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Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN)
Q4 FY07 Earnings Call
February 14, 2008, 11:00 AM ET
Leonard Bell - Director and CEO
Irving Adler - Senior Director, Corporate Communications
David W. Keiser - President and COO
Vikas Sinha - Sr. VP and CFO
Stephen P. Squinto - EVP and Head, Research
Sapna Srivastava - Morgan Stanley
William Sargent - Banc of America Securities
Meg Malloy - Goldman Sachs
Rachel McMinn - Cowen and Company
John Sonnier - William Blair & Company
Michael Aberman - Credit Suisse
Michelle Ha - Ferris, Baker Watts
Please standby. We are about to begin. Good day and welcome everyone to the Alexion Pharmaceuticals Incorporated Fourth Quarter Financial Results Conference Call. Today's call is being recorded.
At this time for opening remarks and introductions, I would like to turn the call over to Dr. Leonard Bell. Please go ahead, Doctor.
Leonard Bell - Director and Chief Executive Officer
Thank you, operator. Good morning. And of course, first, I'd like to wish everyone on the call a very happy Valentine's Day. Thank you though for joining us on today's conference call to discuss Alexion's financial results and corporate developments for the fourth quarter and full year of 2007.
I am glad to be joined this morning by members of Alexion management, including David Keiser, President and Chief Operating Officer; Vikas Sinha, Senior Vice President and Chief Financial Officer; Stephen Squinto, Executive Vice President and Head of R&D; Dave Hallal, Senior Vice President and Head of U.S. Commercial Operations; and Irving Adler, Senior Director of Corporate Communications.
I also welcome the entire Alexion team here at our headquarters in Connecticut, at our manufacturing facility in Rhode Island, and of course, across the countries of Europe.
After a review of the quarter, we will have time for several questions, but before we begin Mr. Adler will apprise you of our potential to make forward-looking statements. Irv?
Irving Adler - Senior Director, Corporate Communications
Thank you, Lenny. During the conference call, we may make forward-looking statements, including: statements related to expected 2008 financial results, medical benefits and commercial potential of Soliris, timing of commercial and regulatory milestones for Soliris in different territories, commercialization strategies, plans for clinical trials of Soliris and other products, status of reimbursement price approval and trending processes in Europe, and timing of completion and regulatory approval to manufacture at our Rhode Island manufacturing facility.
Forward-looking statements are subject to factors that may cause our results and plans to differ from those expected, including: decisions of regulatory authorities regarding marketing approval or material limitations on the marketing of Soliris. The possibility that results of clinical trials are not predictive of the safety and efficacy of Soliris in broader patient populations. The possibility that initial results of commercialization are not predictive of future rates of adoption, to risk that third parties won't agree to license any necessary intellectual property to us on reasonable terms or that litigation maybe resolved adversely; the risk that third party payers will not reimburse for the use of Soliris at acceptable rates or at all, the risks that estimates regarding the number of people living with PNH are inaccurate, and a variety of other risks set forth from time-to-time in our filings with the SEC, including our 10-Q for the quarter ended September 30, 2007.
We do not intend to update any of these forward-looking statements to reflect events or circumstances after this call, except when a duty arises under law. Thank you. Lenny?
Leonard Bell - Director and Chief Executive Officer
Thanks very much Irv. 2007 was truly a momentous year for Alexion. During this past year, we started to fulfill our mission to improve the lives of people with serious and life threatening disease. Soliris our first marketed product is the only drug, ever to be approved both on their priority review by the FDA and through an accelerated assessment procedure by the European commission.
Our compelling clinical data which compares very favorably to many other medicines today, demonstrates that every patent with PNH treated with Soliris showed an objective response to therapy. As a result, the approvals are broad and paved a way for us to serve all patients with PNH.
Our fourth quarter results reflect our success in serving a growing number of patients with PNH. Our fourth quarter results reflect our success in serving a growing number of patients with PNH. Net product sales of Soliris were $33.9 million in the fourth quarter of 2007 compared with $21.8 million in the third quarter, indicating a sequential quarter-on-quarter increase in sales of 56%. A total of approximately 515 patients were on clinical and commercial Soliris worldwide at the end of the fourth quarter, an increase of approximately 110 patients from the end of Q3. In the fourth quarter as compared to the third quarter, the U.S. continued its steady growth in patients and sales while patient additions and sales in Europe also grew at a rapid per case.
We expect continued strong growth in both territories. An analysis of the marketplace demonstrates that Soliris' performance in its first three quarters of commercial availability places it at the top end of ultra orphan drug launches to date. We believe that this reflects the clinical benefits of the drug and the effectiveness of our global commercial organization.
Looking ahead, we will continue to be keenly focused on meeting and surpassing our own expectations. Alexion's commercial efforts, as you know, are guided by our goal that every patient with PNH who can benefit from Soliris will have access to Soliris. This requires that we proceed one patient at a time working in each country within the unique framework of their particular healthcare delivery system. In all countries, our efforts to facilitate drug access, however, are focused on three fronts. First, working with physicians to identify PNH patients; second, generating demand by helping physicians to increase their understanding of the serious consequences of PNH and the role that Soliris can play to improve patient outcomes; and third, providing payers, either private or public with the information they need to complete their authorization procedures to create efficient and broad access to Soliris.
With respect to patient identification, for example, in the U.S. where we have been in the marketplace now for more than nine months, we are routinely identifying new patients with PNH. Patients who have been previously diagnosed are being identified on an ongoing basis through the meaningfully increased footprint of our U.S. sales organization as well as through physicians [Technical Difficulty] and partnerships with national oncology networks. With respect to patients who may have PNH, but who have not yet been diagnosed, we are working with hematologists and oncologists, including those in the largest community based practices to help them implement standardized pathways for routine PNH testing for their patients who have a higher likelihood of having PNH. We have observed that more hematologists and oncologists are beginning to embrace these diagnostic pathways in order to optimize the care for their patients.
We expect that implementation of these pathways will improve patient care and create a self renewing pipeline of patients who have been newly diagnosed with PNH. Similarly in Europe, these programs are being adapted for implementation by approximately 30 field representatives in the major European countries.
With regard to generating demand, physicians are broadening the use of Soliris in the known PNH population. As we educate them on new clinical data, indicating the progressive, pervasive, and life threatening course of the disease and the observed impact of Soliris. For example, just this past December, an important publication in blood showed that along with the reduction in hemolysis in all PNH patients treated with Soliris, the blood reduced thrombotic events by more than 90%. Also in December, presentations at ASH showed that two-thirds of the clinical trial patients had chronic kidney disease at waistline likely as a consequence of their long-term hemolysis.
In these patients, Soliris treatment was associated with improved their stabilized kidney function. These clinical analyses support the urgency of earlier PNH testing and earlier potential intervention.
Turning to the transition of clinical trial patients, in Germany, studied patients began to transition to fully funded status near year-end and should complete this transition during Q1. In United Kingdom, we are pleased that the first patients will have commenced transition to fully funded status from critical status by the end of the first quarter. We expect patients in additional European countries to transition to fully funded status throughout this year.
Looking beyond the commercialization of Soliris for PNH in the United States and in Europe, we announced in early January that we had commenced dosing in the AEGIS study, a single registration study to evaluate the safety and efficacy of Soliris as a treatment for Japanese patients with PNH. Enrollment in this study is progressing more quickly than initially anticipated. And we currently expect that even though the study was only started last month, enrollment should complete in March. Following 12 weeks of treatment and data analysis, we expect to submit an application for marking approval to the Japanese regulatory authorities in 2009.
Turning to our pipeline. I would like to start by focusing on the roll of compliment inhibition in a broader set of rare and severe diseases. This past November in the journal Nature Biotechnologies, research has reviewed the successful and pioneering developments of eculizumab in PNH. As noted in this article, a similar paradigm of careful and rigorous scientific evaluation maybe applied to the evaluation of the first in class complement inhibitor eculizumab in other uncommon debilitating and life threatening diseases. Hence as our U.S. and European commercial teams are driving steady Soliris growth in PNH, our R&D teams are also diligently working to assume commence studies of eculizumab as a treatment of patients with myasthenia gravis and multifocal motor neuropathy. We expect that our physician sponsored clinical trial evaluating the use of eculizumab in patients undergoing kidney transplantation will also begin this year. Additionally, we are diligently evaluating many queries by physicians concerning the potential role that eculizumab to treat patients with other severe and life threatening hematologic disorders.
Separate from our focus on treatment of patients with rare diseases as our asthma trial continues with intravenous eculizumab treatment, we are also focused on developing a new nebulized dosage form of the drug that can be delivered through an inhaler.
Finally, we expect to commence site initiation for clinical study by new antibody drug candidates targeting anti-CD200 in patients with chronic lymphocytic leukemia in the second quarter.
I would now like to turn to our going forward financial guidance. Increasingly as a business, we are focusing on generating significant growth, but we also recognize that such growth must be obtained through efficient and disciplined deployment of our resources. In that context, we are pleased to announce earlier today that we have accomplished the transfer to Alexion of all of the OMRF rights to certain patents related to Soliris, eculizumab, and the complement an additional technology, with the subsequent elimination of any future royalty obligation from Alexion. This transaction will contribute to a meaningful improvement in our cost of sales.
From enterprise wide perspective, we believe that our focused efforts will enable us to achieve increasing sales with Soliris in the United States and the five largest EU markets and to start to obtain meaningful commercial results from a growing number of additional countries. For 2008, net product sales of Soliris are expected to be within a range of $200 million and $215 million, a level more than three times that of 2007. At the same time, we are committed to drive in clinical studies in four to seven additional medical conditions during this year, while keeping R&D expenses in check.
Two biotech firms make the transition from drug development companies to successful commercial organization, and fewer yet do so simultaneously on a global basis. Many people have contributed to our success including employees, shareholders, medical researchers, practicing physicians and of course patients themselves.
During 2007, we reached an important goal. Successful development of a highly effective complement inhibitor as a treatment for patients with the severe, rare and life threatening disease to which treatment options were sharply limited. However, our true mission is not just to development, but the delivery of life changing drug therapies for patients with serious and life threatening medical conditions. To this end, we are committed to drive the promise of Soliris forward around the world for the benefit of each patient with PNH and for patients with other severe and disabling diseases.
At this point, I will turn the call over to David Kaiser, who will review in more detail our commercial efforts here in the United States as well as across Europe. David?
David W. Keiser - President and Chief Operating Officer
Thank you Lenny. With the addition of our fourth quarter performance our full year results for 2007 reflect Alexion's momentous accomplishments during the year. The most important aspect of our commercial success of course is that it correlates directly with improvements in patients' lives.
Before 2007, patients with PNH have few options, many fears and little hope. In a few short months Soliris has changed the profile of PNH for the better in a growing number of countries. As we gain commercial experience in this ultra rare disease state, we have been pleased to find that our original plans are sound and are yielding the results we expect. These plans are four fold. Identifying patients, generating demand with treating physicians, creating access for all patients with PNH and supporting appropriate utilization.
A key element in these efforts in the U.S. has been the work of our field sales force of 32 professional medical representatives. These regional account managers and oncology clinical specialists are working with physicians to streamline practice protocols regarding the detection of PNH. Once the physician decision to treat a patient for Soliris our sales team works for their one source case managers to speed the reimbursement process to the greatest degree possible.
In Europe, our field teams totaling approximately 30 representatives in the five major markets are building the key relationships to support Soliris in both academic centers where many patients tend to aggregate and also in community practices where a significant number are also treated.
As we have expected from the start there are significant differences in obtaining full commercial status from one country to the next, especially in the key areas of pricing reimbursement and funding.
In Germany as in the U.S. the vast majority of patients for whom Soliris has been prescribed have been able to efficiently obtain access to the drug helping to drive strong sales growth. In France, Italy and Spain product revenues are already becoming meaningful through the named patient programs. In these countries we are continuing to expand this access on a patient by patient basis, while transitioning to full commercial status. These efforts are progressing according to plan and should be completed by mid 2008, with a growing contribution to sales coming from these countries.
In the United Kingdom we believe a growing number of PNH patients will gain access to fully funded Soliris therapy, although funding decisions may typically require more time compared to other markets. As you may know the healthcare delivery system in the U.K. are organized around local and regional funding authorities. Many of these entities are currently reviewing the files of PNH patients who fall within their jurisdiction.
The first of the clinical study patients in the U.K. will start transitioning to fully funded Soliris therapy by the end of the first quarter, and we expect additional U.K. clinical trial patients to transition to funded status during this year. In the future, regional funding decisions could make it easier for larger groups of patients in the U.K. to obtain access simultaneously.
As a reminder and importantly we have been informed that Soliris does not need to read reviewed by NICE, the U.K.'s national institute for clinical excellence. Because of our progress to date and in line with performance of other successful ultra orphan drugs, while we continue to achieve steady growth in the U.S. our European business is on track to account for the majority of our total revenues in 2008.
To sum up, 2007 was a remarkable year for Alexion. One in which our Company was transformed in many ways. We have reached some important milestones with a strong commercial foundation and an impressive product launch. We are now driving to expand our business to deliver robust revenue growth, progress product development into other indications and deliver standout financial results.
I will now turn the conference call to Vikas who will review our financial performance during the fourth quarter. Vikas?
Vikas Sinha - Senior Vice President and Chief Financial Officer
Thank you, David. For the quarter ended December 31, Alexion achieved worldwide Soliris net product sales of $33.9 million, compared to $21.8 million in Q3 2007 the previous quarter. This represents a sequential quarter increase in net sales of 56%. The cost of sales in the quarter was $3.4 million. It is important to note that during the quarter, the product we sold included the last of the one that has been previously accounted for as of not any expense. Therefore, the cost of sales in Q4 is a blend of royalty obligations and cost of goods for the past quarter. We report both GAAP results and non-GAAP results, which are equal to our GAAP results less the impact of share based compensation. To save time on this call I will only discuss non-GAAP results. Please refer to our press release for our complete financial results.
On a non-GAAP basis our operating expense for the fourth quarter 2007 was $40.4 million compared to $31.9 million for the fourth quarter of 2006. R&D expense for Q4 2007 were $14.7 million essentially the same as the $14.8 million reported for the year ago quarter. SG&A expenses for the fourth quarter were $25.8 million compared to $17.1 million for the fourth quarter 2006, primarily reflecting costs associated with the ongoing ramp up of our commercial operations in the United States and Europe.
The Company incurred a non-GAAP net loss for the fourth quarter of $8.5 million compared to $30 million in the fourth quarter of 2006 or a loss of $0.23 per common share in 2007 compared to a loss of $0.90 per common share in 2006. The fourth quarter of 2006 was negatively impacted by costs associated with the consolidation of our research facility in San Diego into our Connecticut operations. On a sequential basis, the Q4 2007 non-GAAP net loss of $0.33 per common share was significantly reduced from a Q3 2007 non-GAAP net loss of $0.38 per common share.
Total revenue for 2007 was $72 million including $66.4 million from Soliris product sales, compared to revenues of $ 1.6 million for 2006 which were entirely from contract research. Approximately $46 million or 70% of 2007 revenues were derived from the United States, with the remaining $20 million coming from Europe. On a non-GAAP basis, we have total operating expense of $144.9 million in 2007 compared to $ 118 million in 2006. Our net loss for 2007 was $72.1 million or $1.99 per common share as compared with a net loss of $110.9 million or $3.50 per common share in 2006.
We have achieved these results due to the successful launch of Soliris in the United States and growing product sales in Europe coupled with rigid cost management controls which we intend to maintain as sales further ramp up. I would like to also point out that our total NOS, net operating loses, at the end of 2007 were $735 million. As we move forward towards profitability, these NOLs will significantly help improve our cash outflows for taxes in the coming years
Now looking at the balance sheet. As of December 31, 2007 we had $106.7 million in cash, cash equivalents and marketable securities compared to $250.1 million at December 31, 2006. The decrease in cash during the year was attributable to factors that included the continued development of our commercial operations, costs associated with completing the construction of our manufacturing facility and purchases of inventory. These were offset by proceeds from cash receipts generated by sales, by exercise of stock options and the July 2007 increase in the Company's existing mortgage loan.
We have accounts receivable of $46.3 million at the end of the fourth quarter. In order to provide for further operating flexibility to grow out our commercial business, we have also instituted two measures to provide for further access to the value of our receivables. First we have recently shortened our commercial terms from those during the initial launch phase. Second, we have recently executed an agreement to obtain a working capital line of credit from a commercial bank for up to $25 million. We expect that these two measures will meaningfully augment our future cash balances without equity dilution.
Looking ahead to 2008. we are providing the following financial guidance. Worldwide Soliris sales are expected to fall within the range of $200 million to $215 million. Please note that, as previously discussed, since there is no simple correlation between patient numbers and sales and as we move beyond the initial launch phase we will no longer be providing total patient numbers.
Our cost of sales including anticipated royalties is expected to be in the range of 14% to 16% as compared to our previous estimate of 18% to 20%. The reduction in forecasted cost of sales is primarily due to improved manufacturing yields and reduced anticipated royalty obligations following today's announcement on private acquisitions.
Looking at expenses. Our non-GAAP R&D expenses are anticipated to be in the range of $65 million to $75 million and non-GAAP SG&A expense in the range of $115 million to $125 million. Our share based compensation expenses for the year are expected to be in the range of $26 million to $28 million. We feel confident that with commercial execution staying on plan, rigid cost controls of proper cash management, we are well positioned to becoming a robust cash generating organization.
In closing, I want to join with Lenny and David and recognizing the great effort that has gone into Alexion's achievement in 2007 and I am looking forward to more accomplishments in the year ahead.
At this point, let me turn the call back to Lenny. Lenny?
Leonard Bell - Director and Chief Executive Officer
Vikas and David, thank you very much. The strong upward trend of the fourth quarter coming on the top of a year of important milestones for the Company, points to continued strong performance in 2008, especially as we serve more patients with PNH in the existing markets and drive expansion into new markets. At all points in the Company's history, the key to our progress has been the individuals on the Alexion team whether it consisted of the original handful of people on a few rooms of a single office in Connecticut or the current 400 people working across the United States in key countries in Europe.
With that our collective experience, expertise, and passion together with the ongoing support of shareholders, researchers, and physicians, we each feel all the urgency to reach and deliver life changing therapies to more patients in more countries around the world.
I thank you very much for your attention. We would like to turn the call over to the operator for questions, Operator?
Question and Answer
Thank you. The question-and-answer session will be conducted electronically. To [Operator Instructions].
And we will take our first question from Sapna Srivastava with Morgan Stanley.
Sapna Srivastava - Morgan Stanley
Thank you. Congratulations on a good year and strong quarter.
Leonard Bell - Director and Chief Executive Officer
Thanks Sapna.
Sapna Srivastava - Morgan Stanley
And the one question we have is… could you tell… could you give us some color for your goals for profitability if I looked at your numbers this year and leverage with cost of goods, it seems like you could pretty much be profitable towards the end of the year. We would just love to hear your thinking on that?
Leonard Bell - Director and Chief Executive Officer
Well, thanks very much obviously Sapna. And we are obviously keenly focused as we describe on obtaining strong results. We provided guidance, of course, with regard to revenues, R&D, SG&A, and cost of goods. And at this point, we don't feel the need to provide any other guidance. I think our plans, Sapna, as you can hear is that maintain very rigid control over costs to invest productively in the key launch phases around the world, and to maintain that leverage. So, at this point, I think that we provided enough flavor for where we are driving without providing any specific numbers for our profitability.
Sapna Srivastava - Morgan Stanley
And just one quick question on the pipeline. Which indications do you think you planning to move forward with first?
David W. Keiser - President and Chief Operating Officer
I think our plan actually would be is that we know a physician is getting ready to start very shortly a study that already received agreement to go forward in kidney transplantation. We ourselves are working diligently with investigators that complete all of the pre-planning to start studies in the U.S. in case of myasthenia gravis and in Europe, in the case of multifocal motor neuropathy. At the same time, the asthma studies are underway. We also, Sapna, are keenly interested as I mentioned in the conference call monolog aspect, a very diligently responding to interest questions and in some cases experience with eculizumab and other indications, typically other human hematologic.
These interests come from both the Europe… European physician community where we have strong ties of course, and increasingly also from the U.S. community where we have a marketing expanding base of PNH treaters now. So, I think, as we move forward as other indications and conditions as I described, will give more color as well. But those are of increasing priority and prominence in our internal thinking.
Sapna Srivastava - Morgan Stanley
Okay. Thank you so much.
Leonard Bell - Director and Chief Executive Officer
Thank you, Sapna.
And next we will hear from William Sargent Banc of America Securities.
William Sargent - Banc of America Securities
Hi. Congratulations on a spectacular launch and a great 2007.
Leonard Bell - Director and Chief Executive Officer
Thank you.
William Sargent - Banc of America Securities
So, first, just in focusing in on the overall patient numbers by quarter, with quarter was similar to third quarter. I was wondering if you could perhaps comment qualitatively how that EU to U.S. mix changed from third quarter to fourth quarter in a percentage of the patients. And then I had a quick follow-up question on the U.K. U. K. comments?
Leonard Bell - Director and Chief Executive Officer
David Keiser?
David W. Keiser - President and Chief Operating Officer
Well as you probably know and particularly in ultra orphan disease areas patient numbers tend to fluctuate depending on the territory. And as I think we mentioned in the last call as it pertains to new patients addition in the U.S. probably in Q3 patient additions were primarily coming out of the U.S. And that's where now we have moved into the fourth quarter we got… pretty much equal coming on board on patients with respect to the U.S. and Europe.
William Sargent - Banc of America Securities
Great. And then just to clarify the U.K. patients are anticipating by the end of the first quarter, that is a local and not an MCG [ph] commercially reimbursed or commercially covered patients, is that correct?
Leonard Bell - Director and Chief Executive Officer
That some more locally oriented commissioning system, that's true.
William Sargent - Banc of America Securities
Do you have any further inside about what do the timeline will be for the national commissioning group is? And then the novel PNH patients that are diagnosed in the U.K. when you anticipate those to being able to be covered by either the local or national MCG?
David W. Keiser - President and Chief Operating Officer
I think you wouldn't be able to expect in 2008 that there would be a national program instituted here with respect to our drug in any event. And certainly, as we go through the year, as we work through the both local and regional funding groups in the U.K., you would expect additional clinical trial patients to be learned over to funding Soliris as well as new patients coming into the system.
Leonard Bell - Director and Chief Executive Officer
I also comment, it's Lenny. That clearly we were already observed that in a variety of territories within the overall United Kingdom, new patients are already been able to access drug and we know that there is at a variety of these local boards of backlog of many patients… or excuse me… many physicians requesting therapy for their new patients so called high priority patients who in their judgment are really can't wait. So, we will certainly monitor this carefully and our objective is always is to make sure that we serve the benefits of patients and I think that increasingly others are looking the same way as well.
William Sargent - Banc of America Securities
Thanks very much for taking my questions.
Leonard Bell - Director and Chief Executive Officer
Thank you Will.
[Operator Instructions].
And next we will hear from Meg Malloy from Goldman Sachs.
Meg Malloy - Goldman Sachs
Thanks very much and also my congratulations on a good year. I just wondering two things. One is, could you explain a little bit on your thought process behind your guidance in terms of expected number of new patients versus patients that have already been identified through various named patients and clinical programs. And then secondly, you had some nice yield improvements that looks like they have translated nicely into the cost of goods guidance this year. I am wondering if there is a room in your view to potentially improve as you scale up to your own manufacturing. Thanks.
Leonard Bell - Director and Chief Executive Officer
Thank you very much, Meg. I will take the first question and then Vikas will take a swing at the second question. So, as we know, in terms of our guidance, as you know, we are as you know are in the midst of launching our first drug together as a team. And today is the first time we expressed our 2008 revenue and also expense guidance. And the types of things that we think about, particularly in a fairly dynamic increasingly global launch period, that is that we recognize that there are uncertainties with regard to pricing still in certain European countries, certainly with regard to funding decisions or reimbursement, and certainly, with regard to the timing of clinical transitions that will occur on a country-by-country or in some cases within a country, local basis.
And then, of course, also new patient addition and we look across all this and take this into consideration and we think in general that this is the guidance that we see with some clinical conversion occurring of course at various times not necessarily early but during the year and we see a steady pace in the United States. Growth which we are very pleased by and are looking to further exploit, but also with ongoing growth with new patients in organic growth across the European countries. So taking all that as the year progresses, if this guidance needs to be updated and it's warranted, we of course will but this is where we feel comfortable now.
Meg Malloy - Goldman Sachs
Thanks very much.
Vikas Sinha - Senior Vice President and Chief Financial Officer
And Meg this is Vikas, and on your second question regarding cost of sales. It is a blend of anticipated royalties and cost of manufacturing of Soliris and on the cost of manufacturing side we've taken a strategy to move forward with two sources, one with Lonza and one ourselves. Since the patient numbers are low and the volumes are low in this business. We see that this balance will fairly maintain our cost of sales. On the other side, on the royalty side as things progress we will come back and periodically review with you all how the progress is going on.
Meg Malloy - Goldman Sachs
Okay. Thanks very much.
And next we will hear from Rachel McMinn from Cowen and Company.
Rachel McMinn - Cowen and Company
Hi. Yes. Thanks very much. I am wondering if you can comment on how many clinical trial patients have or are remaining at the end of the year.
Leonard Bell - Director and Chief Executive Officer
In outside the U.S., you mean, Rachel?
Rachel McMinn - Cowen and Company
Leonard Bell - Director and Chief Executive Officer
Yes. I think there were some reports that some patients have started a transition to commercial drugs in the third quarter even in Europe and that obviously wasn't correct, which we went out of our way to describe in discussions today. So patients really started to move mostly from Germany and towards the end of the quarter and we expect that to be complete in or the very near-term and certainly this quarter absolutely. We are confident of that. We anticipate that the bulk of patients obviously in the U. K. really remain out there and not on transition as well as in Italy and as we mentioned there was a modest number in France but certainly in the Netherlands there is a substantial number of patients, in Spain as well and a smattering of patients that are in Switzerland, Belgium and some of the Northern countries.
Now, there's also a group of patients in Australia and Canada that we don't actually anticipate seeing meaningful revenue, if at all, from those patients in 2008 and taking that all into view, other than Germany all the other European patients effectively remain out there are to be converted.
Rachel McMinn - Cowen and Company
And somewhere around like 120 or so, is that a fair number?
Leonard Bell - Director and Chief Executive Officer
People constantly put out those very high numbers like that and we never really seen it the number could be really as high as that. So, certainly, you back out all of it, at some time years ago, there were only 130-140 patients outside the U.S. and when you look at the other countries and so forth and so on, that kind of number just gets too high a number I think.
Rachel McMinn - Cowen and Company
Okay. And then in terms of, I guess, let me see here, I guess I want to ask about the big differences in prescribing between the E.U. and the U.S. I know it's early days in the European launch, but are you seeing any differences in the way it's positioned approach the treatment or just prescribing of Soliris going more towards sicker patients in Europe than were so in the U.S. or are they just really the same at this point?
David W. Keiser - President and Chief Operating Officer
This is David, Rachel, I think what we are seeing primarily looking across geographies, really is that there's the… I don't think they are really major differences, I think. of course one thing that we're experiencing that's different and in parts of Europe, mainly in France and Italy is that those programs at least to-date, which are named patients, are really stimulated by, by the Physicians themselves, in other words, without really being promotional efforts. So, that selection of patients to be putting, to be put on the drug in those two countries, is truly being driven by the physician and what's interesting there is that the number of patients that have been able to be brought on board on those programs such that we are impacting those two countries generating already now, pretty meaningful revenues.
Leonard Bell - Director and Chief Executive Officer
So, generally, also I just would chime in with David's comments I will see what… which I agree Rachel, it's typically, we certainly see that patients who have been more frequently or less frequently or not transfused or are, requesting access to drugs in different areas, there is it does both in the U.S. and in European countries there does tend to be, a greater number of sophisticated prescribers in some of the European countries who are much more keen to the serious consequences of the disease. Out of the gate actually. And so, though they may have a greater insight and certainly as David described, this is all obtained obviously without any promotion, whereas in the United States they allow running a strong excellent and growing U.S. commercial team, quite a bit of the early out of the gate is being focused on disease education, education of the serious consequences of the disease, the long-term impact of chronic hemolysis and the potential beneficial impact on patient outcome of Soliris therapy. Much of that actually is understood by many more people… many more potential prescribers in the European countries. Then again, I wouldn't focus just here on the U. K. I would focus strongly on Germany, France, Italy, increasingly so in Spain and in addition of course the U. K.
Rachel McMinn - Cowen and Company
Thanks, very much.
Leonard Bell - Director and Chief Executive Officer
Thank you, Rachel.
And next we'll hear from John Sonnier from William Blair.
John Sonnier - William Blair & Company
Thank you. Congratulations on a lot of wonderful progress you guys have made over the past year. I had questions today about Japan, from a clinical and regulatory standpoint, I know you said you're going to file in '09, but can you give us a little bit more insight into the, I guess the size and shape of that study and then from a commercial standpoint, I believe Aplastic Anemia rates are significantly higher in… in Asia and there's also the very provocative comparative analysis that was done at Duke a couple of years ago that suggests that thrombosis rates are lower in Japanese population. Sort of, so, should we think the patient management might be different there once you're approved?
Leonard Bell - Director and Chief Executive Officer
Sure John. Thanks very much. I'll make a couple of comments then Steve's going to well, also give our views. The first comment I'd make is, sort of, an overarching comment that in my experience supervising trials and 15,000 to 17,000 patients over the last ten years or so in particular. Most times actually, we internally are disappointed by the performance in getting a clinical trial go underway and enrollment and bring it to a speedy completion. And there are two times actually that I think, stand out in that very strongly. Of course, the first one will be the U.K only study, our Phase II study, which was really ground breaking describing a small cohort of patients generally run out of leads, really outstanding results by our committed researchers who knew a lot about the disease and a lot of enthusiasm for the drug. I think, the second study quite frankly is going to be the Japanese registration study. Where it turns out, as we just spoke last month at one of the investment banking conferences and an anticipated enrollment completing three or four months away.
They actually have driven very, very hard; they've also demonstrated an enthusiasm and ground swell of patient support to rapidly enroll that trial such that all of the patients are already been screened and treated, additional treatments will start sometime by next month. So, that's actually an indication of what we anticipate to see very strong metrics for both physician and prescriber enthusiasm on the ground. It's about a 25 patient trial, where patients will be treated for 12 weeks. It's a lot like that U. K. study, but it's just about twice the size and across all of Japan.
Steve do you want to make some comments also?
Stephen P. Squinto - Executive Vice President and Head, Research
Well, I wanted… I think, you summed it up very nicely. So, the 25 patients will be enrolled at about nine sites and the nine key opinion leaders in Japan are extraordinarily enthused about the prospect of eventually having a drug like Soliris to treat their Japanese patient population. In fact it's kind of interesting if you look back in the literature to some of the early days of science around identifying PNH and understanding PNH. It actually tracks back to some of these early Japanese… investigated by these very same Japanese investigators. So, a lot of enthusiasm on the part of those investigators in Japan to… to move these trials forward.
Leonard Bell - Director and Chief Executive Officer
And certainly for laying the ground work. It's quite remarkable that as we actually completed development across the U.S. and Europe and are launching successfully across the U.S. and European countries as well. With a global realization, we have the reach to be able to implement and drive a Japanese registration trial, which obviously we're very, very excited about this. And I think, additionally, the fact that it's spread out among a number of sites really bodes well for… a lot of appreciation for the drug, which again is some what different than the dynamics we had in the United States. So, a lot of… it really appears to be much more a ground swell, which we're very enthused by. And in regard John, to your other comments or questions. Certainly there is a marked increase in the incidence of Aplastic Anemia in the far East and just about a three or four fold higher likelihood as you pointed out and we obviously know that the proportion of patients with Aplastic Anemia who have the common PNH clones depending what threshold the PNH clones could be anywhere from a quarter to two-thirds of the patients.
So, we think that there are probably a fair number of patients with PNH in Japan. There is a fair amount of published data that suggests that thrombosis is a less likely to be occur and be life threatening. And in fact what moves up the order for high morbidity in patients of Japanese decent, who have PNH interestingly enough is Renal disease and I would point out that certainly it was really serendipitous, of course, that we had all of this new renal data come out presented by leading researchers from Europe to the United States at ASH and certainly we were comfortable and shared that information and detail of that data with the entire Japanese community involved in the trial and they are also very enthused about that. So, I think, that there will be slightly different messages per se but I think, they cut their role that Soliris is a highly effective and safe drug that can transform these patients lives through a number of different improvements in clinical morbides [ph] I think, that's pretty much the same.
John Sonnier - William Blair & Company
Is it possible, it sounds like it's going fast is it possible that the filing time line gets pulled into '08 because it sounds like if it's in '09, it's going to be early '09 for a 12 week study?
Leonard Bell - Director and Chief Executive Officer
It's a big challenge to pull off together something we have done obviously successfully two times. And we have met all these challenges in the course that we have laid out during 2007 which was a very challenging year for us and the fourth quarter was challenging, we did quite well. We are giving guidance that we expect to… that we are comfortable with and I think we are also comfortable with the 2009 submission. There are additional challenges, of course regarding regulatory aspects and language issues and so forth which we have to allow for which adds some of the timeline for Japan submission.
John Sonnier - William Blair & Company
That's it. Just one last question just so I understand it. There are nine, you believe nine key opinion leaders in Japan and are patients aggregated in Japan as they are in Europe or these nine traders would manage most of the population now.
David W. Keiser - President and Chief Operating Officer
No. Actually there are nine sites that are enrolling patients, they are more key opinion leaders than sites of course, but the nine sites that are enrolling are represented by very strong leaders in the field of PNH studies in Japan.
John Sonnier - William Blair & Company
Okay. Hey, thanks a lot.
David W. Keiser - President and Chief Operating Officer
Thank you John.
Our next one from Michael Aberman from Credit Suisse.
Michael Aberman - Credit Suisse
Hey guys. Thanks. Thanks for the Valentine Day wishes.
David W. Keiser - President and Chief Operating Officer
You are welcome, Michael.
Michael Aberman - Credit Suisse
Very important for me. Can you not… can you give me any update on the EXPLORE trial in terms of enrollment and the number of patients, a percentage of patients that screen that actually get on drugs and how much of the U.S. growth comes from that trial?
David W. Keiser - President and Chief Operating Officer
Sure. Thank you Michael. EXPLORE continues to rely very important information regarding association of teenage… with a variety of bone marrow disorders and we have now enrolled about 3,800 or so patients with aplastic anaemia or one of the mild displastic syndromes or some related bone marrow disorder and it's really rolling out well over 200 sites in the U.S. So, over the last period of time, in the last six months or so is about a 50% increase in enrollment or a number of patients have been enrolled which we are enthused by and we think that it's provided a greater awareness or treat it as a greater awareness of the importance of our… call it a teenage clone of almost any size really in other bone marrow disorders. And as we look at EXPLORE we would expect value with the data. We are working increasingly with MDS thought leaders here in the United States to appreciate importance of the data not only for the identification of patients with important PNH, but also for the improvement of the therapy of patients bypassing imminent MDS irrespective of PNH.
And we think that's providing an important driver for how we look to position some of the diagnostic pathways that Dave Weil has pioneered here in the U.S. and we also understand that are some patients with EXPLORE. In EXPLORE trial we would have probably gone on to receive Soliris although of course our primary objective really is driven by our interest in obtaining medical information about the association of PNH with bone marrow disorders.
Michael Aberman - Credit Suisse
In terms of data, should we expect data from Myasthenia Gravis or MMN thought. Can you give us a little more color on how you are studying this and how you plan to get to the concept of this drug is affecting on those diseases?
Leonard Bell - Director and Chief Executive Officer
Yes. Actually Mike, Michael, we will give you some thought as well. We are looking in and working again as I mentioned both in the U.S. and with European thought leaders on the different studies and there is probably three or four additional studies that we are looking at outside the ones we describe here as I implied couple of times earlier today, and I think that what we are thinking about is that one of the major things that it accomplishes, we know really the dosing of Soliris that will completely lock confidence in the patient. We also appreciate the designer trials, and what's been done before in multifocal motor neuropathy and also in Myasthenia Gravis. And we are probably at this point looking at in those cases really a crossover design, something we are not able to do in PNH because of the peculiarities of PNH, but I think it's that classic rare disease design. We have a crossover design make use and patients control for themselves in a crossover setting.
We would expect that type of data if we were to execute these trials to really help the physician community and also to understand whether the drug is very likely to be effective in that population and we think that that will meaningfully impact how we go forward in each of those populations as well, as I mentioned some other rare… from hemolytic diseases. We think that those are studies probably really will provide a meaningful data probably not till the end of this year but more likely early part of next year is where we are currently looking although we might have some insights will help us.
Michael Aberman - Credit Suisse
And you will provide updates as that progressive data will come early or presumably one or two patients with Myasthenia Gravis and the crossover to design can give a pretty strong signal?
Leonard Bell - Director and Chief Executive Officer
Yes. We are looking at and I think what's guiding us quite a bit and Michael having followed us… I don't think followed us but I think examined us carefully over years. You recognize we probably learnt a lot, I said a little hard way quite frankly of how to do efficient drug development, but I think we have come to from a variety of sort of medical, scientific and commercial reasons. It's really only recently seen very striking signals and that's what we are interested in really making a contribution to patients who have got a severe disease and now as we have done in PNH, step in with a drug that transforms that patient's outlook and we would anticipate actually to be to design trials that provide us that insight.
Michael Aberman - Credit Suisse
And mine is just quickly on database. In terms of myasthenia gravis if you do show an effect on a severe population, how big is that population in North America and Europe?
Stephen P. Squinto - Executive Vice President and Head, Research
So, we are actually really focused on probably a subset of myasthenia patients, of course those patients that are not deriving benefit, good clinical benefit from the current use of immunosuppressive therapies. So that is probably… maybe 10% to 25% of the total Myasthenia population, somewhere in the 4,000 to 5,000 range. Yes.
Leonard Bell - Director and Chief Executive Officer
And increasingly look as you are sort of describe us as well, we look to focus where we can really make a difference and far from being scared of by lower numbers we actually find it at this point, very attractive.
Michael Aberman - Credit Suisse
All right. I will get back, actually that's enough. Thanks. Appreciate it.
Leonard Bell - Director and Chief Executive Officer
Thank you Michael.
And next we will hear from Michelle Ha from Ferris, Baker Watts.
Michelle Ha - Ferris, Baker Watts
Hi. Congratulations. Could you expand on some of the diagnostic pathways that you reach you, maybe talk about FLAER a little bit?
Leonard Bell - Director and Chief Executive Officer
Dave Weil?
David W. Keiser - President and Chief Operating Officer
Sure. Thanks for the question and it relates back also to the question about EXPLORE, we are really commercially focused on a broader initiative to identify patients with PNH, so let me just talk a little bit about those steps. First is we indicated on the call, really on a routine basis we are identifying patients that have been previously diagnosed with PNH as well as taking it upon ourselves to elevate and educate physicians, about patients who are at a higher likelihood for having PNH, these patients are likely been seen by physicians on a frequent and ongoing basis and it requires really a simple peripheral blood test for the physician to order to really diagnose the patient with PNH. When we think about those patients who have been previously diagnosed with PNH as we suggest, our increased footprint in the United States with our sales organization, our frequent attendance of physician meetings, the website activity that we have seen, in our partnerships with some of the largest national oncology networks are really facilitating that identification.
Back to the diagnostic pathway and then I will pass it over to Steve to comment a bit on FLAER. When we really think about those pathways, the good news for us as I stated is the patients are being seen in these large oncology treatment centers and really by delivering messages to the physicians and sharing that third party reference data on the patients that are at higher likelihood for PNH. What we are seeing is a significant interest in the physicians to then order the test, but it isn't simply ordering the test, but it is the right test at the right lab and I will finally just say what we have seen in some cases is the numbers of known PNH patients and some of these practices in fairly short period of time, potentially jump from a single known PNH patient and the practice to multiple patients, and gives us some confidence that over the long run this is going to be a very successful approach for us.
I will pass it over to Steve for comments on FLAER. Steve?
Stephen P. Squinto - Executive Vice President and Head, Research
Yes. I think what we are seeing slowly but surely in the field that there are a number of commercial labs that are beginning to adopt the use of the FLAER reagent. As you know it's a reagent that is used as part of a flow psychometric based diagnosis of PNH and more and more is becoming their assay of choice for PNH panels. And FLAER is really just one part as David mentioned of our overall strategy to inform physicians on best practices for the diagnosis of PNH. FLAER itself is a reagent is important. As you know it is a more sensitive measure and more importantly a very accurate measure of PNH clone size. And this is clinically important since it both facilitates a diagnosis of PNH and it more accurately reflects the PNH burden faced by any individual patient. As with many diseases, the diagnosis is the appreciation of the risk, this disease is usually contributors regarding decisions to treat patients. And also, as an example of the importance that we put on FLAER, so the central lab that does all of the diagnostic work for our support trial, just recently as of January 1, 2008 switched up all analyses now to the FLAER reagent for evaluation of PNH clones, in aplastic anemia, MDS and bone marrow failure patients.
And I'll just close by saying what we are seeing from the physician community with their awareness of patients who may be at higher likelihood of having, is demand for a test that utilizes the FLAER reagent, so that they can have the highest level of accuracy and specificity on the results. Lenny?
Leonard Bell - Director and Chief Executive Officer
I'll pass it over David. Thanks so much Steve.
Stephen P. Squinto - Executive Vice President and Head, Research
Michelle, that answer your question?
Michelle Ha - Ferris, Baker Watts
Yes. It does. Thanks very much and another question sort of unrelated. Can you provide any color on the pricing for Soliris in Europe or anything, Germany, U.K. anything to that nature?
David W. Keiser - President and Chief Operating Officer
Yes. I think as we stated our objective here with respect to pricing is that we developed a relatively narrow band or quarter of our prices, both globally as well as specifically as it relates to Europe and that band or quarter also capturing what we are doing here in the U.S. and in terms of what there has been developed so far certainly in those countries where we do have a price at this point that particular objective has been accomplished. We have been able to develop our pricing strategy here in a way in which it could be effectively implemented.
Michelle Ha - Ferris, Baker Watts
Okay. Thank you.
And that does conclude the question and answer session. I would like to turn it back over to Dr. Leonard Bell for closing remarks and comments.
Leonard Bell - Director and Chief Executive Officer
Thank you very much operator and again I thank everyone for joining us this morning on really a momentous day for us reporting our results for the first nine months commercial availability of Soliris in the United States and Europe. We are very excited by capping off 2007 with a very strong quarter four which sets us up, we think to do and provide strong performance here in 2008. We are well focused on driving our topline growth. At the same time making disciplined investments to provide for strong opportunities for Soliris and a variety of other indications to help patients who currently now have no help for their disease. We are going to provide updates obviously, as we go forward and thank you very much again to Michael and everyone else as well. Happy Valentine's Day.
And this does conclude today's conference. We thank you for your participation and ask that you enjoy the remainder of your day.
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text:
UMass Amherst Rn to BSN online program
0 Anyone have info on this program ? I was accepted for summer 2013 , wondering what course load is like.
ThanksJun 10, '13 by MangoeaterHi,
The course load is do-able. Lots of paper writing for the ethics in writing course, but the others are not too bad. I worked full time while in the program, and it did cut into personal time but was not unbearable. It helped me to map out the whole semester ahead of time, due dates etc.. and thoroughly explore the syllabus and grading rubrics for each class at the beginning of each semester.Jun 10, '13 by ualskyguyThanks , Im writing for one of the many assignments in "Ethics" as we speak.Jun 12, '13 by deemarysI am thinking of applying for the fall. What courses are required to complete BSN? I already have micro, Organic Chem, bunch of electives like Americ Lit, US History. Think I need Statistics.
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subset: commoncrawl


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Murray-Darling prospects still grim
The Murray-Darling Basin Commission says the most critical areas of the basin are unlikely to improve this year.
The latest drought update predicts a worsening downstream in South Australia.
It says the water level in the lower lakes of the Murray, near the mouth, are the lowest in living memory.
Water is being pumped from Lake Alexandrina into neighbouring Lake Albert to prevent acid sulphate from forming.
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Commission chief executive Wendy Craik says emergency measures could include dipping into storages interstate, but that will be up to the states to negotiate if critical human water needs cannot be met.
Low autumn rainfall is forecast for the Murray-Darling Basin, which is likely to mean a zero water allocation for South Australian irrigators.
Dr Craik says water storages across the basin overall are slightly higher than this time last year but still well below average.
"I think the fact that there's nothing on horizon in next few months in terms of increasing, higher chance of wetter-than-average rainfall, that's what's concerning," she said.
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First posted


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Check in from 15h / Check out prior to 11h
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CA Technologies Adds To Security, DevOps And Management Product Portfolios
At this week's CA World '15 conference, the company expanded its offerings in its three core software categories.
10 Cloud Predictions For 2017
With 2016 in the rearview mirror, here are 10 developments that cloud industry experts tell CRN are in store for 2017.
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October 21, 2010 at 22:20:17 Oct 21, 2010 @ 22:20
goddamnit, noah why'd you do that
i refuse to vote..i ain't gay i aint judging no man dressing
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Originally posted by Inactive UserOh my god why is it so close?
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text:
The Internal Revenue Service said contribution limits to your Thrift Savings Plan will not change in 2011.
The limit will continue to be $16,500 and the catch-up contribution limit will remain $5,500.
Tom Trabucco of the Federal Thrift Investment Board had predicted that contribution levels would stay the same in 2011 because social security and civil service retirement benefits had not increased either.
According to the IRS, pension plan limits increased slightly due to inflation adjustments:
Blast from the past: House reinstates rule targeting agency spending, employee salaries
Blast from the past: House reinstates rule targeting agency spending, employee salaries
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Photos of the amazing, moving, important and amusing things happening in the federal community.
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Viral Videos
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Secret Confessions Made By Visitors To Our Site
cans do fly
Tonight I got really pissed at my best friend for raggin on my kid. She always feels the need to correct my kids. To make them feel two inches tall. And if she doesn't get her way. Watch out. Every few years we really fight bad because she is very manipulative and tries to control everyone's lives. She got mad I got mad she was walking toward my kid and I threw my soda can at her. it hit her on the head square. she said she was gonna pass out, She started yelling and screaming then came over and punched me in the face hard. her husband got mad and started screaming about the neighbors. she went to the hospital to have her head checked out. i remained calm enough not to punch her lights out when she hit me back. sometimes i can't believe the stuff that she does. i think that she is stealing from people and she lies a lot. more then is normal. she always has to be right. she will do anything to cover her butt. i get so mad at her bad behavior. Now i am screwed. she will probably press charges if she's injured. She likes to fake injuries to get money too. What a glorious day this has turned out to be. My kids are freaked out. her kids are freaked out and we both have injuries. Points go to letting some stupid getting the best of you. Can I rewind please.
I just cheated on my husband for the first time ever. We have been together for almost ten years and something like this would never have crossed my mind. It felt so good in the moment. The worst part is I don't even feel bad about it. It was amazing to feel someone different inside me. I wish he wasn't leaving. I don't want to get attached to someone it's highly unlikely to have a future with.
Im broke
I am broke, I am a professional that lives in a nice house, who is happly married with children and I am broke. my credit cards are max'ed, I am upside down on a minivan, I have $40 in the bank. I had to spend my 401k of $36000 to help us with a layoff. I have no retirement. I am 38 and feel like I will be working for the rest of my life just to stay out of a nursing home. My wife tells me not to worry about it, but she has always been care free and go lucky. I do not know what I am going to do.
the girl
So my girlfriend is being totally stupid. Shes in a bad mood and taking it out on me. I know she doesn't mean 2, but it just sucks!
my roommate
I love you, and I think we're going to end up getting married, but I don't want to put myself out there yet until I know you realize you love me too.
bad mom
i don't have the heart to tell my gf that i think she's a bad mother. sometimes i just want to smack some sense into her.
I have no patience for incompetent people!
I hate saying this, but I have no patience for people who are lacking in intelligence, education, or just a clue. We have a young woman at our office who's getting training through a job-readiness program, and SHE IS COMPLETELY CLUELESS! I've almost yelled at her several times, and it's only her second day on the job. Everything I ask her to do, I end up redoing because she screwed it up. I know I should have compassion for her ("but for the grace of God" and all that) but I get so irritated with her. What makes it worse is that she's really sweet and really willing to work.
drive myself mad
i do this all the time, unable to turn around this feeling inside my head that somethings going to go wrong. and that its going to be my fault. or his. but im just so scared. always anxious. thinking. about him. and wishing i could just be thinking about happy stuff or other stuff...just not all this bad stuff. why? why? why? why? why do i do what i do? what do i have to be told, how do i have to be held, touched, to know that "everything's ok"? i want that feeling, but i feel so terrible at the mean and annoying ways i try to get that feeling. asking questions...making faces. feeling low. i feel terrible and want to make it all up to him. he has done wrong but i know that this larger hump in our feelings, is all me. i have to make him feel at ease. i have to let him know that i AM happy, that this IS what i want. i can do it...i just know ive messed up again yesterday. texted too long, wrote an email. immed. i shouldve just shut my mouth. closed my laptop. not written to him. but i couldnt. i had to hear from him. and then i let it make me feel worse. all because he didnt call me "baby". and why is that important? and why on earth does that make me cry?? i have to stop treating him this way. i will. i just hope he sticks around after yesterday and all the dumb crap i said like a desperate fool.
Want to be forgiven...
I've known my husband for almost 6 years now (dating and marriage together). This year will be our 4th wedding anniversary. Up until two years ago, our whole relationship was long distance (even the first two years of our marriage). When we started living together, things changed. In the begining, we'd had lots of ups and downs...lots of talk of divorce, or more so him telling me to leave because he wanted to go back to live with his family after his father passed away. I knew he was trying to push me away. I'd hear on an almost daily basis that he wanted me out, that if I wasn't in his life he wouldn't have to worry about "what to do" that he'd up and leave with no worries...This was a daily trend. At first I thought it may have to do with the stress of him being laid off, but even when he did find employment it didn't help. He has 4 sisters...and he loves them very very much...and everytime we got into an argument, I always told him that "how would you feel if some guy told your sister the same thing"? So..., when we were at the peak of one of our arguments, it was pretty severe (just words but they can cut like a knife too) I seeked God and I just begged, I begged from the depths of my soul that the only single sister that he has to get married and that her husband treats her the same way mine treated me...but our good times and our bad no more no less, so that he can see, realize how much he'd hurt me. I begged God because I didn't and don't want to leave him. I love him and know that we can have a good life together, if he can get passed his depression and realize that his father's passing didn't have to do with him (he had a tumor) but he feels alot of guilt for not being there and everyday our life is just building upon a thread. And so I prayed for his sister...Less than a couple of weeks later we received word that she's met someone, less than a couple of months later she was engaged and this March they were married and now she's pregnant and complaining to her brother talking about possibly getting a divorce and lot of their issues are the almost the same as ours...he's quiet at home, wants to be with his friends, wants her to leave so he can be with his family...the only difference is that she's pregnant and almost has no choice be to stay at least for the child...and now I feel really guilty...I didn't mean for this to happen. I never prayed for this...And the worst is yesterday, I told my husband that maybe it's Karma...maybe you're now seeing how you treated me and he was hurt...and I'm ashamed that I even said it especially in her situation... I don't know what to do except pray that things get better for her that it's just the first two months and their marriage will be strong, but I don't know. I prayed alot of things that night...I was having problems with my own family too...because of little dumb things that they all pick on me for and use as solid excuses not to speak to me...so I prayed that each and everyone in my own family experiences what I did that each of my sisters and my brother (when they do get married one day) to experience how horrible they made me feel...And above all at the time I seeked God and prayed never to be able to get pregnant...and then later I prayed that if we're meant to be together (not get divorced) that I get pregnant, but if not then no matter how much we try I don't...And now we've tried for a few months last summer with no results...I don't know if that's God answering my prayers saying that we're not going to be together...or just answering the first part I did in anger and never letting me get pregnant regardless...I feel that I've used God and my prayers for all the wrong reasons. I was heart broken and let my emotions get the better of me and I prayed and wished for some things that I shouldn't have and I don't know how to take it back and how I'm going to pay for all of this in the near future....I just want to be forgiven and I want to not be so cold...I don't know how to change all that i've done...I want to un-do all this...everyting and I don't know how...
i hate my family, they manipulate me and order me around. im pretty much their own personal slave. one day ill escape from here and leave this messed up world behind!!!! i wont be dead and cold anymore. who knows, maybe im capable of feeling anything other than sadness and anger.
I'm converting to Judaism but I just can't stop eating pork!
She voted for Huckabee
I broke up with her because she voted for Huckabee. I used the typical lies about needing space, being at different places in our lives, blah blah blah. But the actual reason is because she voted for Huckabee, and nothing else.
i told my mom i hated her
I told my mom i hated her, i didn't mean it. I pushed her into a wall, I didn't mean it. I broke her $3000 clock from germany, I didn't mean it. Now I'm lost, lost in this cold world and confused. Sorry mom, I wish you knew, I do love you, with all of my heart.
I never really knew why I liked you. At first I thought it was just because you had large brown eyes that always seemed to drawn me in. And I thought it might just be because you were the only guy who talked to me when nobody liked me because they thought I was ugly. That was almost four years ago. Now I'm sitting here without those glasses and gap-filled teeth and bushy eyebrows and even though I've changed and a lot of people find me beautiful, you haven't really. You still like the same girl you did three years ago, and yet again I can't compare. I don't see what you see in her, with her wide but flat butt, flat chest, and large nose. But whatever it is, I know you don't see it in me. I want to just give up on you. But it's not happening. Somehow, I still love you.
dead best friend
my best friend died a couple of years ago and i feel sad all the time now. What do you guys and girls out there think i should im only 11 years old he got cancer in first grade and died in third he wasnt able to go to school and he wasnt able to see us very often either i really miss him and on top of that i never got the chance to tell him i love him he was always there for me and my friends and he would always help us if we needed it i just miss him so much
im stuck
I don't love him and he loves me, im only with him cos i dont wanna be on my own... im kinda ashamed of him and in 3 weeks i stupidly suggested he meets my dad... when im not with him i forget why hes my boyfriend.. i dont wanna hurt him... im scared and i cant talk to anyone..i really dont wanna hurt him
Seeing 2 guys
I was with someone for a long time, but I was fairly young and wasn't ready to settle down. This guy who I always talked to and flirted with - well, we talked more and more and I fell in love with him; however, he had no direction, no motivation and was unempathetic at times. I couldn't stay away from him though, because I truly loved him. I wanted to marry him. If he could only get his stuff together and think about someone besides himself...but he didn't. I moved in with him anyway, and he found out about the other guy. Needless to say - his heart was broken and I became the devil to him. I know what I did was totally selfish. I miss this man so much and if he had just said - let's get married....we can struggle...and have our hard times but let's do it together...I would have been with him solely. Or if he just made some committment to himself with his future. I would have given myself completely. But I didn't, so I hung on to the other guy. I miss him so much, and I hate him for not getting his stuff together. I hate him because I know he loves me and cares for me...but it was never enough for him to get his butt in gear. Now, I told someone about my future plans with the other guy- just so he would hear, and just so he could be hurt.
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CFTC, EU Vow Cooperation on Swaps Oversight
U.S. and European officials pledged their support for strong new regulations to police the $615 trillion over-the-counter derivatives market.
Commodity Futures Trading Commission Chairman Gary Gensler and European Commissioner Michel Barnier issued a joint statement following meetings with industry officials in Chicago, where the Futures Industry Association is holding an expo this week.
The European Commission recently...


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41760, KY Rent to Own Homes
|12 Listings Found
Great income producing property! Rent one unit building and live in the other! Featuring 3 beds & 1
348 River View, Hazard, KY, 41701Details »
in the City School District. Live in one-plex and rent the other!
1209 North Main St, Hazard, KY, 41701Details »
, restrooms, green outsideárea with chairs and outside showers, own parkingplaces leisureárea, special
Emmalena, KY, 41740Details »
. Seller is also willing to lease. Only ten minutes from ARH.
472 Chance Way, Bonnyman, KY, 41719Details »
. Seller is also willing to lease. Only ten minutes from ARH.
466 Chance Way, Bonnyman, KY, 41719Details »
. Seller also willing to lease.
460 Chance Way, Bonnyman, KY, 41719Details »
, This home is brand new and in the finishing stages. Seller is also willing to lease. Located just ten
454 Chance Way, Bonnyman, KY, 41719Details »
the first level office / business space and live in the second & third floor house or simply lease out both
60 Cavalier Boulevard, Hallie, KY, 41821Details »
I have a commercial property listing located on HWY 160 in Hindman, Ky offered for Sale or Lease
Hindman, KYDetails »
a nice clean place to rent We have no animals It s Just myself my husband amp baby girl Please leave me
Hindman, KYDetails »
-7960 for sale "as-is" to best cash offer ... mobile home previously on property has been removed, seller cannot
Hyden, KY, 41749Details »
WATER BILL FREE LOT RENT INCLUDED IN LEASE TO OWN PRICE Pictures and contact details on Advertigo
Garrett, KYDetails »
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Brokerage firm Citigroup Maintains its rating on National-Oilwell Varco(NYSE:NOV). In a research note issued to the investors, the brokerage major Raises the price-target to $37.00 per share. The shares have been rated Neutral. The rating by Citigroup was issued on Sep 12, 2016.
In a different note, On Jul 29, 2016, Johnson Rice said it Upgrades its rating on National-Oilwell Varco. The shares have been rated 'Accumulate' by the firm. On Jul 11, 2016, Jefferies said it Maintains its rating on National-Oilwell Varco. In the research note, the firm Raises the price-target to $30.00 per share. The shares have been rated 'Hold' by the firm.
National-Oilwell Varco (NOV) shares turned negative on Tuesdays trading session with the shares closing down -0.45 points or -1.39% at a volume of 33,36,419. The pessimistic mood was evident in the company shares which never went considerably beyond the level of $32.46. The peak price level was also seen at $32.46 while the days lowest was $31.89. Finally the shares closed at $31.91. The 52-week high of the shares is $42.62 while the 52-week low is $25.74. According to the latest information available, the market cap of the company is $12,050 M.
National-Oilwell Varco(NOV) last announced its earnings results on Jul 28, 2016 for Fiscal Year 2016 and Q2.Company reported revenue of $1.72B. Analysts had an estimated revenue of $1.79B. Earnings per share were $-0.30. Analysts had estimated an EPS of $-0.32.
Several Insider Transactions has been reported to the SEC. On Aug 8, 2016, Scott K. Duff (VP Cntrlr Chf Acctg Offcr) sold 3,181 shares at $33.40 per share price.Also, On Nov 10, 2015, David D Harrison (director) sold 16,352 shares at $38.79 per share price.On Apr 30, 2015, Greg L Armstrong (director) sold 5,736 shares at $54.49 per share price, according to the Form-4 filing with the securities and exchange commission.
National Oilwell Varco Inc. (NOV) is engaged in providing design manufacture and sale of equipment and components used in oil and gas drilling completion and production operations. The Company also provides oilfield services to the upstream oil and gas industry. The Company operates through four segments: Rig Systems Rig Aftermarket Wellbore Technologies and Completion & Production Solutions. Its Rig Systems segment makes and supports the capital equipment and integrated systems needed to drill oil and gas wells on land and offshore. Its Rig Aftermarket segment provides aftermarket products and services to support land and offshore rigs and drilling rig components manufactured by the Company's Rig Systems segment. Its Wellbore Technologies segment sells and rents solids control equipment; and provides solids control waste management and drilling fluids services. Its Completion & Production Solutions segment provides technologies for well completions and oil and gas production.


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NFL Standings Through Week 7
Bear Report Top Stories
Bears Rookie Review: S Deon BushA detailed examination of Chicago Bears fourth-round S Deon Bush, a hard-hitting back-end player who started six games his rookie season.
Bear ReportYesterday at 11:33 AM
AFC Championship preview: Rich with ringsThe AFC Championship on Sunday evening provides two teams rich in Super Bowl history and loaded with talent and experience at quarterback.
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Bears to carry over $8.1 million in cap spaceThe Chicago Bears will roll over more than $8.1 million in cap space to be used next year, which is the eighth highest "carryover" amount in the NFL.
Scout NFL NetworkWednesday at 10:01 AM
Bears won't see Deshaun Watson at Senior BowlClemson QB Deshaun Watson has declined his invitation to the 2017 Senior Bowl, meaning the Chicago Bears coaching staff won't get an up-close look at a player they may select with…
Bear ReportWednesday at 9:34 AM


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PUNJAB NATIONAL BANK RTGS HO Branch in KHANPAR (DISTT RAJKOT) - Address, IFSC, MICR Code
PUNB0767500MICR Code
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Results 1 to 3 of 3
- 02-25-2012, 11:19 AM Thread Author #1
- Posts
- 6 Posts
- Global Posts
- 26 Global Posts
Creating Folders for Apps
Just picked up a new a200. I am totally new to the android platform. Did the OtA update to ICS.
I would like to create folder on my "desktop" to organize apps of different types such a "games" etc, rather than just have apps everywhere.
I opened astro and figured out how to make the folder, I just don't know where in the file structure to create it to get it to show up on the home screen (where the preinstalled apps are)
I realize this isn't very clear and I may now be using the proper geek terminology. But I'd appreciate any help.
- 02-25-2012, 01:34 PM Thread Author #3
- Posts
- 6 Posts
- Global Posts
- 26 Global Posts
Re: Creating Folders for Apps
Thank you...
Guess I was overthinking it too much. I appreciate your help.


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Mark McMinn and James Foster demonstrate that it is never safe or spiritually superior to merely accept what we are told to believe. Rather than telling us what to think, however, the authors guide us in how to think critically and clearly.
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A former work furlough facility next to the Middlefield light rail station will soon be razed to make way for a new three-story office building. The city approved a gatekeeper request to have the plot rezoned to accommodate a structure with a higher floor area ratio.
By approving Four Corners' gatekeeper request, the city has allowed for a change in the zoning ordinance currently in place on the land, bumping up the permitted floor area ratio from 0.5 to 0.65. The higher floor area ratio will allow for a higher intensity building -- a designation that refers to the capacity of a given office or retail space.
"In key areas where there is adequate infrastructure, there is an interest in higher intensity structures," said Peter Gilli, zoning administrator for the city. According to Gilli, 0.65 floor area ratio is higher than many other buildings in the area.
Gilli said that the zoning change is in line with the city's forthcoming new general plan, which is scheduled to be complete by 2012 and calls for reducing traffic congestion and increasing use of public transit.
Giving a large number of people the opportunity to work directly adjacent to a VTA light rail station -- as this zoning change will do -- will encourage that goal, Gilli said.
This story contains 257 words.
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