Full Press Release Details
TG Therapeutics, Inc. Announces Fourth Quarter and Year-End
2013 Financial Results and Business Update
Investor Conference Call to be held Thursday, March 6, 2014
New York, NY, (March 5, 2014) - TG Therapeutics,
Inc. (TGTX), an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization
of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs, today announced
its financial results for the fourth quarter and year ended December 31, 2013 and provided recent company developments along with
an outlook for 2014.
Financial Results for the Fourth Quarter and Full Year
At December 31, 2013, the Company had cash, cash equivalents,
investment securities, and interest receivable of $45.4 million, as compared to $16.5 million at December 31, 2012.
The consolidated net loss for the year ended December 31, 2013
was $20.5 million, or $0.81 per diluted share, as compared to a consolidated net loss of $26.2 million for the year ended December
31, 2012. Included in the consolidated net loss year ended December 31, 2012 was $16.6 million in noncash stock expense recorded
in conjunction with the license for TG-1101, which was partially offset in the year ended December 31, 2013 by an increase in other
research and development expenses of $8.6 million, principally related to the TG-1101 and TGR-1202 clinical development programs
and drug supply costs. Also included in the consolidated net loss for the year ended December 31, 2013 are the following non-cash
items: $2.8 million for the impairment of in-process research and development expenses; and $5.2 million of non-cash compensation
expense related to equity incentive grants; partially off-set by non-cash income of $3.3 million related to the change in fair
value of notes payable.
The consolidated net loss for the fourth quarter ended December
31, 2013 was $5.7 million, or $0.19 per diluted share, as compared to a consolidated net loss of $3.5 million during the comparable
quarter in 2012. The consolidated net loss for the fourth quarter ended December 31, 2013 included an increase in other research
and development expenses of $2.7 million, principally related to the TG-1101 and TGR-1202 clinical development programs and drug
supply costs. Also included in the consolidated net loss for the fourth quarter ended December 31, 2013 are the following non-cash
items: $2.8 million for the impairment of in-process research and development expenses; and $0.9 million of non-cash compensation
expense related to equity incentive grants; partially off-set by non-cash income of $2.4 million related to the change in fair
value of notes payable.
Recent Developments & Highlights
Key Objectives for 2014
Michael S. Weiss, the Company's Executive Chairman and Interim
Chief Executive Officer, stated, "2013 was an exciting and productive year for TG Therapeutics. In addition to demonstrating
clinical activity of both TG-1101 and TGR-1202, we launched two cutting edge combination clinical trials, TG-1101 plus ibrutinib
and TG-1101 plus TGR-1202, making us the first company to combine a novel glycoengineered anti-CD20 monoclonal antibody with a
B-cell receptor inhibitor. With TG-1101 and TGR-1202 in one company, we believe we are uniquely positioned to harness the broad
potential of these two complementary targeted agents and positions us at the forefront of developing novel non-chemotherapy based
treatment options for patients with B cell malignancies." Mr. Weiss continued, "For 2014, we look forward to presenting
clinical data from our recently started combination studies and ultimately commencing one or more combination registration trials
before year-end for either TG-1101 or TGR-1202 or possibly for both."
The Company will host an investor conference call Thursday,
March 6, 2014, at 8:30am ET, to discuss the Company's fourth quarter and year end 2013 financial results and provide a business
In order to participate in the conference call, please call
1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Year-End 2013 Earnings Call. A live
webcast of the call will be available at www.tgtherapeutics.com on the Events page. The
audio recording of the conference call will be available for replay at www.tgtherapeutics.com,
for a period of 30 days after the call.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical
company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment
of cancer and other underserved therapeutic needs. Currently, the company is developing two therapies targeting hematological malignancies. TG-1101
(ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found
on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta
isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and
survival of B-lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies.
TG Therapeutics is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly
those anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101
and TGR-1202 may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim
the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of
1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully
and cost-effectively complete pre-clinical and clinical trials for TG-1101 and TGR-1202; the risk that early pre-clinical and
clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients
or in future studies; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development
following the completion of the current phase 1 study; the risk that the data (both safety and efficacy) from future clinical
trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer
to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in
line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange
Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We
do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date
hereof. This press release and prior releases are available at www.tgtherapeutics.com.
The information found on our website is not incorporated by reference into this press release and is included for reference purposes
Director- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4484
Email: ir@tgtxinc.com
TG Therapeutics, Inc.
Selected Consolidated Financial Data
Statements of Operations Information
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| License revenue | $ | 38,095 | $ | 19,048 | $ | 152,381 | $ | 19,048 | ||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development: | ||||||||||||||||
| Noncash stock expense associated with in-licensing agreement | -- | -- | -- | 16,578,000 | ||||||||||||
| Noncash compensation | 149,206 | 219,520 | 1,041,519 | 455,809 | ||||||||||||
| Other research and development | 3,606,385 | 860,222 | 12,621,161 | 3,994,182 | ||||||||||||
| Total research and development | 3,755,591 | 1,079,742 | 13,662,680 | 21,027,991 | ||||||||||||
| General and administrative: | ||||||||||||||||
| Noncash compensation | 797,942 | 1,024,072 | 4,161,629 | 2,966,373 | ||||||||||||
| Other general and administrative | 662,728 | 501,123 | 2,496,461 | 1,815,083 | ||||||||||||
| Total general and administrative | 1,460,670 | 1,525,195 | 6,658,090 | 4,781,456 | ||||||||||||
| Impairment of in-process research and development | 2,797,600 | 1,104,700 | 2,797,600 | 1,104,700 | ||||||||||||
| Total costs and expenses | 8,013,861 | 3,709,637 | 23,118,370 | 26,914,147 | ||||||||||||
| Operating loss | (7,975,766 | ) | (3,690,589 | ) | (22,965,989 | ) | (26,895,099 | ) | ||||||||
| Other (income) expense: | ||||||||||||||||
| Interest income | (15,768 | ) | (3,076 | ) | (30,822 | ) | (15,787 | ) | ||||||||
| Other income | (108,894 | ) | -- | (108,894 | ) | (272,232 | ) | |||||||||
| Interest expense | 240,872 | 228,901 | 952,888 | 905,744 | ||||||||||||
| Change in fair value of notes payable | (2,428,124 | ) | (744,360 | ) | (3,300,951 | ) | (1,659,872 | ) | ||||||||
| Total other income | (2,311,914 | ) | (518,535 | ) | (2,487,779 | ) | (1,042,147 | ) | ||||||||
| Consolidated net loss before income taxes | (5,663,852 | ) | (3,172,054 | ) | (20,478,210 | ) | (25,852,952 | ) | ||||||||
| Income taxes | -- | 330,000 | -- | 330,000 | ||||||||||||
| Consolidated net loss | (5,663,852 | ) | (3,502,054 | ) | (20,478,210 | ) | (26,182,952 | ) | ||||||||
| Net loss attributable to non-controlling interest | -- | (42,317 | ) | -- | (8,110,233 | ) | ||||||||||
| Net loss attributable to TG Therapeutics, Inc. and subsidiaries | $ | (5,663,852 | ) | $ | (3,459,737 | ) | $ | (20,478,210 | ) | $ | (18,072,719 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.19 | ) | $ | (0.17 | ) | $ | (0.81 | ) | $ | (1.38 | ) | ||||
| Weighted average shares used in computing basic and diluted net loss per common share | 29,440,013 | 19,776,138 | 25,413,964 | 13,113,758 |
Balance Sheet Information:
| December 31, 2013 | December 31, 2012* | |||||||
| (unaudited) | ||||||||
| Cash, cash equivalents, long-term investment securities and interest receivable | $ | 45,431,532 | $ | 16,455,995 | ||||
| Total assets | 48,112,390 | 22,074,037 | ||||||
| Accumulated deficit | (39,404,003 | ) | (18,925,793 | ) | ||||
| Total equity | 40,054,492 | 15,550,301 |
* Condensed from audited financial statements.