>>Medarex Announces 2006 Fourth Quarter and Year End Financial Results
Wednesday February 28, 4:00 pm ET
PRINCETON, N.J., Feb. 28 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today its financial results for the quarter and year ended December 31, 2006.
Medarex's net loss for the year ended December 31, 2006 was $181.7 million, or ($1.50) per share as compared to a net loss of $148.0 million, or ($1.34) per share for 2005. Medarex's net loss for 2006 includes $10.3 million, or ($0.08) per share representing Medarex's share of the 2006 net loss of Celldex Therapeutics, Inc. (a 60% owned subsidiary of Medarex), a non- cash charge of $19.2 million, or ($0.16) per share for stock based compensation recorded in accordance with FAS 123( R ) adopted effective January 1, 2006, and a non-cash impairment charge of $5.2 million, or ($0.04) per share related to a write-down of Medarex's investment in one its corporate partners. Excluding the impact of these items, Medarex's net loss on a non- GAAP basis for 2006 was $147.0 million, or ($1.21) per share.
Total revenues for the year ended December 31, 2006 were $48.6 million as compared to $51.5 million for 2005.
Research and development (R&D) expenses for the year ended December 31, 2006 increased by $57.6 million, from $136.9 million in 2005 to $194.5 million in 2006. The increase relates primarily to the following: (i) approximately $6.8 million attributable to Celldex's 2006 R&D activities, (ii) approximately $8.6 million of non-cash stock based compensation expense recorded in accordance with FAS 123( R ), and (iii) approximately $15.7 million of increased costs associated with the development of ipilimumab (MDX-010). General and administrative expenses increased by $22.9 million for the year ended December 31, 2006, from $29.0 million in 2005 to $51.9 million in 2006. The 2006 increase is primarily attributable to the following: (i) approximately $9.4 million in legal and other professional fees associated with Medarex's internal investigation of its prior stock option grant practices, (ii) approximately $5.6 million attributable to Celldex's 2006 general and administrative activities, (iii) approximately $6.9 million of non-cash stock based compensation expense recorded in accordance with FAS 123 ( R ), and (iv) approximately $3.7 million represents non-cash stock based compensation expense associated with one of our officers stepping down in November 2006.
Medarex ended 2006 with approximately $341.0 million in cash, cash equivalents, marketable securities and segregated cash. Approximately $14.2 million of this balance relates to Celldex. In addition, the fair market value of Medarex's equity interest in Genmab was approximately $494.4 million.
For the three-month period ended December 31, 2006, Medarex reported a net loss of $57.7 million, or ($0.46) per share. This compares to a net loss of $45.6 million, or ($0.41) per share for the three-month period ended December 31, 2005. Included in the consolidated net loss for the three-month period ended December 31, 2006 is a net loss of $3.2 million, or ($0.03) per share representing Medarex's share of the net loss of Celldex for the period; a non- cash charge of $7.1 million, or ($0.06) per share for stock based compensation expense recorded in accordance with FAS 123( R ); and a non-cash impairment charge of $5.2 million, or ($0.04) per share related to a write-down of Medarex's investment in one of its corporate partners. Excluding the impact of these items, Medarex's net loss on a non-GAAP basis for the three-month period ended December 31, 2006 was $42.2 million, or ($0.34) per share.
Non-GAAP Financial Measurements
This press release and the accompanying tables include non-GAAP financial measures. For a description of these non-GAAP financial measures, including the reasons management uses each measure, and reconciliations of these non- GAAP financial measures to the most directly comparable financial measures prepared in accordance with Generally Accepted Accounting Principles, please see the section of the accompanying tables titled "NON-GAAP Financial Measures".
Medarex's product development and business accomplishments during the fourth quarter of 2006 include the following:
- Completing enrollment of the 150 patient pivotal registrational trial
evaluating ipilimumab (also known as MDX-010) as a monotherapy for the
treatment of second-line (previously treated) metastatic melanoma;
- Announcing the grant of fast track designation by the U.S. Food and Drug
Administration (FDA) for ipilimumab used as a monotherapy in second-line
metastatic melanoma patients, as well as in combination with
chemotherapy in first-line (previously untreated) metastatic melanoma
patients;
- Announcing complete and partial response data from a Phase I clinical
trial in patients with lymphoma treated with a single-dose of ipilimumab
after relapse of their tumor following allogeneic hematopoietic stem
cell transplantation;
- Receiving an undisclosed milestone payment from Amgen, Inc. for the
advancement of Amgen's fourth UltiMAb®-derived antibody into clinical
development;
- Announcing at the annual meeting of the Infectious Diseases Society of
America Phase I safety results in healthy volunteers for Valortim(TM)
(also known as MDX-1303), a fully human antibody for anthrax that is
being jointly developed with PharmAthene, Inc.;
- Announcing with PharmAthene, Inc. the grant of $1.0 million in funding
from the 2007 U.S. Department of Defense Appropriations bill for the
development of Valortim(TM); and
- Collaborating with PacMab Limited for the development of a fully human
antibody for the treatment of blood cancer.
In addition to fourth quarter events, other 2006 highlights include:
- Expanding the ipilimumab registrational program with the initiation of
two separate registrational studies each under separate Special Protocol
Assessment (SPA) agreements with the FDA, one for monotherapy treatment
of second-line metastatic melanoma and one for combination chemotherapy
(dacarbazine) treatment of first-line metastatic melanoma;
- Presenting encouraging Phase II and Phase I clinical data from multiple
ipilimumab trials for the treatment of hormone refractory prostate
cancer in combination with chemotherapy or in combination with
immunotherapies, such as GM-CSF or the Cell Genesys, Inc. product,
GVAX®, at the annual meeting of the American Society of Clinical
Oncology (ASCO);
- Announcing at the annual meeting of ASCO and follow-up data at the
EORTC-AACR-NCI meeting interim ipilimumab Phase II clinical data
indicating the safety, tolerability, and potential association with
relapse prevention in the melanoma adjuvant setting, where 24 of 25
patients with resected Stage IIIc or Stage IV melanoma were alive at 18
months of median follow-up;
- Initiating a Phase I clinical trial of MDX-1106, a fully human anti-PD-1
antibody, for the treatment of cancer that is being developed with Ono
Pharmaceutical Co. Ltd.;
- Filing an Investigational New Drug (IND) application for MDX-1388, a
fully human antibody being developed with Massachusetts Biologic
Laboratories that targets C. difficile Toxin B, for the treatment of C.
difficile-acquired diarrhea (CDAD);
- Presenting at the Digestive Diseases Week meeting Phase I safety data
for MDX-066, a fully human antibody being developed with Massachusetts
Biologic Laboratories that targets C. difficile Toxin A, for the
treatment of CDAD;
- Initiating a Phase II clinical trial of MDX-1388 in combination with
MDX-066 for the treatment of CDAD;
- Announcing the IND filings by licensing partners ImClone Systems
Incorporated for an undisclosed anti-cancer antibody; by NovImmune SA
for NI-0401, for a fully human anti-CD3 antibody for the treatment of
autoimmune disease; and by two undisclosed partners for two separate
undisclosed programs;
- Announcing with PharmAthene, Inc. the grant of orphan drug status and
fast track designation by the U.S. Food and Drug Administration for
Valortim(TM) for the treatment of anthrax infection, as well as the
receipt of $2.05 million in funding from the 2006 U.S. Department of
Defense Appropriations bill;
- Entering into a licensing agreement with Organon, the human health care
business unit of Akzo Nobel, to develop fully human antibodies for the
treatment of a variety of diseases;
- Collaborating with Ono Pharmaceutical Co., Ltd., for the research and
development of a fully human anti-SDF-1 antibody for the potential
treatment of multiple indications;
- Entering into strategic partnerships with Celera Genomics (an Applera
Corporation business), GenPat77 Pharmacogenetics AG, Oxford Genome
Sciences (UK) Ltd. and Euroscreen s.a. for developing fully human
antibody products for cancer and other diseases; and
- Completing an offering of Medarex common stock to raise approximately
$128 million.
"2006 was an exciting year for Medarex across our product pipeline, and in particular, we made terrific strides in advancing our lead program, ipilimumab, toward commercialization, with the initiation of two additional melanoma registrational studies in both the second-line and first-line settings and the completion of enrollment of the monotherapy registrational study," said Irwin Lerner, Interim President and CEO of Medarex. "We believe that the efforts made by us and our partners to develop innovative and potentially important therapeutics, supported by our strong business fundamentals and strategic funding opportunities, will continue to build and augment the intrinsic value of the pipeline."
Subsequent accomplishments thus far in 2007 include:
- Adding approximately $152 million to our cash resources through the sale
of approximately 2.5 million shares of Genmab A/S common stock, bringing
Medarex's equity ownership in Genmab to approximately 11%;
- Filing the IND for MDX-1401, a fully human anti-CD30 antibody for the
treatment of Hodgkin's disease;
- Announcing the IND filing by licensing partner, ImClone Systems, for
IMC-3G3, a fully human antibody for the treatment of cancer; and
- Collaborating with Compugen Ltd. to develop antibodies for the treatment
of cancer and autoimmune diseases.
Medarex will hold a public conference call today, February 28, 2007, at 4:30 PM Eastern Time to discuss earnings and other business results. To access the call live, please dial 1-800-591-6923 within the U.S. or 1-617-614-4907 outside the U.S. The conference call passcode number is 67798978. The call will also be broadcast live via the Internet at www.medarex.com/Investor/Webcasts.htm. An archived broadcast of the call will be available until midnight Eastern Time, March 14, 2007. The archive may be accessed via the Internet at www.medarex.com or by dialing 1-888-286-8010 within the U.S. or 1-617-801-6888 outside the U.S. The archive conference call passcode number is 77716602.<<
snip
Guess we gotta listen to the CC for details on guidance of various kinds.
Cheers, Tuck |
