Halozyme Therapeutics (HALO)
Q3 2012 Earnings Call
November 08, 2012 4:30 pm ET
Gregory I. Frost - Co-Founder, Chief Executive Officer, President and Director
Kurt A. Gustafson - Chief Financial Officer, Principal Accounting Officer, Vice President and Secretary
Matthew Harrison - UBS Investment Bank, Research Division
Ying Huang - Barclays Capital, Research Division
Jim Birchenough - BMO Capital Markets U.S.
Jason N. Butler - JMP Securities LLC, Research Division
Richard M. Reznick
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It is now my pleasure to introduce your host, Anne Erickson, Executive Director of Investor Relations at Halozyme Therapeutics. Thank you, Ms. Erickson. You may begin your conference.
Good afternoon, everyone. Thank you for joining Halozyme's quarterly update conference call. With me on the call today are Gregory Frost, President and Chief Executive Officer; and Kurt Gustafson, Chief Financial Officer.
This afternoon, Halozyme released third quarter 2012 financial results. If you've not received this news release or if you'd like to be added to the company's distribution list, please e-mail me directly at firstname.lastname@example.org.
This call is also being webcast live over the Internet at www.halozyme.com, and a replay will be available on the company's website for the next 14 days.
Before we begin, let me remind you that during this conference call, we'll be making forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a Safe Harbor for forward-looking statements. The company's actual results may differ materially from those expressed in or indicated by such forward-looking statements. All statements made during this conference call that are not statements of historical fact constitute forward-looking statements. The matters referred to in forward-looking statements could be affected by the risks and uncertainties of Halozyme's business, both known and unknown. Such risks inherent in the company's business are described in our filings with the Securities and Exchange Commission, as well as in our news release.
With that, I would like to turn the call over to Gregory Frost, Halozyme's President and CEO.
Gregory I. Frost
Thanks, Anne, and good afternoon to everyone. We're glad that you've joined us for our third quarter call for 2012. Today, I'll provide you with an update on the business and a recap of the quarter's highlights, and then Kurt Gustafson, Halozyme's CFO, will review the quarter's underlying financial results with you.
Halozyme's continuing into the fourth quarter on track and progressing very well towards some important milestones for 2013. Let's begin focusing first on the late-stage programs with our partner, Roche.
The subcutaneous formulations of Herceptin and MabThera Roche has developed with Halozyme's enhanced technology represent near-term revenue streams for us, with the European Medicines Agency or EMA's decision on Herceptin estimated for early next year and the MabThera marketing application anticipated to be filed with the EMA by the end of this year.
As you may have seen the abstracts on subcu MabThera are now available on the American Society of Hematology or ASH website, Roche will be presenting data from 3 subcu MabThera studies at the meeting in early December. Roche continues to reiterate their intent to file the marketing authorization application for subcu MabThera to the EMA by the end of this year.
This could be an important opportunity for patients with non-Hodgkin lymphoma, as this therapy could reduce infusion times from several hours with the IV formulation to just 5 to 7 minutes with the subcu formulation, providing an easier, less invasive and more efficient route of administration without compromising the established safety and efficacy of the intravenous product.
It's worth noting that Roche continues to make significant investments in the clinical development programs for both subcu Herceptin and MabThera, with numerous studies that range in focus from efficacy and safety to health economics and patient preference.
As many of you have seen, Roche presented half a dozen posters on the subcu Herceptin program at the European Society for Medical Oncology meeting a few weeks ago in Vienna. They presented additional data from the HannaH registration trial, as well as detail on the 2,500 patients SafeHer trial, which we believe should adequately evaluate any questions physicians may have about self administration of the subcutaneous therapy for eligible patients.
Roche is putting significant resources behind this program to help patients make the transition from IV to subcutaneous administration as smooth as possible, and we look forward to being able to provide women with HER2-positive breast cancer a more convenient treatment option for this disease.
On our side, we continue working closely with the Roche Genentech CMC teams to ensure adequate prelaunch bulk enzyme inventories to support potential launches.
In summary, subcu Herceptin and MabThera are progressing on track, and we're working with Roche to advance these programs through their final stages. Both of these subcutaneous products could be very important to Halozyme.
As combined, worldwide sales of the intravenous administered forms are [ph] $13 billion in sales. Royalty streams and milestone payments from the subcu formulations of these products, once approved, will drive our near-term profitability and help fund future growth and innovation.
To round out updates on our partnered programs, I'll quickly touch on HyQ and Cinryze, the development programs with our partners, Baxter and ViroPharma, respectively. To summarize, FDA has requested additional pre-clinical data to complete their review of the HyQ Biologics License Application. This request came in August in the form of a Complete Response Letter. We're currently working with Baxter to meet with the agency and propose studies we believe can address their questions.