Q1 2010
FRANK BALDINO, JR., PH.D.
Chairman/CEO
I am pleased to say that Cephalon is off to a great start in 2010, and we expect to deliver another year of strong sales and earnings.
This first quarter of 2010 we hit new quarterly records in our financial performance. Sales for Q1 2010 were $576.7 million, a 12 percent increase compared to sales in first quarter of 2009. In that number is an impressive 44 percent increase in oncology sales due to strong sales of TREANDA® (bendamustine HCl) for Injection. Adjusted net income for the first quarter of 2010 was $144.0 million, a 42 percent increase over the comparable period in 2009. Truly outstanding performance for the quarter!
During the quarter, we made two very important acquisitions – Ception Therapeutics and Mepha AG. Ception brings us the late-stage compound CINQUIL™ (reslizumab) in development for a severe type of asthma, and Mepha AG essentially doubles our business outside the U.S. with 120 additional products and 50 geographic territories.
We will continue to diversify our business in terms of products, type of business and territories. The more diversified we become, the more stable our business becomes as well.
Even after paying for Ception Therapeutics and Mepha AG, Cephalon still has over $1 billion in cash on hand today. This means we can continue to pursue additional acquisitions as opportunities materialize. Our goal is to bring new medications to more and more patients around the world.
Q4 2009
FRANK BALDINO, JR., PH.D.
Chairman/CEO
The year 2009 was rich in achievement for Cephalon. The giant strides we took in our research, our sales campaigns for new and existing products, and our business development activities moved us significantly closer to developing novel therapies that will bring relief to millions of underserved patients.
In early 2010, we reported 2009 net sales of $2.152 billion, an 11 percent increase compared to net sales for 2008. For 2010, we project that sales could reach approximately $2.7 billion.
Over the past six years, Cephalon has grown more than three-fold in both sales and net income, and last year’s performance contributed mightily to this result.
In June, we launched NUVIGIL®, and within six months, we achieved a market share of more than 24 percent. In addition, we nearly doubled AMRIX® sales over 2008, and we nearly tripled TREANDA® sales over 2008.
In 2009, we made important progress toward developing a pipeline that is deeper and more diversified than at any time in the company’s 22-year history.
If development activities proceed as planned, Cephalon could obtain product approvals from 2009 through 2015, including line extensions for products such as NUVIGIL, FENTORA®, and TREANDA.
Outside the U.S., we launched EFFENTORA® in the UK, Ireland, Germany Italy and Austria in 2009. We also opened new offices in China and strengthened our presence in Japan.
Finally, we launched the CephalonCares Foundation to improve access to our medications for those people who are truly in need.
We remain incredibly excited about the opportunities that lie ahead for Cephalon and for the millions of patients who depend on us today, and will depend on us even more in the months and years ahead.
Q3 2009
FRANK BALDINO, JR., PH.D.
Chairman/CEO
I am pleased to report solid results for the third quarter of 2009. Cephalon delivered strong growth of both sales and adjusted net income compared to the third quarter of 2008, despite the difficult economic environment. Our quarterly sales reached an impressive $535 million and adjusted net income exceeded the high end of our guidance.
We have added assets and expertise through business development activities that will help us build our business through the remainder of this year, and for the future . In August, we completed the acquisition of Arana Therapeutics, which reinforced our commitment to the area of inflammatory diseases, and provided us a firm footing in biologics. Our entry into the biologics space combined with our efforts with our small molecule products creates a strong pipeline of rich and diverse opportunities to address unmet medical needs. Read press release >>
Cephalon has enjoyed considerable success over the past years by aggregating an impressive collection of small molecule products that serve as important therapeutic options for millions of patients. We have been remarkably successful through our commitment to further developing our medicines to bring them to more patients in need. NUVIGIL launched this past June, and has been recognized as one of the most successful pharmaceutical product launches to date. We recently completed and filed a supplemental New Drug Application (sNDA) for NUVIGIL for jet lag disorder – a condition for which there are no FDA-approved treatments -- and continue to study the potential of NUVIGIL in several other conditions.
Most recently, we signed an agreement establishing an option to acquire BioAssets Development Corporation, a company whose technology in the area of treatment of radicular pain in spinal disorders may help us develop our tumor necrosis factor inhibitor as a non-surgical therapy for sciatica, an extremely painful, neuropathic inflammatory condition affecting 1.5 million people in the US. This is an exciting opportunity to combine innovations and ultimately, address unmet patient needs.
During these times of industry-wide change and uncertainty, one thing does not change -- our rock-solid commitment to patients, and to doing everything we can to bring them innovative medicines that make a difference.
Q3 2009
FRANK BALDINO, JR., PH.D.
Chairman/CEO
This has been another outstanding quarter for Cephalon. In early June we launched NUVIGIL® (armodafinil) Tablets (C-IV), a treatment for three chronic sleep conditions: treated obstructive sleep apnea (OSA), shift work sleep disorder -- also known as shift work disorder (SWD) -- and narcolepsy.
I am pleased to report that the NUVIGIL launch is off to a terrific start. Physicians are responding to the product's clinical benefits and introducing it to new patients. As a company, we are keenly aware of the impact the economy has had on the healthcare system and on patients’ ability to pay for medicines. We introduced a co-pay assistance program that helps offset much of the out of pocket prescription costs facing patients prescribed NUVIGIL.
We are confident in the value of NUVIGIL, and have invested in a comprehensive clinical program to study its use in other important medical conditions. In fact, less than one month after launch, we filed for approval of NUVIGIL for the treatment of another sleep condition – excessive sleepiness associated with jet lag disorder – marking the first of four indications for NUVIGIL we expect to file over the next five years.
To supplement our own research and development efforts, we are expanding our pipeline across several therapeutic categories through business development activities. During this quarter, Cephalon acquired a controlling interest – surpassing 90 percent ownership-- in Arana Therapeutics, and its pipeline of biologic compounds for inflammatory diseases and cancer. We are excited about the biologics technology platform and expertise that Arana brings to our company.
Have you noticed our new corporate tagline? Insights into MedicineSM. We arrived at this tagline because it tells you a story about our innovative spirit and our disciplined focus, about who we are, what makes us special, and why we do what we do. And it reminds us that we are challenged every day to go beyond what is called for in small ways, so ultimately, we can make a difference in big ways.
Not an easy task. But we are more than up for the challenge.
Q2 2009
FRANK BALDINO, JR., PH.D.
Chairman/CEO
Each day, millions of people struggle with excessive sleepiness associated with obstructive sleep apnea (OSA), shift work sleep disorder -- also known as shift work disorder (SWD) -- and narcolepsy. These are serious and chronic medical conditions that impair the body's ability to stay awake, stay alert, and function.
Cephalon first recognized the breadth of this medical need more than a decade ago, when we introduced the first, new FDA-approved treatment for patients with excessive sleepiness associated with narcolepsy in 40 years. We remain committed to those patients, to the sleep community, and to developing medicines that provide true patient value. Today, we are proud to introduce NUVIGIL® (armodafinil) Tablets (C-IV), a once-daily, longer-lasting formulation of modafinil. NUVIGIL was scientifically designed with the potential to keep patients awake for longer periods of time throughout the day. Read press release >>
With the commercial availability of NUVIGIL, we reinforce our promise to serve patients and healthcare professionals by expanding access to our medicines. I recognize that particularly in these economic times, paying for medicines can be a barrier to access. Our new patient support programs can help.
For patients with health insurance, Cephalon offers a program to help offset the prescription co-payment costs for NUVIGIL. To help patients and healthcare providers navigate through the managed care authorization and reimbursement process, we established the NUVIGIL Reimbursement hotline.
And, through our newly-established CephalonCares® Foundation we can help more patients without health care insurance access the Cephalon medicines they need. The CephalonCares Foundation is the heart of our company, and just another example of our efforts to make a meaningful difference in the lives of patients.
Through our clinical development program, we are evaluating the potential for use of NUVIGIL in a wide array of conditions beyond the current indications. Earlier this year, we reported encouraging results from a clinical trial using NUVIGIL in patients with excessive sleepiness associated with jet lag disorder. Our plan is to file a supplemental new drug application for NUVIGIL in jet lag disorder later this year . In fact, our plan is to seek a new indication for NUVIGIL every year and our robust clinical development program will allow us to evaluate NUVIGIL in other serious medical conditions including bipolar depression, negative symptoms of schizophrenia, cancer treatment-related fatigue and excessive sleepiness associated with traumatic brain injury.
It is our hope - and my sincere belief - that the introduction of NUVIGIL and our expanded patient support programs will benefit many patients. The value we bring to patients and the healthcare community has guided our business for more than two decades. And rest assured, it will continue to guide Cephalon, every step of the way.
Q2 2009
FRANK BALDINO, JR., PH.D.
Chairman/CEO
In spite of the current economic climate, Cephalon reported strong results in the first quarter of 2009. Our core business is growing, and our clinical development and business development efforts will help position us well for the future.
Our oncology medicine TREANDA® (bendamustine hydrochloride) just celebrated its first year on the market, and it continues to exceed expectations. Nothing is more gratifying to me than hearing stories about patients who at one point were short on treatment options but long on hope, and who finally had treatment success because of our medicine.
For research-based pharmaceutical companies like ours, the pipeline is a bridge to the future -- to the promise of a treatment option. Cephalon is fortunate to have robust clinical development programs for many of our approved medicines. We also have advanced several research compounds into clinical development for serious and rare disorders.
For example, NUVIGIL® (armodafinil) Tablets [C-IV] will be available in the near future for patients with excessive sleepiness caused by three conditions that affect their ability to stay awake.
We are already underway with an extensive clinical development program to provide data to support its use in other medical conditions. We announced positive results for NUVIGIL as a potential acute treatment for excessive sleepiness associated with jet lag disorder, and positive results from a trial in patients suffering from bipolar depression. We are exploring whether NUVIGIL can help patients with excessive sleepiness associated with traumatic brain injury, as an adjunctive therapy in schizophrenia, and in fatigue related to the treatment of cancer.
Also during this quarter, we announced three business transactions. We acquired an option to buy Ception Therapeutics, including its lead compound for the treatment of pediatric eosiniphilic esophagitis and eosiniphilic asthma in adults; exercised an option to license worldwide rights to ImmuPharma's compound for the treatment of systemic lupus erythematosus; and moved to purchase Arana Therapeutics, a company developing treatments for several inflammatory diseases and cancer. These transactions reinforce our commitment and expansion into the area of inflammatory diseases.
In all that we do, we remain firmly committed to improving the lives of patients, and developing medicines that matter to them.
Q1 2009
FRANK BALDINO, JR., PH.D.
Chairman/CEO
I am very pleased to report that 2008 was another fantastic year for
Cephalon. It was, in fact, a record year on several levels. We
exceeded our financial guidance for the year, generating sales of $1.943 billion, had two very successful product launches, and announced deals that we believe will continue to position us well now - and for the future.
Our core business is strong and growing. This was fueled in part by the latest addition to our oncology franchise, TREANDA® (bendamustine HCl) for Injection, which was approved and launched in 2008 for two separate hematological indications. More and more physicians are recognizing the benefits of TREANDA for their patients, and the feedback we hear is enthusiastic and positive. Our central nervous system franchise, anchored by flagship product PROVIGIL® (modafinil) Tablets [C-IV] , exceeded $1 billion in sales. We extended AMRIX® (Cyclobenzaprine Hydrochloride Extended-Release Capsules) to more patients in need of a once-daily, extended release treatment for muscle spasm associated with acute, painful musculoskeletal conditions. And we continue to explore in clinical studies the possibility that soon-to-launch NUVIGIL® (armodafinil) Tablets [C-IV] may have therapeutic benefits for conditions with symptoms beyond its approved excessive sleepiness-related indications. Read press release >>
We are pleased with the depth and breadth of our own internal research pipeline, which continues to move our compounds into the clinic. We are able to move quickly in acquiring promising assets and recently we announced several important deals that mark our expansion into the inflammatory diseases area. In January 2009, we licensed LUPUZORTM, a compound being studied for the treatment of systemic lupus erythematosus, a chronic, potentially life-threatening autoimmune disease that affects 1.5 million Americans, and more than 5 million people worldwide. And we entered an agreement providing us an option to acquire Ception Therapeutics, a biotech company developing reslizumab, a compound in a Phase IIb/III clinical trial for the treatment of an inflammatory condition in children called eosinophilic esophagitis.
The future looks bright for Cephalon, and for the millions of patients who rely on us -- and our medicines -- to improve their health, their lives, and their futures.
Click here to download Cephalon's 2008 Accomplishments >>
Q1 2009
FRANK BALDINO, JR., PH.D.
Chairman/CEO
Frank Baldino, Jr. always knew he wanted to be a scientist. What he didn't know was that his journey would take him from bench scientist to CEO of one of the top ten biotechnology companies in the world.
Learn more from Cephalon's Chairman and CEO Dr. Baldino about realizing his vision of starting and building a company; the challenges and obstacles encountered through two decades of drug research, discovery and commercialization; and the rewards of knowing that he and his entire Cephalon team are at the forefront of bringing important medicines to millions of people around the globe:
I'm Frank Baldino, CEO and Chairman of Cephalon, Inc. Cephalon is an S&P 500 company now, with sales that will exceed $2 billion, and a highly profitable enterprise with operations in 35 countries in the world. We sell 30 drugs in those countries; and the main categories of those products treat diseases of the central nervous system, pain and cancer.
I got a bachelor's degree from Muhlenberg College and went on for a PhD at Temple University in pharmacology. We're in the business of making drugs. Pharmacology is the discipline of how you understand how drugs work. It was a perfect match for me.
I knew I wanted to be a scientist from the very early phase of my existence. I was a pretty geek-y kid. I was always pulling the wings off bugs and collecting things and categorizing things and looking at them under microscopes and magnifying glasses. I always knew I wanted to be a biologist. And then I became a biologist.
Becoming a businessman was a whole other thing, something completely unexpected.
I went to California and met some very creative venture capitalists. We connected well and they gave me some seed money so I could write a business plan. I wrote a business plan and part of that business plan we're still following today. I made sure I put people around me who were smarter than me, who had more experience than me. And I continue to do that today. I'm very proud to say I'm not the brightest guy in the boardroom. I think that's what you really need to be successful in this business.
There's a lot you don't know when you start businesses like this. It's probably good you don't know, because it's very, very difficult and if you knew all the problems…if you really understood all the pitfalls…you'd probably be a little more reticent about getting involved in something like this. I didn't expect how difficult it is getting drugs approved. I never expected how difficult it would be to raise money in the early years. I never expected how difficult it would be to bring exceptional talent into the company.
But, if you continue to see the glass half-full, and you believe that for every obstacle there's an answer or a solution, and you work through that solution, and you have this vision and you never deviate from it…you will be successful.
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