Halozyme Reports Fourth Quarter And Year End 2013 Financial Results

Feb 27, 2014, 16:15 ET from Halozyme Therapeutics, Inc.

SAN DIEGO, Feb. 27, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the fourth quarter and full year ended December 31, 2013. Financial highlights for the fourth quarter include revenues of $12.5 million and a net loss of $22.0 million, or $0.19 per share. This compares to revenues of $21.8 million and a net loss of $4.4 million, or $0.04 per share, for the fourth quarter of 2012.  Financial highlights for the full year 2013 include revenues of $54.8 million and a net loss of $83.5 million, or $0.74 per share. This compares to revenues of $42.3 million and a net loss of $53.6 million, or $0.48 per share, in the prior year.  

"2013 was a year of execution, growth and transformation for Halozyme. Two of our partnered programs using the ENHANZE platform received European approvals, we worked with Baxter on their resubmission of an amended BLA to the FDA for HyQvia® and we communicated early clinical data in pancreatic cancer from our PEGPH20 program," stated Dr. Helen Torley, President and Chief Executive Officer. "With the proceeds from our recently completed equity offering, we begin 2014 well-positioned to advance our broad proprietary portfolio of therapeutic candidates that could potentially serve cancer, diabetes and cellulite patients."

Fourth Quarter Highlights

  • HyQvia®: During the fourth quarter of 2013, Baxter completed submission of an amended biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) to re-initiate the review process for approval of HyQvia [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency (PI). HyQvia is a combination of human immune globulin (IG) and recombinant human hyaluronidase. Baxter and Halozyme submitted additional preclinical data in response to the Complete Response Letter from the FDA in 2012, and expect a six-month review period. Baxter launched HyQvia into the first EU country in July 2013, and introductions in additional markets are continuing.

Fourth Quarter and Full Year 2013 Financial Highlights

  • Revenues for the fourth quarter of 2013 were $12.5 million, compared to $21.8 million for the fourth quarter of 2012. Revenues in the fourth quarter of 2013 included $5.8 million in product sales of bulk rHuPH20 for use in partnered product manufacturing, $4.0 million in Hylenex® product sales, including a one-time adjustment of $1.1 million, and $2.7 million in collaboration revenues. Revenues in the fourth quarter of 2012 included one-time, upfront payments of $9.5 million from Pfizer. Revenues for the full year 2013 were $54.8 million compared to $42.3 million for 2012.
  • Research and development expenses for the fourth quarter of 2013 were $20.9 million, compared with $18.6 million for the fourth quarter of 2012. The increase is primarily due to increased clinical trial activities, offset in part by a decrease in manufacturing costs.
  • Selling, general and administrative expenses for the fourth quarter of 2013 were $9.4 million, compared to $7.0 million for the fourth quarter of 2012. The increase was mainly due to an increase in commercial activities.
  • The net loss for the fourth quarter of 2013 was $22.0 million, or $0.19 per share, compared with a net loss for the fourth quarter of 2012 of $4.4 million, or $0.04 per share. The net loss for the 12 months ended December 31, 2013 was $83.5 million, or $0.74 per share, compared to a net loss of $53.6 million, or $0.48 per share for the full year 2012.
  • Cash, cash equivalents and marketable securities were $71.5 million at December 31, 2013, compared with $65.3 million at September 30, 2013 and $99.5 million at December 31, 2012. Cash, cash equivalents and marketable securities at December 31, 2013 included net proceeds of $19 million from the additional term loan with Oxford Finance and Silicon Valley Bank for working capital and other near-term growth initiatives. Excluding the proceeds from the term loan, net cash used in the fourth quarter of 2013 was approximately $12.8 million. In February 2014, the Company raised approximately $107.8 million through an underwritten public offering of 8.8 million shares of its common stock.

Financial Outlook for 2014

  • For 2014, excluding the proceeds from the recent financing, the Company expects net cash burn to be between $45 and $55 million for the year.

Webcast and Conference Call Halozyme will webcast its quarterly update conference call today, February 27, 2014 at 4:30 p.m. EST/1:30 p.m. PST. During the call, management will discuss the financial results for the fourth quarter of 2013 and provide a business update. To listen to the live webcast please visit the "Investors" section of Halozyme's corporate website at www.halozyme.com. A webcast replay will be available shortly after the call at the same address. To participate by phone, please dial (877) 407-8037 (domestic callers) or (201) 689-8037 (international callers). A telephone replay will be available by dialing (877) 660-6853 (domestic callers) or (201) 612-7415 (international callers) using replay ID number 13576874.

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, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, 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 and follow us on Twitter @HALOTherapeutic.

Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the expected timing of the FDA's response to the HyQvia® amended BLA submission, the Company's future expectations and plans for the development and commercialization of product candidates and the potential benefits and attributes of such product candidates and expected cash burn for 2014) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, 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 and costs, unexpected fluctuations or changes in revenues from collaborators, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 2013.

Investor Contact: Schond Greenway Halozyme Therapeutics 858-704-8352 ir@halozyme.com

Media Contact: Nurha Hindi Hill + Knowlton Strategies 310-633-9434 Nurha.Hindi@hkstrategies.com

 

 

Halozyme Therapeutics, Inc

 Condensed Consolidated Statements of Operations

(Unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

2013

2012

2013

2012

REVENUES:

Product sales, net

$    9,806,378

$  1,459,735

$  24,439,724

$    2,887,442

Revenues under collaborative agreements

2,692,555

20,333,814

30,359,723

39,437,784

Total revenues

12,498,933

21,793,549

54,799,447

42,325,226

OPERATING EXPENSES:

Cost of product sales

3,540,128

653,884

6,245,761

1,094,400

Research and development

20,925,194

18,567,744

96,639,575

70,044,073

Selling, general and administrative

9,356,971

6,979,034

32,347,748

24,812,199

Total operating expenses

33,822,293

26,200,662

135,233,084

95,950,672

OPERATING LOSS

(21,323,360)

(4,407,113)

(80,433,637)

(53,625,446)

Investment and other income

64,685

1,257

229,229

73,444

Interest expense

(727,628)

-

(3,274,143)

-

NET LOSS

$ (21,986,303)

$ (4,405,856)

$ (83,478,551)

$ (53,552,002)

Basic and diluted net loss per share

$            (0.19)

$          (0.04)

$            (0.74)

$            (0.48)

Shares used in computing basic and diluted

net loss per share

113,550,229

112,323,056

112,805,439

111,077,105

 

 

Halozyme Therapeutics, Inc

Condensed Consolidated Balance Sheets

(Unaudited)

December 31,

December 31,

2013

2012

ASSETS

Current assets:

Cash and cash equivalents

$   27,356,947

$   99,501,264

Marketable securities, available-for-sale

44,145,697

-

Accounts receivable, net

9,097,084

15,703,087

Inventories

6,169,982

2,670,696

Prepaid expenses and other assets

8,425,684

12,752,888

Total current assets

95,195,394

130,627,935

Property and equipment, net

3,421,506

3,700,462

Prepaid expenses and other assets

2,675,692

-

Restricted cash

500,000

400,000

Total Assets

$ 101,792,592

$ 134,728,397

LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY

Current liabilities:

Accounts payable

$     3,134,757

$     2,271,689

Accrued expenses

14,920,446

7,783,447

Deferred revenue, current portion

7,397,829

8,891,017

Total current liabilities

25,453,032

18,946,153

Deferred revenue, net of current portion

45,745,449

34,954,966

Long-term debt, net

49,771,737

29,661,680

Lease financing obligation

-

1,450,000

Deferred rent, net of current portion

794,782

861,879

Other long-term liability

18,268

-

Stockholders' (deficit) equity:

Common stock

114,534

112,709

Additional paid-in capital

361,929,935

347,314,658

Accumulated other comprehensive income

17,054

-

Accumulated deficit

(382,052,199)

(298,573,648)

Total stockholders' (deficit) equity

(19,990,676)

48,853,719

Total Liabilities and Stockholders' (Deficit) Equity

$ 101,792,592

$ 134,728,397

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SOURCE Halozyme Therapeutics, Inc.



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