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TRACON To Report Third Quarter 2020 Financial Results And Company Highlights On November 10, 2020

On November 3, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it will report its third quarter 2020 financial and operating results after the close of U.S. financial markets on Tuesday, November 10, 2020 (Press release, Tracon Pharmaceuticals, NOV 3, 2020, View Source [SID1234569778]). In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly financial results.

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Altimmune To Announce Third Quarter 2020 Financial Results On November 10

On November 3, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it will release its third quarter 2020 financial results on Tuesday, November 10, 2020 (Press release, Altimmune, NOV 3, 2020, View Source [SID1234569777]).

Altimmune management will host a conference call for investors beginning at 8:30 a.m. ET on Tuesday, November 10, 2020 to discuss the financial results and provide a business update.

Affimed to Report 3rd Quarter 2020 Financial Results & Corporate Update November 10, 2020

On November 3, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release third quarter 2020 results on Tuesday, November 10, 2020 and host a conference call at 8:30 a.m. ET to discuss financial results and corporate developments (Press release, Affimed, NOV 3, 2020, View Source [SID1234569776]).

The conference call will be available via phone and webcast. To access the call, please dial +1-646-741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference conference ID 9847055 approximately 15 minutes prior to the call.

To access the live audio webcast of the conference call please visit the "Investors" section of the company’s website at View Source A replay of the call will be archived on the Affimed website for 30 days after the call.

Massive Bio Secures Additional $2.6 Million Financing Round Led by Revo Capital and Tops its Total Raise to $6.6 Million

On November 3, 2020 Massive Bio, Inc., a leader in precision medicine and artificial intelligence (AI) enabled patient centric clinical trial enrollment, reported a $2.6 million round of funding led by Revo Capital with additional participation from Cavendish Impact Foundation (CIF), through their donor advised fund at ImpactAssets (Press release, Massive Bio, NOV 3, 2020, View Source [SID1234569774]). The investment brings Massive Bio’s total funding since launch to $6.6 million and will enable the biotechnology company to scale to meet the demand in the U.S. and overseas for its oncology clinical trial recruitment platform solutions. The financing round builds on an exceptional year for Massive Bio which saw a rapidly growing roster of clients across the pharmaceutical company and contract research organization (CRO) industry globally, and exponential demand which was further accelerated by COVID-19.

Massive Bio Co-founder and CEO Selin Kurnaz stated, "Since our foundation in 2015, Massive Bio has experienced impressive growth, relying mostly on revenue generated by customer demand to fuel its growth. However, due to an additional layer of growth at rapid pace that we have been experiencing in 2020, we have partnered with very hard working and passionate investors, Revo Capital and CIF, to execute our vision even more rapidly and broadly. I could not be prouder of our team and success, and this is our time to expand globally." Massive Bio has focused on improving patient enrollment for oncology clinical trials since the company was founded in 2015. Approximately 3%-5% of cancer patients participate in clinical trials and enrollment rates have decreased further since the COVID-19 pandemic. Dr. Kurnaz added, "As an industry we are just scratching the surface of how powerful digital health technology and value-added services can be when combined with the massive scale offered by the global research portfolio ecosystem".

"Amid the COVID-19 pandemic and beyond, the clinical trial industry needs a digital health technology solution to assist in study enrollment now more than ever," said Cenk Bayrakdar, Revo Capital’s Managing Director. "Massive Bio has a unique solution that was purpose-built to address the challenges associated with clinical trial recruitment challenges, which aligned with their patient-centric approach makes it a powerful solution for the industry, and we are excited to collaborate with and support them as they work to transform their ideas into a world-changing company."

"At CIF, we are committed to being long-term partners and supporters of the companies in which we invest. We have been impressed with Massive Bio because of their innovative approach to a significant problem in cancer care equality – helping to enroll as many patients as possible in clinical trials, which can potentially be life saving for patients who may have few other options," said Rachel Butler, President and Board Co-Chair of the Cavendish Impact Foundation. "Selin and the Massive Bio team have built an impressive business and expansive list of clients, and we look forward to supporting the team as they build the company into the premier global oncology trial recruitment platform."

Supernus Announces Third Quarter 2020 Financial Results

On November 3, 2020 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the third quarter of 2020 and associated Company developments (Press release, Supernus, NOV 3, 2020, View Source [SID1234569769]).

"During the first nine months of 2020, we delivered strong product sales growth, diversified our revenue base and enhanced our long term growth with two corporate transactions" said Jack Khattar, President and CEO of Supernus. "Our employees have been hard at work in anticipation of the launch of SPN-812. Based on the efficacy and safety demonstrated in its clinical program, SPN-812 can potentially offer an important new option in the treatment of ADHD."

Commercial Update

Third quarter 2020 net product sales were $152.1 million, 52% higher than the same period in 2019, driven by the addition of $40.9 million of net product sales from the acquired commercial products and $11.2 million in net product sales growth from Trokendi XR and Oxtellar XR.

Product Pipeline Update

SPN-812 – Novel non-stimulant for the treatment of ADHD in children and adults

The Company continues to prepare for the commercial launch of SPN-812, which is expected in January 2021, if approved by the FDA. The New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date is November 8, 2020.
The Company completed enrollment in the SPN-812 Phase III trial in adult patients with ADHD. Topline data from the trial is expected in the first quarter of 2021.
SPN-830 (Apomorphine infusion pump) – Continuous treatment of motor fluctuations ("on-off" episodes) in PD

NDA was submitted to the U.S. Food and Drug Administration (FDA) in September 2020 for the continuous treatment of "on-off" episodes in adults with Parkinson’s disease (PD) whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy.
The Company expects to launch SPN-830 in the fourth quarter of 2021, if approved by the FDA.
SPN-820 – Novel first-in-class activator of mTORC1

Preclinical and development activities are ongoing, with the goal of initiating a Phase II clinical program in treatment-resistant depression by the end of 2021.
Operating Expenses

Research and development (R&D) expenses in the third quarter of 2020 were $16.8 million, essentially unchanged from $16.9 million in the same quarter last year.

Selling, general and administrative (SG&A) expenses in the third quarter of 2020 were $54.7 million, compared to $39.3 million in the same quarter last year. This increase was primarily due to costs associated with the new CNS portfolio of commercial products acquired from US WorldMeds (USWM Acquisition) in the second quarter of 2020 and our ongoing preparations for the potential launch of SPN-812.

Amortization expense of intangible assets in the third quarter of 2020 were $6.1 million, compared to $1.3 million in the same quarter last year. This increase results from the USWM Acquisition.

Operating Earnings and Earnings Per Share

Operating earnings (GAAP) in the third quarter of 2020 were $56.1 million, compared to $39.7 million in the third quarter of 2019. Net earnings (GAAP) in the third quarter of 2020 were $40.0 million, or $0.74 per diluted share, as compared to $28.9 million, or $0.54 per diluted share, in the same period last year.

Balance Sheet Highlights

As of September 30, 2020, the Company had $740.1 million in cash, cash equivalents, marketable securities and long term marketable securities, compared to $938.8 million at December 31, 2019. During the first nine months of 2020, the Company generated $107.5 million of cash from operations, inclusive of net changes in working capital. The Company made cash payments of approximately $300 million for acquisition of the CNS portfolio of US WorldMeds and $25 million paid to Navitor upon executing the development and option agreement for SPN-820.

Financial Guidance

The Company is revising full year 2020 financial guidance, which consists of the following components, inclusive of the impact of acquiring the CNS portfolio of US WorldMeds as of June 9, 2020:

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer and the executive management team to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, November 4, 2020.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.