Showing posts with label Halozyme. Show all posts
Showing posts with label Halozyme. Show all posts

Thursday, 29 August 2013

The Baker Brothers Increase Shares In Halozyme By 105%, Insider Makes Big Buy And Options Heat Up

Written by Scott Matusow. Mr. Matusow has a position in Halozyme.

Often times, certain biotech institutional investors just seem to pick winner after winner, and stay on a hot streak -- so to speak. Baker Brothers LLC is one such institution that is becoming well-known and gaining great respect from the small cap biotech space. The company was founded in the year 2000 and is run by brothers Julian C. Baker and Felix Baker, Ph.D.

Last year, the Bakers made a significant bet on ACADIA Pharma (ACAD) when the stock was selling for under $2 per share. Many investors felt ACADIA was a long shot, at best, to receive positive data from its 2nd Phase III trial of pimavanserin, which is designed to treat Parkinson's disease psychosis (PDP). However, on November 27th, 2012, the company reported positive data results, prompting a huge rally in the stock that has continued to this day. Since PDP is a serious unmet need, the speculation continues to swell around ACADIA, and an FDA approval which could come late next year should further rally the stock, perhaps even 100% or higher. The Baker Brothers currently hold over 19M shares of ACADIA stock, and have recently increased their position by over 27%.

The Bakers hold a huge 20M + share position in XOMA Corp. (XOMA). XOMA has several near-term catalysts that the Bakers likely find interesting. The company expects to release Phase II top-line data on its drug gevokizumab, for the indication of erosive osteoarthritis of the hand with elevated CRP in October. Additionally, XOMA anticipates full results from its two POC studies in patients with erosive osteoarthritis of the hand, and data from the National Eye Institute's study of gevokizumab in patients with active non-infectious anterior scleritis later this year. With an investment of over 20M shares in XOMA, it is clear the Bakers are very bullish on XOMA's chances of positive data from these studies.

The Bakers also have a 19M + share position in Seattle Genetics Inc. (SGEN). In the last 2 years, Seattle Genetics has almost tripled in price, going from around $15 to near $40 a share today. Many analysts have recently raised their price targets on the company, as it recently posted higher-than-expected second quarter earnings, not to mention a strong and deep developmental pipeline. Alternatively, some analysts have downgraded the stock, believing the shares have risen too far, too fast. So far, the bearish view on Seattle Genetics is losing out big-time.

Jim Cramer recently mentioned Seattle Genetics as a strong take-over candidate in the ever consolidating biotech sector, where small cap companies are increasingly being acquired by monster large cap biotechs. I agree with Jim and also like the company's longer-term prospects, while feeling even the bullish analysts might be a bit too low in their price target estimates. Based on the Baker's large buy here, it seems they are also very bullish on Seattle Genetic's prospects.

Additionally, the Bakers have also opened a new position in Incyte Corp (INCY) recently, purchasing over 14M shares. Incyte focuses on the discovery, development, and commercialization of proprietary small molecule drugs for oncology and inflammation. Incyte has a significant catalyst coming up in the beginning of next year, according to the company:

RESPONSE, a Phase III study being conducted under a Special Protocol Assessment (SPA) in collaboration with Novartis, is evaluating ruxolitinib in patients with polycythemia vera (PV), and results are expected in early 2014. Completion of this pivotal trial, if positive, would allow for the filing of a supplemental new drug application submission in the first half of 2014. The FDA has granted fast track designation for ruxolitinib for the treatment of patients with PV who are resistant to or intolerant of hydroxyurea.

The Bakers like to buy biotechs with near-term catalysts, and as mentioned, they have been very successful with this, earning themselves and their clients huge returns in a short period of time. Perhaps the most interesting of their recent buys could be Halozyme (HALO). Halozyme engages in the research, development, and commercialization of human enzymes. Its research focuses on human enzymes that transiently modify tissue under the skin to facilitate the delivery of injected drugs and fluids, or to alter abnormal tissue structures for clinical benefit.

Along with a large increase in Acadia shares, the Bakers have recently more than doubled their initial investment in Halozyme, as indicated by the chart below, up 105%.

A 6.5M share investment is significant in a small cap company such as Halozyme. Perhaps it's because the company expects to hear a decision soon from The European Medicines Agency (EMA) on MabThera Subcutaneous (SC), and Herceptin SC.

Halozyme is in partnership with Hoffman-La Roche with three biologic subcutaneous solutions. Subcutaneous Herceptin and subcutaneous Mabthera are currently in Phase III clinical trials, while subcutaneous Actemra has completed a Phase 1 clinical trial.

According to the company's recent earning's call;

Before Herceptin SC product launch in EU can get underway, the European Commission must provide marketing authorization, which we believe could be forthcoming soon. In the meantime, we continue to work closely with Roche on the manufacture of the necessary rHuPH20 supply to support the launch and rollout of Herceptin (SC) in numerous territories around the globe.

Our second relevant program with Roche, MabThera SC, is also under review by European regulators. As a reminder, Roche filed its MAA for MabThera SC in December of last year, and we look forward to updates on the regulatory status of this program.

Herceptin SC and MabThera SC are part of a family of human enzymes, known as hyaluronidases, which increase the absorption and dispersion of biologics, drugs and fluids which addresses certain therapeutic areas such as diabetes, oncology, and dermatology that have significant unmet medical need. Both are administered subcutaneously through the use of the rHuPH20 enzyme, instead of intravenously.

The Bakers are not the only investors to have made a bullish bet on Halozyme. Recently, company director Kathryn E. Falberg bought $681.6K of the company's stock in the open market, at an average cost of $6.82 a share. Many times, company directors are awarded stock options, and often times acquire the shares at no monetary cost to themselves. Sadly, many biotech companies see directors constantly dump these shares on the open market. With Halozyme, this is not the case.

I have been watching Halozyme since both The Baker Brothers and Falberg's buy. I have especially been keeping an eye on the option chain. Often times, sudden short term call contract purchases are a tip-off of positive news coming soon. The other day, I noticed a block of 1132 September $7.50 strike contracts bought at $0.55, and took a screen shot of the buy.

(click to enlarge)It seems strange to me that someone would "gamble" over $62k on a call option that expires next month simply on a "hunch." In my opinion, this almost always means that someone "knows something." After the option buy, I decided to buy some shares of the stock.

With the near-term catalysts, The Baker Brother's bullish bet, the director's substantial open market buy, along with the single big call option buy, it seems to me that Halozyme might be a substantial gainer in the near-term. Biotech traders and investors should take a serious look at this company for both long and short term positions.

Disclosure: I am long HALO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

Additional disclosure: Disclaimer: This article is intended for informational and entertainment use only, and should not be construed as professional investment advice. They are my opinions only. Trading stocks is risky -- always be sure to know and understand your risk tolerance. You can incur substantial financial losses in any trade or investment. Always do your own due diligence before buying and selling any stock, and/or consult with a licensed financial adviser.

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Halozyme: Drug Delivery Specialist With Multiple Near-Term Catalysts

Halozyme Therapeutics (HALO) (Q2 2013 conference call transcript, a source for many of the projected catalyst time frames outlined below) develops enzyme-based (hyaluronidase) products for a wide variety of conditions, which include diabetes, cancer, autoimmune disorders and cosmetic medicine (cellulite).

CLINICAL AND REGULATORY CATALYSTS:

Below is a summary of the Company's clinical development pipeline which includes collaborations with Roche (RHHBY.OB), Pfizer (PFE) and Baxter (BAX) in addition to an FDA approved product, HYLENEX (human recombinant formulation of hyaluronidase), which improves the absorption and dispersion of drugs injected under the skin (subcutaneously) (e.g. insulin) on a temporary basis (approximately 24 hours) with plans to increase sales through a recently initiated post-marketing study in Type 1 diabetes using insulin pumps.

1.) Herceptin-SC (trastuzumab) and MabThera-SC (rituximab) (novel subcutenous injected rHuPH20 formulations) are currently pending European Medicines Agency (EMA) decisions in the form of line extension applications for new formulations of approved anti-cancer drugs. In late June, partner Roche received a positive CHMP opinion for EU approval of Herceptin-SC with final EU approval expected approximately two months later by late August-early September.

Partner Roche filed a MabThera-SC line extension application in December 2012 with the next CHMP meeting scheduled for September 16-19 and a meeting update to follow on Friday 9/20/13. The May Pharmacovigilance Risk Assessment Committee (PRAC) meeting minutes posted in June (page 40-41) indicated that both line extension applications are acceptable with Herceptin-SC subsequently receiving a positive CHMP opinion in late June.

In addition, Roche has two ongoing Phase III clinical trials to evaluate patient preference and support pending European marketing efforts upon final approval for both Herceptin-SC (ClinicalTrials.gov ID NCT01810393) and MabThera-SC (ClinicalTrials.gov ID NCT01724021) compared to the standard, longer IV infusion delivery route for these products.

2.) HyQvia (novel subcutaneous injection formulation of immune globulin) received a Complete Response Letter (CRL) in August 2012 for a Biologics License Application (BLA) seeking approval as a novel formulation of immune globulin for subcutaneous injection due to elevated anti-rHuPH20 antibody titers and partner Baxter expects to submit additional data to the FDA by year-end 2013 to support potential FDA approval by mid-2014 to H2 2014 (Baxter Q2 2013 conference call transcript). In May, HyQvia received EU approval with the initial product launch ongoing.

3.) HTI-501 (recombinant human cathepsin L) (lysosomal proteinase) is currently being evaluated in a Phase II clinical trial and in late June HALO presented interim Phase II results from 12 of planned 34 evaluable patients in a fully enrolled Phase I/II clinical trial for the treatment of cellulite with the last patients dosed in July and final follow-up results through six-months post-treatment expected in early 2014.

4.) ClinicalTrials.gov ID NCT01839487 is the identifier for a Phase II clinical trial with results expected during Q3 2015 in a study evaluating PEGPH20 (PEGylated form of rHuPH20) in combination with nab-paclitaxel and gemcitabine for the first-line treatment of metastatic pancreatic cancer.

HALO will present more complete Phase IB data at the EU Cancer Congress on 9/30/13 following initial results presented at ASCO 2013 (42% overall response rate) and the Company is also developing a companion diagnostic with a planned start of a Phase II pancreatic cancer trial by Southwest Oncology Group by the end of Q3 2013.

5.) ClinicalTrials.gov ID NCT01848990 is the identifier for a fully enrolled Phase IV post-marketing clinical trial evaluating HYLENEX (rHuPH20 hyaluronidase human injection) in combination with rapid-acting analog insulin in Type I diabetics using insulin pumps with results expected in early 2014. HYLENEX is FDA approved to facilitate subcutaneous fluid administration for a variety of indications (e.g. hydration and to increase dispersion of other drugs as illustrated in the pipeline above).

6.) In December 2012, HALO announced an agreement with Pfizer to develop and commercialize biologic agents using Halozyme's Enhanze (hyaluronidase-based) drug delivery technology in up to six targets. Pfizer paid HALO an initial cash payment of $8 million for the initial two targets along with the right to add four more targets (additional fees apply) and the deal also includes potential regulatory and sales-based milestone payments of up to $507 million plus royalties.

FINANCIAL STATS (Q2 2013 results press release):

- On August 12 & 14, director Kathryn Falberg purchased a total of 100,000 shares of HALO on the open market at an average price of $6.82 increasing her stake to 280,000 shares (SEC filing link) while CEO Gregory Frost exercised options into 20,000 shares of common stock which increased his large ownership stake to approximately 3.6 million shares (SEC filing link).

- On 8/14/13, Swiss BB Biotech reported a 5.1% ownership stake (5.75 million shares) in HALO (SEC filing link).

- HALO currently has a high percentage of insider and institutional investors which account for nearly 70% ownership of outstanding common stock and includes major holders such as Randal Kirk / Third Security (combined ownership stake of 23.3 million shares which equates to a 20.6% ownership stake) and Baker Brothers (6.5 million shares).

- Randal Kirk is a billionaire biotech entrepreneur who recently netted over $1 billion on the highly successful IPO for Intrexon (XON) (Forbes overview article) and he also serves on the Board of Directors for HALO.

- As of 6/30/13, HALO reported $76 million (M) in cash and equivalents with $11.4M in cash used to fund operations during Q2 2013.

- During 2Q13, HALO reported revenue of $14.5M vs. $7.8M in the year-ago period.

- As of 8/5/13, HALO reported approximately 113M shares of common stock outstanding with $29.7M in total debt as of 6/30/13 ($26.1M classified as long-term debt which reflects a term loan from Oxford Finance and Silicon Valley Bank with a maturity date of 12/1/16).

- HALO has provided guidance for potential to be cash flow positive in 2014 (PR link) based upon key partner product launches that include HyQvia, Herceptin-SC and MabThera-SC in Europe with adequate cash to fund operations into late 2014 based upon the current cash and burn rate with an expected decrease over time as additional revenue offsets R&D expenses for the Company's three wholly owned programs (HTI-501 for cellulite, Hylenex for use w/ insulin pumps and PEGPH20 for pancreatic cancer).

TRADE SUMMARY & OUTLOOK:

With final European approval for Herceptin-SC due any day now and a very likely (90%) positive CHMP opinion for MabThera-SC in the near-term; I expect shares of HALO to fill the gap-down in the chart if positive news comes in as expected in the coming weeks with the potential to reach low double digits during H2 2013 ($10-12 target) as additional catalysts approach and the Company continues narrowing the cash burn with a goal of becoming cash flow positive by next year.

I believe the decision by ViroPharma (VPHM) to discontinue development of Cinryze-SC will have no impact on other programs as discussed by HALO on the most recent quarterly conference call and the enzyme-related antibodies have never been linked to any side effects with no clinical impact observed to date for an issue that was known in summer 2012 and being addressed by Baxter as part of plans to resubmit a BLA for HyQvia which is already being marketed in Europe following approval earlier this year.

In addition, HALO spiked by approximately $2 earlier this year on both Phase 1b pancreatic cancer data for PEGPH20 and again in late June on the positive CHMP opinion for Herceptin-SC so there is potential for another $1-2 upside each for upcoming Phase 1b data being presented on 9/30 and an expected positive CHMP opinion for MabThera-SC.

Other recent bullish developments include a recent open market insider/director buy for nearly $700,000 and bullish trading in the September $7.50 and October/December $10 call options so in the short-term, I expect the positive uptrend in the six-month chart below to continue with an upper $7-lower $8 short-term swing / run-up target with key risks being potential for an overall market correction and unexpected bad news on any of the upcoming regulatory or clinical trial catalysts which would have the potential for downside risk that is similar to the upside targets outlined earlier.

(click to enlarge)

Disclosure: I am long HALO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

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