and to reduce the severity of migraines too—but don’t try tacking either treatment onto your cosmetic visit. You’ll need to book separate appointments. One quick tip: always take a quick peek at the box. “Botox meant for cosmetic purposes will say ‘Botox Cosmetic’ on the packaging,” says Dr. Khan. “Botox for medical purposes will say that on the package.”

A Happier Look Might Actually Improve Your Mood
If you’re prone to frowning, “eventually those muscles strengthen in that formation, which means it takes much effort to smile and look happy. When Botox relaxes those muscles, you look happier, which can really improve your mood and confidence,” says Dr. Gross.

Kristin Booker is a contributing writer on iVillage. Follow her on Twitter andGoogle+.

Connect with Us Follow Our Pins

Yummy recipes, DIY projects, home decor, fashion and more curated by iVillage staffers.

The very dirty truth about fashion internships... DUN DUN @srslytheshow http://t.co/wfewf

On Instagram

Behind-the-scenes pics from iVillage.

View the original article here

There’s a Black Market for Botox & Other Things to Know Before Getting Injected

Botox might take years off your appearance, but before requesting your own injectable Fountain of Youth, make sure you know exactly what you're doing

By Kristin Booker - July 5, 2013

Botox Might Not Do What You Want It to
Many people confuse what Botox actually does with other age-fighting beauty injectables. “[Botox's] only benefit is to render a muscle weaker for 3-4 months. It doesn't fill lines, it just makes it harder to make the muscle contraction that creates the lines,” explains board-certified dermatologist Dr. Misbah Khan, owner of M. Khan Dermatology in New York City. So will it work on those wrinkles around the mouth? “No. If you have smile lines [the parentheses around the mouth], you'll need a filler [like Restylane] to erase them.”

There's a Black Market
Many coupon services run deals for cheap series of Botox, and they’re probably all too good to be true. Before you buy into anything, know who and what you’re dealing with. “Do not look for the better deal. Make sure you know what’s going in your face. If it's too cheap, it may be acquired on the black market, or the Botox they’re using might be expired or about to expire," warns Dr. Khan.

You Could Have an Allergic Reaction
You may know that Botox is derived from the same bacteria as the toxin botulism, and while you absolutely cannot catch botulism from the use of Botox, there is a small chance that you could have an allergic reaction to preservatives and ingredients used. "Some reactions that have been reported include itching, rash, welts, asthma symptoms or feeling faint,” says Dr. Dennis Gross, founder of 900 5th Dermatology and creator of Dr. Dennis Gross Skincare. If you do have a reaction, call your doctor right away.

An Unskilled Injector Might Leave You Lopsided
“If the Botox is injected wrong in any part of your face, you may have a lopsided appearance,” says Dr. Gross. “Just remember that there is an artistry involved in the technique, so be sure your physician is highly experienced and skilled at administering it.”

Overdoing It Could Lead to Drooping—or Worse
“Drooping of the eyebrows can happen even in the best of hands; it can occur if too much is injected in one place,” says Dr. Khan. And if you’re already using Botox, over-application could make it worse. “Overuse of Botox can cause the muscles to become so weak that they can't support the flesh.” The results can look unnatural, and even worse, be painful. “If too much Botox is applied during a neck rejuvenation, it can cause the side of the face to droop, or in some cases the muscles that hold the neck up weaken to the point where you can't swallow or hold your head up."

Speaking Up Can Divert Disaster
You might think that you really, really want Botox no matter the small risks, but the pursuit of beauty is never worth harming your health. As with any other procedure, you should always disclose your full medical history before sitting in the chair. “Make sure to tell your doctor about all of your muscle or nerve conditions, as you may have an increased risk of serious side-effects, including difficulty swallowing and/or breathing,” cautions Dr. Gross. “Also, inform your doctor of any surgery plans, weakness of forehead muscles, recent injections, or medicines you are currently taking.” Dr. Gervaise Gerstner, L’Oréal Paris Consulting Dermatologist adds one more caution to that list: “Be sure to disclose any autoimmune neuromotor disease like myasenthia gravis.”

Results Are Not Instant
“It takes about three to seven days to show the full effect, and results will last about four months,” says Dr. Gross. And those results vary, depending on the depth of your wrinkles. “If you start Botox treatments just as fine lines are beginning to appear and continue them as you age, you can prevent select expression lines from forming at all,” advises Dr. Gross. Patients who already have pronounced lines may see benefits in a bit more time, “It takes a few days to see results, and a full two weeks to see the full effects of a Botox treatment,” explains Dr. Khan.

Botox is Not Painless
Although getting Botox is not particularly painful for most patients, since there are needles involved, you can’t expect to feel absolutely nothing when getting injected. “During the procedure, you can expect a slight pinch from the needle. There are numbing creams available in topical and aesthetic forms,” says Dr. Gross. Dr. Khan is also known to use ice to numb the area for people who have a low tolerance or phobia of needles.

Aspirin and Fish Oil Don't Mix With Botox
“We tell our patients to stop using aspirin products up to a week before a treatment because they are blood thinners,” cautions Dr. Gross. "Discontinuing the use of aspirin the week before will help to keep bruising down. Also, we tell our patients to stop using fish oils a week beforehand because they also promote bruising for the same blood thinning reason.” Of course, always discuss changing the dosage of medicine with your primary physician beforehand.

Hair-Drying Is Off Limits Right After the Procedure
“There’s no lowering of the head for two hours post-procedure,” says Dr. Gerstner. “No yoga, no bending over, no blow drying your hair, no tight hats, no napping. In other words, heads up!”

It Might Cure More Than Wrinkles
If you have excessive underarm or palm sweating or suffer from serious migraines, talk to your doctor about using Botox to cure these ills. It's been proven to diminish or stop excessive sweating, called hyperhidrosis, and to reduce the severity of migraines too—but don’t try tacking either treatment onto your cosmetic visit. You’ll need to book separate appointments. One quick tip: always take a quick peek at the box. “Botox meant for cosmetic purposes will say ‘Botox Cosmetic’ on the packaging,” says Dr. Khan. “Botox for medical purposes will say that on the package.”

A Happier Look Might Actually Improve Your Mood
If you’re prone to frowning, “eventually those muscles strengthen in that formation, which means it takes much effort to smile and look happy. When Botox relaxes those muscles, you look happier, which can really improve your mood and confidence,” says Dr. Gross.

Kristin Booker is a contributing writer on iVillage. Follow her on Twitter andGoogle+.

Connect with Us Follow Our Pins

Yummy recipes, DIY projects, home decor, fashion and more curated by iVillage staffers.

The very dirty truth about fashion internships... DUN DUN @srslytheshow http://t.co/wfewf

On Instagram

Behind-the-scenes pics from iVillage.

View the original article here

There’s a Black Market for Botox & Other Things to Know Before Getting Injected

Botox might take years off your appearance, but before requesting your own injectable Fountain of Youth, make sure you know exactly what you're doing

By Kristin Booker - July 5, 2013

Botox Might Not Do What You Want It to
Many people confuse what Botox actually does with other age-fighting beauty injectables. “[Botox's] only benefit is to render a muscle weaker for 3-4 months. It doesn't fill lines, it just makes it harder to make the muscle contraction that creates the lines,” explains board-certified dermatologist Dr. Misbah Khan, owner of M. Khan Dermatology in New York City. So will it work on those wrinkles around the mouth? “No. If you have smile lines [the parentheses around the mouth], you'll need a filler [like Restylane] to erase them.”

There's a Black Market
Many coupon services run deals for cheap series of Botox, and they’re probably all too good to be true. Before you buy into anything, know who and what you’re dealing with. “Do not look for the better deal. Make sure you know what’s going in your face. If it's too cheap, it may be acquired on the black market, or the Botox they’re using might be expired or about to expire," warns Dr. Khan.

You Could Have an Allergic Reaction
You may know that Botox is derived from the same bacteria as the toxin botulism, and while you absolutely cannot catch botulism from the use of Botox, there is a small chance that you could have an allergic reaction to preservatives and ingredients used. "Some reactions that have been reported include itching, rash, welts, asthma symptoms or feeling faint,” says Dr. Dennis Gross, founder of 900 5th Dermatology and creator of Dr. Dennis Gross Skincare. If you do have a reaction, call your doctor right away.

An Unskilled Injector Might Leave You Lopsided
“If the Botox is injected wrong in any part of your face, you may have a lopsided appearance,” says Dr. Gross. “Just remember that there is an artistry involved in the technique, so be sure your physician is highly experienced and skilled at administering it.”

Overdoing It Could Lead to Drooping—or Worse
“Drooping of the eyebrows can happen even in the best of hands; it can occur if too much is injected in one place,” says Dr. Khan. And if you’re already using Botox, over-application could make it worse. “Overuse of Botox can cause the muscles to become so weak that they can't support the flesh.” The results can look unnatural, and even worse, be painful. “If too much Botox is applied during a neck rejuvenation, it can cause the side of the face to droop, or in some cases the muscles that hold the neck up weaken to the point where you can't swallow or hold your head up."

Speaking Up Can Divert Disaster
You might think that you really, really want Botox no matter the small risks, but the pursuit of beauty is never worth harming your health. As with any other procedure, you should always disclose your full medical history before sitting in the chair. “Make sure to tell your doctor about all of your muscle or nerve conditions, as you may have an increased risk of serious side-effects, including difficulty swallowing and/or breathing,” cautions Dr. Gross. “Also, inform your doctor of any surgery plans, weakness of forehead muscles, recent injections, or medicines you are currently taking.” Dr. Gervaise Gerstner, L’Oréal Paris Consulting Dermatologist adds one more caution to that list: “Be sure to disclose any autoimmune neuromotor disease like myasenthia gravis.”

Results Are Not Instant
“It takes about three to seven days to show the full effect, and results will last about four months,” says Dr. Gross. And those results vary, depending on the depth of your wrinkles. “If you start Botox treatments just as fine lines are beginning to appear and continue them as you age, you can prevent select expression lines from forming at all,” advises Dr. Gross. Patients who already have pronounced lines may see benefits in a bit more time, “It takes a few days to see results, and a full two weeks to see the full effects of a Botox treatment,” explains Dr. Khan.

Botox is Not Painless
Although getting Botox is not particularly painful for most patients, since there are needles involved, you can’t expect to feel absolutely nothing when getting injected. “During the procedure, you can expect a slight pinch from the needle. There are numbing creams available in topical and aesthetic forms,” says Dr. Gross. Dr. Khan is also known to use ice to numb the area for people who have a low tolerance or phobia of needles.

Aspirin and Fish Oil Don't Mix With Botox
“We tell our patients to stop using aspirin products up to a week before a treatment because they are blood thinners,” cautions Dr. Gross. "Discontinuing the use of aspirin the week before will help to keep bruising down. Also, we tell our patients to stop using fish oils a week beforehand because they also promote bruising for the same blood thinning reason.” Of course, always discuss changing the dosage of medicine with your primary physician beforehand.

Hair-Drying Is Off Limits Right After the Procedure
“There’s no lowering of the head for two hours post-procedure,” says Dr. Gerstner. “No yoga, no bending over, no blow drying your hair, no tight hats, no napping. In other words, heads up!”

It Might Cure More Than Wrinkles
If you have excessive underarm or palm sweating or suffer from serious migraines, talk to your doctor about using Botox to cure these ills. It's been proven to diminish or stop excessive sweating, called hyperhidrosis, and to reduce the severity of migraines too—but don’t try tacking either treatment onto your cosmetic visit. You’ll need to book separate appointments. One quick tip: always take a quick peek at the box. “Botox meant for cosmetic purposes will say ‘Botox Cosmetic’ on the packaging,” says Dr. Khan. “Botox for medical purposes will say that on the package.”

A Happier Look Might Actually Improve Your Mood
If you’re prone to frowning, “eventually those muscles strengthen in that formation, which means it takes much effort to smile and look happy. When Botox relaxes those muscles, you look happier, which can really improve your mood and confidence,” says Dr. Gross.

Kristin Booker is a contributing writer on iVillage. Follow her on Twitter andGoogle+.

Connect with Us Follow Our Pins

Yummy recipes, DIY projects, home decor, fashion and more curated by iVillage staffers.

The very dirty truth about fashion internships... DUN DUN @srslytheshow http://t.co/wfewf

On Instagram

Behind-the-scenes pics from iVillage.

View the original article here

There’s a Black Market for Botox & Other Things to Know Before Getting Injected

Botox might take years off your appearance, but before requesting your own injectable Fountain of Youth, make sure you know exactly what you're doing

By Kristin Booker - July 5, 2013

Botox Might Not Do What You Want It to
Many people confuse what Botox actually does with other age-fighting beauty injectables. “[Botox's] only benefit is to render a muscle weaker for 3-4 months. It doesn't fill lines, it just makes it harder to make the muscle contraction that creates the lines,” explains board-certified dermatologist Dr. Misbah Khan, owner of M. Khan Dermatology in New York City. So will it work on those wrinkles around the mouth? “No. If you have smile lines [the parentheses around the mouth], you'll need a filler [like Restylane] to erase them.”

There's a Black Market
Many coupon services run deals for cheap series of Botox, and they’re probably all too good to be true. Before you buy into anything, know who and what you’re dealing with. “Do not look for the better deal. Make sure you know what’s going in your face. If it's too cheap, it may be acquired on the black market, or the Botox they’re using might be expired or about to expire," warns Dr. Khan.

You Could Have an Allergic Reaction
You may know that Botox is derived from the same bacteria as the toxin botulism, and while you absolutely cannot catch botulism from the use of Botox, there is a small chance that you could have an allergic reaction to preservatives and ingredients used. "Some reactions that have been reported include itching, rash, welts, asthma symptoms or feeling faint,” says Dr. Dennis Gross, founder of 900 5th Dermatology and creator of Dr. Dennis Gross Skincare. If you do have a reaction, call your doctor right away.

An Unskilled Injector Might Leave You Lopsided
“If the Botox is injected wrong in any part of your face, you may have a lopsided appearance,” says Dr. Gross. “Just remember that there is an artistry involved in the technique, so be sure your physician is highly experienced and skilled at administering it.”

Overdoing It Could Lead to Drooping—or Worse
“Drooping of the eyebrows can happen even in the best of hands; it can occur if too much is injected in one place,” says Dr. Khan. And if you’re already using Botox, over-application could make it worse. “Overuse of Botox can cause the muscles to become so weak that they can't support the flesh.” The results can look unnatural, and even worse, be painful. “If too much Botox is applied during a neck rejuvenation, it can cause the side of the face to droop, or in some cases the muscles that hold the neck up weaken to the point where you can't swallow or hold your head up."

Speaking Up Can Divert Disaster
You might think that you really, really want Botox no matter the small risks, but the pursuit of beauty is never worth harming your health. As with any other procedure, you should always disclose your full medical history before sitting in the chair. “Make sure to tell your doctor about all of your muscle or nerve conditions, as you may have an increased risk of serious side-effects, including difficulty swallowing and/or breathing,” cautions Dr. Gross. “Also, inform your doctor of any surgery plans, weakness of forehead muscles, recent injections, or medicines you are currently taking.” Dr. Gervaise Gerstner, L’Oréal Paris Consulting Dermatologist adds one more caution to that list: “Be sure to disclose any autoimmune neuromotor disease like myasenthia gravis.”

Results Are Not Instant
“It takes about three to seven days to show the full effect, and results will last about four months,” says Dr. Gross. And those results vary, depending on the depth of your wrinkles. “If you start Botox treatments just as fine lines are beginning to appear and continue them as you age, you can prevent select expression lines from forming at all,” advises Dr. Gross. Patients who already have pronounced lines may see benefits in a bit more time, “It takes a few days to see results, and a full two weeks to see the full effects of a Botox treatment,” explains Dr. Khan.

Botox is Not Painless
Although getting Botox is not particularly painful for most patients, since there are needles involved, you can’t expect to feel absolutely nothing when getting injected. “During the procedure, you can expect a slight pinch from the needle. There are numbing creams available in topical and aesthetic forms,” says Dr. Gross. Dr. Khan is also known to use ice to numb the area for people who have a low tolerance or phobia of needles.

Aspirin and Fish Oil Don't Mix With Botox
“We tell our patients to stop using aspirin products up to a week before a treatment because they are blood thinners,” cautions Dr. Gross. "Discontinuing the use of aspirin the week before will help to keep bruising down. Also, we tell our patients to stop using fish oils a week beforehand because they also promote bruising for the same blood thinning reason.” Of course, always discuss changing the dosage of medicine with your primary physician beforehand.

Hair-Drying Is Off Limits Right After the Procedure
“There’s no lowering of the head for two hours post-procedure,” says Dr. Gerstner. “No yoga, no bending over, no blow drying your hair, no tight hats, no napping. In other words, heads up!”

It Might Cure More Than Wrinkles
If you have excessive underarm or palm sweating or suffer from serious migraines, talk to your doctor about using Botox to cure these ills. It's been proven to diminish or stop excessive sweating, called hyperhidrosis, and to reduce the severity of migraines too—but don’t try tacking either treatment onto your cosmetic visit. You’ll need to book separate appointments. One quick tip: always take a quick peek at the box. “Botox meant for cosmetic purposes will say ‘Botox Cosmetic’ on the packaging,” says Dr. Khan. “Botox for medical purposes will say that on the package.”

A Happier Look Might Actually Improve Your Mood
If you’re prone to frowning, “eventually those muscles strengthen in that formation, which means it takes much effort to smile and look happy. When Botox relaxes those muscles, you look happier, which can really improve your mood and confidence,” says Dr. Gross.

Kristin Booker is a contributing writer on iVillage. Follow her on Twitter andGoogle+.

Connect with Us Follow Our Pins

Yummy recipes, DIY projects, home decor, fashion and more curated by iVillage staffers.

The very dirty truth about fashion internships... DUN DUN @srslytheshow http://t.co/wfewf

On Instagram

Behind-the-scenes pics from iVillage.

View the original article here