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Pharming Group NL0010391025

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Santarus

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  1. [verwijderd] 15 november 2011 19:37

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    Santarus Reports Third Quarter 2011 Financial Results

    Total revenues up 48% over prior year period

    Full year net income guidance improved to approximately $3.0 million

    Plans to add 40 contract sales representatives in the first quarter of 2012

    Announces plans for Phase IIIb study with UCERIS (budesonide) as add-on therapy

    Conference call to begin at 4:30 p.m. Eastern time today

    SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today reported financial and operating results for the quarter ended September 30, 2011. Key financial results include:

    Total revenues of $26.8 million increased 48% over the prior year period
    Net income of $0.6 million, or $0.01 per diluted share, compared with a net loss of $25.7 million, or $0.44 per share, for the 2010 third quarter, which included one-time restructuring costs of $7.3 million and a $15 million upfront payment to acquire rights to RHUCIN®
    Cash, cash equivalents and short-term investments of $58.7 million as of September 30, 2011
    “Among our positive developments in recent months, we entered into a new commercialization agreement for GLUMETZA® and reported supportive top-line results from our extended use study with UCERIS™, the proposed trade name for our budesonide MMX® product candidate. We also are pleased with the overall financial results we are reporting today,” said Gerald T. Proehl, president and chief executive officer of Santarus.

    He added, “We are taking actions to increase our commercial activities to capture what we see as additional sales potential for our prescription products for type 2 diabetes, particularly in light of our new commercial agreement for GLUMETZA. These actions include expanding our field sales organization with 40 contract sales representatives, which will increase our total number of sales representatives to approximately 150. With additional representatives, we intend to increase call frequency and share of voice with our called-on physicians, as well as improve sales representative efficiency by reducing territory size and increasing the number of sales calls made each day. We have contracted with inVentiv Health for the expansion based on our positive past experience with this organization.”

    Santarus executive vice president of research and development Wendell Wierenga, Ph.D., said, “We are currently on track to submit the New Drug Application (NDA) for UCERIS to the FDA next month. We plan to continue advancing this product candidate’s development and potential future commercialization by conducting a Phase IIIb clinical study to evaluate UCERIS 9 mg as an add-on therapy to current oral 5-ASA drugs for induction of remission of active ulcerative colitis. We expect to initiate this study in the first quarter of 2012 with a goal of enrolling approximately 500 patients at clinical sites in the U.S., Canada and Europe.”

    Business Highlights

    Recent business highlights include the following:

    Entered into a commercialization agreement for GLUMETZA (metformin hydrochloride extended release tablets) with Depomed, Inc. under which Santarus has assumed broad commercial, manufacturing and regulatory responsibilities to replace a prior promotion agreement with Depomed entered into in July 2008. Under the commercialization agreement, Santarus commenced recording net sales of GLUMETZA on September 1, 2011. Under the previous promotion agreement, Depomed recorded GLUMETZA net sales and Santarus earned promotion revenue.
    Contracted with inVentiv Health to add 40 contract sales representatives to its sales organization. The expanded sales organization will focus on the promotion of GLUMETZA and CYCLOSET® (bromocriptine mesylate) tablets, the company’s prescription products for type 2 diabetes. Santarus expects the new sales representatives to be trained and in place during the first quarter of 2012.
    Announced that an analysis of pooled data from two Phase III clinical studies indicated that UCERIS 9 mg taken once daily for the induction of remission of mild or moderate active ulcerative colitis was statistically superior to placebo in clinical and endoscopic remission and in symptom resolution. The findings were presented in a poster session at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Washington, D.C. in early November.
    Announced supportive top-line results from a double-blind, multicenter, 12-month, extended use study with UCERIS 6 mg, which was undertaken to evaluate its long-term safety and tolerability in patients with ulcerative colitis. This data will be provided as support for the company’s planned submission of an NDA for UCERIS 9 mg for the induction of remission of mild or moderate active ulcerative colitis.
    Reached agreement with the FDA on the design of a Phase III clinical study with the late-stage investigational drug RHUCIN® (recombinant human C1 inhibitor) under the Special Protocol Assessment process that is intended to support the submission of a U.S. Biologics License Application. As a result of the discussions with the FDA, the number of patients in the clinical study has been increased from 50 to approximately 75. The study, which is being conducted by the company’s collaboration partner Pharming Group NV, is expected to be completed by the third quarter of 2012.
    Third Quarter 2011 Financial Results

    Total revenues for the third quarter of 2011 were $26.8 million compared with total revenues for the third quarter of 2010 of $18.1 million.

    Net product sales of $19.8 million for the third quarter of 2011 increased approximately 81% over net product sales of $11.0 million for the third quarter of 2010. For the third quarter of 2011, net product sales consisted of $9.9 million in net sales of ZEGERID® (omeprazole/sodium bicarbonate) brand and authorized generic prescription products and $2.1 million in net sales of CYCLOSET, as well as $7.8 million in net sales of GLUMETZA for the month of September under the new commercialization agreement. GLUMETZA net sales reflect a gross to net adjustment for eVoucher discounts of approximately $0.7 million related to potential eVoucher redemptions on shipments of GLUMETZA prior to September 2011. For the third quarter of 2010, net product sales consisted of net sales of ZEGERID brand and authorized generic prescription products.

  2. [verwijderd] 15 november 2011 19:39

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    GLUMETZA promotion revenue of $6.0 million for the third quarter of 2011 was based on GLUMETZA net sales recorded by Depomed for July and August 2011. GLUMETZA promotion revenue was impacted by an increase of $3.5 million in Depomed’s allowance for product returns related to a GLUMETZA pricing action taken in August 2011. GLUMETZA promotion revenue of $6.8 million for the third quarter of 2010 was impacted by a voluntary recall and supply interruption for GLUMETZA 500 mg and resulted in this dosage strength being unavailable from mid-June 2010 through early January 2011. Shipments of GLUMETZA 500 mg resumed in January 2011.

    Santarus reported net income of $0.6 million, or $0.01 per diluted share, for the third quarter of 2011, compared with a net loss of $25.7 million, or $0.44 per share, for the third quarter of 2010. The 2010 net loss included $7.3 million in one-time restructuring costs and a $15 million upfront payment to Pharming for North American rights to RHUCIN.

    The cost of product sales was $2.2 million for the third quarter of 2011 and $1.2 million for the third quarter of 2010, both approximately 11% of net product sales.

    License fees and royalties were $3.7 million for the third quarter of 2011, significant components of which included royalties payable to Depomed on net sales for GLUMETZA for the month of September under the new commercialization agreement, the gross margin split on CYCLOSET net sales payable to S2 Therapeutics, Inc. and VeroScience, LLC, as well as royalties payable to the University of Missouri on ZEGERID net sales. License fees and royalties were $16.0 million for the third quarter of 2010, which included the $15 million upfront payment made to Pharming for North American rights to RHUCIN, as well as royalties payable to the University of Missouri.

    Research and development (R&D) expenses were $3.8 million for the third quarter of 2011, compared with $4.4 million for the third quarter of 2010. The decrease in R&D expenses was primarily attributable to lower costs associated with the UCERIS Phase III clinical program.

    Selling, general and administrative (SG&A) expenses were $16.2 million for the third quarter of 2011, and $15.0 million for the third quarter of 2010. The increase in SG&A expenses was primarily attributable to an increase in promotional spending related to GLUMETZA and CYCLOSET.

    Nine Months Ended September 30, 2011

    For the nine months ended September 30, 2011, the company reported total revenues of $76.2 million, compared with total revenues of $99.5 million for the nine months ended September 30, 2010.

    Santarus reported net income of $2.8 million, or $0.04 per diluted share, for the first nine months of 2011, compared with a net loss of $16.4 million, or $0.28 per share, for the first nine months of 2010.

    As of September 30, 2011, Santarus had cash, cash equivalents and short-term investments of $58.7 million, compared with $60.8 million as of December 31, 2010.

    Financial Outlook for 2011

    The company has revised its outlook for 2011 as follows:

    Affirmed total revenues of at least $115 million.
    Provided guidance for 2011 license fees and royalties of approximately $18 million, which now includes royalties payable to Depomed on net sales of GLUMETZA under the new commercialization agreement.
    Reduced its estimate for R&D expenses to a range of approximately $19 million to $21 million compared with the prior estimate of $20 million to $23 million. In addition to its ongoing clinical development costs, in the fourth quarter the company also expects to pay an approximate $2 million filing fee in December for the UCERIS NDA and to incur start-up costs associated with the UCERIS Phase IIIb clinical study.
    Reduced its estimate of SG&A expenses to up to approximately $68 million compared with the prior estimate of up to approximately $70 million.
    Improved its estimate for net income to approximately $3.0 million compared with prior guidance of approximately $2.0 million.
    Conference Call

    Santarus has scheduled an investor conference call regarding this announcement at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) today, November 7, 2011. Individuals interested in participating in the call may do so by dialing 888-803-8275 for domestic callers, or 706-643-7736 for international callers. A telephone replay will be available for 48 hours following conclusion of the call by dialing 855-859-2056 for domestic callers, or 404-537-3406 for international callers, and entering reservation code 17727411. The live conference call also will be available via the Internet by visiting the Investor Relations section of the company’s website at www.santarus.com and a recording of the call will be available on the company’s website for 14 days following the completion of the call.

    About Santarus

    Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes.

    Santarus also has a diverse development pipeline, including three investigational drugs in Phase III clinical programs: UCERIS™ (budesonide) Tablets for induction of remission of active ulcerative colitis, RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX® for treatment of travelers’ diarrhea, in addition to other earlier-stage development programs. More information about Santarus is available at www.santarus.com.


  5. pharman 15 november 2011 20:57

    • pharman

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    quote:

    de aanhouder schreef:

    niemand reageert?
    ik wil wel, maar we zijn de afgelopen tijd met zoveel links en berichten van derden, met een link naar Pharming, overspoeld, dat ik weliswaar wat meer vertrouwen heb gekregen, maar geen beweging voor ons lieve aandeeltje kan ontdekken.
    Ik wil graag de berichten van Pharming afwachten a.s. donderdag.
    Er is de afgelopen jaren een stal aan paarden vertrokken na eveneens goed nieuws van derden, maar Pharming wist dat iedere keer weer te niet te doen. Het huidige vertrouwen is slechts gebaseerd op een nachtijs en heeft dus een flinke vorstperiode nodig om te herstellen.
  6. [verwijderd] 15 november 2011 20:59

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    quote:

    de aanhouder schreef op 15 november 2011 20:50:

    niemand reageert?
    Waarop reageren, op een draadje die ons niet eens financieel gewin oplevert.
    Ze doen ons wel financieel ondersteunen, nee ze worden pas belangrijk met de cijfers op het moment als wij voet aan wal kunnen zetten in Amerika.

    Shit toch gereageerd.

    Gijs
  8. jip banaan! 16 november 2011 13:37

    • jip banaan!

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    Santarus reported net income of $0.6 million, or $0.01 per diluted share, for the third quarter of 2011, compared with a net loss of $25.7 million, or $0.44 per share, for the third quarter of 2010.
    The 2010 net loss included $7.3 million in one-time restructuring costs and a $15 million upfront payment to Pharming for North American rights to RHUCIN.

    Jammer dat Santarus geen commentaar geeft op die investering van een jaar geleden, vooral nu het allemaal langer duurt dan gedacht.
    Is die markt er nog steeds als ze er over anderhalf jaar (?) mee aan de slag kunnen?
    Voor Pharming geldt; deze 15 milj.dollar hebben ze binnen maar hoeveel kan er nog volgen??? zeker nu je ziet hoe traag het in europa verloopt.

    groetjip

  12. [verwijderd] 13 december 2011 17:30

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    quote:

    herewijn1 schreef op 13 december 2011 17:24:

    [...]

    Geen idee, wel bizar idd, gaat bijna tot 0..
    Vermoedelijk foutje van het grafiekapparaatje.
    Kijk maar: day low is 3,02, dus niets aan de hand!
  20. [verwijderd] 10 januari 2012 09:21

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    quote:

    RRR schreef:

    www.fnno.com/story/fast-lane/331-sant...

    twijfel om alles om te ruilen voor Santarus...
    santarus is een stabieler aandeel geworden,pharming is verwaterd,maar ik denk dat pharming wel wordt opgeslokt door een grote pharmaceutisch bedrijf,dan wordt het mischien nog wel wat met pharmings medicijn.
349 Posts
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