On February 25, 2020 Veracyte, Inc., (Nasdaq: VCYT) reported financial results and business progress for the quarter and full year ended December 31, 2019, and provided financial guidance for 2020 (Press release, Veracyte, FEB 25, 2020, View Source [SID1234554738]).

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"Veracyte experienced a transformational year in 2019 as we successfully drove strong revenue and volume growth across our products, secured strategic biopharmaceutical collaborations, advanced our pipeline – specifically, our nasal swab test for early lung cancer detection – and positioned the company to become a global leader in advanced genomic diagnostics on a world-class instrumentation platform," said Bonnie H. Anderson, chairman and chief executive officer of Veracyte. "We also achieved cashflow breakeven status for the fourth quarter of 2019, underscoring our focus on driving business growth, while maintaining financial discipline. We expect 2020 to be a big year for the company as we grow our business, advance our pipeline and leverage the opportunity to expand our global footprint."

Fourth Quarter and Full-Year 2019 Financial Results

For the three months ended December 31, 2019, compared to the prior year:

Total Revenue was $29.7 million, an increase of 15%;
Gross Margin was 66%, unchanged;
Operating Expenses, Excluding Cost of Revenue, were $27.8 million, an increase of 38%;
Net Loss and Comprehensive Loss was ($7.5) million, an increase of 140%;
Basic and Diluted Net Loss Per Common Share was ($0.15), an increase of 88%;
Net Cash Provided by Operating Activities was $1.8 million, compared to $1.2 million used; and
Cash and Cash Equivalents was $159.3 million at December 31, 2019.
For the year ended December 31, 2019, compared to the prior year:

Total Revenue was $120.4 million, an increase of 31%;
Gross Margin was 70%, an increase of six percentage points;
Operating Expenses, Excluding Cost of Revenue, were $99.0 million, an increase of 22%;
Net Loss and Comprehensive Loss was ($12.6) million, an improvement of 45%;
Basic and Diluted Net Loss Per Common Share was ($0.27), an improvement of 56%; and
Net Cash Used in Operating Activities was $3.2 million, an improvement of 76%.
2019 Full-Year and Recent Business Highlights

Commercial Growth:

Achieved strong revenue growth across our testing and product portfolio delivering $29.5 million in the fourth quarter and $108.3 million for 2019, an increase of 16% and 19%, respectively, compared to the prior year.
Accelerated pulmonology testing revenue to $2.0 million and $5.5 million for the fourth quarter and full year, respectively, a 123% and 174% increase compared to prior year.
Grew total genomic volume (Afirma, Percepta and Envisia) by 18% to 10,846 tests in the fourth quarter of 2019 and by 25% to 39,612 tests in 2019, compared to prior year.
Increased genomic volume for our pulmonology products by 136% in 2019 compared to prior year, achieving growth targets for both the Percepta and Envisia classifiers.
Received final Medicare coverage in March 2019 for the Envisia classifier and published strong clinical validation and clinical utility data in The Lancet Respiratory Medicine, propelling nationwide commercial expansion of the test in the second half of 2019.
Expanded payer contracts by 14.4 million lives, making Veracyte an in-network genomic testing provider to health plans representing over 225 million members.
Continued to build an extensive library of clinical data across our portfolio in 2019, including 8 publications and 11 presentations at leading medical meetings, demonstrating our Afirma and pulmonology tests’ performance and clinical utility.
Eleven abstracts were presented at the San Antonio Breast Cancer Symposium in December 2019, including data showing a benefit of Prosigna over other genomic testing to identify patients’ long-term risk of developing distant metastases. In addition, data were presented showing the test’s ability to identify patients with intrinsic breast cancer subtypes that may potentially benefit from CDK4/6 inhibitors in place of standard chemotherapy.
Biopharmaceutical Collaborations/Pipeline Advancement:

In January 2019, announced a long-term strategic collaboration with Johnson & Johnson Innovation LLC to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable.
Presented preliminary data at the American College of Chest Physicians (CHEST) annual meeting for our first-of-its-kind noninvasive nasal swab classifier for improved lung cancer diagnosis. The test, being developed through our Johnson & Johnson collaboration, is expected to launch in early 2021.
Launched the second-generation Percepta GSC, completing the transition of our core classifiers to our RNA whole-transcriptome sequencing platform.
Announced a multi-year collaboration with Acerta Pharma, the hematology research and development arm of AstraZeneca plc, to provide genomic information that will support the biopharmaceutical company’s development of oncology therapeutics in lymphoma.
Global Expansion:

Acquired the exclusive global diagnostic rights to the NanoString nCounter FLEX Analysis System, as well as the Prosigna breast cancer assay and the in-development LymphMark lymphoma subtyping test. We believe this transaction positions us to access a $40 billion global market for our current and pipeline products, by offering a broad menu of advanced genomic tests in oncology and other indications using a distributed-kit model.
2020 Outlook

Veracyte is guiding to full-year 2020 total revenue in the range of $138 million to $142 million and net cash used in operating activities in the range of $8 million to $12 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source approximately two hours following the completion of the call.

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):

(855) 541-0980

International participant dial-in number:

(970) 315-0440

Conference I.D.:

1184223

On February 25, 2020 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Jeff Goater, chief executive officer, and Robert Ross, M.D., chief medical officer, will participate in a fireside chat at the 40th Annual Cowen Healthcare Conference, discussing Surface Oncology’s lead programs, SRF617 (targeting CD39) and SRF388 (targeting IL-27) (Press release, Surface Oncology, FEB 25, 2020, View Source [SID1234554737]). The fireside chat will take place on Tuesday, March 3, 2020 at 12 p.m. EDT at the Boston Marriott Copley Place in Boston, Mass.

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The live audio and subsequent archived webcasts of the Company’s presentations will be accessible from the Company’s investor relations website, investors.surfaceoncology.com.

On February 25, 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 fourth quarter and full year of 2019, and associated Company developments (Press release, Supernus, FEB 25, 2020, View Source [SID1234554736]).

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Commercial Update

Full year 2019 product prescriptions for Trokendi XR and Oxtellar XR, as reported by IQVIA, totaled 836,399, a 6.4% increase over full year 2018. Fourth quarter 2019 product prescriptions for Trokendi XR and Oxtellar XR totaled 212,780, a 1.4% increase over the fourth quarter of 2018.

As previously disclosed, wholesalers, distributors and pharmacies increased their inventory levels of the Company’s products in the fourth quarter of 2018. The Company estimates that this caused net product sales in both the fourth quarter and full year 2018 to be approximately $10 million higher than would have been otherwise; i.e., had inventory levels remained consistent quarter to quarter. The inventory build in the fourth quarter of 2018 was then effectively reversed in the first quarter of 2019, causing net product sales to be $10 million lower in both the first quarter and full year 2019 than would have been otherwise.

Net product sales for full year 2019 were $383.4 million, compared to $399.9 million for full year 2018. Net product sales for the fourth quarter of 2019 were $97.9 million, compared to $113.5 million in the fourth quarter of 2018. The decrease in both quarter over quarter and year over year comparisons is due to the aforementioned increase in inventory holdings in the fourth quarter of 2018.

In addition, net product sales in both the fourth quarter and full year 2019 were adversely impacted by continued pressure on gross-to-net deductions, as compared to 2018.

Progress of Product Pipeline

SPN-812 – Novel non-stimulant for the treatment of ADHD

The U.S. Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for SPN-812 for the treatment of ADHD, with a Prescription Drug User Fee Act (PDUFA) target action date of November 8, 2020.
The Company plans to launch SPN-812 at the end of 2020, if approved by the FDA.
The Company expects to complete enrollment in the ongoing Phase III program in adult patients by the end of 2020.
SPN-810 – Novel treatment of Impulsive Aggression (IA) in patients with ADHD

Phase III P302 trial in patients 6 to 11 years old did not meet its primary endpoint. The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in patients diagnosed with ADHD. Patients receiving SPN-810 36 mg showed a median percent reduction of 51.3% in the average weekly frequency of impulsive aggression episodes from baseline that was not statistically significant (p=0.961) compared to placebo. Consistent with the P301 trial, the drug was safe and well tolerated.
The Company will halt all development activities on SPN-810 in IA.
SPN-604 – Novel treatment of bipolar disorder

The Company expects enrollment in the ongoing pivotal Phase III monotherapy trial for the treatment of bipolar disorder to continue through 2021.
"With our NDA for SPN-812 in ADHD accepted for review by the FDA, we continue to prepare the Company for the commercial launch of SPN-812 and look forward to bringing this important new treatment option to patients and physicians. If approved by the FDA, SPN-812 has the potential of becoming the first novel treatment to be introduced in the ADHD market in more than a decade" said Jack Khattar, President and CEO of Supernus.

"While we are certainly disappointed with the results from the second trial on SPN-810, Supernus continues to invest in R&D programs and is planning to provide an R&D update later in the year." Mr. Khattar added, "We extend our sincere thanks to all our employees for working diligently to complete the SPN-810 studies, and to all our patients, their families, and our investigators for participating in our studies."

Operating Expenses

Full Year

Research and development (R&D) expenses for full year 2019 were $69.1 million, lower than the $89.2 million in 2018. This decrease is primarily due to the one-time upfront expense of approximately $14 million incurred in the fourth quarter of 2018 for the acquisition of Biscayne Neurotherapeutics, Inc. (Biscayne). To a lesser extent, the completion of four Phase III clinical trials for SPN-812 contributed to the year-over-year decline. These reductions were partially offset by SPN-812 manufacturing costs in 2019 to support the Company’s NDA submission.

Selling, general and administrative (SG&A) expenses for full year 2019 were $158.4 million, essentially unchanged from $159.9 million in 2018.

Fourth Quarter

R&D expenses in the fourth quarter of 2019 were $19.8 million, lower than the $29.8 million in the same quarter last year. This decrease was primarily due to the one-time upfront expense of approximately $14 million incurred in the fourth quarter of 2018 for the acquisition of Biscayne.

SG&A expenses in the fourth quarter of 2019 were $35.7 million, lower than the $42.1 million in the same quarter last year. This decrease is primarily due to expenses incurred in the fourth quarter of 2018 for the development and production of promotional materials and marketing programs associated with the launch of the monotherapy indication for Oxtellar XR. In addition, employee-related costs were lower.

Operating Earnings and Earnings Per Share

Operating earnings for full year 2019 were $148.6 million, compared to $144.4 million in 2018. The increase in operating earnings is primarily due to lower R&D and SG&A expenses in 2019. Operating earnings for the full year 2019 were negatively impacted by the aforementioned inventory drawdown in the first quarter of 2019. This resulted in full year 2018 operating earnings being $10 million higher, and the full year 2019 operating earnings being $10 million lower than would have been otherwise.

Operating earnings in the fourth quarter of 2019 were $40.8 million, compared to $39.9 million in the fourth quarter of 2018. The quarterly comparison was negatively impacted by the aforementioned increase in channel inventory holdings in the fourth quarter of 2018. The increase in channel inventory holdings in 2018 caused the fourth quarter 2018 operating earnings to be higher by approximately $10 million than would have been otherwise.

Net earnings (GAAP) were $113.1 million for full year 2019, or $2.10 per diluted share, compared to $111.0 million, or $2.05 per diluted share, for full year 2018.

Net earnings (GAAP) in the fourth quarter of 2019 were $33.1 million, or $0.62 per diluted share, an increase of 29% on a diluted share basis, as compared to $25.9 million, or $0.48 per diluted share, in the same period last year.

Weighted-average diluted common shares outstanding were approximately 53.8 million for the full year 2019 and 53.6 million for the fourth quarter of 2019, as compared to approximately 54.1 million for each of the respective prior year periods.

Balance Sheet Highlights

As of December 31, 2019, the Company had $938.8 million in cash, cash equivalents, marketable securities and long term marketable securities, as compared to $774.8 million at December 31, 2018. This increase primarily reflects cash generated from operations in 2019.

Financial Guidance

For full year 2020, the Company estimates net product sales and operating earnings as set forth below:

Net product sales to range from $360 million to $390 million.
Operating earnings to range from $70 million to $100 million.
Other than the impact from the addition of salesforce personnel at the end of 2020 in anticipation of the launch of SPN-812, SG&A expenses are expected to be consistent quarter to quarter in 2020.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, February 26, 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.

Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 7796907
Conference Call Name: Supernus Pharmaceuticals Fourth Quarter and Full Year 2019
Earnings Conference Call
Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".

On February 25, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that Dr. Thomas Cannell, President and CEO, will host a conference call on Monday, March 16, 2020 at 8:00 a.m. ET to provide an overview of 2019 operational performance and key updates on the Company’s regulatory progress and commercial opportunity for Vicinium (Press release, Sesen Bio, FEB 25, 2020, http://ir.elevenbio.com/news-releases/news-release-details/dr-thomas-cannell-president-and-ceo-sesen-bio-host-conference-0 [SID1234554735]).

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To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 1497176. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

About Vicinium
Vicinium, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On February 25, 2020 Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, reported financial results and provided an update on corporate activities for the fourth quarter and year-ended December 31, 2019 (Press release, Paratek Pharmaceuticals, FEB 25, 2020, View Source [SID1234554734]).

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"2019 was a transformative year for Paratek. Demand for NUZYRA continued to increase in the fourth quarter with net sales growing a robust 74% versus the prior quarter." said Evan Loh, M.D., Chief Executive Officer. "With particular strength seen with the oral formulation, NUZYRA is on track to have one of the most successful antibiotics launches in the last decade."

Dr. Loh continued, "In December, we announced that we entered into a 5-year contract valued up to $285 million with Biomedical Advanced Research and Development Authority, or BARDA, to support the development of NUZYRA for the treatment of pulmonary anthrax. We believe that this long-term Project BioShield agreement with BARDA, along with the approved indications for NUZYRA in CABP and ABSSSI, solidify Paratek’s position as a leader in the anti-infective space. The magnitude of the projected funding through this BARDA agreement and the expected continued strong launch trajectory of NUZYRA will significantly strengthen Paratek’s balance sheet."

"The recent news with coronavirus only further highlights the urgent need for innovative therapeutics to fight this devastating disease," said Randy Brenner, Chief Development & Regulatory Officer. "As with influenza, many of the coronavirus fatalities are unfortunately associated with secondary bacterial pneumonia infections, further highlighting the importance of a novel once daily well-tolerated oral and IV antibiotic in the treatment paradigm for pandemic preparedness. With a broad-based public-private partnership established by our recently announced BARDA contract, anchored by a therapy that is approved for pneumonia, we are aggressively pursuing other opportunities within the government to support national pandemic preparedness."

NUZYRA Commercial Highlights

NUZYRA generated $11.5 million in net sales in the 11 months since its February 2019 launch.

NUZYRA generated $5.4 million in net sales in the fourth quarter of 2019, an increase of 74% versus prior quarter, driven by increases in demand.

Over 80% of commercial lives and greater than 50% of Medicaid lives in the U.S. now have access to NUZYRA.

Recent Highlights

BARDA awarded Paratek a 5-year contract valued at up to $285 million, with an option to extend to 10-years, to support: 1) the development of NUZYRA for the treatment of pulmonary anthrax; 2) all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval; and 3) the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax to be secured in the Strategic National Stockpile.

The pre-Emergency Use Authorization (EUA) for NUZYRA is targeted for submission to the FDA in the first quarter of 2020. The purchase of the first 2,500 treatment courses will be initiated once FDA agrees the application is sufficient which is expected in the second quarter of 2020.

Zai Lab Limited announced its New Drug Application for omadacycline for the treatment of CABP and ABSSSI infections has been accepted in China.

Paratek earned $3.0 million upon this regulatory submission in the fourth quarter of 2019.

Paratek is eligible to receive $6.0 million upon regulatory approval and royalties on net sales.

Paratek entered into a license grant with Almirall (ALM) for SEYSARA (sarecycline) for the greater China region, which includes the Peoples Republic of China, Hong Kong, and Macau. Almirall plans to develop sarecycline for acne in China, with a submission to the China National Medical Products Administration expected in 2023. Under the terms of the agreement, Paratek will earn high single-digit royalties on net sales.

Fourth Quarter and Full Year 2019 Financial Results

Paratek reported a net loss of $27.4 million, or ($0.81) per share, for the fourth quarter of 2019, compared to a net loss of $22.8 million, or ($0.71) per share, for the same period in 2018.

For the year ended December 31, 2019, Paratek reported a net loss of $128.8 million, or ($3.93) per share, compared to a net loss of $112.4 million, or ($3.57) per share, for the same period in 2018.

Revenue earned during the fourth quarter of 2019 of $9.0 million was attributable to U.S. NUZYRA net sales of $5.4 million and collaboration and royalty revenue of $3.6 million, which included a $3.0 million milestone earned from Zai Lab and royalties earned from SEYSARA sales in the U.S. Revenue earned during the fourth quarter of 2018 was primarily attributable to a $12.0 million milestone earned from Almirall, LLC upon FDA approval of SEYSARA and a $5.0 million milestone earned from Zai Lab upon FDA approval of NUZYRA.

Revenue earned during the year ended December 31, 2019 of $16.5 million was attributable to U.S. NUZYRA net sales of $11.5 million and royalty and collaboration revenues of $5.0 million, consisting primarily of a $3.0 million milestone payment earned in December 2019 upon submission of the first regulatory approval application for a licensed product in the People’s Republic of China and royalties earned from SEYSARA sales in the United States. Revenue earned during the year ended December 31, 2018 of $17.0 million was primarily attributable to a $12.0 million milestone earned from Almirall, LLC upon FDA approval of SEYSARA and a $5.0 million milestone earned from Zai Lab upon FDA approval of NUZYRA.

Research and development expenses were $9.1 million in the fourth quarter of 2019 compared to $11.8 million for the same period in 2018.

Research and development expenses were $39.6 million for the year ended December 31, 2019, compared to $57.5 million for the year ended December 31, 2018. The $17.9 million decrease is primarily the result of the capitalization of NUZYRA commercial supply costs, which were classified as research and development expense until FDA approval of NUZYRA on October 2, 2018, partially offset by higher clinical study costs associated with our Phase 2 UTI program.

Selling, general and administrative expenses were $21.3 million in fourth quarter of 2019, compared to $25.3 million for the same period in 2018.

Selling, general and administrative expenses were $89.1 million for the year ended December 31, 2019, compared to $63.7 million for the year ended December 31, 2018.  The $25.4 million increase is primarily the result of the cost of our contract sales force, higher marketing, trade and distribution fees, and increased salaries, benefits and other personnel-related costs in support of the commercialization of NUZYRA.

As of December 31, 2019, Paratek had $215.4 million in cash, cash equivalents and marketable securities.

Financial Guidance

Paratek also announced its full year 2020 financial guidance. This financial guidance consists of the following components:

Paratek estimates 2020 total revenues to be between $75 and $80 million. This revenue consists of the following elements:

2020 NUZYRA U.S. net product sales is expected to be approximately $66 million with approximately $38 million of these sales coming from the initial BARDA procurement of 2,500 anthrax treatment courses.

The initial NUZYRA BARDA procurement is anticipated to be secured in the first half of 2020.

Royalty and collaboration revenue and BARDA grant revenue are expected to be approximately $9 to $14 million.

Of note, BARDA grant revenue consists of reimbursement associated with the post-marketing requirement clinical development activities, the anthrax development program and the onshoring of U.S. NUZYRA manufacturing.

2020 R&D and SG&A expense is expected to be approximately $140 million.

R&D expense includes approximately $5 million earmarked for start-up activities in preparation for a potential NTM registrational study.

Excluding the BARDA R&D and onshoring cost reimbursement, R&D and SG&A expense is expected to remain relatively flat when compared to 2019.

Based upon our current operating plan which includes estimated NUZYRA product sales, and the BARDA expense reimbursement of activities related to the Project BioShield contract, we anticipate that our existing cash, cash equivalents and marketable securities of $215.4 million as of December 31, 2019, extend our cash runway through the end of 2023 with a pathway to cash flow break even.

This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement under its existing terms.

Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance.

Call and Webcast

Paratek’s earnings conference call for the quarter ended December 31, 2019 will be broadcast today at 4:30 p.m. EDT on February 25, 2019. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek’s website at www.ParatekPharma.com.

Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13699046. Investors can also access the call at View Source

Website Information

Paratek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek’s website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek’s website is not incorporated by reference into, and is not a part of, this document.