On March 8, 2018 INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported financial results for its fourth quarter and full year ended Dec. 31, 2017 (Press release, Insys Therapeutics, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337183 [SID1234524561]).

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OVERALL HIGHLIGHTS

Achieved gross revenue of $46.1 million, resulting in net revenue of $31.5 million.
Advanced product pipeline with total R&D investment of $16.4 million.
Completed pharmacokinetics (PK) study of naloxone nasal spray as investigational treatment of opioid overdose.
Completed FDA filing of NDA for buprenorphine sublingual spray as investigational treatment for moderate-to-severe acute pain.
Initiated Phase 2 clinical trial of cannabidiol (CBD) oral solution as investigational treatment for medically refractory childhood absence epilepsy.
Enrolled first patient in proof-of-concept study of epinephrine nasal spray as investigational treatment for anaphylaxis.
Received ‘Fast Track’ designation from FDA for CBD oral solution as investigational treatment for Prader-Willi syndrome.
Settled lawsuit with one major health insurer.
"Over the course of 2017, we implemented a series of significant changes that set the foundation for a new strategic direction for the company as a leader in pharmaceutical cannabinoids and spray technologies," said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. "This foundation was built around new leadership and elevated capabilities at all levels of the organization, which has allowed us to aggressively reposition and advance our product pipeline. Most importantly, this foundation establishes an unwavering commitment to enhance the quality of life for underserved patient populations, and we look forward to finding solutions for a number of orphan diseases through our R&D programs."

Motahari continued, "In the fourth quarter, we continued our efforts to stabilize SUBSYS despite the declining market for TIRF medications by securing several managed care wins that went into effect in January 2018. We also continued our controlled rollout of SYNDROS during the period. As a result, we intend to achieve top-line stability in 2018 in parallel with our ongoing transformation of the company."

Motahari concluded, "We believe our R&D in both pharmaceutical cannabinoids and spray technology platforms will propel INSYS to a strong market position for the coming years."

Financial & Operating Highlights

Net revenue for the fourth quarter of 2017 was $31.5 million, compared to $54.9 million for the fourth quarter of 2016.
Gross margin was 85.4 percent for the fourth quarter of 2017, compared to 82.1 percent in the same period of 2016.
Sales and marketing investment was $7.1 million for the fourth quarter of 2017, compared to $13.5 million for the fourth quarter of 2016.
Research and development investment increased to $16.4 million for the fourth quarter of 2017, compared to $15.5 million for the same period in 2016.
General and administrative expense increased to $19.7 million for the fourth quarter of 2017 from $15.8 million for the fourth quarter of 2016.
Income tax expense was $26.8 million for the fourth quarter of 2017 and included a $7.5 million charge related to the change in tax code and $22.6 million of expense to fully reserve our deferred tax assets, compared to an expense of $0.3 million during the fourth quarter of 2016.
Net loss for the fourth quarter of 2017 was $47.0 million, or ($0.65) per basic and diluted share, compared to a net loss of $3.7 million, or ($0.05) per basic and diluted share, for the fourth quarter of 2016.
Adjusted EBITDA loss for the fourth quarter of 2017 was $11.5 million, compared to Adjusted EBITDA of $6.1 million in the prior-year quarter. The reconciliation of net income to Adjusted EBITDA is included at the end of this news release.
The company had $163.9 million in cash, cash equivalents, and short-term and long-term investments with no debt as of Dec. 31, 2017.

Webcast Information

A conference call is scheduled for 5:00 p.m. Eastern Standard Time on March 8, 2018, to discuss the financial and operational results for the fourth quarter of and full year 2017. Interested parties can listen to the call live via the company’s website, View Source, on the INVESTORS section Presentations & Events page; or by dialing 844-263-8304 (from inside the U.S.) or 213-358-0958 (from outside the U.S.). A webcasted replay of the call will be available on the site a few hours after the event.

On March 8, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will host a conference call on Thursday, March 15, 2018, at 4:30 p.m. ET to review its fourth quarter and full year 2017 financial results and provide an update on the company (Press release, Infinity Pharmaceuticals, MAR 8, 2018, View Source [SID1234524560]).

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A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 5558799. An archived version of the webcast will be available on Infinity’s website for 30 days.

On March 8, 2018 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, Dynavax Technologies, MAR 8, 2018, View Source [SID1234524559]). The net loss for the year ended December 31, 2017, was $95.2 million, or $1.81 per share, compared to $112.4 million, or $2.92 per share, for the year ended December 31, 2016.

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Recent Highlights

Received FDA approval of first and only two-dose hepatitis B vaccine, HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for prevention of infection caused by all known subtypes of the virus in adults age 18 years and older

Launched HEPLISAV-B in the U.S. with a 60-person field sales team covering over 75% of the target market

HEPLISAV-B recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) for use in the vaccination of adults, which is a critical milestone to drive broad insurance coverage and adoption for HEPLISAV-B

$100 million received in initial tranche of $175 million non-dilutive term loan agreement to support commercial efforts and advance and expand immuno-oncology platform

"On the heels of HEPLISAV-B’s FDA approval, we entered 2018 positioned to achieve significant milestones and are excited about our accomplishments to date," said Eddie Gray, Chief Executive Officer of Dynavax. "We have strengthened our balance sheet with a non-dilutive financing, enabling us to focus on value creation for our shareholders through both our commercial and clinical development programs. Our commercial team has done an excellent job launching HEPLISAV-B and executing our strategy to ensure we build a solid foundation to drive sales as the year progresses. We are confident that the HEPLISAV-B two-dose in one month administration and the earlier and higher seroprotection rates demonstrated versus ENGERIX-B will make it the new standard of care."

"Equally exciting are the opportunities to generate significant additional value for Dynavax as we report clinical data from our immuno-oncology clinical trials. Data from the phase 2 studies of our lead oncology product candidate, SD-101, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, are expected to be presented at major oncology conferences in the first half of the year. We believe that data from these trials in head and neck cancer and melanoma will support the initiation of a Phase 3 study in the second half of the year. In parallel, we are pursuing additional opportunities to expand our TLR platform and will continue to provide updates on our progress."

The Company had $191.9 million in cash, cash equivalents and marketable securities at December 31, 2017 compared to $81.4 million at December 31, 2016. In addition, in the first quarter of 2018 the

Company closed on a $175 million term loan agreement and received $100 million in a first tranche funding. Up to an additional $75 million may be borrowed in a second tranche at the Company’s option.

Additional Financial Results

Research and development expenses for the quarter and year ended December 31, 2017, were $17.4 million and $65.0 million, respectively, compared to $18.4 million and $84.5 million for the same periods in 2016. The overall decrease in the 2017 periods reflects reduced compensation and related personnel costs as a result of the January 2017 restructuring and cost reduction initiative. Additionally, the 2017 period reflects lower costs related to HEPLISAV-B clinical and manufacturing activity partially offset by increased costs related to the FDA approval process for HEPLISAV-B and the ongoing development of SD-101, DV281 and earlier stage oncology programs. In the fourth quarter of 2017, we reinitiated manufacturing operations, and began hiring personnel and retaining vendors as we prepared for the commercial launch of HEPLISAV-B in January 2018.

Selling, general and administrative expenses for the quarter and year ended December 31, 2017, were $9.3 million and $27.4 million, respectively, compared to $8.2 million and $37.3 million for the same periods in 2016. The overall decrease in 2017 reflects reduced compensation and related personnel costs as described above. In the fourth quarter of 2017, we had expenses related to preparation for the commercial launch of HEPLISAV-B in January 2018. In 2016, expenses included costs related to hiring of consultants for administrative and commercial development services for an anticipated commercial launch of HEPLISAV-B which was delayed.

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. Hepatitis B is a major public health issue in the United States, where an estimated 20,000 new infections occur each year, and approximately 850,000 people are currently living with this chronic disease.i 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 that individuals at high risk for hepatitis B infection due to their jobs, lifestyle, living situations and travel to certain areas be immunized.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.

Indication and Use

HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Important Safety Information (ISI)

Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

For full Prescribing Information for HEPLISAV-B, click here.

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 2 study in combination with Keytruda (pembrolizumab), an anti-PD-1 therapy, in patients with metastatic 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 aerosol. Both SD-101 and DV281 are designed to activate plasmacytoid dendritic cells and 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. Dynavax has initiated dosing in a phase 1B dose escalation clinical trial of DV281 in patients with non-small cell lung cancer.

For information about SD-101 and DV281 trials that are currently recruiting patients, please visit www.clinicaltrials.gov

On March 8, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS), reviewed corporate events and reported financial results for the quarter and full year ended December 31, 2017 (Press release, Coherus Biosciences, MAR 8, 2018, View Source/phoenix.zhtml?c=253655&" target="_blank" title="View Source/phoenix.zhtml?c=253655&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2337143 [SID1234524558]).

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Fourth Quarter and Full Year 2017 Financial Results:

Research and development (R&D) expenses for the fourth quarter of 2017 were $31.5 million compared to $59.0 million for the same period in 2016. R&D expenses for the fiscal year 2017 were $162.4 million, as compared to $254.4 million for the same period in 2016. The decrease in R&D expenses in the fourth quarter over the same period in 2016 was mainly due to the reduction in manufacturing, analytical and clinical costs associated with the CHS-0214 (etanercept (Enbrel) biosimilar candidate) and CHS-1420 (adalimumab (Humira) biosimilar candidate) programs. The decrease in R&D expenses in the fiscal year ended 2017 over the same period in 2016 was mainly attributable to a decrease in clinical development costs associated with the CHS-0214 and CHS-1420 programs. General and administrative (G&A) expenses for the fourth quarter of 2017 were $15.0 million, compared to $15.3 million for the same period in 2016. G&A expenses for the fiscal year 2017 were $71.3 million, as compared to $51.6 million for the same period in 2016. The increase in G&A expenses in 2017 were mainly attributable to salary and stock compensation costs associated with the hiring of personnel in the first half of 2017 to support the CHS-1701 (pegfilgrastim (Neulasta) biosimilar candidate) pre-commercial activities and costs related to legal and other professional services. Net loss attributable to Coherus for the fourth quarter of 2017 was ($49.1) million, or ($0.84) per share, compared to a net loss of ($75.9) million, or ($1.71) per share, for the same period in 2016. Net loss attributable to Coherus for 2017 was ($238.2) million, or ($4.48) per share, compared to a net loss of ($127.3) million, or ($3.04) per share, for 2016. Cash and cash equivalents and investments in marketable securities – short term totaled $126.9 million as of December 31, 2017, compared to $150.1 million as of September 30, 2017.
Guidance for 2018:
CHS-1701 (pegfilgrastim (Neulasta) biosimilar)

Anticipate resubmitting the biologics license application (BLA) directly after receipt of minutes post completion of FDA meetings concerning the complete response letter, completion of immunogenicity sample processing and integration of such data into the resubmission. Anticipate European approval opinion in the second half of 2018. Commercial partnering discussions are projected to continue for certain ex-U.S. territories. Anticipate U.S. commercial launch in the second half of 2018, dependent on regulatory review and approval timing.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (Eylea biosimilar)

Initiate clinical development of CHS-3351. Continue preclinical development of CHS-2020.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of a BLA. Prepare for partnering pursuant to a 2022 launch.
CHS-0214 (etanercept (Enbrel) biosimilar)

Expect the Patent Trial and Appeal Board of the USPTO to enter institution decisions with respect to two Inter Partes Review filings, by March 13, 2018 for patent 8,163,522, and by March 15, 2018 for the patent 8,063,182.
CHS-131 central nervous system anti-inflammatory asset

Anticipate a potential global license, dependent on outcome of certain preclinical studies.
Cash flow

Anticipate cash use in operations of approximately $30 – $35 million per quarter in the first half of 2018.

Conference Call Information
When: Thursday, March 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 7098068
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On March 8, 2018 Cerus Corporation (Nasdaq: CERS) reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, Cerus, MAR 8, 2018, View Source [SID1234524557]).

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Recent developments and highlights include:

Reported record fourth quarter product revenue of $16.2 million, an increase of 60% compared to the same period in the year prior.
Established 2018 annual product revenue guidance of $51 million to $53 million, which would represent a 17% to 22% increase over 2017 reported product revenue.
Successfully met primary safety and efficacy endpoints in SPARC, Cerus’ European Phase 3 clinical trial evaluating INTERCEPT red cell transfusions in thalassemia patients.
Completed an underwritten public offering of common stock raising gross proceeds of $57.5 million.
Advanced release assay for commercial manufacturing of the S303 compound used in the INTERCEPT red blood cell system to enable H2 2018 CE Mark submission.
"As we reported in our January 8, 2018 press release, we experienced a strong finish to 2017 with fourth quarter results exceeding our expectations. We saw robust sales activity in multiple geographies including France, the U.S., and the Middle East. In addition, we continue to make progress on the final CMC activities needed for the planned INTERCEPT red blood cell system CE Mark submission which will include data from the SPARC clinical study. In the U.S. we received IDE approval from the FDA to initiate our second Phase 3 RBC study," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "With the $57.5 million of gross proceeds and the remaining borrowing availability under our growth capital facility, combined with BARDA funding, we believe we are now well capitalized to focus on commercial execution and on progressing our pipeline opportunities from late stage development to potential market launch."

Revenue

Product revenue for the fourth quarter of 2017 was $16.2 million, compared to $10.1 million during the same period in 2016. Product revenue for the year ended December 31, 2017 was $43.6 million, compared to $37.2 million for the year ended December 31, 2016. The increases in reported product revenue were driven by year-over-year increases in platelet kit demand, both in international and domestic markets, partially offset by declines in plasma kits and illuminator sales. Growth in sales from France and the U.S. were the primary drivers of the increased platelet kit sales in both periods. Demand for platelet kits was up more than 100% when comparing the fourth quarter of 2017 to the same period in 2016, and up almost 40% for the full year 2017 compared to 2016.

Government contract revenue from our Biomedical Advanced Research and Development Authority (BARDA) agreement was $2.4 million in the fourth quarter of 2017 compared to $1.8 million during the same period in 2016. Government contract revenue from our BARDA agreement for the year ended December 31, 2017 was $7.8 million, compared to $2.1 million for the year ended December 31, 2016.

Gross Margins

Gross margins on product revenue for the fourth quarter of 2017 were 44%, compared to 45% for the fourth quarter of 2016. Gross margins for the year ended December 31, 2017 were 48%, compared to 45% in the same period in 2016.

Despite the more than a 100% increase in demand for platelet kits, gross margins on product revenue for the fourth quarter of 2017 was relatively consistent compared to the same period in 2016 due to fewer illuminator sales in the fourth quarter of 2017 compared to the same period in 2016, as well as the impact of pricing from higher volume platelet contracts. Gross margin on product revenue for the full-year 2017 increased due to the increase in demand for higher margin platelet disposable kits and favorable foreign exchange rates. Going forward, the Company expects to continue to realize economies of scale and lower cost of goods sold from its primary kit manufacturing agreement due to tiered pricing, which declines as production volume tiers are achieved.

Operating Expenses

Total operating expenses were $20.3 million and $86.3 million for the quarter and year ended December 31, 2017, compared to $21.5 million and $80.4 million for the quarter and year ended December 31, 2016, respectively.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2017 were $12.5 million compared to $12.4 million for the fourth quarter of 2016. SG&A expenses for the year ended December 31, 2017 were $52.4 million compared to $48.8 million in the same period in 2016. The increase in SG&A expenses was due largely to increased commercial activity in the U.S.

Research and development (R&D) expenses for the fourth quarter of 2017 were $7.8 million compared to $8.8 million for the fourth quarter of 2016. R&D expenses in the quarter declined primarily due to the timing of activities related to the BARDA agreement. R&D expenses for the year ended December 31, 2017 were $33.7 million compared to $31.3 million in the same period in 2016. The increase in R&D expenses was primarily tied to increased headcount costs and costs tied to the clinical development of our INTERCEPT red blood cell program, the pursuit of supplemental approvals for the platelet and plasma systems, and activities related to our BARDA agreement.

Operating and Net Loss

Operating losses during the fourth quarter of 2017 were $10.9 million, compared to $15.1 million during the fourth quarter of 2016, and $57.5 million compared to $61.4 million for years ended December 31, 2017 and 2016, respectively.

Net loss for the fourth quarter of 2017 was $11.5 million, or $0.10 per diluted share, compared to a net loss of $13.5 million, or $0.13 per diluted share, for the fourth quarter of 2016. Net loss for the year ended December 31, 2017, was $60.6 million, or $0.56 per diluted share, compared to a net loss of $62.9 million, or $0.62 per diluted share, for the same period of 2016.

Cash, Cash Equivalents and Investments

At December 31, 2017, the Company had cash, cash equivalents and short-term investments of $60.7 million compared to $71.6 million at December 31, 2016.

At December 31, 2017, the Company had approximately $29.8 million in outstanding debt under its loan agreement with Oxford Finance. The loan agreement provides for an additional $10 million term loan and an extension of the interest only period upon the Company achieving pre-determined revenue levels.

In January 2018, the Company completed an underwritten public offering of its common stock for gross proceeds of $57.5 million, before deducting offering expenses payable by the Company.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 3395359. The replay will be available approximately three hours after the call through March 22, 2018