Attached files
| file | filename |
|---|---|
| 8-K - 8-K - DYNAVAX TECHNOLOGIES CORP | dvax-8k_20150305.htm |
Exhibit 99.1
DYNΛVAX
INNOVATING IMMUNOLOGY
2929 Seventh Street, Suite 100
Berkeley, CA 94710
DYNAVAX REPORTS FOURTH QUARTER AND YEAR END 2014
FINANCIAL RESULTS
BERKELEY, CA – March 5, 2015 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2014.
The Company had $122.7 million in cash, cash equivalents and marketable securities as of December 31, 2014. Loss from operations of $91.3 million for the year ended December 31, 2014 increased by $24.8 million compared to the year ended December 31, 2013 primarily as a result of expenses relating to conduct of clinical trials. A Phase 3 clinical trial of hepatitis B vaccine HEPLISAV-B™ (known as HBV-23) was initiated in the second quarter of 2014 and an independent Data and Safety Monitoring Board (DSMB) reviewed available data in early November 2014 and late February 2015 and recommended continuation of the trial without change. A Phase 1/2 study of SD-101 in combination with local radiation for the treatment of indolent lymphoma was initiated in the fourth quarter.
The net loss allocable to common stockholders for the twelve months ended December 31, 2014 was $90.7 million, or $3.45 per basic and diluted share. The net loss allocable to common stockholders for the twelve months ended December 31, 2013 was $75.2 million, or $3.83 per basic and diluted share, which includes a one-time non-cash deemed dividend of $8.5 million related to the beneficial conversion feature of the Series B Convertible Preferred Stock.
About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.
About SD-101
SD-101 is a proprietary, second-generation, TLR 9 agonist CpG oligodeoxynucleotide (CPG ODN). In preclinical studies, TLR 9 agonists have shown activity as monotherapy or in combination with various interventions, including immunotherapeutic and tumor-specific antibodies. SD-101 has been evaluated in two Phase 1 studies to assess its preliminary safety and tolerability.
About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.
– tables to follow –
DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
|
|
Three Months Ended |
|
|
Years Ended |
|
||||||||||
|
|
December 31, |
|
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December 31, |
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||||||||||
|
|
2014 |
|
|
2013 |
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|
2014 |
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|
2013 |
|
||||
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
$ |
1,734 |
|
|
$ |
1,580 |
|
|
$ |
7,933 |
|
|
$ |
4,929 |
|
|
Grant revenue |
|
142 |
|
|
|
1,283 |
|
|
|
2,688 |
|
|
|
5,138 |
|
|
Service and license revenue |
|
401 |
|
|
|
(16 |
) |
|
|
411 |
|
|
|
1,184 |
|
|
Total revenues |
|
2,277 |
|
|
|
2,847 |
|
|
|
11,032 |
|
|
|
11,251 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
19,638 |
|
|
|
12,131 |
|
|
|
84,580 |
|
|
|
50,870 |
|
|
General and administrative |
|
5,052 |
|
|
|
3,700 |
|
|
|
17,377 |
|
|
|
25,943 |
|
|
Unoccupied facility expense |
|
- |
|
|
|
8 |
|
|
|
386 |
|
|
|
926 |
|
|
Total operating expenses |
|
24,690 |
|
|
|
15,839 |
|
|
|
102,343 |
|
|
|
77,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(22,413 |
) |
|
|
(12,992 |
) |
|
|
(91,311 |
) |
|
|
(66,488 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
29 |
|
|
|
(47 |
) |
|
|
191 |
|
|
|
116 |
|
|
Interest expense |
|
(35 |
) |
|
|
83 |
|
|
|
(35 |
) |
|
|
- |
|
|
Other income (expense), net |
|
133 |
|
|
|
(100 |
) |
|
|
433 |
|
|
|
(348 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(22,286 |
) |
|
$ |
(13,056 |
) |
|
$ |
(90,722 |
) |
|
$ |
(66,720 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock deemed dividend |
|
- |
|
|
|
(8,469 |
) |
|
|
- |
|
|
|
(8,469 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss allocable to common stockholders |
$ |
(22,286 |
) |
|
$ |
(21,525 |
) |
|
$ |
(90,722 |
) |
|
$ |
(75,189 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share allocable to common stockholders |
$ |
(0.85 |
) |
|
$ |
(0.91 |
) |
|
$ |
(3.45 |
) |
|
$ |
(3.83 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per share allocable to common stockholders |
|
26,298 |
|
|
|
23,588 |
|
|
|
26,289 |
|
|
|
19,628 |
|
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
|
|
December 31, |
|
|
December 31, |
|
||
|
|
2014 |
|
|
2013 |
|
||
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
122,652 |
|
|
$ |
189,376 |
|
|
Property and equipment, net |
|
7,924 |
|
|
|
8,706 |
|
|
Goodwill |
|
2,277 |
|
|
|
2,579 |
|
|
Other assets |
|
5,437 |
|
|
|
3,961 |
|
|
Total assets |
$ |
138,290 |
|
|
$ |
204,622 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Deferred revenues |
$ |
12,765 |
|
|
$ |
7,298 |
|
|
Other liabilities |
|
15,484 |
|
|
|
11,030 |
|
|
Long-term debt |
|
9,559 |
|
|
|
- |
|
|
Total liabilities |
|
37,808 |
|
|
|
18,328 |
|
|
Stockholders’ equity |
|
100,482 |
|
|
|
186,294 |
|
|
Total liabilities and stockholders’ equity |
$ |
138,290 |
|
|
$ |
204,622 |
|
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