|
Okay. Thanks
Incyte's CEO Discusses Q4 2013 Results
Greetings ladies and gentlemen and welcome to the Incyte Corporation Fourth Quarter and Year End 2013 Earnings Call,nike air max 1 sale. A brief question and answer session will follow the formal presentation. (Operator Instructions) As a reminder this conference is being recorded.
It is now my pleasure to introduce your host, Ms. Pamela Murphy, Vice President,hogan bambino, Investor Relations and Communications. Thank you, Ms. Murphy, you may now begin.
Good morning and again welcome to Incyte's fourth quarter and year end conference call. On the call today is Herv Hoppenot who as most of you know joined Incyte last month as President and Chief Executive Officer. Also on the call today are Jim Daly, who leads our Commercial Team; Dave Hastings, our Chief Financial Officer; Rich Levy, who directs Drug Development; and Reid Huber who heads Discovery Biology.
Herv will begin with a brief overview of the quarter and Jim will follow with an update on Jakafi, and Rich will highlight progress made in our lead clinical programs. Dave will then describe our fourth quarter financial results and 2014 financial guidance. After our formal remarks we will open up the call for Q beginning,tn outlet, we would like to remind you that some of the statements made during the call today are forward looking statements including statements regarding our expectations for the commercialization of Jakafi, our development plans for Jakafi and other indications and for other compounds in our pipeline and our 2014 financial guidance. These forward looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially including those described in our 10 Q for the quarter ended September 30, 2013 and from time to time in our SEC documents. Herv?
Thank you, Pam and thank you all for attending this call. So, first obviously I am very excited of joining the Incyte team and I want to congratulate and thank Paul Friedman for building such a company that it's in a great position to continue to develop a broad portfolio of products to significantly improve patient outcomes.
Now looking back at 2013, we delivered a very strong and sustained sales growth for Jakafi in myelofibrosis and exceeded the revenue guidance. The big news,scarpe hogan outlet, obviously, for patients was at ASCO when we updated our survival data and suggested that we can slow progression of disease and prolong life of patient with myelofibrosis.
We also saw data from RECAP our Phase II trial of ruxolitinib in pancreatic cancer and that this data are encouraging for patient not only with pancreatic cancer, but also with other solid tumors. And obviously we developed our pipeline of advanced number of projects and during the year we also restructured and strengthened the balance sheet which gives us the ability to invest and grow our pipeline and continue to discover and develop new drugs.
Now looking forward to the future starting obviously now in 2014. First, we believe we will see continued growth in myelofibrosis, which you can see reflected in our net product guidance for 2014 in the range of $315 million to $335 million.
Now remember myelofibrosis is just the beginning for Jakafi. We look forward for expanding to other indications, first in the PV where we expect to file sNDA in the first half of the year, and are getting our team ready for successful launch. And next,air maxes, solid tumor,hogan outlet roma, where we are planning two Phase III studies in pancreatic cancer and Phase II trials in breast cancer, colon cancer and non small cell lung cancer. Our lead JAK1 inhibitor also has the potential in treating solid tumor and we're testing it first in non small cell lung cancer.
We are also obviously excited about the potential of our IDO program. Just last week we announced that the deal with Merck to combine our IDOl inhibitor with their anti PD 1 immunotherapy in non small cell lung cancer, where we would be starting studies during the year. And we intend to establish all the collaboration to show that our IDO1 inhibitor can do in various types of cancer. Another combination we are working on is when where we are combining two of our own compound PI3 kinase delta inhibitor and the JAK1 inhibitor first in B lymphoid malignancies.
Now that is for the oncology portfolio. Now we also where we have obviously a very growing portfolio, but we are not forgetting the potential revenue streams that we have from our compound in inflammation where our alliance with Lilly could deliver significant value for baricitinib, our second JAK1, JAK2 inhibitor, and we are starting Phase II trials for our second JAK1 inhibitor in rheumatoid arthritis in the first half of the year. And you simply have an opportunity there to have an approach where we will have two different JAK1 inhibitor, one in oncology and one in inflammations just as we did with ruxolitinib and baricitinib.
Now, Jim will provide more details around our commercialization of Jakafi.
Thank you Herv and good morning everyone. Our gross strategy for Jakafi to add new patients at a healthy consistent rate while keeping patients on treatment longer yielded continued solid results in the fourth quarter as evidenced by the $72.9 million in net product revenues,kids nike air max. I would like to thank our Incyte colleagues for their tireless efforts in educating physicians about optimal use of Jakafi to benefit patients with intermediate or high risk myelofibrosis.
In terms of quarter over quarter growth net sales grew 21% with the following components of growth.
Underlying demand as measured by bottles dispensed to patients grew by 7%. Net price accounted for seven points of growth and inventory accounted for 7 points of growth. We exited the fourth quarter with inventory levels at the high end of our normal range of three to 3.5 weeks. The dollar value increase in inventory between the third and the fourth quarters was approximately $4 million, a portion of which we expect to reduce in the first quarter.
Our full year 2013 net sales of $235.4 million, reflects 73% growth over 2012 net sales of $136 million. Our fourth quarter performance was consistent with our expectations for steady growth and underlying demand which we saw throughout 2013. New patient starts remain consistent with previous quarters and the number of prescribers have continued to increase. Through the fourth quarter, nearly 60% of our target prescribers have prescribed Jakafi at least once and 36% have prescribed for two or more patients. One third of new patients come from new prescribers and two thirds come from previous prescribers, reflecting a gradual shift to existing prescribers relative to prior quarters.
We continue to see increasing use of lower dosage strengths, which is driven by physicians individualizing treatment. In the fourth quarter, 5 milligram and 10 milligram strengths represented nearly 50% of dispensed bottles, up from 43% during the same period last year and slightly up from the third quarter this year. This reflects appropriate patients starting on lower dosage strengths or patients titrating downward as necessary. population of patients with myelofibrosis is between 16,000 and 18,nike air max 90 sale,500. Approximately 80% to 90% of patients diagnosed with MF are intermediate or high risk and we believe there is significant proportion of patients who may benefit from Jakafi, still remain untreated, which provides an opportunity for future growth.
From a physician perspective, we see an opportunity to increase breadth of prescribing while also increasing depth of prescribing. Our expanded sales force will enable us to reach more physicians with greater frequency in 2014. We continue to experience a favorable reimbursement environment.
Financial assistance is provided by our IncyteCARES program or through independent foundations. Through scientific channels emerging data on overall survival are emphasizing the medical imperative to treat patients earlier in the course of the disease. We hope to have certain overall survival data reflected in the product package insert as a result of a labeling update expected in the third quarter.
Our guidance of $315 million to $335 million in net product revenues in 2014 reflects year over year growth between 34% and 42%, driven by new patient starts and continued improvement in persistency. Our guidance assumes no meaningful contribution to revenues in 2014 from an FDA approved indication in PV.
Based on our market research, we continue to expect,hogan rebel outlet, assuming FDA approval, that PV indication will make a substantial contribution in Jakafi sales in 2015. The addressable patient population for PV is larger than that of MF and the length of treatment of PV is likely to be longer than MF. 60% of them are currently on HU or previously on HU, but discontinued because of side effects or lack of efficacy.
We estimate that approximately 25,hogan prezzi,000 of these patients are resistant to or intolerant of HU and suffer from uncontrolled PV while on best available therapies. A primary treatment goal for PV patients to consistently reduce and maintain hematocrit levels below 45% was achieved in the Jakafi Phase II study in almost all patients who were resistant to of intolerant of HU.
Patients also experienced reductions in spleen size and improvements in debilitating symptoms. These uncontrolled PV patients have significant unmet needs and reflect a major commercial opportunity for Jakafi. We are taking all appropriate steps to help insure that we will maximize the opportunity in front of us with PV.
We've always said that MPNs are just the beginning. We have a deep pipeline of novel molecules and innovative programs that represent an exceptional opportunity to make a difference for patients,cheap air max,
To discuss this in more detail I'll now turn it over to Rich.
Okay. Thanks, Jim. Our development efforts with the Jakafi in myeloproliferative neoplasms continue to advance on several fronts. With respect to intermediate or high risk myelofibrosis we submitted an sNDA early in the fourth quarter for inclusion of certain survival data in our label and we expect to have a response from the agency by the third quarter.
Additionally, our Phase III registration study for polycythemia vera, that is being conducted under an SPA will readout soon. We expect to have top line data to announce in March or April and then to submit the sNDA in June for the treatment of PV patients resistant to or intolerant of hydroxyurea. As we said in our third quarter call, the FDA granted Fast Track status for this indication and assuming six months review we would potentially have approval by year end.
Finally,nike air max, we expect to submit full results from the symptom improvement study in patients with PV, study called RELIEF for presentation at ASH, which should be around the time of our potential PV launch after which we intend to submit an sNDA labeling update for the symptomatic benefit.相关的主题文章:
look at how they're handling
it was slick
Syne." As he told Jill, "Blue is easier to rhyme than green." Also, her then husband was not an architect but a physical education teacher. Jill doubts Fogelberg knew what her husband did for a living. She thinks Fogelberg probably just thought "architect" sounded right for the song. |
|