Full Press Release Details
TG Therapeutics, Inc. Announces Fourth Quarter and Year-End
2014 Financial Results and Business Update
Investor Conference Call to be held Thursday, March 12, 2015
New York, NY, (March 11, 2015) - TG Therapeutics,
Inc. (NASDAQ:TGTX) today announced its financial results for the fourth quarter and year ended December 31, 2014 and provided recent
company developments along with a business outlook for 2015.
"2014 was an exciting and productive year for TG Therapeutics
as we continued to aggressively move forward with the development of our lead drug candidates, TG-1101 and TGR-1202. We ended the
year on a high note presenting a significant amount of data at the American Society of Hematology meeting. In addition to very
encouraging data on the combination of TG-1101 and TGR-1202, we also presented data demonstrating high response rates for the combination
of TG-1101 and ibrutinib, data that we believe supports our now on-going Phase 3 trial of that combination being conducted under
a Special Protocol Assessment," stated Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer.
"With TG-1101 and TGR-1202, we believe we have two drug candidates each with safety and efficacy profiles that are differentiated
and uniquely suited for combination therapy, both with other novel agents, but most importantly, together in our proprietary 1303'
combination regimen. For 2015, we plan to focus on recruitment into our GENUINE Phase 3 study, as well as our planned first Phase
3 clinical trial of the combination of TG-1101 and TGR-1202, with a longer term vision toward additional combination trials with
the goal of continuing to push toward better patient outcomes."
Recent Developments & Highlights
Key Objectives for 2015
Financial Results for the Fourth Quarter and Full Year
At December 31, 2014, the Company had cash, cash equivalents,
investment securities, and interest receivable of $78.9 million, as compared to $45.4 million at December 31, 2013.
Pro-forma cash, cash equivalents, investment securities, and
interest receivable as of December 31, 2014 are approximately $98.2 million, including $19.3 million of net proceeds from the utilization
of the Company's at-the-market ("ATM") sales facility during the first quarter of 2015.
Our consolidated net loss for the year ended December 31, 2014,
excluding non-cash items and a one-time upfront cash milestone payment, was approximately $25.3 million. The consolidated net loss
for the year ended December 31, 2014, inclusive of the items above, was $55.8 million, or $1.64 per diluted share, compared to
a consolidated net loss of $20.5 million for the year ended December 31, 2013, representing an increase in consolidated net loss
of $35.3 million. The increase in consolidated net loss during the year ended December 31, 2014 was primarily the result of $8.1
million of expense ($4.1 million of which was non-cash stock expense) recorded in conjunction with the Company's conversion
from a JV agreement to a licensing agreement for TGR-1202, $1.2 million in non-cash stock expense recorded in conjunction with
the licensing arrangement for the IRAK4 inhibitors program, and a $15.9 million increase in non-cash compensation expense related
to equity incentive grants. Exclusive of the items mentioned above, other research and development expenses for TG-1101 and TGR-1202
increased $7.1 million and $3.8 million, respectively, over the comparable period in 2013.
Our consolidated net loss for the fourth quarter ended December
31, 2014, excluding non-cash items, was approximately $13.8 million, which included approximately $8.9 million of manufacturing
and CMC readiness expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the
fourth quarter ended December 31, 2014, inclusive of non-cash items, was $18.8 million, or $0.48 per diluted share, compared to
a consolidated net loss of $5.7 million during the comparable quarter in 2013, representing an increase in consolidated net loss
of $13.1 million. The increase in consolidated net loss during the fourth quarter ended December 31, 2014 was primarily the result
of other research and development expenses for TG-1101 and TGR-1202 increasing $9.0 million and $0.2 million, respectively, over
the comparable period in 2013. The increase in other research and development expenses related to TG-1101 was primarily the result
of increased manufacturing and clinical trial expenses in preparation for the launch of Phase 3 registration programs. Also contributing
to the increase in consolidated net loss during the quarter ended December 31, 2014 was a $4.1 million increase in non-cash compensation
expense related to equity incentive grants.
The Company will host an investor conference call Thursday,
March 12, 2015, at 8:30am ET, to discuss the Company's 2014 financial results and provide a business outlook for 2015.
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 2014 Earnings Call. A live
webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's
website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com,
for a period of 30 days after the call.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. 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. The Company also has a pre-clinical program to develop
IRAK4 inhibitors, as well as an antibody research program to develop anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered
Cautionary Statement
Some of the statements included in this press release, particularly
those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects
for TG-1101, TGR-1202, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies 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, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical
and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1
and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which
underlie certain assumptions of future performance of TGR-1202 will not continue, 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: 212.554.4351
Email: ir@tgtxinc.com
TG Therapeutics, Inc.
Selected Consolidated Financial Data
Statements of Operations Information
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| License revenue | $ | 38,095 | $ | 38,095 | $ | 152,381 | $ | 152,381 | ||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development: | ||||||||||||||||
| Noncash stock expense associated with in-licensing agreements | -- | -- | 5,350,094 | -- | ||||||||||||
| Noncash compensation | 2,329,270 | 149,206 | 8,731,566 | 1,041,519 | ||||||||||||
| Other research and development | 12,807,504 | 3,606,385 | 26,004,687 | 12,621,161 | ||||||||||||
| Total research and development | 15,136,774 | 3,755,591 | 40,086,347 | 13,662,680 | ||||||||||||
| General and administrative: | ||||||||||||||||
| Noncash compensation | 2,709,166 | 797,942 | 12,373,726 | 4,161,629 | ||||||||||||
| Other general and administrative | 913,279 | 662,728 | 3,413,400 | 2,496,461 | ||||||||||||
| Total general and administrative | 3,622,445 | 1,460,670 | 15,787,126 | 6,658,090 | ||||||||||||
| Impairment of in-process research and development | -- | 2,797,600 | -- | 2,797,600 | ||||||||||||
| Total costs and expenses | 18,759,219 | 8,013,861 | 55,873,473 | 23,118,370 | ||||||||||||
| Operating loss | (18,721,124 | ) | (7,975,766 | ) | (55,721,092 | ) | (22,965,989 | ) | ||||||||
| Other (income) expense: | ||||||||||||||||
| Interest income | (16,741 | ) | (15,768 | ) | (55,049 | ) | (30,822 | ) | ||||||||
| Other income | -- | (108,894 | ) | (95,427 | ) | (108,894 | ) | |||||||||
| Interest expense | 234,787 | 240,872 | 930,701 | 952,888 | ||||||||||||
| Change in fair value of notes payable | (142,741 | ) | (2,428,124 | ) | (720,040 | ) | (3,300,951 | ) | ||||||||
| Total other (income) expense | 75,305 | (2,311,914 | ) | 60,185 | (2,487,779 | ) | ||||||||||
| Net loss | (18,796,429 | ) | (5,663,852 | ) | (55,781,277 | ) | (20,478,210 | ) | ||||||||
| Basic and diluted net loss per common share | $ | (0.48 | ) | $ | (0.19 | ) | $ | (1.64 | ) | $ | (0.81 | ) | ||||
| Weighted average shares used in computing basic and diluted net loss per common share | 38,913,211 | 29,440,013 | 34,068,926 | 25,413,964 |
Balance Sheet Information:
| December 31, 2014 | December 31, 2013* | |||||||||||||||
| (Unaudited) | ||||||||||||||||
| Cash, cash equivalents, investment securities and interest receivable | $ | 78,861,334 | $ | 45,431,532 | ||||||||||||
| Total assets | 86,746,890 | 48,112,390 | ||||||||||||||
| Accumulated deficit | (95,185,280 | ) | (39,404,003 | ) | ||||||||||||
| Total equity | 80,101,884 | 40,054,492 |
* Condensed from audited financial statements.