Analyst Greg Wade Bets On Extraordinary Science And Clinical Data

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 |  Includes: ANAC, HALO, JNJ, NVAX, PCYC
by: Life Sciences Report

Managing Director Greg Wade of Wedbush Securities doesn't use a cookie-cutter approach to picking biotechnology stocks. He directs investors to companies with strong science, well-executed clinical studies and data that points toward future success. In this exclusive interview with The Life Sciences Report, Wade shares his favorite names and the compelling stories behind each company.

The Life Sciences Report: The Wedbush Management Conference was held in New York City in mid-August. What was the mood of institutional life sciences investors?

Greg Wade: The investors I talked to were upbeat. Most were looking for new ideas. They were optimistic that the marketplace would be stable enough in the latter half of 2012 for folks to make money in equities with good fundamentals. It was a very positive outlook.

TLSR: You also had some private companies presenting at the conference. What kind of exit strategies are they looking for? Do most of them want to do an initial public offering (IPO)?

GW: Yes. The valuations that can be achieved with public offerings are sufficiently positive, and some private companies are considering them as viable financing options. The investing community, too, is more broadly considering IPO candidates, which is heartening for companies looking to meet with investors.

TLSR: Are companies expected to have clinical assets before they think about going public?

GW: That almost always depends on the indication and whether the data at hand predicts ultimate clinical success. Certainly, more advanced companies are going to have a broader audience of potential investors, but we've also seen promising, unique technology platforms. Companies with these platforms could attract the type of capital that would propel them to the clinical stage.

TLSR: We have had a wonderful rally in biotech since the end of last year. In talking with investors, especially institutional investors, do they feel the rally is going to continue?

GW: One reason for the strong rally that must be recognized is a real decline in volatility. That decline has created a very healthy financing environment for development-stage companies, and is very supportive of a strong overall index. Most of the investors I talk to are not trading the market; they are looking for specific investment ideas that might be well financed and have immediate attractive valuation.

TLSR: Could we talk about some companies that you like?

GW: There are two companies on the Wedbush Securities Best Ideas List, currently in my coverage, that I'd like to discuss. The first is Pharmacyclics Inc. (NASDAQ:PCYC), which we added when the stock was priced in the low-teens. It has since blown through our price target -- up well over 350% since it was added and continuing to move up. The stock is trading at about $63 per share presently.

Investors clearly appreciate the safety and efficacy of the company's lead drug ibrutinib [PCI-32765], and the global development partnership that the company has struck with Janssen Biotech Inc., a unit of Johnson & Johnson (NYSE:JNJ). The expected results from phase 3 studies and the absence of a requirement to finance the company's participation in global development of the drug make this a must-own hematology/oncology company. We continue to recommend the stock to investors, believing that there's some further work required on our model to properly value the biggest opportunity for the drug, which we think is as a chronic treatment for chronic lymphocytic leukemia (CLL).

TLSR: Ibrutinib is a small-molecule Bruton's tyrosine kinase (BTK) inhibitor, and it is well into phase 3. The company must have seen some outstanding phase 2b data for the stock to be up nearly 500% over the past 12 months.

GW: Yes. Even the phase 1 data -- the first experience in humans -- were incredibly striking, with a response rate of about 80% in patients. In the CLL setting, close to 90% of patients remaining on treatment were without progression, suggesting that the BTK target, at least in the CLL setting, might be an Achilles' heel for the disorder in some patients. Chronic therapies for hematologic malignancies have attracted significant interest from investors, the CLL market being the most well recognized. With CLL, you have a patient population of 115,000 in the U.S. alone, and the company has a dramatic opportunity to market a high-priced, safe medicine that folks will take every day for treatment of their leukemia. That is the biggest driver, and timing is really a question of when we'll have the first phase 3 data and how quickly the U.S. Food and Drug Administration (FDA) will act on the application.

TLSR: Looking at the performance of ibrutinib, are we apt to see an earlier approval than might be anticipated?

GW: I think the Street is comfortable with the idea that the CLL phase 3 study, which is beginning now, will probably finish early so the company can provide data for a new drug application (NDA), with data in H1/14 by our estimate. We certainly expect the data to be positive. At the same time, there is the chance that a single-arm mantle cell lymphoma study may read out positive data sufficiently robust to motivate the FDA to provide an accelerated approval. However, I don't think we'll see an application from Pharmacyclics prior to the completion of those studies, which I believe is the earliest potential data point for approval, regardless of strong results. There are a lot of existing therapies for these indications, and the FDA is somewhat bound by its regulations, which stipulate that when there are existing therapies, good clinical data must be presented before it considers approval of something new.

TLSR: What is the other best idea from the Wedbush list?

GW: We originally added Halozyme Therapeutics (NASDAQ:HALO) to our Best Ideas List in the latter half of last year. We thought the risk profile and opportunity were attractive. The company has a partnership with Roche Holding AG (OTCQX:RHHBY), one of the largest pharmaceutical companies in the world, for multiple injectable protein therapeutics, as well as its own proprietary programs. There have been some ups and downs in the stock, but we have conviction that both the underlying business and the fundamentals of the technology are strong. We continue to recommend the stock to our clients, believing that Roche's Herceptin (trastuzumab) will have a fairly rapid transition outside the U.S. for the subcutaneous route of administration that is facilitated by Halozyme's Enhanze technology.

We also have a very significant focus on one of Halozyme's in-house programs, which improves the predictability of both timing and potency of insulin's activity when delivered via a subcutaneous pump. We are confident the company will be on a commercial footing in the U.S. with that technology in the first part of 2013. It's a fairly straightforward technology that's had a few bumps in the road, but we are confident that the fundamentals are going to drive the stock going forward.

TLSR: HALO's technology has led to the advancement of a couple of products that have nearly made it through major regulatory decisions. One is Herceptin for HER2-positive breast cancer patients, yet the stock has been very weak. It's down 33% over the past four weeks. Why has it been weak?

GW: The first product expected to be approved using the Enhanze technology was Baxter International Inc.'s [BAX] HyQ (immune globulin + Halozyme's rHuPH20 [recombinant human hyaluronidase] enzyme). Some non-neutralizing antibodies to the active ingredient that facilitates the subcutaneous route of administration with hyaluronidase were observed. As a result, the FDA indicated to the sponsor, Baxter, that it was likely to receive a complete response letter instead of an approval, and that it would need to do more work to understand if this autoimmune observation, which was not clinically significant, was potentially troublesome. The Street is always concerned when the FDA raises a potential safety issue. But we note that there was no change to the Hylenex (hyaluronidase) label, and no warning letter associated with what is an already-approved product. Hyaluronidase is approved to facilitate the absorption and distribution of drugs delivered subcutaneously, and that continues to be the labeled indication for the enzyme on its own.

TLSR: Will approval of Herceptin support the rest of the pipeline? Will it prove the concept of the platform?

GW: Yes. A regulatory success will certainly be well respected by the marketplace and viewed as a significant positive. I also believe the income statement is going to be the driver for value creation for Halozyme starting in 2013 with its commercial efforts in the insulin pump setting.

TLSR: Are you playing this as a turnaround story?

GW: Well, it is now. It wasn't when we put it on our Best Ideas List. But we believe we understand the issues and the opportunities. The Street is more focused on regulatory issues right now and needs to look more at what the opportunity is.

TLSR: Your next pick?

GW: I would focus investors on Anacor (NASDAQ:ANAC), a platform-chemistry company. It utilizes boron-based organic molecules to create new drugs. It is appropriately conservative in its approach. Boron-based molecules are fairly reactive. It started by making topical drugs. The main indication of the company's lead drug is on onychomycosis -- toenail fungus. Phase 3 data for its first of two phase 3 studies are expected in the second week of January 2013, and the next is expected six weeks later. The drug is tavaborole (AN2690), and it is well tolerated by patients. We know it gets through the toenail. I think the marketplace is ready for a safe, effective, topical treatment for this dermatologic indication.

TLSR: What's your next idea?

GW: Novavax Inc. (NASDAQ:NVAX) has a very robust and interesting biologic manufacturing capability. It uses its expression system to manufacture virus-like particles to make vaccines, and has significant government support for both pandemic and seasonal flu vaccines. Recently, the company has shown a good result for treatment of a respiratory syncytial virus (RSV), one of the last significant pathogens that we don't have a vaccine for. This product would protect elderly folks, neonates (newborns) and young children against the virus. There is a strong chance that the company will enter into a significant global partnership for development of an RSV vaccine this year. That, combined with the opportunity it has in flu vaccine development, is very interesting. A lot of investor attention is being paid to Novavax.

TLSR: This sounds like the kind of company that could receive nondilutive capital from governments. Has Novavax been able to finance itself with grants from European or North American governments?

GW: Yes. The U.S. government is supporting the company through a contract in excess of $100 million to advance development of both pandemic and seasonal flu vaccines. The money will support the creation of manufacturing infrastructure and clinical regulatory work on the product. The technology allows for very rapid production of the vaccine, which will help in the event of a global health issue.

TLSR: Rapid production is the real value driver here, isn't it?

GW: Yes. Historically, very significant mortality has been associated with pandemic flu. The U.S. government places a very high priority on protecting the population from another potential pandemic.

TLSR: Thank you, Greg. This has been fun.

GW: Any time you want to talk about stocks, I'm always here.

This interview was conducted by George S. Mack of The Life Sciences Report and can be read in its entirety at http://www.thelifesciencesreport.com/pub/na/14232 or on our instablog.

Greg Wade earned both an undergraduate honors degree in medical biophysics and a doctorate in physiology from the University of Western Ontario in London, Canada. He has worked on the sellside since early in 2000, first at Pacific Growth Equities and subsequently at Wedbush PacGrow LifeSciences, where he was promoted to managing director in 2011. Greg's coverage of emerging biopharmaceutical companies is supported by his analyst team members, David Nierengarten and Chris Marai.

Disclosure: 1) George S. Mack of The Life Sciences Report conducted this interview. He personally and/or his family own shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the interview are sponsors of The Life Sciences Report: None. Streetwise Reports does not accept stock in exchange for services. Interviews are edited for clarity.
3) Greg Wade: I personally and/or my family own shares of the following companies mentioned in this interview: Pharmacyclics Inc. I personally and/or my family am paid by the following companies mentioned in this interview: None. I was not paid by Streetwise Reports for participating in this interview.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. 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.