On May 8, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering, developing and commercializing novel vaccines and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2019 (Press release, Dynavax Technologies, MAY 8, 2019, View Source [SID1234535937]).
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"HEPLISAV-B net product revenue was $5.6 million for the first quarter of this year, which was in line with our expectations," said Eddie Gray, chief executive officer of Dynavax. "As the only two-dose hepatitis B vaccine, we are focused on making HEPLISAV-B the standard of care hepatitis B adult vaccine in the U.S. On the immuno-oncology development front, we will have three SD-101 data presentations at ASCO (Free ASCO Whitepaper)."
First Quarter and Recent Business Highlights
HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]
First quarter 2019 sales of $5.6 million compared to $3.9 million in the fourth quarter 2018
The company has achieved sales into 3 of the 4 top national retail pharmacy chains, and contracting efforts are underway to secure additional pharmacy partners
More than 1,454 individual customers have purchased HEPLISAV-B since launch
Only 4% of doses sold to date were to customers who have not reordered after at least 45 days
15 of the top 20 Integrated Delivery Networks (IDNs) have made HEPLISAV-B available to order
557 of the targeted 1,419 accounts have made HEPLISAV-B available to order, representing 50% of the targeted adult hepatitis B market
164 of the top 300 targeted customers have ordered HEPLISAV-B
In May, the company announced the enrollment of the first patient in an open-label, single-arm study of HEPLISAV-B in adults with end-stage renal disease who are initiating or undergoing hemodialysis. The study is designed to evaluate immunogenicity and safety.
Immuno-oncology
SD-101
Three Dynavax abstracts have been accepted for presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting 2019 in June.
Abstract #6039, "Phase 1b/2, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naive patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)"
Abstract #9534, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy"
Abstract #9555, "Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy"
DV281
Dynavax presented phase 1b data on inhaled DV281 TLR9 agonist at the 2019 AACR (Free AACR Whitepaper) Annual Meeting. Key highlights from the clinical data presentation include:
In this safety study, two doses of DV281 monotherapy followed by combination with nivolumab was well tolerated
Inhalation of DV281 leads to dose-dependent target engagement as measured by induction of IFN-regulated genes at all evaluated dose levels
DV281 plus nivolumab demonstrates early signs of antitumor activity in heavily pretreated patients
Financial Results
Product Revenue, Net. Dynavax’s first commercial product, HEPLISAV-B, was launched in the first quarter of 2018. Net product revenue for the first quarter of 2019 was $5.6 million, compared to $0.2 million for the first quarter of 2018. Product revenue from sales is recorded at the net sales price, which includes estimates of product returns, chargebacks, discounts and other fees.
Cost of Sales – Product. Cost of sales – product, for the first quarter of 2019 was $1.8 million, compared to $0.2 million for the first quarter of 2018. Included in cost of sales – product, are fill, finish and overhead costs for HEPLISAV-B incurred after U.S. Food and Drug Administration (FDA) approval. A higher percentage of HEPLISAV-B inventory sold in 2019 used components manufactured after FDA approval compared to 2018, when most of the expense associated with product sold was expensed to research and development prior to approval. The company expects its HEPLISAV-B cost of sales to increase in future periods as it produces and then sells inventory that reflects the full cost of manufacturing the product.
R&D Expenses. Research and development expenses for the first quarter of 2019 were $21.2 million, compared to $19.0 million for the first quarter of 2018. The increase reflects additional personnel and clinical trial expense for ongoing development of SD-101 and DV281.
SG&A. Selling, general and administrative expenses for the first quarter of 2019 were $18.3 million, compared to $16.9 million for the first quarter of 2018. The increase was due primarily to additional personnel in support of HEPLISAV-B commercial activities.
Net Loss. Net loss for the first quarter of 2019 was $39.7 million, or $0.62 per basic and diluted share, compared to a net loss of $39.0 million, or $0.63 per basic and diluted share, for the first quarter of 2018.
Cash Position. Cash, cash equivalents and marketable securities totaled $183.2 million at March 31, 2019, compared to $145.5 million at December 31, 2018. In March 2019, Dynavax exercised its option to draw down $75 million of non-dilutive capital under its existing term loan agreement with CRG Servicing LLC.
Conference Call and Webcast Information
Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. To access the call, participants may dial (855) 327-6837 (domestic) or (631) 891-4304 (international) and refer to conference ID 10006654. The live call will be webcast and can be accessed in the "Investors and Media" section of the company’s website at www.dynavax.com. A replay of the webcast will be available for 30 days following the live event.
About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.ii There is no cure for hepatitis B, but effective vaccination can prevent the disease.
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.iv Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.v
About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.
For more information about HEPLISAV-B, visit View Source
About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 1b/2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.
About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an inhaled therapy. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.