e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2007
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 000-49616
HALOZYME THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Nevada
(State or other jurisdiction of
incorporation or organization)
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88-0488686
(I.R.S. Employer
Identification No.) |
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11588 Sorrento Valley Road, Suite 17 |
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San Diego, CA
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92121 |
(Address of principal executive offices)
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(Zip Code) |
(858) 794-8889
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d)
of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a
non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No þ
The number of outstanding shares of the registrants common stock, par value $0.001 per share, as of May 4, 2007 was
71,944,186.
TABLE OF CONTENTS
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS UNAUDITED
AS OF MARCH 31, 2007 AND DECEMBER 31, 2006
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March 31, |
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December 31, |
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2007 |
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2006 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
70,970,875 |
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$ |
44,189,403 |
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Accounts receivable |
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552,789 |
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370,068 |
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Inventory |
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475,185 |
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442,492 |
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Prepaid expenses and other assets |
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1,295,675 |
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591,587 |
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Total current assets |
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73,294,524 |
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45,593,550 |
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PROPERTY AND EQUIPMENT, net |
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572,026 |
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497,770 |
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Total Assets |
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$ |
73,866,550 |
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$ |
46,091,320 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
1,072,178 |
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$ |
2,017,395 |
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Accrued expenses |
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1,187,146 |
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1,011,153 |
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Deferred revenue |
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2,896,932 |
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1,221,992 |
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Total current liabilities |
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5,156,256 |
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4,250,540 |
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Deferred revenue, net of current portion |
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27,806,645 |
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18,759,545 |
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COMMITMENTS AND CONTINGENCIES (NOTE 9) |
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STOCKHOLDERS EQUITY: |
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Preferred stock, $0.001 par value; 500,000 shares authorized; none
issued and outstanding |
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Common stock, $0.001 par value; 150,000,000 and 100,000,000 shares
authorized; 71,531,197 and 68,736,993 shares issued and
outstanding
as of March 31, 2007 and December 31, 2006, respectively |
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71,531 |
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68,737 |
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Additional paid-in-capital |
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85,288,662 |
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64,111,738 |
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Accumulated deficit |
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(44,456,544 |
) |
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(41,099,240 |
) |
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Total Stockholders Equity |
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40,903,649 |
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23,081,235 |
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Total Liabilities and Stockholders Equity |
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$ |
73,866,550 |
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$ |
46,091,320 |
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The accompanying notes are an integral part of these financial statements.
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS UNAUDITED
FOR THE THREE MONTHS ENDED MARCH 31, 2007 AND 2006
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2007 |
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2006 |
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REVENUES: |
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Product sales |
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$ |
187,086 |
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$ |
73,281 |
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Revenue under collaborative agreements |
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623,129 |
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Total Revenues |
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810,215 |
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73,281 |
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EXPENSES: |
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Cost of sales |
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76,228 |
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22,959 |
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Research and development |
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2,829,364 |
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2,192,070 |
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Selling, general and administrative |
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1,985,034 |
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1,531,292 |
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Total Expenses |
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4,890,626 |
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3,746,321 |
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LOSS FROM OPERATIONS |
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(4,080,411 |
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(3,673,040 |
) |
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Interest income |
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723,107 |
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182,846 |
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NET LOSS |
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$ |
(3,357,304 |
) |
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$ |
(3,490,194 |
) |
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Net loss per share, basic and diluted |
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$ |
(0.05 |
) |
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$ |
(0.06 |
) |
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Shares used in computing net loss per share,
basic and diluted |
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69,984,931 |
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60,456,462 |
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The accompanying notes are an integral part of these financial statements.
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS UNAUDITED
FOR THE THREE MONTHS ENDED MARCH 31, 2007 AND 2006
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2007 |
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2006 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
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$ |
(3,357,304 |
) |
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$ |
(3,490,194 |
) |
Adjustments to reconcile net loss to net cash provided by (used in)
operating activities: |
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Depreciation and amortization |
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86,635 |
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52,985 |
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Share-based compensation expense |
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415,480 |
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273,092 |
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Issuance of common stock and stock options for goods and services |
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9,323 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(182,721 |
) |
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320,240 |
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Inventory |
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(32,693 |
) |
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(7,231 |
) |
Prepaid expenses and other assets |
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(704,088 |
) |
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(350,229 |
) |
Accounts payable and accrued expenses |
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(769,224 |
) |
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389,899 |
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Deferred revenue |
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10,722,040 |
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Net cash provided by (used in) operating activities |
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6,178,125 |
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(2,802,115 |
) |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchase of property and equipment |
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(160,891 |
) |
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(38,879 |
) |
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Net cash used in investing activities |
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(160,891 |
) |
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(38,879 |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from issuance of common stock net |
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19,946,411 |
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Proceeds from exercise of stock options |
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459,918 |
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Proceeds from exercise of warrants |
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357,909 |
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1,279,301 |
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Net cash provided by financing activities |
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20,764,238 |
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1,279,301 |
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NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
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26,781,472 |
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(1,561,693 |
) |
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CASH AND CASH EQUIVALENTS, beginning of period |
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44,189,403 |
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19,132,194 |
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CASH AND CASH EQUIVALENTS, end of period |
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$ |
70,970,875 |
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$ |
17,570,501 |
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The accompanying notes are an integral part of these financial statements.
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
Halozyme Therapeutics, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Organization and Business
Halozyme Therapeutics, Inc. (Halozyme, we or the Company) is a biopharmaceutical company
dedicated to the development and commercialization of recombinant human enzymes for the drug
delivery, palliative care, oncology, and infertility markets.
Our operations to date have been limited to organizing and staffing the Company, acquiring,
developing and securing our technology and undertaking product development for our existing
products and for a limited number of product candidates. In June 2005, we launched our first
product, Cumulase®, a product used for in vitro fertilization, and transitioned from a
development-stage organization to a commercial entity.
2. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with United States generally accepted accounting principles (U.S. GAAP) and with the
rules and regulations of the Securities and Exchange Commission related to a quarterly report on
Form 10-Q. Accordingly, they do not include all of the information and disclosures required by U.S.
GAAP for complete financial statements. The interim financial statements reflect all adjustments
which, in the opinion of management, are necessary for a fair presentation of the financial
condition and results of operations for the periods presented. Except as otherwise disclosed, all
such adjustments are of a normal recurring nature.
Operating results for the three months ended March 31, 2007 are not necessarily indicative of the
results that may be expected for the fiscal year ending December 31, 2007 or for any future period.
For further information, see the
financial statements and disclosures thereto for the year ended December 31, 2006 included in our
Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 9, 2007 and
other regulatory reports and filings made with the Securities and Exchange Commission.
The preparation of financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities as well as
disclosures of contingent assets and liabilities at the date of the financial statements.
Estimates also affect the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates. The unaudited condensed consolidated financial
statements include the accounts of Halozyme Therapeutics, Inc. and its wholly owned subsidiary,
Halozyme, Inc. All intercompany accounts and transactions have been eliminated.
3. Summary of Significant Accounting Policies
Revenue Recognition
We recognize revenue in accordance with the SECs Staff Accounting Bulletin No. 104, Revenue
Recognition and Emerging Issues Task Force Issue (EITF) No. 00-21, Revenue Arrangements with
Multiple Deliverables. Revenue is recognized when all of the following criteria are met: (1)
persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been
rendered; (3) the sellers price to the buyer is fixed and determinable; and (4) collectibility is
reasonably assured.
Product Sales We recognize Cumulase revenue when the transfer of ownership occurs, upon shipment
to the distributor. Accounts receivable is recorded net of an allowance for doubtful accounts.
Currently, the allowance for doubtful accounts is zero as the collectibility of accounts receivable
is reasonably assured. We are not obligated to accept returns for products that have reached their
expiration date. Thus, no allowance for product returns has been established.
On February 13, 2007, we amended certain agreements with Baxter Healthcare Corporation (Baxter)
(the Baxter Agreement) for Hylenex and entered into a new agreement for kits and co-formulations
with rHuPH20. Under the terms of the Baxter Agreement, we will supply Baxter the active
pharmaceutical ingredient (API) for Hylenex at our fully burdened cost plus a margin and Baxter
will fill and finish Hylenex and hold it for subsequent distribution. Because of our continued
involvement in the development and production process of Hylenex under the terms of the Baxter
Agreement, the earnings process is not considered to be complete. Accordingly, we defer revenue
and the related product costs resulting from transfers of the active pharmaceutical ingredient for
Hylenex to Baxter until the product is filled, finished, packaged and released.
License and Collaborative Arrangement Revenues from licensing agreements are recognized based on
the performance requirements of the agreement. Revenue is deferred for fees received before
earned. Non-refundable upfront fees, where we have an ongoing involvement or performance
obligation, are recorded as deferred revenue and recognized as revenue over the contract or
development period. In February 2007, we entered into the Baxter Agreement which consists of
non-refundable upfront license fees, reimbursements of research and development services and
various performance or sales milestones and future product royalty payments. Due to our ongoing
involvement obligation, we recorded the non-refundable upfront license fee received under the Baxter
Agreement as deferred revenue when received in February 2007 and will recognize it over the term of
the contract.
Reimbursements of research and development services are recognized as revenues during the period in
which the services are performed. Payments related to substantive, performance-based milestones in
a collaborative agreement are recognized as revenue upon the achievement of the milestones as
specified in the underlying agreements when they represent the culmination of the earnings process.
Royalty revenue from licensed products will be recognized when earned in accordance with the terms
of the license agreements.
Cost of Sales
Cost of sales consists primarily of raw materials, third-party manufacturing costs, fill and finish
costs, and freight associated with the sales of Cumulase, and the API for Hylenex.
Clinical Trial and Contract Research Expenses
Research and development expenditures are charged to operations as incurred in accordance with
Statement of Financial Accounting Standards (SFAS) No. 2 Accounting for Research and
Development Costs. Our expenses related to clinical trials are based on estimates of the services
received and efforts expended pursuant to contracts with multiple research institutions, clinical
research organizations, and other vendors that conduct and manage clinical trials on our behalf.
Share-Based Compensation Expense
On January 1, 2006, we adopted the provisions of revised SFAS No. 123 (SFAS 123(R)), Share-Based
Payment, including the provisions of Staff Accounting Bulletin No. 107 (SAB 107), using the
modified prospective transition method to account for our employee share-based awards. Under SFAS
123(R), share-based compensation cost is measured at the grant date, based on the estimated fair
value of the award, and is recognized as expense over the employees requisite service period. We
have no awards with market or performance conditions. The valuation provisions of SFAS 123(R)
apply to new awards and to awards that are outstanding at the effective date and subsequently
modified or cancelled. Estimated compensation expense for awards outstanding at the effective date
will be recognized over the remaining service period using the compensation cost calculated for pro
forma disclosure purposes under SFAS No. 123, Accounting for Stock-Based Compensation (SFAS 123).
Total compensation expense related to all of our employee share-based awards, recognized under SFAS
123(R), for the three months ended March 31, 2007 and 2006 was comprised of the following:
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2007 |
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2006 |
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Research and development |
|
$ |
145,322 |
|
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$ |
98,580 |
|
Selling, general and administrative |
|
|
270,158 |
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|
174,512 |
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Share-based compensation expense before taxes |
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|
415,480 |
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|
273,092 |
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Related income tax benefits |
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Share-based compensation expense |
|
$ |
415,480 |
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$ |
273,092 |
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Net share-based compensation expense per
basic and diluted share |
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$ |
0.01 |
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|
$ |
0.00 |
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Share-based compensation expense from: |
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Stock options |
|
$ |
360,480 |
|
|
$ |
273,092 |
|
Restricted stock awards |
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|
55,000 |
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Total |
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$ |
415,480 |
|
|
$ |
273,092 |
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4. Inventory
Inventory consists of our Cumulase product and our Hylenex API as of March 31, 2007 and December
31, 2006 as follows:
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2007 |
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2006 |
|
Raw materials |
|
$ |
399,407 |
|
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$ |
337,344 |
|
Work in process |
|
|
63,576 |
|
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|
76,257 |
|
Finished goods |
|
|
12,202 |
|
|
|
28,891 |
|
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|
|
|
|
|
|
$ |
475,185 |
|
|
$ |
442,492 |
|
|
|
|
|
|
|
|
Inventories are used in the manufacture of the Companys Cumulase and Hylenex products and are
stated at the lower of cost or market.
5. Property and Equipment
Property and equipment consist of the following as of March 31, 2007 and December 31, 2006:
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|
2007 |
|
|
2006 |
|
Research equipment |
|
$ |
907,225 |
|
|
$ |
805,077 |
|
Computer and office equipment |
|
|
238,508 |
|
|
|
217,418 |
|
Leasehold improvements |
|
|
215,592 |
|
|
|
179,822 |
|
|
|
|
|
|
|
|
|
|
|
1,361,325 |
|
|
|
1,202,317 |
|
Less accumulated depreciation |
|
|
(789,299 |
) |
|
|
(704,547 |
) |
|
|
|
|
|
|
|
|
|
$ |
572,026 |
|
|
$ |
497,770 |
|
|
|
|
|
|
|
|
Depreciation and amortization expense totaled $86,635 and $52,985, for the three months ended March
31, 2007 and 2006, respectively.
6. Deferred Revenue
Deferred revenue consists of the following as of March 31, 2007 and December 31, 2006:
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|
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|
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|
|
|
2007 |
|
|
2006 |
|
Collaborative agreements |
|
$ |
29,552,337 |
|
|
$ |
19,918,965 |
|
Prepaid royalties |
|
|
1,000,000 |
|
|
|
|
|
Product sales |
|
|
151,240 |
|
|
|
62,572 |
|
|
|
|
|
|
|
|
|
|
|
30,703,577 |
|
|
|
19,981,537 |
|
|
Less: current portion |
|
|
2,896,932 |
|
|
|
1,221,992 |
|
|
|
|
|
|
|
|
Long-term portion |
|
$ |
27,806,645 |
|
|
$ |
18,759,545 |
|
|
|
|
|
|
|
|
Roche Agreement On December 5, 2006, we entered into a license and collaborative agreement with
F. Hoffmann-La Roche Ltd (LTD) and Hoffmann-La Roche Inc. (INC) (LTD and INC, collectively,
Roche) (the Roche Agreement). Under the terms of the Roche Agreement, Roche will obtain a
worldwide, exclusive license to develop and commercialize product combinations of rHuPH20, our
proprietary recombinant human hyaluronidase, and up to thirteen Roche target compounds resulting
from the collaboration. Roche paid us $20 million in December 2006 as an initial upfront payment
for the application of rHuPH20 to three pre-defined Roche biologic targets. Due to our continuing
involvement obligations, revenue from the $20 million upfront payment was deferred and is being
recognized over the term of the agreement. We recognized $289,854 in revenue from license fees in
the three months ended March 31, 2007.
Baxter Agreements On February 13, 2007, we amended certain agreements with Baxter for Hylenex and
entered into a new agreement for kits and co-formulations with rHuPH20. Under the terms of these
agreements, Baxter paid us an initial upfront payment of $10 million. In addition, Baxter will pay
royalties on the sales of products covered under the agreements. Baxter prepaid $1 million of
these royalties in connection with the execution of the agreements and Baxter will be obligated to
prepay $9 million of additional royalties on or prior to January 1, 2009. Due to our continuing
involvement obligations, revenue from the $10 million upfront payment was deferred and is being
recognized over the term of the agreement. We recognized $76,774 in revenue from license fees in
the three months ended March 31, 2007. In addition, the $1 million royalty prepayment was also
deferred and will be recognized as revenue as we earn royalties from the sales of Hylenex.
7. Net Loss Per Common Share
In accordance with SFAS No. 128, Earnings Per Share, and SAB No. 98, basic net loss per common
share is computed by dividing net loss for the period by the weighted average number of common
shares outstanding during
the period. Under SFAS No. 128, diluted net income (loss) per share is computed by dividing the
net income (loss) for the period by the weighted average number of common and common equivalent
shares, such as stock options and warrants, outstanding during the period. Such common equivalent
shares have not been included in the Companys computation of net loss per share as their effect
would have been anti-dilutive.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
Numerator Net loss |
|
$ |
(3,357,304 |
) |
|
$ |
(3,490,194 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator Weighted average shares outstanding |
|
|
69,984,931 |
|
|
|
60,456,462 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share |
|
$ |
(0.05 |
) |
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incremental common shares (not included
because of their anti-dilutive nature) |
|
|
|
|
|
|
|
|
Stock options and awards |
|
|
8,650,443 |
|
|
|
8,599,833 |
|
Stock warrants |
|
|
6,204,006 |
|
|
|
10,458,548 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Potential common equivalents |
|
|
14,854,449 |
|
|
|
19,058,381 |
|
|
|
|
|
|
|
|
8. Stockholders Equity
During January, February and March 2007, holders of the Companys various outstanding warrants
exercised rights to purchase 510,397 common shares for gross proceeds of approximately $357,909.
Warrants to purchase approximately 6.2 million shares of our common stock are outstanding as of
March 31, 2007. During January, February, and March 2007, holders of the Companys various
outstanding options exercised their rights to purchase 283,260 common shares for gross proceeds of
approximately $459,918. Options to purchase approximately 8.7 million shares of our common stock
are outstanding as of March 31, 2007. During February 2007, an affiliate of Baxter purchased
2,070,394 shares of Halozymes common stock for an aggregate of $20 million.
9. Commitments and Contingencies
Operating Leases Our administrative offices and research facilities are currently located in San
Diego, California. We lease 18,400 square feet of office and research space for approximately
$34,000 per month. We have two separate leases for our facilities, which expire in December 2007.
In February 2007, we leased an additional 2,540 square feet of office space in the same building,
commencing on February 22, 2007 and expiring on December 31, 2007. Additionally we lease certain
office equipment under operating leases. Rent expense totaled $95,000 and $62,000 for the three
months ended March 31, 2007 and 2006, respectively.
Material Agreements On February 13, 2007, we amended certain agreements with Baxter for Hylenex
and entered into a new agreement for kits and co-formulations with rHuPH20. Under the terms of
these agreements, Baxter paid us an initial upfront payment of $10 million and, pending the
successful completion of a series of regulatory and sales events, Baxter may make milestone
payments which could potentially reach a value of up to $25 million. In addition, Baxter will pay
royalties on the sales of products covered under the agreements. Baxter prepaid $1 million of
these royalties in connection with the execution of the agreements and Baxter will be obligated to
prepay $9 million of additional royalties on or prior to January 1, 2009. Baxter will also now
assume all development, manufacturing, clinical, regulatory, sales and marketing costs of the
products covered by the agreements. We will continue to supply Baxter with the active
pharmaceutical ingredient, and Baxter will fill and finish Hylenex and hold it for subsequent
distribution. Baxter will obtain a worldwide, exclusive license to develop and commercialize
product combinations of rHuPH20, our proprietary recombinant human hyaluronidase, with Baxter
hydration fluids
and generic small molecule drugs (with the exception of combinations with (i) bisphosphonates, as
well as (ii) cytostatic and cytotoxic chemotherapeutic agents, the rights to which have been
retained by us). Additionally, Baxter will pay royalties on the sales, if any, of the products
that result from the collaboration. In addition, on February 13, 2007, an affiliate of Baxter
purchased 2,070,394 shares of Halozymes common stock for an aggregate of $20 million.
On December 5, 2006, we entered into a license and collaboration Agreement with Roche for Enhanze
Technology. Under the terms of the agreement, Roche will obtain a worldwide, exclusive license to
develop and commercialize product combinations of rHuPH20, our proprietary recombinant human
hyaluronidase, and up to thirteen Roche target compounds resulting from the collaboration. Roche
paid us $20 million as an initial upfront payment for the application of rHuPH20 to three
pre-defined Roche biologic targets. Pending the successful completion of a series of clinical,
regulatory, and sales events, Roche may pay us further milestones which could potentially reach a
value of up to $111 million. In addition, Roche may pay us royalties on potential product sales
for these first three targets. Over the next ten years, Roche will also have the option to
exclusively develop and commercialize rHuPH20 with an additional ten targets to be identified by
Roche, provided that Roche will be obligated to pay continuing exclusivity maintenance fees to us
in order to maintain its exclusive development rights for these targets. For each of the
additional ten targets, Roche may pay us further upfront and milestone payments of up to $47
million per target as well as royalties on potential product sales for each of these additional ten
targets. Additionally, Roche will obtain access to our expertise in developing and applying
rHuPH20 to Roche targets. In addition, on December 5, 2006, an affiliate of Roche purchased
3,385,000 shares of common stock for an aggregate of approximately $11.1 million.
On December 15, 2006, we amended our Commercial Supply Agreement (the Amendment) with Avid
Bioservices, Inc. (Avid) that was originally entered into on February 16, 2005. Under the terms
of the Amendment, we are committed to certain minimum annual purchases equal to two quarters of
forecasted supply of Active Pharmaceutical Ingredient (API). In addition, Avid will have the
right to manufacture and supply a certain percentage of the API that will be used in our Cumulase
and Hylenex products.
On December 30, 2005, we entered into a First Amendment to a November 15, 2002 license agreement
(the Agreement) with the University of Connecticut Health Center (UCHC). The original license
agreement provided for certain payments to be made to UCHC in connection with the development and
commercialization of certain products defined in the Agreement. The First Amendment to the License
Agreement (the First Amendment) calls for payments of a one time Supplemental License Fee of
$25,000, a $250,000 Technology Access Fee and a Technology Fee of $2,500,000 to be paid to UCHC in
annual installments of $250,000 payable in February each year commencing with 2006 and ending 2015.
Other terms of the amendment include a termination clause which allows us to discontinue
commercialization of certain products covered under the Agreement and to cease making the annual
$250,000 payment with a one time termination fee of $250,000. The annual technology fee payments
are recognized to expense on a straight-line basis.
Legal Contingencies In the ordinary course of business, we may face various claims brought by
third parties, including claims relating to the safety or efficacy of our products. Any of these
claims could subject us to costly litigation and, while we generally believe that we have adequate
insurance to cover many different types of liabilities, our insurance carriers may deny coverage or
our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were
to happen, the payment of any such awards could have a material adverse effect on our operations
and financial position. Additionally, any such claims, whether or not successful, could damage our
reputation and business. Currently we are not involved in any litigation.
10. Segment Information
We operate in one segment, which is the research, development and commercialization of recombinant
human enzymes for the drug delivery, palliative care, oncology, and infertility markets. The chief
operating decision-makers review our operating results on an aggregate basis and manage our
operations as a single operating segment.
11. New Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS 157
defines fair value, established a framework for measuring fair value in generally accepted
accounting principles and expands disclosures about fair value measurements. SFAS 157 is effective
for financial statements issued for fiscal years beginning after November 15, 2007. We do not
expect the adoption of SFAS 157 to significantly affect our financial condition or results of
operations.
The Emerging Issues Task Force (EITF) has two issues currently under consideration that may
impact the Company. EITF 07-01, Accounting for Collaboration Arrangements Related to the
Development and Commercialization of Intellectual Property, is focused on how the parties to a
collaborative agreement should account for costs incurred and revenue generated on sales to third
parties, how sharing payments pursuant to a collaboration agreement should be presented in the
income statement and certain related disclosure questions. EITF 07-3, Accounting for
Non-Refundable Advance Payments for Goods or Services to Be Used in Future Research and Development
Activities, is focused on whether non-refundable advance payments for goods that will be used or
services that will be performed in future research and development activities should be accounted
for as research and development costs or deferred and capitalized until the goods have been
delivered or the related services have been rendered. The Company will continue to monitor the
development of these EITFs and evaluate the effects on its financial statements and disclosures.
12. Income Taxes
On July 13, 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income
Taxes An Interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting
for uncertainty in income taxes recognized in an entitys financial statements in accordance with
FASB Statement No. 109, Accounting for
Income Taxes and prescribes a recognition threshold and
measurement attributes for financial statement disclosure of tax positions taken or expected to be
taken on a tax return. Under FIN 48, the impact of an uncertain income tax position on the income
tax return must be recognized at the largest amount that is more-likely-than-not to be sustained
upon audit by the relevant taxing authority. An uncertain income tax position will not be
recognized if it has less than a 50% likelihood of being sustained. Additionally, FIN 48 provides
guidance on derecognition, classification, interest and penalties, accounting in interim periods,
disclosure and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006.
The Company adopted the provisions of FIN 48 on January 1, 2007. The total amount of unrecognized
tax benefits as of the date of adoption is not material. There are no unrecognized tax benefits
included in the balance sheet that would, if recognized, affect the effective tax rate.
The Companys practice is to recognize interest and/or penalties related to income tax matters in
income tax expense. During the three months ended March 31, 2007 and 2006, the Company has not
recognized any interest or penalties. Upon adoption of FIN 48 on January 1, 2007, the Company did
not record any interest or penalties.
The Company is subject to taxation in the US and various state jurisdictions. The Companys tax
years for 1998 and forward are subject to examination by the US and California tax authorities due
to the carryforward of unutilized net operating losses and research and development credits.
The adoption of FIN 48 did not impact our consolidated financial condition, results of operations
or cash flows. At January 1, 2007, we had net deferred tax assets of $17.8 million. The deferred
tax assets are primarily composed of federal and state tax net operating loss (NOL) carryfowards
and federal and state research and development (R&D) credit carryforwards. Due to uncertainties
surrounding our ability to generate future taxable income to realize these assets, a full valuation
has been established to offset our net deferred tax asset. Additionally, the future utilization of
our NOL and R&D credit carryforwards to offset future taxable income may be subject to an annual
limitation as a result of ownership changes that may have occurred previously or that could occur
in the future. We have not yet determined whether such an ownership change has occurred, however,
the Company plans to complete a Section 382 analysis regarding the limitation of the net operating
losses and research and development credits. When this project is completed, the Company plans to
update their unrecognized tax benefits under FIN 48. Therefore, the Company expects that the
unrecognized tax benefits may change within 12 months of this reporting date. At this time, the
Company cannot estimate how much the unrecognized tax benefits may change. Any
carryforwards that will expire prior to utilization as a result of such limitations will be removed
from deferred tax assets with a corresponding reduction of the valuation allowance. Due to the
existence of the valuation allowance, future changes in our unrecognized tax benefits will not
impact our effective tax rate.
13. Subsequent Events
On April 23, 2007, Halozyme Therapeutics, Inc. (Halozyme), and New River Management V, LP (New
River), entered into a definitive stock purchase agreement (the Purchase Agreement). Under the
terms of the Purchase Agreement New River will purchase 3,500,000 newly-issued shares of Halozymes
common stock for an aggregate price of $32,095,000. The sale of the shares is contingent upon the
satisfaction of customary closing conditions, including the receipt of anti-trust clearance. If
the necessary closing conditions are not met on or before July 6, 2007, then either party will have
the right to not proceed with the transaction. The Company anticipates that the sale of the shares
will be completed in late May 2007. Shareholder approval is not required for the sale of the Shares. The Company will not immediately file a registration statement with the
Securities and Exchange Commission (the SEC) covering the resale of the shares, but we have
agreed to file a registration statement with the SEC on or before November 1, 2007, covering the
resale of the shares.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
In addition to historical information, the following discussion contains forward-looking statements
that are subject to risks and uncertainties. Actual results may differ substantially from those
referred to herein due to a number of factors, including but not limited to risks described in the
section entitled Risks Related to Our Business and elsewhere in this Quarterly Report.
Overview
We are a biopharmaceutical company dedicated to the development and commercialization of
recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility
markets. Our existing products and our products under development are based on intellectual
property covering the family of human enzymes known as hyaluronidases. Hyaluronidases are enzymes
(proteins) that break down hyaluronic acid, which is a naturally occurring substance in the human
body. Our technology is based on recombinant human PH20 (rHuPH20), a human synthetic version of
hyaluronidase that degrades hyaluronic acid, a space-filling, gel-like substance that is a major
component of tissues throughout the body, such as skin and cartilage. The PH20 enzyme is a
naturally occurring enzyme that digests hyaluronic acid to temporarily break down the gel, thereby
facilitating the penetration and diffusion of other drugs and fluids that are injected under the
skin or in the muscle. It also degrades the cumulus matrix surrounding oocytes (eggs) facilitating
in vitro fertilization (IVF).
Currently, we have only limited revenue from Cumulase product sales, the sale of the active
pharmaceutical ingredient (API) for Hylenex, and revenue from collaborative agreements with
Baxter and Roche. All of our potential products, with the exception of Cumulase and Hylenex, are
either in the research, pre-clinical, or clinical stage. It may be years, if ever, before we are
able to obtain the regulatory approvals necessary to generate meaningful revenue from the sale of
these product candidates. In addition, we have only generated minimal revenue from our
biopharmaceutical operations and we have had operating and net losses each year since inception,
with an accumulated deficit of $44,456,544 as of March 31, 2007.
We currently have an effective universal shelf registration statement which will permit us,
from time to time, to offer and sell up to $32.5 million of additional equity or debt securities.
Sales of substantial amounts of shares of our common stock pursuant to this registration statement
or in connection with other transactions, or even the potential for such sales through the exercise
of currently outstanding warrants, could lower the market price of our common stock and impair the
Companys ability to raise capital through the sale of equity securities. In the future, we may
also issue additional options, warrants or other derivative securities convertible into Halozyme
common stock to fund the continued development of our product candidates and other general
corporate purposes.
Current Products and Product Candidates
We currently have two FDA-approved products, Cumulase and Hylenex. We also have one product
candidate, Chemophase, which is currently in clinical development. All of our other product
candidates are in the research or pre-clinical stage of development. We received a CE (European
Conformity) Mark for Cumulase in December 2004 and FDA clearance in April 2005. We launched
Cumulase in the European Union and in the United States in June 2005.
During March 2005, we filed a new drug application (NDA) for the spreading agent Hylenex.
Other manufacturers have FDA approved products for use as spreading agents, including ISTA
Pharmaceuticals, Inc. (ISTA), with an ovine (ram) hyaluronidase, Vitrase®, Amphastar
Pharmaceuticals, Inc., with a bovine (bull) hyaluronidase, Amphadase, and Primapharm, Inc. also
with a bovine hyaluronidase, Hydase. The FDA has determined that Amphadase, Hydase, Hylenex and
Vitrase are distinct new chemical entities and hence afforded five years of market exclusivity.
The five year market exclusivity precludes identical new chemical entity products from being
marketed for a period of five years. As each of these products is established as distinctly
different new chemical entities, the marketing exclusivity granted does not prohibit the marketing
of the products. During December 2005, we received FDA approval for our Hylenex NDA.
During June 2005, we submitted an investigational new drug application (IND) in order to
begin clinical testing of our Chemophase® product candidate. We received authorization
to initiate clinical testing of Chemophase in August 2005, and we commenced patient enrollment in
our initial clinical protocol under this IND in October 2005. In March 2006, we completed
enrollment in our Chemophase Phase I clinical trial. In April 2006, we commenced patient
enrollment in our Chemophase Phase I/IIa clinical trial.
Roche Agreement
In December 2006, we entered into a license and collaboration Agreement with Roche for Enhanze
Technology. Under the terms of the agreement, Roche will obtain a worldwide, exclusive license to
develop and commercialize product combinations of rHuPH20, our proprietary recombinant human
hyaluronidase, and up to thirteen Roche target compounds resulting from the collaboration. Roche
paid us $20 million as an initial upfront payment for the application of rHuPH20 to three
pre-defined Roche biologic targets. Pending the successful completion of a series of clinical,
regulatory, and sales events, Roche may pay us further milestones which could potentially reach a
value of up to $111 million. In addition, Roche may pay us royalties on potential product sales
for these first three targets. Over the next ten years, Roche will also have the option to
exclusively develop and commercialize rHuPH20 with an additional ten targets to be identified by
Roche, provided that Roche will be obligated to pay continuing exclusivity maintenance fees to us
in order to maintain its exclusive development rights for these targets. For each of the
additional ten targets, Roche may pay us further upfront and milestone payments of up to $47
million per target as well as royalties on potential product sales for each of these additional ten
targets. Additionally, Roche will obtain access to our expertise in developing and applying
rHuPH20 to Roche targets. In addition, on December 5, 2006, an affiliate of Roche purchased
3,385,000 shares of common stock for an aggregate of approximately $11.1 million.
Baxter Agreements
In February 2007, we amended certain agreements with Baxter for Hylenex and entered into a new
agreement for kits and co-formulations with rHuPH20. Under the terms of these agreements, Baxter
paid us an initial upfront payment of $10 million and, pending the successful completion of a
series of regulatory and sales events, Baxter may make milestone payments which could potentially
reach a value of up to $25 million. In addition, Baxter will pay royalties on the sales of
products covered under the agreements. Baxter prepaid $1 million of these royalties in connection
with the execution of the agreements and Baxter will be obligated to prepay $9 million of
additional royalties on or prior to January 1, 2009. Baxter will also now assume all development,
manufacturing, clinical, regulatory, sales and marketing costs of the products covered by the
agreements. We will continue to supply Baxter with the active pharmaceutical ingredient, and
Baxter will fill and finish Hylenex and hold it for subsequent distribution. Baxter will obtain a
worldwide, exclusive license to develop and commercialize product combinations of rHuPH20, our
proprietary recombinant human hyaluronidase, with Baxter hydration fluids and generic small
molecule drugs (with the exception of combinations with (i) bisphosphonates, as well as (ii)
cytostatic and cytotoxic chemotherapeutic agents, the rights to which have been retained by
us). Additionally, Baxter will pay royalties on the sales, if any, of the products that result
from the collaboration. In addition, on February 13, 2007, an affiliate of Baxter purchased
2,070,394 shares of Halozymes common stock for an aggregate of $20 million.
Revenues
Product revenue will depend on our ability to develop, manufacture, obtain regulatory
approvals for and successfully commercialize our product candidates. We received a CE (European
Conformity) Mark for Cumulase in December 2004, which allows the Company to market Cumulase in the
European Union. In addition, we received FDA clearance for Cumulase in April 2005, which allows
the Company to market Cumulase in the United States. In June 2005, Cumulase was launched in the
European Union and United States. In December 2005, we received FDA approval for Hylenex.
Revenues from collaborative and licensing agreements are recognized based on the performance
requirements of the agreement. Revenue is deferred for fees received before earned. Non-refundable
upfront fees, where we have an ongoing involvement or performance obligation, are recorded as
deferred revenue and recognized as revenue over the contract or development period. In December
2006, we entered into the Roche Agreement which consists of non-refundable upfront license fees,
reimbursements of research and development services and various performance or sales milestones and
future product royalty payments. Due to our ongoing involvement obligation, we recorded the
non-refundable upfront license fee received under the Roche Agreement as deferred revenue when
received in December 2006 and recognized over the term of the contract.
In addition, in February 2007, we entered into the Baxter Agreement which consists of
non-refundable upfront license fees, reimbursements of research and development services and
various performance or sales milestones and future product royalty payments. Due to our ongoing
involvement obligation, we recorded the non-refundable upfront license fee received under the Baxter
Agreement as deferred revenue when received in February 2007 and recognized over the term of the
contract.
Costs and Expenses
Cost of Sales. Cost of sales consists primarily of raw materials, third-party manufacturing
costs, fill and finish costs, and freight costs associated with the sales of Cumulase, and the API
for Hylenex.
Research and Development. Our research and development expenses consist primarily of costs
associated with the development and manufacturing of our product candidates, compensation and other
expenses for research and development personnel, supplies and materials, costs for consultants and
related contract research, clinical trials, facility costs, and depreciation. We charge all
research and development expenses to operations as they are incurred. Our research and development
activities are primarily focused on the development of our Chemophase and Hylenex product
candidates which are both based on our recombinant human PH20 (rHuPH20) enzyme, a human synthetic
version of hyaluronidase. We completed enrollment in our Chemophase Phase I clinical trial in
March 2006 and commenced patient enrollment in our Chemophase Phase I/IIa clinical trial in April
2006.
Since our inception through March 31, 2007, we have incurred research and development costs of
$31.1 million. From January 1, 2002 through March 31, 2007, approximately 51% of our research and
development costs were associated with the research and development of our recombinant human PH20
enzyme used in our Cumulase and Hylenex products and approximately 15% of our research and
development costs were associated with the development of our Chemophase product candidate. Due to
the uncertainty in obtaining FDA approval, our reliance on third parties, and competitive
pressures, we are unable to estimate with any certainty the additional costs we will incur in the
continued development of our Hylenex product and our Chemophase product candidate for
commercialization. However, we expect our research and development costs to increase substantially
if we are able to advance our product candidates into later stages of clinical development.
Clinical development timelines, likelihood of success, and total costs vary widely. Although
we are currently focused primarily on advancing Chemophase, we anticipate that we will make
determinations as to which
research and development projects to pursue and how much funding to direct to each project on
an ongoing basis in response to the scientific and clinical progress of each product candidate and
other market and regulatory developments.
Product candidate completion dates and costs vary significantly for each product candidate and
are difficult to estimate. The lengthy process of seeking regulatory approvals, and the subsequent
compliance with applicable regulations, require the expenditure of substantial resources. Any
failure by us to obtain, or any delay in obtaining, regulatory approvals could cause our research
and development expenditures to increase and, in turn, have a material adverse effect on our
results of operations. We received FDA approval for our Hylenex product candidate in December
2005. We submitted an IND for our Chemophase product candidate in June 2005, and initiated Phase I
clinical trials in October 2005. In March 2006, we completed enrollment in our Chemophase Phase I
clinical trial. In April 2006, we commenced patient enrollment in our Chemophase Phase I/IIa
clinical trial. We cannot be certain when or if our Chemophase product candidate, or any of our
other product candidates, will receive regulatory approval or whether any net cash inflow from our
Chemophase product candidate, or any of our other product candidates, or development projects, will
commence.
Selling, General and Administrative. Selling, general and administrative expenses consist
primarily of compensation and other expenses related to our corporate operations and administrative
employees, accounting and legal fees, other professional services expenses, marketing expenses, as
well as other expenses associated with operating as a publicly traded company. We anticipate
continued increases in selling, general and administrative expenses as our operations continue to
expand.
Interest Income. Interest income consists primarily of income earned on our cash and cash
equivalents. We anticipate increases in interest income due to increases in our cash and cash
equivalents.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on
our financial statements, which have been prepared in accordance with U.S. generally accepted
accounting principles, or U.S. GAAP. The preparation of these financial statements requires us to
make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and
expenses and related disclosure of contingent assets and liabilities. We review our estimates on an
ongoing basis. We base our estimates on historical experience and on various other assumptions that
we believe to be reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities. Actual results may differ from these
estimates under different assumptions or conditions. We believe the following accounting policies
to be critical to the judgments and estimates used in the preparation of our financial statements.
Revenue Recognition
We recognize revenue in accordance with the SECs Staff Accounting Bulletin No. 104, Revenue
Recognition and Emerging Issues Task Force, or EITF, Issue No. 00-21, Revenue Arrangements with
Multiple Deliverables. Revenue is recognized when all of the following criteria are met: (1)
persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been
rendered; (3) the sellers price to the buyer is fixed and determinable; and (4) collectibility is
reasonably assured.
Product Sales
Cumulase revenue is recognized when the transfer of ownership occurs, upon shipment to the
distributor. Accounts receivable is recorded net of an allowance for doubtful accounts.
Currently, the allowance for doubtful accounts is zero as the collectibility of accounts receivable
is reasonably assured. We are not obligated to accept returns for products that have reached their
expiration date. Thus, no allowance for product returns has been established.
Under the terms of our Baxter Agreement, we will supply Baxter the active pharmaceutical
ingredient for Hylenex at our fully burdened cost plus a margin and Baxter will fill and finish
Hylenex and hold it for subsequent
distribution. Because of our continued involvement in the development and production process
of Hylenex under the terms of the Baxter Agreement, the earnings process is not considered to be
complete. Accordingly, we defer revenue and the related product costs resulting from transfers of
the active pharmaceutical ingredient for Hylenex to Baxter until the product is filled, finished,
packaged and released.
Revenues under Collaborative Agreements
Revenues from collaborative and licensing agreements are recognized based on the performance
requirements of the agreement. Revenue is deferred for fees received before earned. Non-refundable
upfront fees, where we have an ongoing involvement or performance obligation, are recorded as
deferred revenue and recognized as revenue over the contract or development period. In February
2007, we entered into the Baxter Agreement which consists of non-refundable upfront license fees,
reimbursements of research and development services and various performance or sales milestones and
future product royalty payments. Due to our ongoing involvement obligation, we recorded the
non-refundable upfront license fee received under the Baxter Agreement as deferred revenue when
received in February 2007 and recognized over the term of the contract.
Reimbursements of research and development services are recognized as revenues during the
period in which the services are performed. Payments related to substantive, performance-based
milestones in a collaborative agreement are recognized as revenue upon the achievement of the
milestones as specified in the underlying agreements when they represent the culmination of the
earnings process. Royalty revenue from licensed products will be recognized when earned in
accordance with the terms of the license agreements.
Share-based Compensation Expense
We grant options to purchase our common stock to our employees, directors and consultants
under our stock option plans. The benefits provided under these plans are share-based payments
subject to the provisions of revised Statement of Financial Accounting Standards No. 123,
Share-Based Payment (SFAS 123(R)). Effective January 1, 2006, we adopted SFAS 123(R), including
the provisions of the SECs Staff Accounting Bulletin No. 107 (SAB 107) and use the fair value
method to account for share-based payments with a modified prospective application which provides
for certain changes to the method for valuing share-based compensation. The valuation provisions of
SFAS 123(R) apply to new awards and to awards that are outstanding on the effective date and
subsequently modified or cancelled. Under the modified prospective application, prior periods are
not revised for comparative purposes. Total compensation cost for our share-based payments
recognized for the three months ended March 31, 2007 was $415,000. Selling, general and
administrative expense and research and development expense for the three months ended March 31,
2007 included share-based compensation of $270,000 and $145,000, respectively. As of March 31,
2007, $3.0 million of total unrecognized compensation costs related to nonvested awards is expected
to be recognized over a weighted average period of 2.0 years.
The fair value of each option award is estimated on the date of grant using a
Black-Scholes-Merton option pricing model (Black-Scholes model) that uses assumptions regarding a
number of complex and subjective variables. These variables include, but are not limited to, our
expected stock price volatility, actual and projected employee stock option exercise behaviors,
risk-free interest rate and expected dividends. Expected volatilities are based on historical
volatility of our common stock and our peer group. The expected term of options granted is based on
analyses of historical employee termination rates and option exercises. The risk-free interest
rates are based on the U.S. Treasury yield in effect at the time of the grant. Since we do not
expect to pay dividends on our common stock in the foreseeable future, we estimated the dividend
yield to be 0%. SFAS 123(R) requires forfeitures to be estimated at the time of grant and revised,
if necessary, in subsequent periods if actual forfeitures differ from those estimates. We estimate
pre-vesting forfeitures based on our historical experience and those of our peer group.
If factors change and we employ different assumptions in the application of SFAS 123(R) in
future periods, the compensation expense that we record under SFAS 123(R) may differ significantly
from what we have recorded in the current period. There is a high degree of subjectivity involved
when using option pricing models to estimate share-based compensation under SFAS 123(R). Certain
share-based payments, such as employee stock options, may expire worthless or otherwise result in
zero intrinsic value as compared to the fair values originally estimated on the grant date and
reported in our financial statements. Alternatively, values may be realized from these instruments
that are significantly in excess of the fair values originally estimated on the grant date and
reported in our financial
statements. There is currently no market-based mechanism or other practical application to
verify the reliability and accuracy of the estimates stemming from these valuation models, nor is
there a means to compare and adjust the estimates to actual values. Although the fair value of
employee share-based awards is determined in accordance with SFAS 123(R) and the SECs Staff
Accounting Bulletin No. 107 (SAB 107) using an option-pricing model, that value may not be
indicative of the fair value observed in a willing buyer/willing seller market transaction.
Clinical Trial and Contract Research Expenses
Research and development expenditures are charged to operations as incurred. Our expenses
related to clinical trials are based on estimates of the services received and efforts expended
pursuant to contracts with multiple research institutions, clinical research organizations, and
other vendors that conduct and manage clinical trials on our behalf. The financial terms of these
agreements are subject to negotiation and vary from contract to contract and may result in uneven
payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed
fee or unit price. Payments under the contracts depend on factors such as the successful enrollment
of patients or the completion of clinical trial milestones. Expenses related to clinical trials
generally are accrued based on contracted amounts applied to the level of patient enrollment and
activity according to the protocol. If timelines or contracts are modified based upon changes in
the clinical trial protocol or scope of work to be performed, we modify our estimates accordingly
on a prospective basis.
In addition, we have several contracts that extend across multiple reporting periods,
including our largest contract representing a $260,000 development contract. We recognize expenses
as the services are provided pursuant to managements assessment of the progress that has been made
to date. Such contracts require an assessment of the work that has been completed during the
period, including measurement of progress, analysis of data that justifies the progress and
managements judgment. Based on Company experience and managements
intimate involvement with
these outsourced contracts, it is reasonably likely that we may experience a 3% variance in our
estimate of the work completed. A 3% variance in our estimate of the work completed in our largest
contract could increase or decrease our operating expenses by $7,800, which would not represent a
material change to historically reported results of operations.
Inventory
Inventory consists of our Cumulase product and our Hylenex API. Inventory primarily represents
raw materials used in production, work in process, and finished goods inventory on hand, valued at
actual cost. Inventories are reviewed periodically for slow-moving or obsolete status. If a launch
of a new product is delayed, inventory may not be fully utilized and could be subject to
impairment, at which point we would record a reserve to adjust inventory to its net realizable
value.
The above listing is not intended to be a comprehensive list of all of our accounting
policies. In many cases, the accounting treatment of a particular transaction is specifically
dictated by U.S. GAAP. There are also areas in which our managements judgment in selecting any
available alternative would not produce a materially different result. Please see our audited
financial statements and notes thereto included elsewhere in our Annual Report on Form 10-K for the
year ended December 31, 2006, which contain accounting policies and other disclosures required by
U.S. GAAP.
Results of Operations Comparison of Three Months Ended March 31, 2007 and 2006
Revenues Product sales were $187,000 for the three months ended March 31, 2007 compared to
$73,000 for the three months ended March 31, 2006, an increase of $114,000, or 156%. Cumulase
product sales were $171,000 and $73,000 and sales of the API for Hylenex were $16,000 and $0 for
the three months ended March 31, 2007 and 2006, respectively.
Revenues under collaborative agreements were $623,000 for the three months ended March 31, 2007
compared to $0 for the three months ended March 31, 2006. Revenues under collaborative agreements
primarily consist of the amortization of upfront fees received from Baxter and Roche of $367,000
and research and development payments from Baxter and Roche of $256,000.
Cost of Sales Cost of sales were $76,000 for the three months ended March 31, 2007 compared to
$23,000 for the three months ended March 31, 2006, an increase of $53,000, or 230%. This was due
to the increase in product sales for Cumulase and the API for Hylenex.
Research and Development Research and development expenses were $2.8 million for the three months
ended March 31, 2007 compared to $2.2 million for the three months ended March 31, 2006. Our
research and development expenses consisted primarily of costs associated with the development and
manufacturing of our product candidates, compensation and other expenses for research and
development personnel, supplies and materials, costs for consultants and related contract research,
facility costs, and depreciation. Research and development expenses increased by $637,000
primarily due to increased clinical trial costs of $344,000, higher compensation costs of $232,000
and increased share-based compensation costs of $47,000. We expect research and development costs
to increase in future periods as we increase our research efforts, expand our clinical trials, and
continue to develop and manufacture our product candidates.
Selling, General and Administrative Selling, general and administrative expenses were $2.0
million for the three months ended March 31, 2007 compared to $1.5 million for the three months
ended March 31, 2006. Selling, general and administrative expenses increased by $454,000 primarily
due to increased compensation costs of $222,000, increased share-based compensation expenses of
$96,000, increased professional fees of $85,000, which were primarily associated with higher audit
and consulting fees related to internal controls documentation and testing under the Sarbanes-Oxley
Act of 2002, and increased marketing costs of $50,000.
Share-Based Compensation Through 2005, we accounted for our stock plans using the intrinsic value
method and recorded no stock based compensation for options granted to employees. Effective at the
beginning of 2006, we adopted Statement of Financial Accounting Standards No. 123(R) (SFAS
123(R)), Share-Based Payment, and elected to adopt the modified prospective application method.
SFAS No. 123(R) requires us to use a fair-valued based method to account for share-based
compensation. Accordingly, share-based compensation cost is measured at the grant date, based on
the fair value of the award, and is recognized as expense over the employees requisite service
period. Total compensation cost for our share-based payments for the three months ended March 31,
2007 was $415,000 compared to $273,000 for the three months ended March 31, 2006. Selling, general
and administrative expense and research and development expense for the three months ended March
31, 2007 include share-based compensation of $270,000 and $145,000, respectively. As of March 31,
2007, $3.0 million of total unrecognized compensation costs related to nonvested awards is expected
to be recognized over a weighted average period of 2.0 years. See Note 3, Summary of Significant
Accounting Policies Share-Based Compensation in the Notes to Condensed Consolidated Financial
Statements for further discussion.
Interest Income Interest income was $723,000 for the three months ended March 31, 2007 compared
to $183,000 for the three months ended March 31, 2006. The increase in interest income was a
result of maintaining higher average cash balances during 2007. We anticipate continued increases
in interest income due to increases in our cash and cash equivalents.
Net Loss Net loss for the three months ended March 31, 2007 was $3.4 million, or $0.05 per common
share, compared to $3.5 million, or $0.06 per common share for the three months ended March 31,
2006. The decrease in net loss was due to an increase in revenues and interest income partially
offset by an increase in operating expenses.
Liquidity and Capital Resources
As of March 31, 2007, cash and cash equivalents were $71.0 million versus $44.2 million as of
December 31, 2006, an increase of $26.8 million. This increase resulted primarily from the $10
million initial up front payment received from Baxter, $1 million in prepaid royalties received
from Baxter, $20.0 million in net proceeds from the sale of common stock to Baxter, and net
proceeds from the exercise of warrants and stock options of $0.8 million during the three months
ended March 31, 2007, offset by our net cash used in operations and for the purchase of property
and equipment for the three months ended March 31, 2007.
Operating activities
Net cash provided by operations was $6.2 million during the three months ended March 31, 2007
compared to $2.8 million of cash used in operations during the three months ended March 31, 2006.
This change was due to the $11 million initial up front payments received from Baxter in 2007 of
which $10.9 million was recorded as deferred revenue.
Investing activities
Net cash used in investing activities was $161,000 during the three months ended March 31,
2007 compared to $39,000 during the three months ended March 31, 2006. This was due to the
increased purchase of property and equipment during the three months ended March 31, 2007.
Financing activities
Net cash provided by financing activities was $20.8 million during the three months ended
March 31, 2007 compared to $1.3 million during the three months ended March 31, 2006. In February
2007, we sold common stock for approximately $20 million, net of issuance costs. Additionally, we
received approximately $0.8 million in net proceeds from warrant and stock option exercises during
the three months ended March 31, 2007.
We expect our cash requirements to increase significantly as we continue to increase our
research and development for, seek regulatory approvals of, and develop and manufacture our current
product candidates. As we expand our research and development efforts and pursue additional
product opportunities, we anticipate significant cash requirements for hiring of personnel, capital
expenditures and investment in additional internal systems and infrastructure. The amount and
timing of cash requirements will depend on the research, development, manufacture, regulatory and
market acceptance of our product candidates, if any, and the resources we devote to researching,
developing, manufacturing, commercializing and supporting our product candidates.
We believe that our current cash and cash equivalents will be sufficient to fund our
operations for at least the next twelve months. Until we can generate significant cash from our
operations, we expect to continue to fund our operations with existing cash resources that were
primarily generated from the proceeds from our recent Roche and Baxter collaborations. We may
finance future cash needs through the sale of other equity securities, the exercise of our callable
warrants, strategic collaboration agreements, debt financing, or any combination of the foregoing.
On June 10, 2005, we filed a shelf registration statement on Form S-3 (Registration No.
333-125731), which was declared effective on June 17, 2005, which initially allowed us, from time
to time, to offer and sell up to $50 million of equity or debt securities. We have previously sold
common stock under this registration statement for an aggregate of approximately $17.5 million, so
we currently have the ability to issue debt and equity securities for an aggregate of $32.5
million. We cannot be certain that our existing cash and cash equivalents will be adequate for our
anticipated needs or that additional financing will be available when needed or that, if available,
financing will be obtained on terms favorable to us or our stockholders. Having insufficient funds
may require us to delay, scale back or eliminate some or all of our research and development
programs or delay the launch of our product candidates. If we raise additional funds by issuing
equity securities, substantial dilution to existing stockholders could result. If we raise
additional funds by incurring debt financing, the terms of the debt may involve significant cash
payment obligations as well as covenants and specific financial ratios that may restrict our
ability to operate our business.
Off-Balance Sheet Arrangements As of March 31, 2007, we did not have any relationships with
unconsolidated entities or financial partnerships, such as entities often referred to as structured
finance or special purpose entities, which would have been established for the purpose of
facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In
addition, we do not engage in trading activities involving non-exchange traded contracts. As such,
we are not materially exposed to any financing, liquidity, market or credit risk that could arise
if we had engaged in these relationships.
Risk Factors
The following information sets forth factors that could cause our actual results to differ
materially from those contained in forward-looking statements we have made in this quarterly report
and those we may make from time to time. For a more detailed discussion of the factors that could
cause actual results to differ, see the Risk Factors section in our Annual Report on Form 10-K
filed with the Securities and Exchange Commission on March 9, 2007.
Risks Related To Our Business
We have generated only minimal revenue from product sales to date; we have a history of net losses
and negative cash flow, and we may never achieve or maintain profitability.
We have generated only minimal revenue from product sales to date and may never generate
significant revenues from future product sales. Even if we do achieve significant revenues from
product sales, licensing revenues and milestone payments, we expect to incur significant operating
losses over the next several years. We have never been profitable, and we may never become
profitable. Through March 31, 2007, we have incurred aggregate net losses of $44,456,544.
We may need to raise funds in the next twelve months, and there can be no assurance that such funds
will be available.
During the next twelve months we may need to raise additional capital to complete the steps
required to continue development of our product candidates and to fund general operations. If we
engage in acquisitions of companies, products, or technology in order to execute our business
strategy, we may need to raise additional capital. We may be required to raise additional capital
in the future through the public offering of securities, collaborative agreements, private
financings and various other equity or debt financings, including calling outstanding warrants to
purchase our common stock.
Currently, warrants to purchase approximately 5.9 million shares of our common stock are
outstanding and this amount of outstanding warrants may make us a less desirable candidate for
investment for some potential investors. Approximately 2.1 million of our outstanding warrants
contain a call feature that, potentially, may allow us to raise funds from the holders of these
warrants. If our common stock closes at a price equal to or greater than $2.00 per share for
twenty consecutive trading days, we have the ability, at our sole discretion, to call warrants
exercisable for up to approximately 1.9 million shares of common stock, provided that we have not
exercised a call right in the preceding three months. Upon such a call, the holders of these
warrants have thirty days to decide whether to either exercise their warrants at a price of $1.75
per share or receive $0.01 from us for each share of common stock that is not exercised. If we
need to raise funds in the future and we wish to utilize this call right, we will not be able to
exercise the call right if we do not meet the minimum closing price condition and, even if we meet
this condition, we cannot be sure of the amounts that will be raised by such a call because some or
all warrant holders may decide not to exercise their warrants.
Considering our stage of development and the nature of our capital structure, if we are
required to raise additional capital in the future, the additional financing may not be available
on favorable terms, or at all. If we are successful in raising additional capital, a substantial
number of additional shares may be issued and these shares will dilute the ownership interest of
our current investors.
If we do not receive and maintain regulatory approvals for our product candidates, we will not be
able to commercialize our products, which would substantially impair our ability to generate
revenues.
With the exception of the December 2004 receipt of a CE (European Conformity) Mark and April
2005 FDA clearance for Cumulase, and the December 2005 FDA approval for Hylenex, none of our
product candidates have received regulatory approval from the FDA or from any similar national
regulatory agency or authority in any other country in which we intend to do business. Approval
from the FDA is necessary to manufacture and market pharmaceutical products in the United States.
Most other countries in which we may do business have similar requirements.
In December 2005, we received FDA approval for Hylenex. Other manufacturers have FDA approved
products for use as spreading agents, including ISTA Pharmaceuticals, Inc. (ISTA), with an
ovine-derived hyaluronidase, Vitrase®, Amphastar Pharmaceuticals, Inc. (Amphastar), with a
bovine-derived hyaluronidase, Amphadase, and Primapharm, Inc. also with a bovine-derived
hyaluronidase, Hydase. The FDA has determined that Amphadase, Hydase, Hylenex and Vitrase are
each distinct new chemical entities and hence afforded five years of market exclusivity. The five
year market exclusivity precludes identical new chemical entity products from being marketed for a
period of five years. For so long as each of these products are established as distinctly
different new chemical entities the marketing exclusivity granted does not prohibit the marketing
of any of these products, including Hylenex. If the FDA changes its earlier determination that
Hylenex is a distinct new chemical entity, our ability to market Hylenex will be materially
impaired.
The processes for obtaining FDA approval are extensive, time-consuming and costly, and there
is no guarantee that the FDA will approve any NDAs that we intend to file with respect to any of
our product candidates, or that the timing of any such approval will be appropriate for our product
launch schedule and other business priorities, which are subject to change. We have not currently
begun the NDA approval process for any of our other potential products, and we may not be
successful in obtaining such approvals for any of our potential products.
We may not receive regulatory approvals for our product candidates for a variety of reasons,
including unsuccessful clinical trials.
Clinical testing of pharmaceutical products is also a long, expensive and uncertain process
and a failure of a clinical trial can occur at any stage. Even if initial results of pre-clinical
studies or clinical trial results are promising, we may obtain different results that fail to show
the desired levels of safety and efficacy, or we may not obtain FDA approval for a variety of other
reasons. The clinical trials of any of our product candidates could be unsuccessful, which would
prevent us from obtaining regulatory approval and commercializing the product. FDA approval can be
delayed, limited or not granted for many reasons, including, among others:
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FDA officials may not find a product candidate safe or effective
enough to merit either continued testing or final approval; |
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FDA officials may not find that the data from pre-clinical testing and
clinical trials justify approval, or they may require additional
studies that would make it commercially unattractive to continue
pursuit of approval; |
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the FDA may reject our trial data or disagree with our interpretations
of either clinical trial data or applicable regulations; |
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the cost of a clinical trial may be greater than what we originally
anticipate, and we may decide to not pursue FDA approval for such a
trial; |
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the FDA may not approve our manufacturing processes or facilities, or
the processes or facilities of our contract manufacturers or raw
material suppliers; |
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the FDA may change its formal or informal approval policies, act
contrary to previous guidance, or adopt new regulations; or |
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the FDA may approve a product candidate for indications that are
narrow or under conditions that place the product at a competitive
disadvantage, which may limit our sales and marketing activities or
otherwise adversely impact the commercial potential of a product. |
If the FDA does not approve our product candidates in a timely fashion on commercially viable
terms or we terminate development of any of our product candidates due to difficulties or delays
encountered in the regulatory approval process, it will have a material adverse impact on our
business and we will be dependent on the development of our other product candidates and/or our
ability to successfully acquire other products and technologies. We may not receive regulatory
approval of Chemophase, or any other product candidates, in a timely manner, or at all.
We intend to market certain of our products, and perhaps have certain of our products
manufactured, in foreign countries. The process of obtaining regulatory approvals in foreign
countries is subject to delay and failure for many of the same reasons set forth above as well as
for reasons that vary from jurisdiction to jurisdiction. The approval procedure varies among
countries and jurisdictions and can involve additional testing. The time required to obtain
approval may differ from that required to obtain FDA approval. We may not obtain foreign
regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by
regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory
authority does not ensure approval by regulatory authorities in other foreign countries or
jurisdictions or by the FDA.
If we fail to comply with regulatory requirements, regulatory agencies may take action against us,
which could significantly harm our business.
Any approved products, along with the manufacturing processes, post-approval clinical data,
labeling, advertising and promotional activities for these products, are subject to continual
requirements and review by the FDA and other regulatory bodies. Regulatory authorities subject a
marketed product, its manufacturer and the manufacturing facilities to continual review and
periodic inspections. We will be subject to ongoing FDA requirements, including required
submissions of safety and other post-market information and reports, registration requirements,
cGMP regulations, requirements regarding the distribution of samples to physicians and
recordkeeping requirements. The cGMP regulations include requirements relating to quality control
and quality assurance, as well as the corresponding maintenance of records and documentation. We
rely on the compliance by our contract manufacturers with cGMP regulations and other regulatory
requirements relating to the manufacture of our products. We are also subject to state laws and
registration requirements covering the distribution of our products. Regulatory agencies may
change existing requirements or adopt new requirements or policies. We may be slow to adapt or may
not be able to adapt to these changes or new requirements.
Later discovery of previously unknown problems with our products, manufacturing processes or
failure to comply with regulatory requirements, may result in any of the following:
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restrictions on our products or manufacturing processes; |
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warning letters; |
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withdrawal of the products from the market; |
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voluntary or mandatory recall;
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fines; |
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suspension or withdrawal of regulatory approvals; |
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suspension or termination of any of our ongoing clinical trials; |
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refusal to permit the import or export of our products; |
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refusal to approve pending applications or supplements to approved applications that we submit; |
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product seizure; and |
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injunctions or the imposition of civil or criminal penalties. |
If our product candidates are approved by the FDA but do not gain market acceptance, our business
will suffer because we may not be able to fund future operations.
Assuming that we obtain the necessary regulatory approvals, a number of factors may affect the
market acceptance of any of our existing product candidates or any other products we develop or
acquire in the future, including, among others:
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the price of our products relative to other therapies for the same or similar treatments; |
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the perception by patients, physicians and other members of the health care community of the
effectiveness and safety of our products for their prescribed treatments; |
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our ability to fund our sales and marketing efforts; |
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the degree to which the use of our products is restricted by the product label approved by the FDA; |
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the effectiveness of our sales and marketing efforts; and |
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the introduction of generic competitors. |
If our products do not gain market acceptance, we may not be able to fund future operations,
including the development or acquisition of new product candidates and/or our sales and marketing
efforts for our approved products, which would cause our business to suffer.
In addition, our ability to market and promote our product candidates will be restricted to
the labels approved by the FDA. If the approved labels are restrictive, our sales and marketing
efforts may be negatively affected.
If we are unable to sufficiently develop our sales, marketing and distribution capabilities or
enter into agreements with third parties to perform these functions, we will not be able to
commercialize products.
We may not be successful in marketing and promoting our existing product candidates or any
other products we develop or acquire in the future. We are currently in the process of developing
our sales, marketing and distribution capabilities. However, our current capabilities in these
areas are very limited. In order to commercialize
any products successfully, we must internally
develop substantial sales, marketing and distribution capabilities, or establish collaborations or
other arrangements with third parties to perform these services. We do not have extensive
experience in these areas, and we may not be able to establish adequate in-house sales, marketing
and distribution capabilities or engage and effectively manage relationships with third parties to
perform any or all of such services. To the extent that we enter into co-promotion or other
licensing arrangements, our product revenues are likely to be lower than if we directly marketed
and sold our products, and any revenues we receive will depend upon the efforts of third parties,
whose efforts may not meet our expectations or be successful.
We have entered into non-exclusive distribution agreements with MediCult AS, a Denmark-based
distributor and MidAtlantic Diagnostics, Inc., a New Jersey-based distributor, to market and sell
our Cumulase product. We have entered into an exclusive sales and marketing agreement with Baxter
Healthcare Corporation (Baxter) to market and sell our Hylenex product candidate in the United
States and Puerto Rico. Baxter also has the right to market and sell Hylenex on an exclusive basis
in all territories outside of the United States, if and when we seek and receive the applicable
regulatory approvals in those territories.
We depend upon the efforts of these third parties to promote and sell our current products,
but there can be no assurance that the efforts of these third parties will meet our expectations or
result in any significant product sales.
If our sole contract manufacturer is unable to manufacture our products, our product development
and commercialization efforts could be delayed or stopped.
We have signed a commercial supply agreement with Avid Bioservices, Inc. (Avid), a contract
manufacturing organization, to produce bulk recombinant human hyaluronidase for clinical trials and
commercial use. Avid will produce the active pharmaceutical ingredient used in each of Cumulase,
Hylenex, Chemophase, and Enhanze Technology under cGMP for commercial scale production and will
provide support for the chemistry, manufacturing and controls sections for FDA regulatory filings.
Avid has only limited experience manufacturing our active pharmaceutical ingredient batches and we
rely on its ability to successfully manufacture these batches according to product specifications.
In addition, as a result of our Roche Agreement, we are required to scale up our active
pharmaceutical ingredient production in order to meet our contractual demands. If Avid does not
maintain its status as an FDA-approved manufacturing facility, is unable to successfully scale our
active pharmaceutical ingredient production, or is unable to manufacture the active pharmaceutical
ingredient used in our products and product candidates for any other reason, the commercialization
of our products and the development of our product candidates will be delayed and our business will
be adversely affected. We have not established and may not be able to establish arrangements with
additional manufacturers for these ingredients or products should the existing supplies become
unavailable or in the event that our sole contract manufacturer is unable to adequately perform its
responsibilities. Any delays or interruptions in the supply of materials by Avid could cause the
delay of clinical trials and could delay or prevent the commercialization of product candidates
that may receive regulatory approval. Such delays or interruptions would have a material adverse
effect on our business and financial condition.
If we have problems with the third parties that prepare, fill, finish, and package our product
candidates for distribution, our product development and commercialization efforts for these
candidates could be delayed or stopped.
In the event that any of our product candidates are used in clinical trials or receive the
necessary regulatory approval for commercialization, we rely on third parties to prepare, fill,
finish, and package the products prior to their distribution. If we are unable to locate third
parties to perform these functions on terms that are economically acceptable to us, the progress of
clinical trials could be delayed or even suspended and the commercialization of approved product
candidates could be delayed or prevented. We currently utilize a third-party to prepare, fill,
finish, and package Cumulase. This third party has only limited experience manufacturing Cumulase
batches and we rely on its ability to successfully manufacture Cumulase according to product
specifications. In addition, one of our distributors, who utilizes our raw material for Cumulase
in production of their proprietary product, is experiencing technical challenges integrating our
raw material into their proprietary manufacturing process. If our third party manufacturer is
unable to successfully manufacture Cumulase, or if our distributor is unable to resolve their
technical issues, we may be unable to supply enough Cumulase product to meet demand. In addition,
we currently utilize a subsidiary of Baxter to prepare, fill, finish, and package Hylenex under a
development and supply
agreement. Baxter has only limited experience manufacturing Hylenex batches
and we rely on its ability to successfully manufacture Hylenex batches according to product
specifications. Any delays or interruptions in Baxters ability to manufacture Hylenex batches
could have a material adverse impact on our business and financial condition.
Developing and marketing pharmaceutical products for human use involves product liability risks,
for which we currently have limited insurance coverage.
The testing, marketing and sale of pharmaceutical products involves the risk of product
liability claims by consumers and other third parties. Although we maintain product liability
insurance coverage, product liability claims can be high in the pharmaceutical industry and our
insurance may not sufficiently cover our actual liabilities. If product liability claims were made
against us, it is possible that our insurance carriers may deny, or attempt to deny, coverage in
certain instances. If a lawsuit against us is successful, then the lack or insufficiency of
insurance coverage could affect materially and adversely our business and financial condition.
Furthermore, various distributors of pharmaceutical products require minimum product liability
insurance coverage before their purchase or acceptance of products for distribution. Failure to
satisfy these insurance requirements could impede our ability to achieve broad distribution of our
proposed products and the imposition of higher insurance requirements could impose additional costs
on us.
Our inability to attract, hire and retain key management and scientific personnel, and to recruit
qualified independent directors, could negatively affect our business.
Our success depends on the performance of key management and scientific employees with
biotechnology experience. Given our small staff size and programs currently under development, we
depend substantially on our ability to hire, train, retain and motivate high quality personnel,
especially our scientists and management team in this field. In addition, we rely on the expertise
and guidance of independent directors to develop business strategies and to guide our execution of
these strategies. Due to changes in the regulatory environment for public companies over the past
few years, the demand for independent directors has increased and it may be difficult for us, due
to competition from both like-sized and larger companies, to recruit qualified independent
directors.
Furthermore, if we were to lose key management personnel, particularly Jonathan Lim, M.D., our
chief executive officer, or Gregory Frost, Ph.D., our chief scientific officer, then we would
likely lose some portion of our institutional knowledge and technical know-how, potentially causing
a substantial delay in one or more of our development programs until adequate replacement personnel
could be hired and trained. For example, Dr. Frost has been with us from soon after our inception,
and he possesses a substantial amount of knowledge about our development efforts. If we were to
lose his services, we would experience delays in meeting our product development schedules. We
have not entered into any retention or other agreements specifically designed to motivate officers
or other employees to remain with Halozyme other than standard agreements relating to the vesting
of stock options that every optionee of Halozyme must enter into as a condition of receiving an
option grant.
We do not have key man life insurance policies on the lives of any of our employees, including
Dr. Lim and Dr. Frost.
Risks Related To Our Stock
Future sales of shares of our common stock upon the exercise of currently outstanding securities or
pursuant to our universal shelf registration statement may negatively affect our stock price.
As a result of our January 2004 private financing transaction, we issued warrants to private
investors for the purchase of 10,461,943 shares of common stock at purchase prices ranging from
$0.77 to $1.75 per share. Currently, approximately 3.3 million shares of common stock remain
issuable upon the exercise of these warrants. As a result of our October 2004 financing
transaction, we issued warrants for the purchase of 2,709,542 shares of common stock at a purchase
of $2.25 per share. The exercise of these warrants could result in significant dilution to
stockholders at the time of exercise which could negatively affect our stock price.
We currently have the ability, from time to time, to offer and sell up to $32.5 million of
additional equity or debt securities under a currently effective universal shelf registration
statement. Sales of substantial amounts of shares of our common stock or other securities under
our universal shelf registration statement could lower the market price of our common stock and
impair the Companys ability to raise capital through the sale of equity securities. In the
future, we may issue additional options, warrants or other derivative securities convertible into
Halozyme common stock.
Our stock price is subject to significant volatility.
We participate in a highly dynamic industry, which often results in significant volatility in
the market price of common stock irrespective of company performance. As a result, our high and
low stock prices during the twelve months ended March 31, 2007 were $9.70 and $2.15, respectively.
We expect our stock price to continue to be subject to significant volatility and, in addition to
the other risks and uncertainties described elsewhere in this report and all other risks and
uncertainties that are either not known to us at this time or which we deem to be immaterial, any
of the following factors may lead to a significant drop in our stock price:
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our failure, or the failure of one of our third-party partners, to comply with the terms of our partnerships; |
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general negative conditions in the healthcare industry; |
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general negative conditions in the financial markets; |
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the failure, for any reason, to obtain FDA approval for any of our products; |
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the failure, for any reason, to secure or defend our intellectual property position; |
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for those products that are approved by the FDA, the failure of the FDA to approve such products in a timely
manner consistent with the FDAs historical approval process; |
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the suspension of our Chemophase clinical trial due to safety or patient tolerability issues; |
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our failure, or the failure of our third-party partners, to successfully commercialize products approved by
the FDA; |
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our failure, or the failure of our third-party partners, to generate product revenues anticipated by
investors; |
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problems with our sole API contract manufacturer or our sole fill and finish manufacturer for Hylenex; |
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the exercise of our right to redeem certain outstanding warrants to purchase our common stock; and |
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the sale of additional debt and/or equity securities by us. |
Trading in our stock has historically been limited, so investors may not be able to sell as much
stock as they want to at prevailing market prices.
Notwithstanding recent increases to the daily trading volume, our stock has historically
traded at a lower daily trading volume. If current trading volumes do not continue and limited
trading in our stock returns, it may be difficult for stockholders to sell their shares in the
public market at any given time at prevailing prices.
Our decision to redeem outstanding warrants may drive down the market price of our stock.
We may have the ability to redeem certain outstanding warrants, under certain conditions, that
may be exercised for approximately 2.1 million shares of common stock. The redemption price for
these warrants is $0.01 per share, but the warrant holders have the opportunity to exercise their
warrants prior to redemption at the price of $1.75 per share. If we decide to redeem any portion
of our outstanding warrants in the future, some selling security holders may choose to sell
outstanding shares of common stock in order to finance the exercise of the warrants prior to their
redemption. This pattern of selling may result in a reduction of our common stocks market price.
Risks Related To Our Industry
Compliance with the extensive government regulations to which we are subject is expensive and time
consuming, and may result in the delay or cancellation of product sales, introductions or
modifications.
Extensive industry regulation has had, and will continue to have, a significant impact on our
business. All pharmaceutical companies, including Halozyme, are subject to extensive, complex,
costly and evolving regulation by the federal government, principally the FDA and, to a lesser
extent, the U.S. Drug Enforcement Administration (DEA) and foreign and state government agencies.
The Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other domestic and
foreign statutes and regulations govern or influence the testing, manufacturing, packaging,
labeling, storing, record keeping, safety, approval, advertising, promotion, sale and distribution
of our products. Under certain of these regulations, Halozyme and its contract suppliers and
manufacturers are subject to periodic inspection of its or their respective facilities, procedures
and operations and/or the testing of products by the FDA, the DEA and other authorities, which
conduct periodic inspections to confirm that Halozyme and its contract suppliers and manufacturers
are in compliance with all applicable regulations. The FDA also conducts pre-approval and
post-approval reviews and plant inspections to determine whether our systems, or our contract
suppliers and manufacturers processes, are in compliance with cGMP and other FDA regulations. If
we, or our contract supplier, fail these inspections, we may not be able to commercialize our
product in a timely manner without incurring significant additional costs, or at all.
In addition, the FDA imposes a number of complex regulatory requirements on entities that
advertise and promote pharmaceuticals, including, but not limited to, standards and regulations for
direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational
activities, and promotional activities involving the Internet.
We are dependent on receiving FDA and other governmental approvals prior to manufacturing,
marketing and shipping our products. Consequently, there is always a risk that the FDA or other
applicable governmental authorities will not approve our products, or will take post-approval
action limiting or revoking our ability to sell our products, or that the rate, timing and cost of
such approvals will adversely affect our product introduction plans or results of operations.
Our suppliers and sole manufacturer are subject to regulation by the FDA and other agencies, and if
they do not meet their commitments, we would have to find substitute suppliers or manufacturers,
which could delay the supply of our products to market.
Regulatory requirements applicable to pharmaceutical products make the substitution of
suppliers and manufacturers costly and time consuming. We have no internal manufacturing
capabilities and are, and expect to be in the future, entirely dependent on contract manufacturers
and suppliers for the manufacture of our products and for their active and other ingredients. The
disqualification of these manufacturers and suppliers through their failure to comply with
regulatory requirements could negatively impact our business because the delays and costs in
obtaining and qualifying alternate suppliers (if such alternative suppliers are available, which we
cannot assure) could delay clinical trials or otherwise inhibit our ability to bring approved
products to market, which would have a material adverse effect on our business and financial
condition.
We may be required to initiate or defend against legal proceedings related to intellectual property
rights, which may result in substantial expense, delay and/or cessation of the development and
commercialization of our products.
We rely on patents to protect our intellectual property rights. The strength of this
protection, however, is uncertain. For example, it is not certain that:
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our patents and pending patent applications cover products and/or technology that we invented first; |
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we were the first to file patent applications for these inventions; |
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others will not independently develop similar or alternative technologies or duplicate our technologies; |
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any of our pending patent applications will result in issued patents; and |
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any of our issued patents, or patent pending applications that result in issued patents, will be held
valid and infringed in the event the patents are asserted against others. |
We currently own or license several U.S. patents and also have pending patent applications.
There can be no assurance that our existing patents, or any patents issued to us as a result of our
pending patent applications, will provide a basis for commercially viable products, will provide us
with any competitive advantages, or will not face third-party challenges or be the subject of
further proceedings limiting their scope or enforceability. Such limitations in our patent
portfolio could have a material adverse effect on our business and financial condition. In
addition, if any of our pending patent applications do not result in issued patents, this could
have a material adverse effect on our business and financial condition.
We may become involved in interference proceedings in the U.S. Patent and Trademark Office to
determine the priority of our inventions. In addition, costly litigation could be necessary to
protect our patent position. We also rely on trademarks to protect the names of our products.
These trademarks may be challenged by others. If we enforce our trademarks against third parties,
such enforcement proceedings may be expensive. We also rely on trade secrets, unpatented
proprietary know-how and continuing technological innovation that we seek to protect with
confidentiality agreements with employees, consultants and others with whom we discuss our
business.
Disputes may arise concerning the ownership of intellectual property or the applicability or
enforceability of these agreements, and we might not be able to resolve these disputes in our
favor.
In addition to protecting our own intellectual property rights, third parties may assert
patent, trademark or copyright infringement or other intellectual property claims against us based
on what they believe are their own intellectual property rights. If we become involved in any
intellectual property litigation, we may be required to pay substantial damages, including but not
limited to treble damages, for past infringement if it is ultimately determined that our products
infringe a third-partys intellectual property rights. Even if infringement claims against us are
without merit, defending a lawsuit takes significant time, may be expensive and may divert
managements attention from other business concerns. Further, we may be stopped from developing,
manufacturing or selling our products until we obtain a license from the owner of the relevant
technology or other intellectual property rights. If such a license is available at all, it may
require us to pay substantial royalties or other fees.
Future acquisitions could disrupt our business and harm our financial condition.
In order to augment our product pipeline or otherwise strengthen our business, we may decide
to acquire additional businesses, products and technologies. As we have limited experience in
evaluating and completing acquisitions, our ability as an organization to make such acquisitions is
unproven. Acquisitions could require significant capital infusions and could involve many risks,
including, but not limited to, the following:
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we may have to issue convertible debt or equity securities to complete
an acquisition, which would dilute our stockholders and could
adversely affect the market price of our common stock; |
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an acquisition may negatively impact our results of operations because
it may require us to incur large one-time charges to earnings,
amortize or write down amounts related to goodwill and other
intangible assets, or incur or assume substantial debt or liabilities,
or it may cause adverse tax consequences, substantial depreciation or
deferred compensation charges; |
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we may encounter difficulties in assimilating and integrating the
business, technologies, products, personnel or operations of companies
that we acquire; |
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certain acquisitions may disrupt our relationship with existing
customers who are competitive with the acquired business; |
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acquisitions may require significant capital infusions and the
acquired businesses, products or technologies may not generate
sufficient revenue to offset acquisition costs; |
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an acquisition may disrupt our ongoing business, divert resources,
increase our expenses and distract our management; |
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acquisitions may involve the entry into a geographic or business
market in which we have little or no prior experience; and |
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key personnel of an acquired company may decide not to work for us. |
If any of these risks occurred, it could adversely affect our business, financial condition
and operating results. We cannot assure you that we will be able to identify or consummate any
future acquisitions on acceptable terms, or at all. If we do pursue any acquisitions, it is
possible that we may not realize the anticipated benefits from such acquisitions or that the market
will not view such acquisitions positively.
If third-party reimbursement and customer contracts are not available, our products may not be
accepted in the market.
Our ability to earn sufficient returns on our products will depend in part on the extent to
which reimbursement for our products and related treatments will be available from government
health administration authorities, private health insurers, managed care organizations and other
healthcare providers.
Third-party payers are increasingly attempting to limit both the coverage and the level of
reimbursement of new drug products to contain costs. Consequently, significant uncertainty exists
as to the reimbursement status of newly approved healthcare products. Third-party payers may not
establish adequate levels of reimbursement for the products that we commercialize, which could
limit their market acceptance and result in a material adverse effect on our financial condition.
Customer contracts, such as with group paying organizations and hospital formularies, will
often not offer contract or formulary status without either the lowest price or substantial proven
clinical differentiation. If our products are compared to animal-extracted hyaluronidases by these
entities, it is possible that neither of these conditions will be met, which could limit market
acceptance and result in a material adverse effect on our financial condition.
The rising cost of healthcare and related pharmaceutical product pricing has led to
cost-containment pressures that could cause us to sell our products at lower prices, resulting in
less revenue to us.
Any of our products that have been or in the future are approved by the FDA may be purchased
or reimbursed by state and federal government authorities, private health insurers and other
organizations, such as health maintenance organizations and managed care organizations. Such
third-party payors increasingly challenge pharmaceutical product pricing. The trend toward managed
healthcare in the United States, the growth of such organizations, and various legislative
proposals and enactments to reform healthcare and government insurance programs, including the
Medicare Prescription Drug Modernization Act of 2003, could significantly influence the manner in
which pharmaceutical products are prescribed and purchased, resulting in lower prices and/or a
reduction in demand. Such cost containment measures and healthcare reforms could adversely affect
our ability to sell our products. Furthermore, individual states have become increasingly
aggressive in passing legislation and implementing regulations designed to control pharmaceutical
product pricing, including price or patient reimbursement constraints, discounts, restrictions on
certain product access, importation from other countries and bulk purchasing. Legally mandated
price controls on payment amounts by third-party payors or other restrictions could negatively and
materially impact our revenues and financial condition. We anticipate that we will encounter
similar regulatory and legislative issues in most other countries outside the United States.
We face intense competition and rapid technological change that could result in the development of
products by others that are superior to the products we are developing.
We have numerous competitors in the United States and abroad, including, among others, major
pharmaceutical and specialized biotechnology firms, universities and other research institutions
that may be developing competing products. Such competitors include, but are not limited to,
Sigma-Aldrich Corporation, ISTA Pharmaceuticals, Inc. (ISTA), Amphastar Pharmaceuticals, Inc., and
Primapharm, Inc., among others. These competitors may develop technologies and products that are
more effective, safer, or less costly than our current or future product candidates or that could
render our technologies and product candidates obsolete or noncompetitive. Many of these
competitors have substantially more resources and product development, manufacturing and marketing
experience and capabilities than we do. In addition, many of our competitors have significantly
greater experience than we do in undertaking pre-clinical testing and clinical trials of
pharmaceutical product candidates and obtaining FDA and other regulatory approvals of products and
therapies for use in healthcare. Other manufacturers have FDA approved products for use as
spreading agents, including ISTA Pharmaceuticals, Inc. (ISTA), with an ovine-derived
hyaluronidase, Vitrase®, Amphastar Pharmaceuticals, Inc., with a bovine-derived
hyaluronidase, Amphadase, and Primapharm, Inc., also with a bovine-derived hyaluronidase, Hydase.
The FDA has determined that Amphadase, Hydase, Hylenex and Vitrase are distinct new chemical
entities and hence afforded five years of market exclusivity. The five year market exclusivity
precludes identical new chemical entity products from being marketed for a period of five years.
As each of these products is established as distinctly different new chemical entities the
marketing exclusivity granted does not prohibit the marketing of the products.
We are exposed to product liability claims, and insurance against these claims may not be available
to us on reasonable terms or at all.
We might incur substantial liability in connection with clinical trials or the sale of our
products. Product liability insurance is expensive and in the future may not be available on
commercially acceptable terms, or at all. We currently carry a limited amount of product liability
insurance. A successful claim or claims brought against us in excess of our insurance coverage
could materially harm our business and financial condition.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our primary exposure to market risk is interest income sensitivity, which is affected by
changes in the general level of U.S. interest rates, particularly because the majority of our
investments are in short-term marketable securities. An immediate 10% change in interest rates
would not have a material effect on the fair market value of our portfolio; therefore, we believe
that we are not subject to any material market risk exposure. We do not have any foreign currency
or other derivative financial instruments.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our
principal executive officer and principal financial officer, we conducted an evaluation of our
disclosure controls and procedures, as such term is defined under Rule 13a-15(e) promulgated under
the Securities Exchange Act of 1934, as amended (the Exchange Act). Based on this evaluation, our
principal executive officer and our principal financial officer concluded that our disclosure
controls and procedures were effective as of the end of the period covered by this Quarterly
Report.
Changes in Internal Control Over Financial Reporting
There have been no significant changes in our internal control over financial reporting that
occurred during the quarter ended March 31, 2007, that have materially affected, or are reasonably
likely to materially affect our internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, Halozyme may be involved in litigation relating to claims arising out of
its operations in the normal course of business. Any of these claims could subject us to costly
litigation and, while we generally believe that we have adequate insurance to cover many different
types of liabilities, our insurance carriers may deny coverage or our policy limits may be
inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment
of any such awards could have a material adverse effect on our results of operations and financial
position. Additionally, any such claims, whether or not successful, could damage our reputation
and business. Halozyme currently is not a party to any legal proceedings, the adverse outcome of
which, in managements opinion, individually or in the aggregate, would have a material adverse
effect on our results of operations or financial position.
Item 1A. Risk Factors
A description of the risk factors associated with our business is included under Risk
Factors in Managements Discussion and Analysis of Financial Condition and Results of
Operations, contained in Item 2 of Part I of this report. This description includes any changes to
and supersedes the description of the risk factors associated with our business previously
disclosed in Item 1 of our 2006 Annual Report on Form 10-K and is incorporated herein by reference.
There are no material changes to the risk factors described in our Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During January, February, and March 2007, holders of the Companys various outstanding
warrants exercised rights to purchase 510,397 common shares for gross proceeds of approximately
$358,000. The shares and
underlying warrants were purchased for investment in a private placement exempt from the
registration requirements of the Securities Act pursuant to Section 4(2) thereof.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Submission of Matters to a Vote of Security Holders
Not applicable.
Item 5. Other Information
Not applicable.
Item 6. Exhibits
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Exhibit |
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Title |
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3.1
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Amended and Restated Articles of Incorporation, as filed with the Nevada Secretary of State on May 4, 2006 (1) |
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3.2
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Certificate of Designation, Preferences and Rights of the terms of the Series A Preferred Stock (1) |
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3.3
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Bylaws as Amended (2) |
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4.1
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Rights Agreement between Corporate Stock Transfer, as rights agent, and Registrant, dated May 4, 2006 (1) |
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10.1
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License Agreement between University of Connecticut and Registrant, dated November 15, 2002 (3) |
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10.2*
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Agreement for Services between Avid Bioservices, Inc. and Registrant, dated November 19, 2003 (3) |
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10.3*
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Distribution Agreement between MidAtlantic Diagnostics, Inc. and Registrant, dated January 30, 2004 (3) |
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10.4*
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Distribution Agreement between MediCult AS and Registrant, dated February 9, 2004 (3) |
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10.5
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2004 Stock Plan and Form of Option Agreement thereunder (4) |
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10.6
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Form of Indemnity Agreement for Directors and Executive Officers (4) |
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10.7
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Form of Callable Stock Purchase Warrant (4) |
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10.8
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Form of Common Stock Purchase Warrant (5) |
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10.9
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DeliaTroph Pharmaceuticals, Inc. 2001 Amended and Restated Stock Plan and form of Stock Option Agreements for options assumed thereunder (6) |
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Exhibit |
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Title |
10.10
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Nonstatutory Stock Option Agreement With Andrew Kim (6) |
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10.11*
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Commercial Supply Agreement with Avid Bioservices, Inc. and Registrant, dated February 16, 2005 (7) |
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10.12
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Halozyme Therapeutics, Inc. 2005 Outside Directors Stock Plan (8) |
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10.13
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Placement Agent Agreement, dated as of December 12, 2005 between Registrant, SG Cowen & Co., LLC, Rodman & Renshaw, LLC and Roth Capital Partners, LLC (9) |
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10.14
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Placement Agent Agreement, dated as of December 13, 2005 between Registrant, SG Cowen & Co., LLC, Rodman & Renshaw, LLC and Roth Capital Partners, LLC (10) |
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10.15
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First Amendment to the License Agreement between University of Connecticut and Registrant, dated January 9, 2006 (11) |
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10.16
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Halozyme Therapeutics, Inc. 2006 Stock Plan (13) |
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10.17
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First Amendment to Standard Industrial Net Lease between Registrant and Sorrento Square, dated as of July 1, 2006 (14) |
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10.18
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Second Amendment to Standard Industrial Net Lease between Registrant and Sorrento Square, dated as of July 1, 2006 (14) |
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10.19
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Form of Stock Option Agreement (2005 Outside Directors Stock Plan) (15) |
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10.20
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Form of Restricted Stock Agreement (2005 Outside Directors Stock Plan) (15) |
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10.21
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Form of Stock Option Agreement (2006 Stock Plan) (15) |
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10.22
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Form of Restricted Stock Agreement (2006 Stock Plan) (15) |
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10.23*
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License and Collaboration Agreement between F. Hoffmann-La Roche Ltd, Hoffmann-La Roche Inc. and Registrant dated December 5, 2006 (16) |
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10.24
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Stock Purchase Agreement between Roche Finance Ltd and Registrant, dated December 5, 2006 (16) |
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10.25*
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First Amendment to the Commercial Supply Agreement between Avid Bioservices, Inc. and Registrant, dated December 15, 2006 (17) |
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10.26*
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Amended and Restated Exclusive Distribution Agreement between Baxter Healthcare Corporation, Baxter Healthcare S.A. and Registrant, dated February 13, 2007 (18) |
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10.27*
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Amended and Restated Development and Supply Agreement between Baxter Healthcare Corporation, Baxter Healthcare S.A. and Registrant, dated February 13, 2007 (18) |
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10.28*
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License and Collaboration Agreement between Baxter Healthcare Corporation, Baxter Healthcare S.A. and Registrant, dated February 13, 2007 (18) |
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10.29
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Stock Purchase Agreement between Baxter International, Inc. and Registrant, dated February 13, 2007 (18) |
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10.30
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Stock Purchase Agreement between New River Management V, LP and Registrant, dated April 23, 2007 (19) |
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21.1
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Subsidiaries of Registrant (12) |
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31.1
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Certification of CEO pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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31.2
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Certification of CFO pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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32.1
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Certification of CEO pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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32.2
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Certification of CFO pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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(1) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed May 8, 2006. |
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(2) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed December 14, 2004, and Exhibit 99.2 of Registrants Current Report on Form 8-K, filed July 6, 2005. |
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(3) |
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Incorporated by reference to the Registrants Registration Statement on Form SB-2 filed with the Commission on April 23, 2004. |
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(4) |
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Incorporated by reference to the Registrants amendment number two to the Registration Statement on Form SB-2 filed with the Commission on July 23, 2004. |
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(5) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed October 15, 2004. |
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(6) |
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Incorporated by reference to the Registrants Registration Statement on Form S-8 filed with the Commission on October 26, 2004. |
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(7) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed February 22, 2005. |
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(8) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed July 6, 2005. |
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(9) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed December 13, 2005. |
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(10) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed December 14, 2005. |
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(11) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed January 12, 2006. |
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(12) |
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Incorporated by reference to the Registrants Annual Report on Form 10-KSB/A, filed March 29, 2005. |
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(13) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed March 24, 2006. |
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(14) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed August 8, 2006. |
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(15) |
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Incorporated by reference to the Registrants Quarterly Report on Form 10-Q, filed August 8, 2006. |
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(16) |
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Incorporated by reference to the Registrants Current Report on Form 8-K/A, filed December 15, 2006. |
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(17) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed December 21, 2006. |
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(18) |
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Incorporated by reference to the Registrants Current Report on Form 8-K/A, filed February 20, 2007. |
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(19) |
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Incorporated by reference to the Registrants Current Report on Form 8-K, filed April 24, 2007. |
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Confidential treatment has been requested for certain portions of this exhibit. These
portions have been omitted from this agreement and have been filed separately with the
Securities and Exchange Commission. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned in the City of San Diego, on May 10,
2007.
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Halozyme Therapeutics, Inc.,
a Nevada corporation
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Date: May 10, 2007 |
By: |
/s/ Jonathan E. Lim
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Jonathan E. Lim, MD |
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Its: |
President, Chief Executive Officer,
(Principal Executive Officer) |
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Date: May 10, 2007 |
By: |
/s/ David A. Ramsay
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David A. Ramsay |
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Its: |
Secretary, Chief Financial Officer
(Principal Financial and Accounting Officer) |
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