SCRX - Sciele Pharma

[BigSully1]

Sciele Pharma Inc.
Five Concourse Parkway
Suite 1800
Atlanta, GA 30328
United States - Map
Phone: 770-442-9707
Fax: 770-442-9594
Web Site: http://www.sciele.com

DETAILS   
Index Membership: S&P 600 SmallCap
S&P 1500 Super Comp
Sector: Healthcare
Industry: Drug Manufacturers - Other
Full Time Employees: 782


BUSINESS SUMMARY   
Sciele Pharma, Inc., a pharmaceutical company, engages in the development, marketing, and sale of prescription products for cardiovascular/diabetes diseases and women's health. The company's products include Sular, an antihypertensive prescription medication; Fortamet, a type 2 diabetes prescription medication; Altoprev for the treatment of high cholesterol; Triglide, an oral treatment for lipid disorders, such as elevated triglycerides; and Nitrolingual spray for acute relief or prevention of chest pain associated with angina pectoris that results from coronary artery disease. It also offers Prenate Elite and OptiNate, a prescription multivitamin/multimineral nutritional supplement for improving the nutritional status of women throughout pregnancy and in the postnatal period; and Ponstel for the relief of pain for patients and for primary dysmenorrhea, which is pain associated with menstruation. In addition, Sciele Pharma offers Zovirax, used in the treatment of type I (cold sores) and type II (genital) herpes simplex viruses; Ostiva, which offers a nutritional foundation for maintaining bone health; Furadantin for the treatment of urinary tract infections; Cognex for the treatment of mild to moderate dementia associated with Alzheimer's disease; Robinul and Robinul Forte that belong to a class of drugs known as anticholinergics, which reduce the motion of the gastrointestinal tract and decrease stomach; Zoto-HC ear drops for the treatment of swimmer's ear infections; and Zebutal capsules for the treatment of tension headaches. The company sells its products to pharmaceutical wholesalers, chain drug stores, other retail merchandisers, and directly to pharmacies. Sciele Pharma was founded in 1992. It was formerly known as First Horizon Pharmaceutical Corporation and changed its name to Sciele Pharma, Inc. in 2006. The company is headquartered in Atlanta, Georgia.
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Up nicely on more very good news

http://biz.yahoo.com/bw/070904/20070904005995.html?.v=1

http://stockcharts.com/h-sc/ui?s=SCRX&p=D&b=5&g=0&id=p72357160490
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I've been watching this stock for quite some time and almost bought early this morn. Well the news came out before I bought and had to pay $24.41. Stock is still a fantastic bargain at 26+ no matter how you look at it. So take a good look. More later.....

[BigSully1]

Management doing a great job expanding the product pipeline through aquisitions. Regularly beats consensus, raises guidance, announced $40M stock buyback. I think one thing that was holding the stock back was the early May announcement of offering of $257M in convertible bonds used for the redemption of $150M in other corporate bonds and for more expansion.

Huge short #'s, outrageous institutional holdings?

[BigSully1]

FDA accepted for review application for new formulation of Sular, SCRX's core hypertension drug. and is schedulued to make a decision early Nov. Potential product launch now 1st Q 2008-ahead of Sular's patent expiration and ahead of  street's expectations.

[BigSully1]

SCRX finally making some small moves now. I can't really explain the really huge institutional holdings along with the almost equally huge short interest, unless someone just keeps shorting (wrongly I really think) and the institutions keep buying it up. DECK had a very similar situation a couple years ago, with huge inst. holdings (like 140%) and huge short interest abou. PPS was about $18 then and there was fear that UGGS was just a fading fad. I sold much too early. PPS is $115 now, very near a new high. I intend to write more in depth on SCRX soon.

FDA accepted for review application for new formulation of Sular, SCRX's core hypertension drug. and is schedulued to make a decision early Nov. Potential product launch now 1st Q 2008-ahead of Sular's patent expiration and ahead of  street's expectations.

[BigSully1]

Well yesterday SCRX broke out to a new multi (5) year high, albeit not a huge move and .. only on 2X volume. Still, I think a very significant move considering the stock has been in a long lull over the last 3 years. Alot of the worry was over the expiration of the patent on Sular in mid 2008, SCRX's core rev producer. Alot has changed now, including an ever expanding pipeline, and the FDA's acceptance for review of it's new formulation of Sular, using Skype Pharmas Geomatrix technology to provide a lower dosage at each dosage level and therefore fewer side effects. With the FDA scheduled to make a decision early Nov, well ahead of street expectations, product launch can potentially be very early 2008, ahead of Sulars' patent exp. and ahead of expectations, and potentially allowing physicians to get their patients on the new, improved Sular before patent expir. This current management seems to be very savvy and on the ball is doing an excellent job expanding the already well diversified product pipeline through quality aquisitions and beating schedules and estimates.

http://stockcharts.com/h-sc/ui?s=SCRX&p=D&b=5&g=0&id=p59191861522
http://stockcharts.com/h-sc/ui?s=SCRX&p=W&b=5&g=0&id=p11329851569
http://stockcharts.com/h-sc/ui?s=SCRX&p=M&b=5&g=0&id=p31306368963

Outstanding fundamentals speak for themselves so do you own DD here. Here are IBD's ratings on SCRX from the medical-Ethical drugs sector;

Score/diagnosis: 96 A
Overall rank: BEST IN GROUP (1st out of 89 stocks)
Technical rank: 3rd out of 89 (maybe move  higher now)
Fundamental rank: BEST IN GROUP
Attractiveness: 2nd out of 89

Here is a dateline from about the time I started following the stock. Dates/info may not be 100% accurate, please also use your own DD.

7/3/06 Changed name from First Horizon Pharma to Sciele Pharma.

8/7/06 EPS up 48% and above consensus, rev up 45%

12/22/06 new promotional agreement with Biovail, management raises guidance

1/12/07 revised profit and sales outlook, reaffirmed guidance, and announced intentions to conduct an additional trial of new Sular

2/23/07 EPS up 19%, sales up 19%, full year EPS up 24% at high end of guidance. Sales of Sular increased 24%. full year rev up 36%.

4/24/07 agrees to aquire Alliant Pharma-private pediatric drug maker for $122M in cash with provisions for up to 65M more if certain growth targets  met.

4/27/07 EPS up 57% and above est. revs up 24%. again raises guidance

5/8/07 announced offering of 250M in convert. bonds proceeds to be used for redemption of 150M in other converts and for further expansion

5/15/07 announces expectation to incur a non cash and after tax expense of about .10/share for June Q, related to redemption of converts and not included in guidance. Announces successful additional clinical trial of new Sular

5/25/07 Aquires 7M stake in Plethora Solutions-U.K drug concern and signed an exclusive marketing agreement in U.S. for development stage treatment male sex dysfunction and also providing exposure to Plethoras pipeline of women's products. Regulators approve Alliant aquisition

6/15/07 completes Alliant aq.. Products include allergy drugs Allegra and Rondec and Methylin for ADHD. Slightly lowered guidance as agreement now excludes Lindane, a head lice treatment.

7/13/07 signs exclusive deal with Addrenex Pharma to market Clonicel for hypertension and ADHD in N. America after FDA approval. SCRX also gains right of first refusal for Addrenex's many other products. purchased a $6M equity in Addrenex and will make milestone payments based on product sales. low risk deal.

7/17/07 Aquired head lice treatment fro Summers Labs for undisclosed sum. Treatment was submitted to FDA for approval in June. Kills lice by asphyxiation, unlike the pesticide based products currently approved.

7/27/07 EPS up 26% again above consensus. Revs up 32%. Management again increases guidance.

8/3/07 authorizes repurchase up to $40M common stock over next 12 mos. 36.8M shares outstanding June Q.

8/14/07 FDA approves SCRX's and partner Lifecycles Pharma cholesterol drug Antara. Paid $5M upfront with a $4M milestone due  Lifecycle

9/4/07 FDA accepts for review application for new formulation of Sular-expected to make a decision by early Nov. ahead of patent exp. and ahead of expectations.  Nice big candle on chart.

9/17/07 completes patient enrollment for pivotal phase III safety trial for Glycopyrrolate treatment for chronic drooling in Ped. patients, resulting from  cerebral palsy or other neuro disorders. Orphan drug designation has goal of FDA application filing mid-year 2008.

10/09/07 completes enrollment of patients in pivotal phase III trial for combo of pravastain and fenofibrate.

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Some recent insider sales might be a little concerning, but still a VERY healthy 12% inside ownership. Theres always the risk of non-approval of new Sular, but it's not a new drug, just a new formulation, and the additional trial was declared successful. I think future estimates and targets are overly conservative and expect major upgrades when/if new Sular is approved, seems  as if non-approval is already priced in. I think buying momentum will start to build going into Nov in anticipation of approval. Shorts may very soon "pay the piper". Hope this doesn't sound like a pump, I have no intention of selling anytime soon, barring some unforeseen event. If I intended it as a pump, I'd plaster this on the public message boards. It's not a Chinese rocket, but I believe a very solid investment. Use your own DD.

[BigSully1]

Adding to dateline;

Sciele completes enrollment of pivotal phase III trial for combo of pravastatin and fenofibrate.

http://biz.yahoo.com/bw/071009/20071009005366.html?.v=1

Lots of good stuff in the works. Hey shorts, whaddaya stupid?

[BigSully1]

Just making little baby steps for now. Momentum should pick up soon as shorts realize the futility of their position and investors recognize the value/growth, IMO.

[BigSully1]

Adding these to dateline;

Sciele Pharma and Plethora Solutions Holdings PLC Announce Initiation of Pivotal Phase III Trials for PSD502 for Premature Ejaculation

http://biz.yahoo.com/bw/071030/20071030005419.html?.v=1

Sciele Pharma and Addrenex Announce Initiation of Pivotal Phase III Trials for Clonicel for ADHD

http://biz.yahoo.com/bw/071030/20071030006171.html?.v=1

Earnings today after close.

[BigSully1]

Sciele Pharma, Inc. Reports Revenues and Earnings for the Third Quarter of 2007
Tuesday October 30, 4:01 pm ET 
Reaffirms Guidance for Full-year 2007
Provides Guidance for Full-year 2008
Third Quarter 2007 Financial Results Include:
-- Revenues were $99.4 million, an increase of 33% over third quarter of 2006.
-- Diluted earnings per share (EPS) were $0.38, an increase of 12% over third quarter of 2006.
-- Increased R&D investments to 9% of sales including $2.2 million of in-process R&D charges for recently licensed products and completion of Phase III patient enrollments for both Glycopyrrolate and the Pravastatin/Fenofibrate combination.
-- EBITDAS (see note (a) to the financials accompanying this release), a non-GAAP measure, were $32 million, an increase of 21% over the third quarter of 2006.
The Company Reaffirms Revenue and EPS Guidance for Full-year 2007:
-- Full-year 2007 revenue is expected to be in the range of $375 million to $385 million.
-- Full-year 2007 diluted EPS, are expected to be in the range of $1.53 to $1.58, after a $0.10 per share non-cash expense related to the Company's redemption of its 1.75% Contingent Convertible Senior Subordinated Notes realized in the second quarter 2007.
The Company Provides Revenue and EPS Guidance for Full-year 2008:
-- Full-year 2008 revenue is expected to be in the range of $430 million to $445 million.
-- Full-year 2008 diluted EPS is expected to be in the range of $1.87 to $1.97.


ATLANTA--(BUSINESS WIRE)--Sciele Pharma, Inc. (NASDAQ:SCRX - News), a specialty pharmaceutical company, today announced increased revenues and earnings for the third quarter and nine months ended September 30, 2007. Net revenues for the third quarter of 2007 increased 33% to $99.4 million from $74.8 million in the third quarter of 2006. Diluted earnings per share (EPS) for the third quarter of 2007 increased 12% to $0.38 compared with $0.34 in the third quarter of 2006.
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"We have delivered another quarter of strong financial results while significantly increasing our R&D investments, which has enabled us to in-license new products and complete the patient enrollments of our Phase III clinical trials for both Glycopyrrolate and the Pravastatin/Fenofibrate combination," said Patrick Fourteau, President and Chief Executive Officer of Sciele Pharma. "We are focused on the efficient use of our resources to develop new products with an emphasis on speed to market."

Earnings before interest, taxes, depreciation, amortization and stock compensation expense, EBITDAS, (a non-GAAP measure) were $32 million in the third quarter of 2007 compared with $26 million in the third quarter of 2006.

Gross margins as a percentage of sales were 87% in the third quarter of 2007 compared with 86% in the third quarter of 2006. This increase in gross margins resulted from higher revenues and a change in the product sales mix. Selling, general and administrative (SG&A) expenses were $47.1 million in the third quarter of 2007, compared with $35.9 million in the third quarter of 2006. The increase in SG&A is primarily due to costs associated with the launch of Prenate DHA and the new pediatric division created through the Alliant acquisition, higher royalties and commissions, and new marketing programs associated with certain products. The Company's SG&A expenses were approximately $1 million lower in the third quarter of 2007 compared to the second quarter of 2007.

Research and development (R&D) expenses were $9.3 million, or 9% of net revenues, for the third quarter of 2007 compared with $4.5 million, or 6% of net revenues, for the third quarter of 2006. This increase was primarily related to $2.2 million of in-process R&D charges for recently licensed products, completion of Phase III patient enrollments for both Glycopyrrolate and the Pravastatin/Fenofibrate combination, and the expansion of the Company's clinical and regulatory group.

For the nine months ended September 30, 2007, net revenues increased 30% to $277.3 million from $213.6 million for the nine months ended September 30, 2006. Diluted EPS were $1.03 for the first nine months of 2007, after a $0.10 per share non-cash expense related to the Company's redemption of its 1.75% Convertible Notes, compared with $0.82 in the same period of 2006. Cash flow per share, (see note (b) to the financials accompanying this release) also a non-GAAP measure, was $1.63 per share for the first nine months of 2007 compared with $1.27 in the prior year-period.

Gross margins as a percentage of sales were 87% in the first nine months of 2007 compared with 86% in the prior-year period. SG&A expenses were $135.3 million in the first nine months of 2007, compared with $107.0 million for the same period of 2006. R&D expenses were $23.3 million, or 8% of net revenues, in the first nine months of 2007 compared with $11.3 million, or 5% of net revenues, in the year-earlier period.

Cardiovascular/Metabolic Products

Net revenues of the Company's Cardiovascular/Metabolic products, which include Sular, Triglide, Fortamet, Nitrolingual Pumpspray, and Altoprev, increased 10% to $65.4 million in the third quarter of 2007, compared with $59.6 million in the third quarter of 2006. The increase was primarily due to the continued growth of Sular and Nitrolingual Pumpspray as well as price increases implemented in the first quarter of 2007. Cardiovascular/Metabolic products represented 66% of the Company's total sales in the third quarter of 2007.

Total prescriptions of Sular increased approximately 5% in the third quarter of 2007 compared with the third quarter of 2006, according to IMS Prescription Audit Plus™ data.

Nitrolingual Pumpspray total prescriptions increased 1% in the third quarter of 2007 compared with the third quarter of 2006, according to IMS Prescription Audit Plus™ data.

Triglide total prescriptions increased 31% in the third quarter of 2007 compared with the third quarter of 2006, according to IMS Prescription Audit Plus™ data. There was a delay in Triglide product deliveries, resulting in product backorders that will be shipped in the fourth quarter of 2007, instead of the third quarter of 2007.

Women's Health Products

Net revenues of the Company's Women's Health products, which include Prenate DHA, Prenate Elite, OptiNate, Zovirax, Ponstel and Ostiva, increased 68% to $21.3 million in the third quarter of 2007 compared with $12.7 million in the third quarter of 2006. Women's Health products represented 21% of the Company's total sales in the third quarter of 2007. The Company's Prenate family of vitamins is a leading brand of prenatal vitamins in the United States.

In June 2007, the Company launched Prenate DHA, the first and only prescription prenatal vitamin with 300 milligrams of DHA (from a total 365 mg. of omega-3 fatty acids), the highest amount available in a prescription prenatal vitamin. Prenate DHA contains a unique one milligram folate combination with 600 micrograms of Metafolin and 400 micrograms of folic acid, nine important vitamins and minerals, and calcium docusate, a gentle stool softener. After approximately three months of promotion, as of October 19, 2007, Prenate DHA had approximately a 14% market share of the prenatal DHA new prescriptions market.

Pediatric and Other Products

Net revenues for the Company's Pediatric and other products, which include Orapred and Orapred ODT; Methylin Oral Solution and Methylin Chewable Tablets; Furadantin, Rondec Syrup, Rondec DM Oral Drops; and Allegra Oral Suspension, increased to $12.7 million in the third quarter of 2007 compared with $2.4 million in the third quarter of 2006, primarily due to the acquisition of Alliant Pharmaceuticals. Sales of many of the products in this division are subject to seasonal sales fluctuations, with stronger sales in the first and fourth quarters of the year. Pediatric and other products represented 13% of the Company's total sales in the third quarter of 2007.

Sciele has fully integrated the pediatric sales force of Alliant Pharmaceuticals, which was acquired by the Company in June 2007, and expanded the number of sales representatives from 75 to approximately 100 in the third quarter of 2007.

Product Development

"We are very pleased with the meaningful progress of our product pipeline, as we expect new product launches to drive much of the future growth of the Company," Mr. Fourteau added. "We have increased our research and development efforts and plan to launch three to four products per year beginning in 2008. Additionally, we believe our strong financial position will enable us to continue to acquire, license and develop additional products."

The Company's product pipeline includes eight products. One has recently been approved by the U.S. Food & Drug Administration (FDA), two are under review at the FDA and five are currently in pivotal Phase III trials.

In October 2007, the Company completed enrollment of patients in a pivotal Phase III clinical trial using pravastatin and fenofibrate to treat mixed dyslipidemia. Mixed dyslipidemia is the presence of elevated levels of "bad" cholesterol, low-density lipoproteins (LDL) and triglycerides and low levels of "good" cholesterol, high-density lipoproteins (HDL) in the blood. The Phase III clinical trial, which compares the efficacy of the combination of pravastatin and fenofibrate versus pravastatin or fenofibrate alone, is being conducted at approximately 75 sites in the United States. The Company expects to complete this efficacy study in mid-2008.

In September 2007, Sciele completed enrollment of patients in a pivotal Phase III safety trial utilizing a liquid formulation of glycopyrrolate to treat chronic, moderate-to-severe drooling in pediatric patients. This condition often results from cerebral palsy as well as from other neurological disorders. This trial has been designed to evaluate safety parameters for glycopyrrolate over a six-month period. The Company expects to file an NDA in mid-2008.

Earlier in September, the FDA accepted the supplemental New Drug Application (sNDA) for Sciele's new Sular formulation, with a Pharmacy Drug User Fee Act (PDUFA) date of November 2, 2007. The new Sular formulation utilizes SkyePharma's (LSE:SKP - News) patented Geomatrix™ technology, which is designed to provide a lower dose of Sular for each of its current doses.

In August 2007, Sciele and LifeCycle Pharma A/S announced that LifeCycle received FDA approval for LifeCycle Pharma's novel formulation of fenofibrate in 120-milligram and 40-milligram dosage strengths for the treatment of hyperlipidemia and hypertriglyceridemia. This fenofibrate utilizes LifeCycle Pharma's Meltdose® technology which is designed to provide enhanced absorption and greater bioavailability. Sciele licensed these products from LifeCycle Pharma earlier in 2007.

In August 2007, the FDA accepted the New Drug Application (NDA) with a PDUFA date of April 15, 2008, that was submitted by Summers Laboratories for a head lice asphyxiation product that utilizes a novel mechanism of action. Sciele acquired the rights to this product for the United States, Canada, and Mexico. Upon FDA approval, it will be the first prescription medication that kills head lice by asphyxiation instead of utilizing a neurotoxic pesticide. The prescription and over-the-counter lice treatment market generated approximately $150 million in sales last year (according to IMS Health's National Prescription Audit Plus™ data).

In July 2007, the Company licensed Clonicel for the treatment of hypertension and attention deficit/hyperactivity disorder (ADHD). Clonicel is currently in pivotal trials for hypertension, and a 505(b)(2) NDA filing with the FDA is expected in the first half of 2008. The patient enrollment for the Phase III trials using Clonicel for ADHD was initiated in October 2007. Clonicel is a 12-hour, sustained-release formulation of clonidine hydrochloride.

In May 2007, the Company licensed from PSD502 from Plethora Solutions. PSD502 is an innovative treatment for premature ejaculation (PE), and it began Phase III clinical trials in the fourth quarter of 2007. PSD502 is a unique, proprietary, rapidly absorbed formulation of two, well-established local anesthetics, lidocaine and prilocaine, dispensed in a metered dose spray.

Financial Strength

As of September 30, 2007, the Company had $204 million in cash, cash equivalents and marketable securities. During the third quarter of 2007, the Company repurchased approximately $7.0 million, or 305,214 shares, of its common stock through its share repurchase program. As of September 30, 2007, approximately $33 million was available for share repurchases under the Company's share repurchase program. In addition to the repurchase, the Company made additional investments in product development and made tax payments related to the retirement of its $150 million convertible debt, totaling a combined $22 million.

Outlook

Sciele Pharma reaffirms its full-year 2007 revenue guidance within a range of $375 million to $385 million. The Company also reaffirms its guidance on full-year 2007 diluted earnings per share within a range of $1.53 to $1.58 per share, after a non-cash expense of $0.10 per share related to the Company's redemption of its 1.75% Convertible Notes. This guidance assumes an R&D expenditure rate of 7% to 8% of revenues, and reflects the anticipated range associated with Sular product sales, based on the potential timing of the approval of the new Sular product.

For 2008, Sciele expects to report revenues in a range of $430 million to $445 million. The Company expects to report diluted earnings per share in a range of $1.87 to $1.97 per share for 2008. This guidance assumes an R&D expenditure rate of 7% to 8% of revenues for 2008. This guidance does not include any unapproved products except the new Sular formulation, or any potential one-time charges related to the new Sular conversion.

Conference Call

Sciele Pharma will host a conference call on Tuesday, October 30, 2007, beginning at 4:30 p.m. ET to discuss the financial results. Analysts, investors and other interested parties are invited to participate by visiting the Company's website, www.sciele.com, and entering the Investor Relations page. You may also dial in to the conference call. The dial-in numbers are (800) 811-8824 for domestic callers and (913) 981-4903 for international callers. All callers should use passcode 6841134 to gain access to the conference call. Please plan to dial-in or log on at least ten minutes prior to the designated start time, so management may begin promptly.

About Sciele Pharma, Inc.

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Metabolic, Women's Health and Pediatrics. The Company's Cardiovascular/Metabolic products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit/hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform – an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.

Safe Harbor Statement

This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations. With respect to such forward-looking statements, we seek the protections afforded by the Private Securities Litigation Reform Act of 1995. These risks include, without limitation:

We may not attain expected revenues and earnings. If we are unsuccessful in obtaining or renewing third party payor contracts for our products, we may experience reductions in sales levels and may fail to reach anticipated sales levels. If demand for our products exceeds our initial expectations or the ability of our suppliers to provide demand-meeting quantities of product and samples, our future ability to sell these products could be adversely impacted. The potential growth rate for our promoted products may be limited by slower growth for the class of drugs to which our promoted products belong and unfavorable clinical studies about such class of drugs.

We may encounter problems in the manufacture or supply of our products, for which we depend entirely on third parties. Strong competition exists in the sale of our promoted products, which could adversely affect expected growth of our promoted products' sales or increase our costs to sell our promoted products. We may not be able to protect our competitive position for our promoted products from patent infringers. If generic competitors that compete with any of our products are introduced, our revenues may be adversely affected.

Certain of our products have experienced manufacturing issues. If the issues recur and cannot be resolved, our ability to acquire product for sale and sampling will be adversely affected. We may incur unexpected costs in integrating new products into our operations.

We may be unable to develop or market line extensions for our products or, even if developed, obtain patent protection for our line extensions; further, introductions by us of line extensions of our existing products may require that we make unexpected changes in our estimates for future product returns and reserves for obsolete inventory. If these risks occur, our financial results could be adversely affected.

If we have difficulties acquiring new products or rights to market new products from third parties, our financial results could be adversely impacted. Our licensor/supplier can terminate our rights to commercialize Nitrolingual and the 60mg dose size of this product has not yet met our expectation.

We may not experience the beneficial results of our acquisitions that we expect to receive, and the acquired products may not meet our sales expectations.

We depend on a small senior management group, the departure of any member of which would likely adversely affect our business if a suitable replacement member could not be retained.

An adverse interpretation or ruling by one of the taxing jurisdictions in which we operate could adversely impact our operating results. An adverse judgment in the securities class action litigation in which we and certain current and former directors and executive officers are defendants could have a material adverse effect on our financial results and liquidity. Our business is subject to increasing government price controls and other healthcare cost containment measures. Side effects or marketing or manufacturing problems with our products could result in product liability claims which could be costly to defend and could result in the withdrawal or recall of products from the market which would adversely affect our business. We may be found noncompliant with applicable federal, state or international laws, rules or regulations which could result in fines and/or product recalls or otherwise cause us to expend significant resources to correct such non-compliance.

A small number of customers account for a large portion of our sales and the loss of one of them, or changes in their purchasing patterns, could result in substantially reduced sales, substantially and adversely impacting our financial results. If third-party payors do not adequately reimburse patients for our products, doctors may not prescribe them.

We rely on operational data obtained from IMS, an industry accepted data source. IMS data may not accurately reflect actual prescriptions (for instance, we believe IMS data does not capture all product prescriptions from some non-retail channels).

Our business and products are highly regulated; the regulatory status of some of our products makes these products subject to increased competition and other risks; and we run the risk that we, or third parties on whom we rely, could violate the governing regulations.

Some unforeseen difficulties may occur.

The above are some of the principal factors that could cause actual results to differ materially from those described in the forward-looking statements included above. These factors are not intended to represent a complete list of all risks and uncertainties inherent in our business, and should be read in conjunction with the more detailed cautionary statements and risk factors included in our other filings with the Securities and Exchange Commission.

         
SCIELE PHARMA, INC.

Condensed Consolidated Statement of Operations

(Unaudited, in thousands, except per share amounts)

       
  For the
Quarter Ended
  For the
Nine Months Ended

  September 30,
  September 30,

  2007
    2006
  2007
    2006

Net revenues   $  99,372    $  74,784   $  277,291    $  213,636 
   
Operating costs and expenses:         
Cost of revenues    13,304     10,283    37,182     30,181 
Selling, general and administrative    47,061     35,912    135,278     106,958 
Depreciation and amortization    7,587     6,752    20,610     19,787 
Research and development      9,262         4,502      23,306         11,323 
Total operating costs and expenses      77,214         57,449      216,376         168,249 
   
Operating income    22,158     17,335    60,915     45,387 
   
Other income (expense), net      (643  )      491      (3,598  )      941 
   
Income before provision for income taxes    21,515     17,826    57,317     46,328 
Provision for income taxes      7,666         5,525      19,832         14,728 
   
Net income   $  13,849      $  12,301   $  37,485      $  31,600 
   
Net income per common share:         
Basic   $  0.39      $  0.35   $  1.06      $  0.90 
Diluted   $  0.38      $  0.34   $  1.03      $  0.82 
   
Weighted average common shares outstanding:         
Basic      35,752         35,043      35,425         35,147 
Diluted      36,466         36,014      36,451         39,270 
         
SCIELE PHARMA, INC.

Condensed Consolidated Balance Sheets 

(Unaudited, in thousands)

 

       
  September 30,
  December 31,

  2007
  2006

ASSETS     
Current assets:     
Cash, cash equivalents and marketable securities   $  204,216    $  166,451   
Accounts receivable, net    73,872     47,551   
Inventories    24,879     26,640   
Other      49,134         28,425     
Total current assets      352,101         269,067     
   
Property and equipment, net    19,235     9,142   
   
Other assets:     
Intangibles, net    423,082     305,040   
Deferred tax asset    150     93   
Other      29,574         6,663     
Total other assets      452,806         311,796     
   
Total assets   $  824,142      $  590,005     
   
LIABILITIES AND STOCKHOLDERS' EQUITY     
Current liabilities:     
Accounts payable   $  39,355    $  18,874   
Accrued expenses      28,992         18,965     
Total current liabilities      68,347         37,839     
   
Long-term liabilities:     
Convertible debt    325,000     150,000   
Deferred tax liability    4,659     12,368   
Other      1,804         1,975     
Total liabilities      399,810         202,182     
   
Stockholders' equity:     
Common stock    36     36   
Additional paid-in capital    281,190     282,718   
Retained earnings    165,044     127,768   
Accumulated other comprehensive loss    (4,431  )    (4,147  ) 
Treasury stock      (17,507  )      (18,552  ) 
Total stockholders' equity      424,332         387,823     
   
Total liabilities and stockholders' equity   $  824,142      $  590,005     
         
SCIELE PHARMA, INC.

 

Reconciliation of EBITDAS (a)

(Unaudited, in thousands)

       
  For the
Quarter Ended
  For the
Nine Months Ended

  September 30,
  September 30,

     2007
          2006
     2007
          2006

Net income, as reported (GAAP)   $  13,849    $  12,301   $  37,485    $  31,600 
Less: Other income, net    (643  )    491    (3,598  )    941 
Add: Provision for income taxes    7,666     5,525    19,832     14,728 
Add: Stock-based compensation expense    1,924     2,140    7,105     6,474 
Add: Depreciation and amortization      7,587         6,752      20,610         19,787 
Earnings before interest, taxes, depreciation, amortization and stock-based compensation expense
  $  31,669      $  26,227   $  88,630      $  71,648 
   
(a) The Company believes that earnings before interest, taxes, depreciation and amortization, and stock-based compensation expense (EBITDAS), is a meaningful non-GAAP financial measure as an earnings-derived indicator that may approximate cash flow. EBITDAS, as defined and presented by the Company, may not be comparable to similar measures reported by other companies.

   
Reconciliation of Cash Flow Per Share (b)

(Unaudited)

   
  For the
Quarter Ended
  For the
Nine Months Ended

  September 30,
  September 30,

     2007
        2006
     2007
        2006

Net income per share, as reported (GAAP)   $  0.38    $  0.34   $  1.03    $  0.82 
Add: Stock-based compensation expense, net of taxes
   0.03     0.04    0.13     0.11 
Add: Depreciation and amortization, net of taxes
   0.13     0.13    0.37     0.34 
Add: Non-cash expense related to the redemption of the Company's 1.75% Convertible Notes, net of tax
     --
        --
     0.10         --

Cash flow per share, net of taxes   $  0.54      $  0.51   $  1.63      $  1.27 
   
(b) The Company believes that cash flow per share is a meaningful non-GAAP financial measure as it is utilized by the financial community in evaluating the Company. Cash flow per share, as defined and presented by the Company as net income per share before stock-based compensation expense, net of taxes, and depreciation and amortization, net of taxes, may not be comparable to similar measures reported by other companies.





Contact:
Sciele Pharma, Inc.
Joseph T. Schepers, 678-341-1401
[email protected]

[BigSully1]

A few things have occurred since I last posted on SCRX.

1) FDA dissappointed by extending the PDUFA date on the new formulation of Sular from Nov 2 to Jan 2, 2008.

2)Sciele Signs Exclusive Agreement with Novo Nordisk to Market Prandin(R) and PrandiMet(R) and again raises outlook.
Monday November 19, 8:56 am ET


3) And now for the very good part;

Sciele Pharma Announces FDA Approval of New Sular(R) Formulation
Wednesday January 2, 6:23 pm ET


ATLANTA--(BUSINESS WIRE)--Sciele Pharma, Inc. (NASDAQ: SCRX - News) today announced that the U.S. Food & Drug Administration (FDA) has approved all four dosage strengths of the new Sular® formulation. The new Sular formulation, which utilizes SkyePharma's (LSE:SKP - News) patented GEOMATRIX™ technology, provides a lower dose of Sular for each of its current doses. The Company expects to launch the new Sular formulation during the first quarter of 2008.
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Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said, "We are excited about this approval by the FDA for the new Sular formulation. This validates our product development and regulatory capabilities, as we have become a fully integrated pharmaceutical company."
----------------------------------------------------------------------------------------------------------------

Since the disappointing news on the delay in Nov, the stock tanked down to 19.70 on Nov 12, made it back up to 23.50 and then fell back down again and by the end of trading today, it nearly made a new low at 19.73, which should now become a double bottom with the news. I am expecting a very large gain here tommorrow and expect to see a new high very soon. The PR came out late and after market didn't have much time to react.

There's still a HUGE short interest to provide more fuel for the rally.

http://stockcharts.com/h-sc/ui?s=SCRX&p=D&b=5&g=0&id=p59191861522

[BigSully1]

--------------------------------------------------------------------------------
Sciele Pharma Rises After FDA OKs Sular
Thursday January 3, 3:21 pm ET
Sciele Pharma Rises After FDA OKs New Version of High Blood Pressure Drug Sular


NEW YORK (AP) -- Shares of Sciele Pharma Inc. rose sharply Thursday after the company received regulatory approval to sell a new version of its high blood pressure drug Sular, which could help it fend off generic competition.
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Late Wednesday, Atlanta-based Sciele said the Food and Drug Administration approved the new formulation in four different dosages. Sciele expects to launch the drug during the first quarter, and several analysts predicted sales will start in February.

The company plans to pull the older formulation from the market, ahead of patent expiration in June, so patients can start getting used to taking the new version before generic versions hit pharmacies.

In a note to investors, Susquehanna Financial Group analyst Angela Larson applauded the company's switch-over strategy, pointing out that generic competition risk is now lifted.

"Given that Sular is the leading product for Sciele's cardiovascular franchise with 2007 sales estimated to be $106 million (or about 28 percent of total sales), this is a prudent strategy," Larson wrote in a note to clients.

She said the company's sales force will have plenty of time to switch patients and physicians before the patent expiry. She maintained a "Positive" rating on the stock.

Neponset Equity Research Inc. analyst Noelle Tune said in a note to clients Sciele is "starting the new year on the right foot."

She expects solid coverage from managed care and believes that more than 80 percent of plans have agreed to include the new Sular on formulary, which a a list of preferred prescribed prescription drugs.

Tune reiterated a "Buy" rating on shares.

Sciele's stock rose $2.42, or 12.2 percent, to $22.24 during afternoon trading. Over the past 52 weeks, the stock has ranged between $19.70 and $28.83. 

[BigSully1]

--------------------------------------------------------------------------------
Ahead of the Bell: Sciele Pharma
Friday January 4, 8:11 am ET 
Sciele Pharma Upgraded As Analyst Predicts Successful Switch to New Versions of Sular


NEW YORK (AP) -- A Friedman Billings Ramsey analyst upgraded shares of Sciele Pharma Inc. Friday, saying he believes Sciele will be able to switch patients over to a newly approved version of its high-blood-pressure drug Sular.
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The Food and Drug Administration approved the new formulation of Sular on Thursday, sending Sciele shares up 11.4 percent to a closing price of $22.10. Analysts questioned whether Sciele would be able to get patients to use the new Sular instead of generic versions of the original, but Robert Uhl said he now believes the switch will succeed.

Uhl said he surveyed pharmacy directors at major health insurers, and learned that many of those companies will cover the new Sular. He upgraded the stock to "Outperform" from "Market Perform" on the results, and raised his price target to $31 per share from $29.

"We believe the company will be able to convert at least a significant portion of its existing Sular franchise over to the new product ahead of patent expiration in June and that the market's skepticism and concern over this issue will dissipate," he said.

[BigSully1]

--------------------------------------------------------------------------------
They might keep SCRX corralled around $22.50 until after options exp. (max pain is $22.50) but I'm convinced the stock is going much higher and should be an excellent LT investment. Huge short position to cover still. Reccesion won't hurt here, great defensive holding.

Sciele Expects to Launch Six Products in 2008; Reaffirms Revenue and EPS Guidance for Full-Years 2007 and 2008
Wednesday January 9, 12:44 pm ET


ATLANTA--(BUSINESS WIRE)--At the JPMorgan 26th Annual Health Care Conference in San Francisco, Sciele Pharma, Inc. (NASDAQ:SCRX - News), today announced that it will be launching during the first quarter of 2008 its new Sular® formulation, which was recently approved by the Federal Food & Drug Administration (FDA) in four dosage strengths: 8.5-milligram, 17-milligram and 25.5-milligram and 34-milligram dosages. In addition, the Company also plans to launch five new products in 2008: 120-milligram and 40-milligram fenofibrate doses for treatment of mixed dyslipidemia; Prandin® (repaglinide) for type II diabetes, and, upon FDA approval, PrandiMet® (repaglinide/metformin) also for type II diabetes; a head lice asphyxiation product upon FDA approval; and a new Women's Health product.
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Sciele also reaffirmed the Company's full-year guidance for both 2007 and 2008. As previously announced, full-year 2007 revenue will be within a range of $375 million to $385 million, and full-year 2007 diluted earnings per share will be within a range of $1.53 to $1.58 per share, after a non-cash expense of $0.10 per share related to the Company's redemption of its 1.75% Convertible Notes. Also as previously announced, full-year revenue guidance for 2008 will be within a range of $440 million to $455 million and full-year 2008 diluted EPS within a range of $1.97 to $2.07 per share. This guidance for 2007 and 2008 assumes an R&D expenditure rate of approximately 8% of revenues and does not include any unapproved products or any potential restructuring time charges related to the new Sular conversion.

About Sciele Pharma, Inc.

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Metabolic, Women's Health and Pediatrics. The Company's Cardiovascular/Metabolic products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit/hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform – an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.