On November 2, 2017 INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”) reported financial results for its third quarter ended Sept. 30, 2017 (Press release, Insys Therapeutics, NOV 2, 2017, View Source [SID1234521480]).

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OVERALL HIGHLIGHTS

Gross revenue was $48.9 million, resulting in net revenue of $30.7 million
Net revenue was unfavorably impacted by approximately $5 million due to product returns
Total R&D investment was $19.6 million
Accrued minimum liability of $150.0 million paid over five years in connection with ongoing Department of Justice (DOJ) investigation
Net loss totaled $166.3 million, which included DOJ accrual, or ($2.30) per basic and diluted share
Launched SYNDROS (dronabinol) oral solution, first and only FDA-approved liquid dronabinol, generating $0.7M of revenue in first two months
Filed New Drug Application (NDA) for novel formulation of buprenorphine as sublingual spray for management of moderate-to-severe acute pain
Completed pharmacokinetics (PK) study of proprietary intranasal naloxone spray formulation for treatment of opioid overdose
“Earlier this year, we took meaningful, strategic steps to restore trust with our key stakeholders, including patients, clinicians, regulators, and investors,” said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “The past few months have only strengthened our commitment to move forward and continue our efforts to address unmet medical needs. In the third quarter, our team soundly executed against the organization’s strategic initiatives and we made strong progress to transform and diversify our business over the long term. This included further work to stabilize our SUBSYS product through the signing of additional managed care contracts. These wins should help solidify the product’s base revenue beginning in 2018. We also continued to realize the benefits of our strong pipeline as we brought our second commercial product to market and delivered on several of our R&D commitments, including the early filing of our NDA for buprenorphine as a sublingual spray. I am pleased with our progress to date across the business and recognize there is still more to be done.”

Mr. Motahari concluded, “As part of our effort to broaden the company’s capabilities, we’ve expanded and upgraded our fully-integrated manufacturing facility in Round Rock, Texas over the last year. The expansion component of the project is complete, and the related upgrade will be finished by the end of the year. This facility will be a distinct competitive advantage for us when it is complete, as we will be one of the only companies in the United States that can manufacture synthetic cannabinoids ranging from clinical to commercial scale. Further, it will allow us to continue to pursue partnership opportunities with supportive institutions, including those in academia and the scientific community, all of whom are currently looking to further the science of cannabinoids.”

Financial & Operating Highlights

Net revenue for the third quarter of 2017 was $30.7 million, compared to $57.8 million for the third quarter of 2016. The results reflect a decline in SUBSYS prescription volumes due to ongoing softness in overall demand in the TIRF category, and was partially offset by $0.7 million in revenues from the recently launched SYNDROS product.
Gross margin was 75.6% for the third quarter of 2017, compared to 91.9% in the same period of 2016. Gross margin was negatively impacted by product returns and inventory expiration.
Sales and marketing investment was $12.8 million during the third quarter of 2017, compared to $16.7 million for the third quarter of 2016. The reduction was driven by cost management in light of lower revenue.
Research and development investment increased to $19.6 million for the third quarter of 2017, compared to $16.5 million for the same period in 2016, reflecting the company’s commitment to its robust new product pipeline including filing fees associated with our NDA for buprenorphine.
General and administrative expense decreased to $15.7 million for the third quarter of 2017 from $17.7 million for the third quarter of 2016, driven by a stock compensation charge taken in the third quarter of 2016, and a reduction in outside legal expenses.
Income tax benefit was $9.0 million for the third quarter of 2017, compared to a benefit of $0.4 million during the third quarter of 2016.
The company accrued an aggregate reserve of $150.0 million in connection with the DOJ investigation.
Net loss for the third quarter of 2017 was $166.3 million, or ($2.30) per basic and diluted share, compared to net income of $2.9 million, or $0.04 per basic and diluted share, for the third quarter of 2016.
Adjusted EBITDA loss for the third quarter of 2017 was $18.4 million, compared to Adjusted EBITDA of $12.2 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 $177.2 million in cash, cash equivalents, and short-term and long-term investments; no debt; and $106.0 million in stockholders’ equity as of Sept. 30, 2017.
Webcast Information
A conference call is scheduled for 8:30 a.m. Eastern Standard Time on Nov. 2, 2017, to discuss the financial and operational results for the third quarter of fiscal year 2017. Investors, analysts and members of the media interested in listening to the live presentation are encouraged to join a webcast of the call available through the INVESTORS section of the company’s website at View Source Interested parties may also participate in the call by dialing 844-263-8304 (from inside the U.S.) or 213-358-0958 (from outside the U.S.). A replay of the conference call will be available a few hours after the event through the website’s INVESTORS section, under the NEWS & EVENTS tab for “Presentations.”

On November 2, 2017 Cerus Corporation (NASDAQ:CERS) reported financial results for the third quarter ended September 30, 2017 (Press release, Cerus, NOV 2, 2017, View Source [SID1234521512]).

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Recent developments include:

Announced national German reimbursement for pathogen-inactivated platelets starting January 1, 2018. Germany is the largest platelet market in Europe with approximately 575,000 units manufactured each year.
Entered into a new supply agreement for the INTERCEPT Blood System for platelets with Centro de Transfusión de la Comunidad (CTCM), one of the largest blood banks in Spain.
Entered into new Italian distribution agreement for INTERCEPT with Kedrion, a global manufacturer and distributor of plasma derivatives, headquartered in Italy.
Announced first Biologics License Application (BLA) approval for U.S. blood center customer.
“I am encouraged by the commercial progress we are making as an organization. The highlight of the third quarter was clearly the rapid deployment of illuminators by the Établissement Français du Sang (EFS), the French National Blood Service,” said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. “With Illuminators now deployed at all French regional blood centers, it gives us greater conviction on our ability to potentially drive revenue growth in the coming quarters. Coupled with the recent national German reimbursement for pathogen-inactivated platelets, we believe we are gaining significant momentum in Europe’s two largest markets for platelets. In addition, with the continued market adoption of INTERCEPT in the U.S., we believe that we are well positioned to grow the business globally. We are also tightening our 2017 product revenue guidance to $41 million to $43 million compared to our previous guidance range of $40 million to $46 million.”

Product Revenue

Product revenue for the third quarter of 2017 was $10.8 million, up 6% compared to $10.2 million recognized during the same period in 2016. The increase in reported product revenue for the quarter was driven primarily by a 12% increase in worldwide demand for platelet kits and an increase in illuminator sales, which were partially offset by a decline in plasma kit sales.

Product revenue for the first nine months of 2017 was $27.3 million, up 1% compared to the first nine months of 2016 of $27.1 million. In addition to an increase in illuminator sales, year-to-date demand for platelet kits was up 15%. These increases were offset by declines in plasma kit sales.

Gross Margins

Gross margins on product revenue for the third quarter of 2017 were 50%, compared to 46% for the third quarter of 2016. Gross margins for the first nine months of 2017 were 51%, compared to 46% for the first nine months of 2016. Gross margins in the quarter benefitted from the increased demand for INTERCEPT platelet products which generate higher gross margins than plasma products, and favorable Euro foreign exchange rates quarter-over-quarter and year-over-year.

Operating Expenses

Total operating expenses for the third quarter of 2017 were $20.1 million, compared to $19.2 million for the third quarter of 2016. Total operating expenses for the first nine months of 2017 were $66.0 million, compared to $59.0 million for the first nine months of 2016. Selling, general and administrative expenses were flat in the third quarter compared to the comparable period in the prior year. Selling, general, and administrative expenses increased for nine months ended September 30, 2017, over the comparable period in 2016, primarily driven by increased commercial activity in the U.S. Research and development expenses increased in both periods primarily due to clinical development activities of our INTERCEPT red blood cell system, and in particular, activities related to our BARDA contract.

Operating and Net Loss

Operating losses during the third quarter of 2017 were $12.4 million, compared to $14.3 million for the third quarter of 2016, and $46.7 million compared to $46.3 million for the nine months ended September 30, 2017 and September 30, 2016, respectively.

Net loss for the third quarter of 2017 was $13.4 million, or $0.12 per diluted share, compared to a net loss of $14.4 million, or $0.14 per diluted share, for the third quarter of 2016. Net loss for the first nine months of 2017 was $49.1 million, or $0.46 per diluted share, compared to a net loss of $49.4 million, or $0.49 per diluted share, for the same period of 2016.

Net loss for the nine months ended September 30, 2017 was positively impacted by the gain of approximately $3.5 million, due to the sale of the Company’s marketable equity investment in Aduro Biotech, Inc (“Aduro”). This gain was offset by non-cash income tax expense of $3.9 million recorded in the nine months ended September 30, 2017, due to the sale of the Company’s shares of Aduro.

Cash, Cash Equivalents and Investments

At September 30, 2017, the Company had cash, cash equivalents and short-term investments of $59.6 million compared to $71.6 million at December 31, 2016.

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 82994688. The replay will be available approximately three hours after the call through November 16, 2017.

Sarepta Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Sarepta Therapeutics, 2017, NOV 1, 2017, View Source [SID1234521418]).

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On November 1, 2017 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the third quarter ended September 30, 2017 (Press release, Pain Therapeutics, NOV 1, 2017, View Source [SID1234521394]). Net loss for the third quarter of 2017 was $2.6 million, or $0.40 per share, respectively, compared to a net loss for the same period in 2016 of $3.5 million, or $0.54 per share. Net cash used during the third quarter was $2.2 million. Cash and investments were $11.9 million as of September 30, 2017, with no debt. The Company still expects net cash usage in the calendar year 2017 may be approximately $10 million. Following the resubmission of the REMOXY NDA in Q1 2018, the Company believes net cash usage in 2018 will decrease significantly compared to 2017.

“The White House recently declared the opioid epidemic a public health emergency,” said Remi Barbier, President & CEO. “We fully support this policy position, and have been a voice in support of such a policy for many years. Nearly 15 years ago, Pain Therapeutics pioneered abuse-deterrent technology for opioid drugs specifically to provide policy makers, regulators, physicians, pharmacists and patients an additional tool to help combat the opioid epidemic. In partnership with all constituents, we look forward to doing our part to address the issues of overdose and death from extended-release opioid drugs.”

Operating Highlights for Q3 2017

In September, the National Institutes of Health (NIH) awarded us a $1.8 million research grant to develop a blood-based diagnostic to detect Alzheimer’s disease.
In September, The National Institute on Drug Abuse (NIDA) awarded us a $2.2 million research grant to further develop FENROCK, an abuse-deterrent transdermal patch that contains the prescription drug fentanyl.
In October, we announced a successful Phase I clinical study for PTI-125, our drug candidate for the treatment of Alzheimer’s disease. As previously announced, our scientists plan to present full results of this study at the 10th Annual International Conference on Clinical Trials on Alzheimer’s Disease, in Boston, MA, on November 1-4th.
In October, we announced the FDA had agreed to a pre-NDA guidance meeting on November 14th to discuss the upcoming resubmission of an NDA for REMOXY ER. We will provide details of this FDA meeting after receipt of final meeting minutes.
Recently, we substantially completed a previously announced human nasal study with REMOXY ER. We plan to announce top-line results of this study by yearend 2017.
Financial Highlights for Q3 2017

At September 30, 2017, cash and investments were $11.9 million, compared to $14.1 million at June 30, 2017. The Company has no debt.
Net cash used during the three months ended September 30, 2017 was $2.2 million.
Research and development expenses for the three months ended September 30, 2017 decreased to $1.6 million, respectively, from $2.7 million for the same period in 2016, primarily due to decreases in REMOXY related expenses and the receipt of research grant funding from the National Institutes of Health for FENROCK and PTI-125, recorded as a reduction in research and development expenses activities. Research and development expenses included non-cash stock-related compensation of $0.3 million in both three months ended September 30, 2017 and 2016.
General and administrative expenses increased slightly to $1.0 million in the three months ended September 30, 2017 from $0.9 million for the same period in 2016. General and administrative expenses included non-cash stock-related compensation of $0.4 million in the three months ended September 30, 2017 compared to $0.5 million for same period in 2016.
About REMOXY ER (extended-release oxycodone capsules CII)
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for “the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” We developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY’s thick, sticky, high-viscosity gel-cap formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remains a serious, persistent problem. Drug overdose deaths exceeded 64,000 in 2016, according to the CDC. For over a decade, Pain Therapeutics has pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it difficult, longer or aversive to tamper with long-acting opioid formulations, recognizing that no drug can be made abuse-proof.

About Pain Therapeutics, Inc.
We develop proprietary drugs that offer significant improvements to patients and physicians. Our expertise consists of developing new drugs and guiding these through various regulatory and development pathways in preparation for their eventual commercialization. We generally focus our drug development efforts around disorders of the nervous system. The FDA has not yet established the safety or efficacy of our drug candidates.

Our pipeline of drug assets includes:

REMOXY ER — (extended-release oxycodone capsules) Proprietary abuse-deterrence, twice-daily oxycodone targeted at severe chronic pain. NDA resubmission planned for Q1 2018.

PTI-125 Rx — Proprietary small molecule drug targeted at the treatment of Alzheimer’s disease. Phase I clinical-stage program, substantially funded by a research grant award from the NIH.

PTI-125 Dx — Blood-based diagnostic to detect Alzheimer’s disease. Early-stage program, substantially funded by a research grant award from the NIH.

FENROCK — (transdermal fentanyl patch system) Proprietary abuse-deterrent skin patch to treat severe pain. Early-stage program, substantially funded by a research grant award from National Institute on Drug Abuse.

NOTE: REMOXY ER and FENROCK are trademarks of Pain Therapeutics, Inc.

Important Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Pain Therapeutics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements regarding our projected cash usage in CY2017 and CY2018, statements regarding potential discussions with the FDA and the abuse-deterrent properties and potential benefits of REMOXY ER. Such statements are based on management’s current expectations but actual results may vary materially due to various factors, many of which are beyond the control of management. Drug development involves substantial risks and uncertainties, including but not limited to those risks and uncertainties relating to successfully completing the activities required to address the issues raised by the FDA in the September 2016 Complete Response Letter for REMOXY ER and the time required to do so, including the time required to reach resolution with the FDA on the scope of the appropriate actions to be undertaken and the possibility that the FDA may raise additional issues in the future that were not raised in the past. In addition, the development of abuse-deterrent drug products is a young and still emerging area of drug development, with regulatory guidance that may be inconsistent, unclear or still in development. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. For further information regarding these and other risks related to our business, investors should consult our filings with the U.S. Securities and Exchange Commission.

On November 1, 2017 MacroGenics, Inc. (Nasdaq: MGNX) reported that on Wednesday, November 8, 2017, the Company will release its financial results for the quarter ended September 30, 2017 (Press release, MacroGenics, NOV 1, 2017, View Source [SID1234521439]). The Company’s management team will host a conference call discussing the Company’s financial results and recent corporate developments on Wednesday, November 8, 2017 at 4:30 pm (ET). The call can be accessed by dialing (877) 303-6253 (domestic) or (+1) (973) 409-9610 (international) five minutes prior to the start of the call and providing the conference ID: 5477659.

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The recorded, listen-only webcast of the conference call can be accessed under “Events & Presentations” in the Investors section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.