Onyx -- Still Waiting

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Oh, Onyx Pharmaceuticals (Nasdaq: ONXX), how I want to love thee. You've got a miracle drug in cancer treatment Nexavar, but your lack of a pipeline just isn't my thing.

That was my feeling up until yesterday. It's started to fix the problem of being pipeline-less. Yesterday, Onyx licensed a pre-clinical drug from England's BTG International -- but it's got a new problem to worry about. Nexavar's growth seems to be coming to a screeching halt.

 

Q1 2008

Q2 2008

Q3 2008

Q4 2008 guidance**

Nexavar Sales*

$151.9

$168.5

$180.9

$158.7-$173.7

Quarter-Over-Quarter Increase

21.6%

10.9%

7.4%

(12.3%)-(4.0%)

Source: Company press releases. *In millions. **Based on full-year guidance of $660 million to $675 million.

Guiding for a quarter-over-quarter drop in sales seems a little ridiculous even for a management that has been pretty conservative in guidance; just last quarter it was still guiding to possibly break even for the year, which -- excluding the milestone payment to BTG -- seems a near certainty at this point.

It seems more likely that sales will come in flat quarter over quarter as the stronger dollar cuts down international growth a little, the company fights for kidney cancer patients with Wyeth's (NYSE: WYE) Torisel and Pfizer's (NYSE: PFE) Sutent, and the liver cancer market gets saturated.

The success of Onyx over the next few years is going to come down to whether it can get Nexavar approved to treat even more cancers and be used as an adjunct to surgery for liver and kidney cancer. Both possibilities could turn the drug into a substantial blockbuster, but approvals are still a ways off as the clinical trials are still underway.

Much like investors in Dendreon (Nasdaq: DNDN), Onyx's investors are sitting around waiting for a catalyst to bring it back to the highs experienced last year.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is a selection of the Income Investor and Inside Value newsletters. The Fool owns shares of Pfizer. The Fool has a disclosure policy.

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On November 07, 2008, at 3:24 PM, Vinman2 wrote:

    You are completely underestimating the growth of Nexavar in HCC, especially in Asia.

  • Report this Comment On November 08, 2008, at 2:53 AM, FlyingTarpon wrote:

    DELCATH SYSTEMS (DCTH@$1.03) could easily make ONXX Liver Cancer Drug ---> WORTHLESS

    In Short... Look at the DATA:

    DCTH Systems -----> Patients have averaged 40 months of survival

    VS>

    ONXX/ Nevavar ------> Patients have averaged 10.7 months of survival

    DCTH's technology is aggressively ---> SHRINKING LIVER TUMORS

    Under ONXX's - Nevavar --------> Liver Tumors continue to "GROW" at a slow rate.... the tumors don't regress

    A recent study of 19 evaluated DELCATH patients, complete radiographic tumor responses (TUMORS SHRANK to REMISSION) were observed in 2 patients and partial responses were observed in 13 patients resulting in an objective tumor response rate of 79%. Median overall survival, based upon an intention to treat analysis, was 40 months and median hepatic progression free survival for treated patients was 39 months

    In ONXX clinical trials, median overall survival for ONXX's NEXAVAR-sorafenib tablet treated patients was 10.7 months to 7.9 months for those patients taking a placebo. The patients who took ONXX's Nexavar lived only 3 months longer on average than patients who took a placebo (dummy drug), and their liver tumors continued to "GROW" while under treatment. The fact is that those patients that did take NEXAVAR saw their disease and their liver tumors continue to -GROW- under treatment

    ONXX currently has a market cap of $1.7 Billion with $400 million in cash, therefore ONXX has a Corporate Business Value/ Enterprise Value of ---> $1.3 Billion

    DCTH @ $1.03 has a market cap of $25 Million with $13 million in Cash ….. therefore DCTH has a Corporate Business Value/ Enterprise Value of ---> $12 Million

    This means that DCTH would trade at over $50 + a share in value if it had the same value that Wall Street currently gives ONXX today !

    Here’s the crazy part….. ONXX only owns only 50% of their Technology

    ONXX only receives 50% of the profits derived from their Liver Cancer drug Nexavar based on the agreement they have in place with Bayer AG. ( A 50/50 profit split)

    DCTH on the other hand ---> Owns 100% of the Worldwide Rights to their Liver Cancer Therapy….

    Thus, DCTH would receive 100% of any Potential Profits from their "Delcath System" …

    Therefore an argument could be made that DCTH should be valued 2X the value of ONXX based on the fact that DCTH would receive 100% of any potential Liver Cancer Cash Flows on a world wide basis.

    DCTH’s treatment is a “Turn Back the Clock Therapy” that SHRINKS LIVER TUMORS and will prove to be far better therapy that anything ONXX has in Liver Cancer.

    In addition, DCTH has publicly announced that they have put 20% of their evaluated patients in REMISSION ... ONXX cannot offer a single patient example

    There is no way that ONXX should be worth BILLIONS and DCTH trade at an enterprise value of only $12 Million !

    BIG HINT :

    Look at the INSIDER BUYING @ DCTH ...

    DCTH Insiders have bought Millions of Shares of their own stock --> in the open Market...

    Then Look at ONXX.... Their INSIDERS have SOLD Millions of Shares !!!

    FOOD for Thought:

    If I owned a single share of ONXX ...

    I would keep a close eye on DCTH ---> Because one of these days, they are going to turn ONXX's Liver Cancer Program into> SAWDUST !

    You heard it here 1st !!

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