Halozyme Reports Second Quarter 2012 Financial Results

Aug 06, 2012, 16:05 ET from Halozyme Therapeutics, Inc.

SAN DIEGO, Aug. 6, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the quarter ended June 30, 2012.

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"With receipt of the complete response letter for the HyQ BLA, we will be working to address the questions raised by FDA's Blood Products Division regarding the subcutaneous plasma derivatives programs," said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. "We are also pleased that after a review of the most recent safety data submitted, we have confirmation from FDA's Drug Division that no action is required on our approved product, Hylenex, or clinical programs under the Hylenex IND."

Second Quarter Highlights Highlights of Halozyme's second quarter activities and recent events include:

  • Confirmed that Baxter received a complete response letter for the HyQ Biologics License Application (BLA) requesting additional preclinical data to support the application.  Additionally, the Blood Products Division requested that patients no longer be dosed with recombinant human hyaluronidase (rHuPH20) in the Baxter and ViroPharma subcutaneous plasma derivative programs, pending review of preclinical data.
    • Based on the most recent data submitted to FDA's Drug Division (the group regulating the other investigational rHuPH20 programs, including insulin and PEGPH20), the division has confirmed that no action is required against Hylenex or ongoing clinical programs under the Hylenex IND.
  • Roche announced that the Phase 3 study of the subcutaneous (SC) formulation of MabThera® (rituxumab with rHuPH20) met its primary endpoint of non-inferior MabThera serum concentrations after SC injection, compared with MabThera IV infusion in patients with follicular lymphoma. Roche also confirmed that data from this trial will be presented by the end of the year.
  • Presented data from two treatment studies at the American Diabetes Association's (ADA's) annual meeting that demonstrated Halozyme's ultrafast insulin formulations accelerated the absorption and action of mealtime insulins and may help reduce glucose swings. Both studies met their primary endpoint of A1C non-inferiority, significantly improved post-prandial glucose control and, in Type 1 patients, significantly reduced hypoglycemia compared to lispro alone.
  • Reported results from studies in insulin pumps at ADA that showed preadministration of Halozyme's rHuPH20 provided a more physiologic profile than current rapid insulin analogs. This also led to more consistent insulin exposure and absorption over the infusion set life. These data show that rHuPH20 preadministration may help people living with Type 1 diabetes achieve better glucose control after meals.
  • Presented data at the American Society of Clinical Oncology annual meeting that evaluated the safety and tolerability of PEGPH20 treatment, a pegylated form of rHuPH20, in patients with solid tumor malignancies, including pancreatic cancer. Data showed that PEGPH20 was generally well tolerated at the recommended Phase 2 dose, enhanced tumor perfusion and reduced tumor metabolic activity. These studies support the ongoing run-in phase of a larger study with chemotherapy in patients with pancreatic cancer.

 

Second Quarter 2012 and Year-To-Date Financial Results The net loss for the second quarter of 2012 was $(14.0) million, or $(0.13) per share, compared with a net income for the second quarter of 2011 of $3.1 million, or $0.03 per share. The net loss for the six months ended June 30, 2012 was $(29.1) million, or $(0.27) per share, compared to a net loss of $(6.5) million, or $(0.06) per share, for the comparable period in 2011.

  • Revenues for the second quarter of 2012 were $7.8 million, compared to $23.2 million for the second quarter of 2011. Revenues in the second quarter of 2012 primarily consisted of $2 million in annual exclusivity fees and $4.4 million in research and development reimbursements from partners.
  • Research and development expenses for the second quarter of 2012 were $16.1 million, compared with $15.3 million for the second quarter of 2011, primarily due to an increase in compensation costs and manufacturing activities, partially offset by a decrease in clinical trial activities. 
  • Selling, general and administrative (SG&A) expenses for the second quarter of 2012 were $5.6 million, compared to $4.6 million for the second quarter of 2011. The increase for SG&A was due to higher compensation costs during the quarter. 
  • Cash and cash equivalents were $102.0 million as of June 30, 2012, compared with $79.1 million as of June 30, 2011. Net cash used in the second quarter of 2012 was approximately $14.6 million.
  • 2012 cash burn guidance remains unchanged at $55-$60 million.

 

Conference Call The call will be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast, please log on to www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (877) 407-8037 (domestic callers) or (201) 689-8037 (international callers). A telephone replay will be available shortly after the call by dialing (877) 660-6853 (domestic callers) or (201) 612-7415 (international callers) using account number 367 and replay ID number 398418.

About Halozyme Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.

Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning ours and our collaborators' programs in development, our intention to address the concerns raised in the complete response letter for HyQ, the anticipated regulatory status of these programs in development, anticipated regulatory milestones, Roche's stated intention to present data from the MabThera Phase 3 trial by the end of the year, our anticipated cash burn for 2012  and potential benefits and attributes of our product candidates. These statements involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures, clinical trial results, delays in development and regulatory review, regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Media/Investor Contact: Anne Erickson Executive Director Halozyme Therapeutics 858-704-8264 aerickson@halozyme.com

 

Halozyme Therapeutics, Inc

Unaudited Condensed Consolidated Statements of Comprehensive Income (Loss)

Three Months Ended

Six Months Ended

June 30, 

June 30, 

2012

2011

2012

2011

REVENUES:

Product sales, net

$       524,942

$     165,470

$       712,353

$     330,919

Revenues under collaborative agreements

7,232,233

23,023,478

14,485,001

30,401,922

Total revenues

7,757,175

23,188,948

15,197,354

30,732,841

OPERATING EXPENSES:

Cost of product sales

143,120

178,235

213,881

189,952

Research and development

16,081,729

15,347,116

31,972,838

29,132,913

Selling, general and administrative

5,580,424

4,567,666

12,199,131

7,973,632

Total operating expenses

21,805,273

20,093,017

44,385,850

37,296,497

OPERATING INCOME (LOSS)

(14,048,098)

3,095,931

(29,188,496)

(6,563,656)

Interest and other income, net

26,979

20,357

48,196

44,226

NET INCOME (LOSS)

$ (14,021,119)

$  3,116,288

$ (29,140,300)

$ (6,519,430)

Basic and diluted net income (loss) loss per share

$            (0.13)

$           0.03

$            (0.27)

$          (0.06)

Shares used in computing net income (loss)

  per share:

Basic

112,063,665

102,671,410

109,826,589

101,804,887

Diluted

112,063,665

104,393,835

109,826,589

101,804,887

COMPREHENSIVE INCOME (LOSS)

$ (14,021,119)

$  3,116,288

$ (29,140,300)

$ (6,519,430)

 

Halozyme Therapeutics, Inc

Unaudited Condensed Consolidated Balance Sheets

June 30, 

December 31,

2012

2011

ASSETS

Current assets:

Cash and cash equivalents

$ 102,041,617

$   52,825,527

Accounts receivable, net

5,687,096

2,262,465

Inventories

1,783,894

567,263

Prepaid expenses and other assets

10,218,468

8,332,242

      Total current assets

119,731,075

63,987,497

Property and equipment, net

2,016,809

1,771,048

      Total Assets

$ 121,747,884

$   65,758,545

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable

$     2,087,432

$     7,556,859

Accrued expenses

7,529,322

5,615,574

Deferred revenue, current portion

6,530,834

4,129,407

      Total current liabilities

16,147,588

17,301,840

Deferred revenue, net of current portion

35,506,951

36,754,583

Deferred rent, net of current portion

859,027

802,006

Stockholders' equity:

Common stock

112,689

103,990

Additional paid-in capital

343,283,575

255,817,772

Accumulated deficit

(274,161,946)

(245,021,646)

      Total stockholders' equity

69,234,318

10,900,116

      Total Liabilities and Stockholders' Equity

$ 121,747,884

$   65,758,545

 

SOURCE Halozyme Therapeutics, Inc.



RELATED LINKS

http://www.halozyme.com