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Medivation – Dimebon Launch in 2012?

admin — Tue, 01 Nov 2011 08:02:04 +0000

Medivation Inc. (MDVN – Analyst Report) reported first quarter 2009 financial results following the market close on May 11, 2009. Revenue came in at $16.34 million, exactly where we had it modeled. Revenue consisted solely of collaboration revenue from Pfizer. EPS was ($0.19), significantly ahead of our forecast of ($0.34), due to substantially lower-than-expected operating expenses.

Pfizer makes quarterly true-up payments to Medivation as reimbursement for a significant portion of Dimebon-related development and commercialization expenses. In the first quarter 2009, Pfizer made a $5.8 million true-up payment to MDVN, which is reflected as a reduction in operating expenses – approximately $5.4 million of the true-up payment hit the R&D expense line-item.

In October 2008 Medivation received $225 million in collaboration revenue from Pfizer, which will be recognized on a straight-line basis through the first quarter of 2012. The company will likely not generate any other revenue or receive any development milestone payments in 2009.

We expect operating expenses to spike to near $120 million in 2009 (from $77 million in 2008), as the company funds larger clinical trials of both Dimebon and MDV3100. We model $65.4 million in collaboration revenue and EPS of ($1.65) in 2009.

An NDA filing for Dimebon for the treatment of Alzheimer’s is possible in 2010, depending on the success of the CONNECTION and safety studies. We more conservatively model a Dimebon Alzheimer’s filing in 2011, supported from all 5 of the phase III Alzheimer’s studies. We believe Dimebon could launch with a broad label, including for the treatment of mild-through-severe Alzheimer’s as a monotherapy as well as a combination therapy. We model a Dimebon launch in 2012 for both the Alzheimer’s and Huntington’s indications.

We view MDV3100 as more of a wild-card, but with significant upside depending on the outcome of phase III trials. Safety, most notably seizures, are a concern but appear to be possibly dose-related or related to background medication, and occurred in patients treated at doses greater than 240mg. The phase III trial will exclusively use the 240mg dose.

We also believe Medivation could be looking to partner MDV3100 in the near-term, potentially before phase III testing begins later this year. A partnership would reduce Medivations’ development costs, dilute the risk of failure of MDV3100 and potentially bolster the company’s cash position.

With cash-burn rates materially increasing in 2009 and 2010, a partnering deal for MDV3100 would also significantly reduce the need to raise additional capital before Dimebon launches.

We expect the company to remain unprofitable through at least 2010 and currently model EPS of $0.11 in 2011 as development milestones push the company towards positive earnings. We think this grows to $0.32 in 2012 on the heels of the Dimebon launch. EPS upside to our forecast could materialize with an earlier-than-expected NDA filing for Dimebon and/or a partnering deal for MDV3100.

Medivation shares currently trade at $22.41. We recommend that investors hold at the current price, and forecast an EPS loss of $1.65 in 2009. Our price target is $25.

http://www.zacks.com/stock/news/21612/Medivation

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Medivation Remains Neutral

admin — Sun, 02 Oct 2011 01:15:57 +0000

We recently reiterated a Neutral recommendation on biopharmaceutical company Medivation Inc. (MDVN – Analyst Report). Medivation, which currently does not have any marketed product in its portfolio, focuses on the development of novel small molecule drugs for the treatment of serious diseases for which there are limited treatment options.

Medivation currently has two lead candidates in its pipeline — dimebon (latrepirdine), which is being developed for the treatment of Alzheimer’s disease, and MDV3100, which is being developed for the treatment of castration-resistant prostate cancer. While dimebon is partnered with Pfizer Inc. (PFE – Analyst Report), the prostate cancer program is partnered with Astellas Pharma. Both dimebon and MDV3100 are in phase III development.

However, Medivation suffered major development setbacks with dimebon, which failed to achieve its primary endpoints in phase III studies for Alzheimer’s and Huntington disease. The results were a huge disappointment for Medivation. Although dimebon is in a phase III study (CONCERT) for mild to moderate Alzheimer’s disease, we have low expectations from this study.

Moreover, we are concerned that partner Pfizer could opt out from the dimebon collaboration. We note that Pfizer already has another Alzheimer’s candidate, bapineuzumab, in its portfolio that is being developed with Johnson & Johnson (JNJ – Analyst Report). Considering the development setbacks with dimebon, Pfizer could decide to focus its efforts towards the development of bapineuzumab.

Meanwhile, MDV3100 is currently in several studies including a phase III study (AFFIRM) in men with castration-resistant prostate cancer who were previously treated with Sanofi-Aventis’ (SNY – Analyst Report) Taxotere (docetaxel)-based chemotherapy. We expect investor focus to remain on an interim analysis of this study scheduled for later this year.

http://www.zacks.com/stock/news/60625/Medivation+Remains+Neutral

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Medivation – Dimebon Launch in 2012?

admin — Tue, 23 Aug 2011 13:35:17 +0000

With cash-burn rates materially increasing in 2009 and 2010, a partnering deal for MDV3100 would also significantly reduce the need to raise additional capital before Dimebon launches.

Medivation shares currently trade at $22.41. We recommend that investors hold at the current price, and forecast an EPS loss of $1.65 in 2009. Our price target is $25.

http://www.zacks.com/stock/news/21612/Medivation

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Medivation Reports Wider Loss

admin — Wed, 17 Aug 2011 06:28:24 +0000

Medivation Inc. (MDVN – Analyst Report) reported a loss of 27 cents per share in the second quarter of 2011, a penny wider than the Zacks Consensus loss Estimate of 26 cents and well above the year-ago loss of 21 cents.

Higher expenses led to the wider loss. Revenues for the quarter were $15.8 million, in-line with the Zacks Consensus Estimate and flat from the year-ago period.

The Quarter in Detail

While the Pfizer payment will be recognized through the fourth quarter of 2013, the Astellas payment will be recognized through the fourth quarter of 2014.

Operating expenses increased 12.9% to $26.2 million. Research and development expenses increased 5% to $19.1 million primarily due to an increase in pre-clinical and other expenses. SG&A expenses increased 41% to $7 million primarily due to higher legal and other expenses.

Maintains 2011 Outlook

Medivation expects operating expenses (after adjusting cost-sharing payments from Pfizer and Astellas) in the range of $100 – $110 million. Medivation, which exited 2010 with a cash and equivalents balance of $207.8 million, expects to be able to fund operations into 2013.

Pipeline Update

Medivation provided an update on its pipeline candidates. Medivation and partner Astellas finished enrolling patients for the phase III AFFIRM study (advanced prostate cancer) in Nov 2010. An interim analysis of this study, which is being conducted in post-chemotherapy patients, will be conducted this year.

The companies initiated another phase III study (PREVAIL), which is being conducted in chemotherapy-naïve advanced prostate cancer patients. A head-to-head phase II study (TERRAIN) between MDV3100 and AstraZeneca’s (AZN – Snapshot Report) Casodex (bicalutamide) commenced in March 2011. A phase II study in hormone-naïve patients is also being conducted.

Dimebon is currently in the CONCERT study, which is being conducted with patients suffering from mild-to-moderate Alzheimer’s disease. Results from the CONCERT study are expected in the first half of 2012.

Neutral on Medivation

We currently have a Neutral recommendation on Medivation. We are concerned about partner Pfizer’s commitment towards the dimebon collaboration. With dimebon failing in two phase III studies, we expect investor focus to remain on Medivation’s prostate cancer candidate, MDV3100.

http://www.zacks.com/stock/news/58937/Medivation+Reports+Wider+Loss

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MDV3100 in New Phase II Study

admin — Sat, 28 May 2011 00:53:52 +0000

Medivation, Inc. (MDVN – Analyst Report) and Astellas Pharma, Inc. recently announced the initiation of a phase II study with their prostate cancer candidate, MDV3100. The study will evaluate MDV3100 as a monotherapy in hormone-naïve prostate cancer patients.

The open-label, single-arm study (n=60) is being conducted in Europe. MDV3100 is currently in another phase II (head-to-head) study (TERRAIN), which is comparing MDV3100 with AstraZeneca’s (AZN – Snapshot Report) Casodex (bicalutamide).

In addition to these two studies, MDV3100 is in two phase III studies – AFFIRM and PREVAIL. The phase III AFFIRM study is being conducted in men with castration-resistant prostate cancer who were previously treated with Sanofi-Aventis’ (SNY – Analyst Report) Taxotere (docetaxel)-based chemotherapy.

Medivation received permission from the FDA to move the candidate into phase III trials based on positive interim data from a phase I/II program. Top-line results from AFFIRM should be out by 2012. However, data could be available in 2011 itself if Medivation and Astellas decide to conduct an interim analysis.

The second phase III study (PREVAIL) is being conducted in men with chemotherapy-naïve castration-resistant prostate cancer.

Neutral on Medivation

We currently have a Neutral recommendation on Medivation, which is supported by a Zacks #3 Rank (short-term “Hold” rating). Medivation suffered major development setbacks with its late-stage pipeline candidate, dimebon, which failed to achieve its primary endpoints in phase III studies for Alzheimer’s and Huntington disease. Given the disappointing track record of dimebon, we are concerned about partner Pfizer’s (PFE – Analyst Report) commitment towards the collaboration. With dimebon failing in two phase III studies, we expect investor focus to shift to the development of MDV3100.

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Medivation Misses Expectations

admin — Sat, 21 May 2011 03:10:25 +0000

Medivation Inc. (MDVN – Analyst Report) reported a loss of 24 cents per share in the first quarter of 2011, a penny wider than the Zacks Consensus Estimate of a loss of 23 cents but well below the year-ago loss of 51 cents. Lower expenses led to the narrower loss. Revenues for the quarter were $14.7 million, well below the Zacks Consensus Estimate of $16 million. Revenues were $15.7 million in the year-ago period.

The Quarter in Detail

Revenues consisted of partial recognition of the non-refundable upfront payment of $225 million received from Pfizer (PFE – Analyst Report) in October 2008 and $110 million received from Astellas in late 2009. The upfront payments are being recognized on a straight-line basis. While the Pfizer payment will be recognized through the fourth quarter of 2013, the Astellas payment will be recognized through the fourth quarter of 2014.

Operating expenses declined 28.7% to $23.8 million. Research and development expenses declined 31.1% to $17.6 million primarily due to a decrease in clinical and preclinical study costs and lower payroll and other related costs due to workforce reduction. Medivation expects its research and development headcount to increase to approximately 80 (from 68) in the next two quarters.

SG&A expenses declined 21.5% to $6.2 million primarily due to the workforce reduction implemented in March 2010.

Maintains 2011 Outlook

Pipeline Update

The companies initiated another phase III study (PREVAIL), which is being conducted in chemotherapy-naïve advanced prostate cancer patients. A head-to-head phase II study (TERRAIN) between MDV3100 and AstraZeneca’s (AZN – Snapshot Report) Casodex (bicalutamide) commenced in March 2011. A phase II study in hormone-naïve patients is scheduled to commence in the second quarter of 2011.

As far as dimebon is concerned, Medivation and partner, Pfizer, decided to discontinue the development of dimebon for Huntington disease following the release of phase III results (HORIZON study) which showed that dimebon failed to achieve its primary endpoints.

Meanwhile, Medivation continues to evaluate dimebon in the CONCERT study, which is being conducted with patients suffering from mild-to-moderate Alzheimer’s disease. Results from the CONCERT study are expected in the first half of 2012.

Neutral on Medivation

We currently have a Neutral recommendation on Medivation, supported by a Zacks #3 Rank (short-term Hold rating). Given the disappointing track record of dimebon, we are concerned about partner Pfizer’s commitment towards the collaboration. With dimebon failing in two phase III studies, we expect investor focus to shift to the development of MDV3100.

http://www.zacks.com/stock/news/52917/Medivation+Misses+Expectations

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Enrollment for Medivation Study

admin — Sun, 12 Dec 2010 12:35:22 +0000

Medivation, Inc. (MDVN – Analyst Report) and partner Astellas Pharma Inc. recently announced that they have finished enrolling patients for a phase III study of their prostate cancer candidate, MDV3100.

The phase III study, AFFIRM, is being conducted in men with castration-resistant prostate cancer who were previously treated with Sanofi-Aventis’ (SNY – Analyst Report) Taxotere (docetaxel)-based chemotherapy. Enrollment was completed on Nov 15, 2010.

The company received permission from the FDA to move MDV3100 into phase III trials based on positive interim data from a phase I/II program. Top-line results from AFFIRM should be out by 2012. Medivation and partner Astellas also have plans to study MDV3100 in early stage prostate cancer patients, which could represent a very big market for the candidate.

During the third quarter of 2010, the companies initiated a phase III study (PREVAIL) with MDV3100 that will be conducted in men with chemotherapy-naïve castration-resistant prostate cancer. Meanwhile, a head-to-head phase II study between MDV3100 and AstraZeneca’s (AZN – Snapshot Report) Casodex (bicalutamide) and a phase II study in hormone-naïve patients are scheduled to commence early next year.

MDV3100, a novel, triple-acting oral androgen receptor antagonist, is being developed in collaboration with Japanese company, Astellas Pharma. We are positive on the deal which was announced in Oct 2009. In addition to receiving an upfront payment of $110 million, Medivation stands to receive up to $335 million on the achievement of development and regulatory milestones, plus $320 million in commercial milestone payments.

Moreover, Medivation is entitled to receive tiered double-digit royalties on ex-US sales. While all US development and commercialization costs and profits will be shared equally, Astellas will be responsible for the ex-US development and commercialization of the candidate. This agreement is a major positive for Medivation. Not only has it brought in cash, Astellas’ strong presence in the urology market should be a major boon once MDV3100 is launched.

Neutral on Medivation

We currently have a Neutral recommendation on Medivation, which is supported by a Zacks #3 Rank (short-term Hold rating). Medivation suffered a major setback earlier this year with its lead pipeline candidate, Dimebon, failing to achieve both its primary and secondary endpoints in a phase III study. The results were a huge disappointment for the company and sent the share price plunging.

Although Medivation is continuing with the development of the candidate, we remain concerned that additional development setbacks would have a major impact on the stock. Moreover, we are concerned about partner Pfizer’s (PFE – Analyst Report) commitment towards the Dimebon collaboration.

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MDV3100 in New Phase III Study

admin — Sat, 09 Oct 2010 14:12:13 +0000

Medivation, Inc. (MDVN – Analyst Report) and Astellas Pharma recently moved their prostate cancer candidate, MDV3100, into another phase III study. The company initiated a phase III trial (PREVAIL) that will evaluate MDV3100 in advanced prostate cancer patients who are yet to receive chemotherapy.

The randomized, placebo-controlled, double-blind, multi-national trial will enroll approximately 1,700 patients across the United States , Canada , Europe, Australia and Israel . The study has two primary endpoints: overall survival and progression-free survival. Secondary endpoints include time to first skeletal-related event and time to initiation of cytotoxic chemotherapy.

MDV3100 is an investigational therapy in clinical development for the treatment of advanced prostate cancer. The candidate is currently in another phase III trial, AFFIRM, that is evaluating MDV3100 in advanced prostate cancer patients who were previously treated with Sanofi-Aventis’ (SNY – Analyst Report) Taxotere (docetaxel)-based chemotherapy. Medivation expects to finish enrolling patients for the AFFIRM study by year-end. Top-line results should be out by 2012.

Preclinical studies have demonstrated that MDV3100 provides more complete suppression of the androgen receptor pathway compared to AstraZeneca’s (AZN – Snapshot Report) Casodex (bicalutamide), the most commonly used anti-androgen.

Medivation has an agreement with Japanese company, Astellas Pharma, for the development and commercialization of MDV3100 for the treatment of prostate cancer. Medivation stands to receive a milestone payment for the initiation of the latest phase III study, PREVAIL.

The prostate cancer market represents significant commercial potential for the company and the successful development of MDV3100 for the treatment of early-stage prostate cancer patients would be a major boost. According to the company, prostate cancer is the most commonly diagnosed cancer among men in the United States , other than skin cancer.

Neutral on Medivation

We currently have a Neutral recommendation on Medivation, which is supported by a Zacks #3 Rank (short-term “Hold” rating). The company suffered a major setback earlier this year with its lead pipeline candidate, Dimebon, failing to achieve both its primary and secondary endpoints in a phase III study. Although Medivation is continuing with the development of the candidate, we remain concerned that additional development setbacks would have a major impact on the stock. Moreover, we are concerned about partner Pfizer’s (PFE – Analyst Report) commitment towards the Dimebon collaboration.

Meanwhile, we are positive on the company’s collaboration agreement with Astellas for MDV3100. Not only has this agreement brought in cash, Astellas’ strong presence in the urology market should be a major boon once MDV3100 is launched.

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