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.

On February 25, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare technology company, reported that Dr. Patrick Soon-Shiong, Chairman and CEO, has been chosen to keynote at the Intelligent Health Pavilion (IHP) during the Healthcare Information Management Systems Society (HIMSS) 2020 Annual Conference & Exhibition in Orlando (Press release, NantHealth, FEB 25, 2020, View Source [SID1234554733]). NantHealth is exhibiting at the show in booth #7366.

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Dr. Soon-Shiong will share how AI technologies and machine learning can improve the diagnosis and treatment of cancer. This keynote address will highlight new clinical evidence and share compelling patient examples, while also revealing how clinicians can collaborate more effectively and access higher quality data to arrive at an accurate hypotheses/diagnosis faster.

What:

"How Data is Revolutionizing Patient Outcomes"

Who:

Dr. Patrick Soon-Shiong, Chairman and CEO of NantHealth

When:

Tuesday, March 10 at 10:30 a.m. ET

Where:

HIMSS Annual Conference & Exhibition

Intelligent Health Pavilion, Leadership Theatre

Orange County Convention Center

Orlando, Florida

The session will also be available for live viewing at View Source

"We are excited and honored to have Dr. Patrick Soon-Shiong share his latest scientific findings, data advancements, and patient stories with HIMSS and the entire healthcare community," said Harry Pappas, Founder & CEO of the IHP. "This keynote will be a great opportunity to hear from a well-respected and proven healthcare and technology innovator on developments that are having a real impact on patients and the healthcare industry at large. Dr. Soon-Shiong and his NantHealth team are truly pioneering real change and influence in the area of personalized medicine."

NantHealth will also feature several use cases highlighting its advanced data expertise in the IHP, including Eviti Advisor, the most comprehensive digital library of unbiased, evidence-based oncology regimens, and NaviNet Open, a powerful payer-provider collaboration platform.

On February 25, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the fourth quarter and full year-ended December 31, 2019 (Press release, Mirati, FEB 25, 2020, View Source [SID1234554732]).

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"In 2019, we advanced MRTX849, our KRAS G12C inhibitor into a Phase 1/2 clinical trial, showing initial promising data, while continuing to move forward our potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor for non-small cell lung cancer (NSCLC)," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer at Mirati. "We continue to grow our targeted oncology portfolio, including investigational new drug (IND)-enabling toxicology studies for our lead KRAS G12D candidates. We are also strengthening our organizational capabilities as we prepare the company to further develop and deliver our novel cancer therapies to the patients most in need of treatments."

RECENT CORPORATE UPDATES:

MRTX849 (KRAS G12C Inhibitor)

Began enrolling patients in the single-agent MRTX849 Phase 2 registrational arm of the KRYSTAL trial as 2nd or 3rd line therapy in NSCLC

Initiated both the combinations of MRTX849 and a PD-1 (pembrolizumab) in NSCLC and MRTX849 and an EGFR inhibitor (cetuximab) in colorectal cancer (CRC) under arms of the KRYSTAL trial

KRAS G12D Inhibitor

Advanced lead candidates in our KRAS G12D inhibitor program into potentially IND-enabling toxicology studies.

Sitravatinib

Presented data in two presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting on November 9, 2019.

Interim Phase 2 data for sitravatinib in combination with nivolumab in urothelial carcinoma. As of the cut-off date of October 17, 2019, 22 patients were evaluable for response with at least one radiographic scan. 6/22 evaluable patients achieved a confirmed Complete Response (CR, 1 patient) or Partial Response (PR, 5 patients). 21/22 evaluable patients

achieved a CR, PR or stable disease and 4/6 responding patients had been treated for more than 6 months. The combination has been well-tolerated.

Interim data in the investigator sponsored Phase 1 SNOW trial (sitravatinib and nivolumab in oral cavity cancer window of opportunity study) was announced in a poster presentation. The preliminary data suggest that the combination of neoadjuvant sitravatinib and nivolumab is safe and active in patients with squamous cell carcinoma of the oral cavity who are candidates for resection. As of the data cut-off date of October 9, 2019, 9 patients had been enrolled. Tumor reduction was observed in all eight patients who were eligible for evaluation, including one complete pathological response. All patients received postoperative radiation therapy, and none required postoperative chemotherapy. The median follow-up shown was 31.4 weeks and all patients were alive with no disease recurrence as of the cut-off date. In most patients, treatment with sitravatinib led to a decrease in myeloid-derived suppressor cells and a shift towards M1-type macrophages in the tumor microenvironment, demonstrating the ability of sitravatinib to re-sensitize the tumor microenvironment to immunotherapy.

Presented interim data for sitravatinib in combination with nivolumab in patients with advanced clear cell renal cell carcinoma (aCCRCC) at the recent ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium on February 15, 2020 in an investigator sponsored trial. As of the data cut-off date of January 1, 2020, 38/40 patients with aCCRCC who had progressed following treatment with a VEGF-targeted therapy, were evaluable for response after greater than 12 weeks on therapy:

15/38 (39%) patients achieved a confirmed partial response (PR) including one PR that had improved to an unconfirmed complete response (CR) and 35/38 (92%) patients achieved clinical benefit (combination of stable disease plus PR plus CR). Initial median progression-free survival (PFS) was 10.3 months with median overall survival (OS) had not yet been reached (median follow-up was 17.7 months) with 30/38 patients (79%) still on study as of the data cut-off date. The combination of sitravatinib with nivolumab was well tolerated with manageable adverse events.

Operational Updates

On January 6th, 2020, announced the appointment of Dan Faga as Executive Vice President, Chief Operating Officer and Ben Hickey as Executive Vice President, Chief Commercial Officer.

Ended the year with $415.1 million in cash, cash equivalents, and short-term investments and, in addition, strengthened our balance sheet by completing a public offering of common stock on January 14th, 2020 that provided net proceeds of $324.1 million.
ncial Results for the Fourth Quarter 2019

License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), dated January 7, 2018. License and collaboration revenues for the three and twelve months ended December 31, 2019 were $0.5 million and $3.3 million, respectively, compared to $3.5 million and $12.9 million for the three and twelve months ended December 31, 2018, respectively. The 2019 revenues relate to revenues earned related to a manufacturing supply services agreement with BeiGene ("MSSA"), and the 2018 revenues relate primarily to the transfer of the license and associated know-how to BeiGene, as well as revenues earned related to the MSSA.

Research and development expenses for the fourth quarter of 2019 were $62.9 million, compared to $26.8 million for the same period in 2018. Research and development expenses for the year ended

December 31, 2019 were $182.9 million, compared to $93.9 million for the same period in 2018. The increase in research and development expenses is due to an increase in expense associated with the development of sitravatinib and MRTX849, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expense of $10.6 million during the fourth quarter of 2019, compared to $2.1 million for the same period in 2018, and $31.0 million during the year ended December 31, 2019, compared to $7.2 million for the same period in 2018.

General and administrative expenses for the fourth quarter of 2019 were $12.2 million, compared to $6.4 million for the same period in 2018. General and administrative expenses for the year ended December 31, 2019 were $42.6 million, compared to $21.7 million for the same period in 2018. The increase is due primarily to an increase in share-based compensation expense and, to a lesser extent, an increase in employee related expense, professional services expense and facilities and insurance expense. The Company recognized general and administrative-related share-based compensation expense of $6.1 million during the fourth quarter of 2019, compared to $2.1 million for the same period in 2018, and $24.5 million during the year ended December 31, 2019, compared to $8.6 million for the same period in 2018.

Net loss for the fourth quarter of 2019 was $72.4 million, or $1.83 per share basic and diluted, compared to net loss of $28.3 million, or $0.87 per share basic and diluted for the same period in 2018. Net loss for the year ended December 31, 2019 was $213.3 million, or $5.69 per share basic and diluted, compared to net loss of $98.4 million, or $3.19 per share basic and diluted for the same period in 2018.

Cash, cash equivalents, and short-term investments were $415.1 million at December 31, 2019, compared to $222.8 million at December 31, 2018. In January 2020, we completed a public offering of common stock that provided net cash proceeds of $324.1 million.

About MRTX849

MRTX849 is an investigational, orally-available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of non-small cell lung cancer adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified, KRAS G12C-positive advanced solid tumors.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

On February 25, 2020 MannKind Corporation (NASDAQ:MNKD) reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Mannkind, FEB 25, 2020, View Source [SID1234554731]).

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"We ended 2019 on a strong note with fourth quarter 2019 Afrezza net revenue of $7.8 million, our best quarter to date," said Michael Castagna, Chief Executive Officer of MannKind Corporation. He also noted, "Our collaboration with United Therapeutics on TreT continues to make progress along the clinical and commercial pathways that are expected to set up a filing with the FDA within 12 months."

Fourth Quarter 2019 Results

Total revenues were $16.0 million for the fourth quarter of 2019, reflecting Afrezza net revenue of $7.8 million and collaborations and services revenue of $8.2 million. Afrezza net revenue increased 35% compared to $5.7 million in the fourth quarter of 2018, primarily driven by higher product demand and price. Collaborations and services revenue decreased $2.1 million compared to the fourth quarter of 2018, primarily due to lower revenue from the United Therapeutics research agreement, which was substantially completed by the second quarter of 2019.

On a GAAP basis, Afrezza gross profit was $3.1 million for the fourth quarter of 2019 compared to $0.7 million in the same period in 2018. Afrezza cost of goods sold for the fourth quarter of 2018 included a fee of $2.0 million recorded in connection with the amendment of our insulin supply agreement with Amphastar. As a result, on a non-GAAP basis, gross profit was $2.7 million or 48% gross margin for the fourth quarter of 2018, compared to a GAAP basis gross margin of 40% for the fourth quarter of 2019.

Research and development (R&D) expenses for the fourth quarter of 2019 were $2.0 million compared to $1.1 million for the fourth quarter of 2018. This 82% increase was primarily attributable to an increase of $0.6 million in personnel costs associated with the United Therapeutics research agreement, which was classified as a cost of collaborations and services revenue in 2018, and to an increase of $0.3 million in maintenance costs for our research facility in Danbury, Connecticut.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2019 were $15.7 million compared to $18.0 million for the fourth quarter of 2018. This decrease of $2.3 million, or 13%, was primarily attributable to a $1.7 million decrease in personnel related costs and a $1.1 million decrease in Afrezza marketing costs, partially offset by an increase of $0.5 million in consulting and professional services costs.

Interest expense on debt for the fourth quarter of 2019 was $2.3 million compared to $1.7 million for the fourth quarter of 2018. This $0.6 million increase, or 35%, was primarily attributable to the net increase in our debt balance as a result of our debt restructuring in the third quarter of 2019.

The net loss for the fourth quarter of 2019 was $14.3 million, or $0.07 per share compared to a $9.8 million net loss in the fourth quarter of 2018 or $0.06 per share. The increase in the net loss of $4.5 million was primarily the result of an increased loss on foreign currency translation of $4.0 million associated with our insulin supply agreement denominated in Euros and of an increase of $0.6 million in interest expense.

Twelve Months Ended December 31, 2019

Total revenues were $63.0 million for the year ended December 31, 2019, reflecting Afrezza net revenue of $25.3 million and collaborations and services revenue of $37.7 million. Afrezza net revenue increased 46% compared to $17.3 million for the year ended December 31, 2018, primarily due to higher product demand, the first sale of Afrezza to our marketing partner in Brazil (Biomm), price increases as well as a more favorable mix of Afrezza cartridges. Collaborations and services revenue increased $27.2 million compared to the full year ended December 31, 2018, which was primarily attributed to the licensing and research agreements with United Therapeutics, both of which began in the fourth quarter of 2018.

On a GAAP basis, Afrezza gross profit was $5.2 million for the year ended December 31, 2019, an improvement of $7.3 million or 347% compared to a gross loss of $2.1 million in the same period in 2018, primarily due to an increase of $8.0 million in net revenue and a $2.2 million decrease in inventory write-offs, partially offset by increased costs due to higher sales and an increase of $0.8 million in fees paid to Amphastar for amendments to our insulin supply agreement. As a result, on a non-GAAP basis, gross profit was $8.0 million, or 32%, for the year ended December 31, 2019 compared to a gross loss of $0.1 million, or 1%, for the full year ended December 31, 2018.

R&D expenses for the year ended December 31, 2019 were $6.9 million compared to $8.7 million for the year ended December 31, 2018. This decrease of $1.8 million, or 21%, was primarily attributable to a $1.7 million decrease in personnel related costs and a $0.9 million decrease in clinical trial spending, partially offset by increased expenses of $0.2 million related to the development of our BluHale inhalation profiling apparatus and increased facility maintenance and equipment repair costs of $0.5 million.

SG&A expenses for the year ended December 31, 2019 were $74.7 million compared to $79.7 million for the year ended December 31, 2018. This decrease of $5.0 million, or 6%, was primarily attributable to a $6.6 million decrease in personnel and employee related costs, decreased consulting costs of $2.5 million and a $1.2 million decrease in stock-based compensation costs, which was partially offset by a $5.6 million increase in costs for television advertising for Afrezza.

Interest income increased by $0.5 million, or 99%, for the year ended December 31, 2019 compared to the year ended December 31, 2018, primarily due to a higher average balance on money market funds and short-term investments.

Interest expense on debt for the year ended December 31, 2019 was $10.9 million compared to $9.4 million for the year ended December 31, 2018. This $1.5 million increase was primarily attributable to a $3.4 million charge realized as a result of achieving a sales milestone in the third quarter of 2019 under our milestone agreement with Deerfield, partially offset by lower interest as a result of the repayment of the Deerfield credit facility.

The net loss for the year ended December 31, 2019 was $51.9 million, or $0.27 per share, compared to $87.0 million net loss for the year ended December 31, 2018, or $0.60 per share. The lower net loss was mainly attributable to a $35.2 million increase in total revenues.

Cash, Cash Equivalents, Restricted Cash and Short Term Investments

Cash, cash equivalents, restricted cash, and short-term investments at December 31, 2019 was $50.2 million compared to $71.7 million at December 31, 2018.

Non-GAAP Measures

Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. To participate in the live call by telephone, please dial (800) 289-0438 or (323) 794-2423 and use the participant passcode: 1233728. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 1233728. A replay will also be available on MannKind’s website for 14 days.

On February 25, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2019 (Press release, MacroGenics, FEB 25, 2020, View Source [SID1234554730]).

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"2019 was an important year for MacroGenics, with the submission of our BLA for margetuximab for HER2-positive breast cancer. We also initiated a registration directed clinical study with margetuximab in combination with checkpoint blockade in advanced HER2-positive gastric cancer," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "During 2020, we anticipate additional key events. Following promising data presented at ASH (Free ASH Whitepaper) in 2019, we plan to define a registration path for flotetuzumab in refractory AML, pending further discussions with FDA. We also look forward to presenting initial clinical data from several of our programs currently in Phase 1, potentially including our two bispecific DART molecules that provide dual checkpoint blockade, MGD013 and MGD019, as well as MGC018, our ADC targeting B7-H3. We look forward to a productive year for MacroGenics in 2020."

Key Pipeline Updates

Recent progress and anticipated events in 2020 related to MacroGenics’ investigational product candidates in clinical development are highlighted below.

Margetuximab is an Fc-engineered, anti-HER2 monoclonal antibody being evaluated for the treatment of patients with advanced HER2-positive cancers.

Metastatic Breast Cancer. In December 2019, MacroGenics submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The safety and efficacy results provided in the BLA are primarily from the pivotal Phase 3 SOPHIA study, which is evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have received prior anti-HER2 therapies. Updated results from the study were presented at the San Antonio Breast Cancer Symposium in December 2019. In February 2020, the BLA was accepted for review by the FDA. MacroGenics expects that there will be a Standard Review process and we anticipate a Prescription Drug User Fee Act (PDUFA) date by the end of 2020. In addition, the Company believes that the FDA will require an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020.

Separately, in February 2020, MacroGenics’ regional partner in Greater China, Zai Lab Limited (Zai Lab), announced the initiation of a registrational bridging study of margetuximab plus chemotherapy for the treatment of patients with metastatic HER2-positive breast cancer who have received prior anti-HER2 therapies.

Advanced Gastric and Gastroesophageal Junction Cancer. In October 2019, MacroGenics announced the initiation of the Phase 2/3 MAHOGANY study designed to evaluate the combination of margetuximab with anti-PD-1-based therapies as a front-line treatment. Initial safety and efficacy data are expected in the second half of 2020 from Module A of this study, which is evaluating a chemotherapy-free regimen. Module A has been designed to support a potential accelerated approval in the U.S. based on evaluation of objective response rate in a single-arm study.
Flotetuzumab is a bispecific CD123 x CD3 DART molecule being evaluated for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). At the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019, MacroGenics presented updated results from patients with AML who are refractory to induction treatment (primary induction failure) in a Phase 1/2 dose expansion study. The Company intends to define a potential registration path in the U.S. for the treatment of patients with primary induction failure AML in the first half of 2020, pending continued discussions with the FDA.

In October 2019, MacroGenics initiated a Phase 1/2 study outside of the U.S. combining flotetuzumab with MGA012, an anti-PD-1 antibody, based on preclinical and translational data that indicate the combination may enhance CD123-directed T cell killing.

MGA012 (INCMGA0012) is an anti-PD-1 monoclonal antibody that has been exclusively licensed to Incyte Corporation. There are currently six registration-directed clinical studies ongoing or planned in 2020 across a broad range of tumor types.

MGD013 is a first-in-class, bispecific PD-1 x LAG-3 DART molecule being evaluated in a Phase 1 dose expansion study. MacroGenics is selecting one or more indications for further development and has submitted data from select cohorts in the ongoing study for presentation at a scientific conference in the first half of 2020. Separately, in February 2020, MacroGenics’ regional partner in Greater China, Zai Lab, announced the initiation of a Phase 1 study of MGD013 in combination with niraparib, a PARP (poly [ADP-ribose] polymerase) inhibitor, for the treatment of patients with advanced gastric or gastroesophageal junction cancer.

Enoblituzumab is an Fc-engineered, anti-B7-H3 monoclonal antibody. In 2020, MacroGenics plans to evaluate the activity of both enoblituzumab plus MGA012 and enoblituzumab plus MGD013 as chemotherapy-free regimens in front-line patients with recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) as a lead-in module before proceeding with one of these combinations in a Phase 2/3 study.

MGC018 is an antibody-drug conjugate (ADC) targeting B7-H3 and MGD019 is a bispecific PD-1 x CTLA-4 DART molecule. The Company expects to complete dose escalation for each of these molecules in 2020 and then initiate focused dose expansion studies in select tumor types. In addition, MacroGenics expects to submit data from the dose escalation cohorts for presentation at scientific conferences in 2020.

2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2019 were $215.8 million, compared to $232.9 million as of December 31, 2018.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $64.2 million for the year ended December 31, 2019, compared to $60.1 million for the year ended December 31, 2018. This increase was primarily due to the timing of revenue recognition under our collaborative agreements.

R&D Expenses: Research and development expenses were $195.3 million for the year ended December 31, 2019, compared to $190.8 million for the year ended December 31, 2018. This increase was primarily due to continued enrollment in multiple ongoing clinical trials.

G&A Expenses: General and administrative expenses were $46.1 million for the year ended December 31, 2019, compared to $40.5 million for the year ended December 31, 2018. This increase was primarily due to an increase in consulting costs related to market research and other commercial preparation activities.

Net Loss: Net loss was $151.8 million for the year ended December 31, 2019, compared to net loss of $171.5 million for the year ended December 31, 2018.

Shares Outstanding: Shares outstanding as of December 31, 2019 were 48,958,763.

Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of December 31, 2019, combined with anticipated and potential collaboration payments, will enable it to fund its operations into 2021, assuming the Company’s programs and collaborations advance as currently contemplated. Through the prioritization of programs and ongoing realignment of its resources, MacroGenics is focused on extending its cash runway into 2022.
Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the year ended December 31, 2019 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 5581596.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations 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.