On February 25, 2020 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, reported its financial results for the year ended November 30, 2019 (Press release, Theratechnologies, FEB 25, 2020, View Source [SID1234554706]).

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Fiscal Year 2019 Financial Highlights

Record revenue with net sales of US$63,216,000, up 39.8% from the previous year

Trogarzo sales reach US$27,696,000, up 212% from the previous year

EGRIFTA sales reach US$35,520,000, down 2.2% from the previous year

Strong cash position of US$41,244,000

"Our last fiscal year was one of many accomplishments. In the last twelve months, we managed to obtain approval for Trogarzo in Europe, to launch a new formulation of tesamorelin, EGRIFTA SVTM, to list our shares on NASDAQ, to grow our revenues by 40 percent, to acquire a unique and highly-promising technology platform in oncology, to launch the development program of tesamorelin for the treatment of NASH in HIV and to manage to record a slightly positive EBITDA while investing in Europe and in our developments programs," said Luc Tanguay, President and CEO, Theratechnologies Inc.

"We ended the year with a company stronger than ever and with tools to sustain growth through our commercialized products and a promising pipeline," added Mr. Tanguay.

Fiscal Year 2019 Financial Results

The financial results presented in this press release are taken from the Company’s Management’s Discussion and Analysis, or MD&A, and audited consolidated financial statements for the twelve-month period ended November 30, 2019, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. The MD&A and the audited consolidated financial statements can be found at www.sedar.com, on EDGAR at www.sec.gov and at www.theratech.com. Unless specified otherwise, all amounts in this press release are in U.S. dollars and all capitalized terms have the meaning ascribed thereto in our MD&A. As used herein, EGRIFTA and EGRIFTA SVTM refer to tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Trogarzo refers to ibalizumab for the treatment of multidrug resistant HIV-1 patients.

For the year ended November 30, 2019

Consolidated revenue for the year ended November 30, 2019 was $63,216,000 compared to $45,217,000 for the same period ended November 30, 2018, an increase of 39.8%. Revenue growth reflects the added contribution of Trogarzo. This was the first full year of commercialization for Trogarzo in the United States where sales reached $27,696,000 as at November 30, 2019. Trogarzo was approved in the United States on March 6, 2018 and has been commercially available since April 30, 2018.

The contribution of EGRIFTA remains significant. For the year ended November 30, 2019, sales of EGRIFTA were $35,520,000 compared to $36,329,000 for the same period last year, representing a decrease of 2.2%. Net sales in 2019 were negatively impacted by an unexpected charge related to government rebates not previously recorded by one of our distributing pharmacies. A portion of units sold to this pharmacy were previously incorrectly identified by the pharmacy as commercial patients, when they were actually government reimbursed patients, who are eligible to rebates.

For the year ended November 30, 2019, cost of sales was $26,076,000 compared to $13,263,000 in the comparable period of Fiscal 2018. Cost of sales includes the cost of goods sold which amounted to $21,125,000 in Fiscal 2019 compared to $9,376,000 in Fiscal 2018. The increase in cost of goods sold is mainly due to the growth of Trogarzo net sales.

Prior to the third quarter of 2018, cost of sales included royalties due under the terms of an agreement terminating our collaboration and licensing agreement with EMD Serono Inc., or EMD Serono. In June 2018, we made a full and final payment of $23,850,000 to EMD Serono which enabled Theratechnologies to realize savings from a reduction of future payment obligations including royalty payments.

The payment in connection with the settlement of the future royalty obligation has been accounted as "Other asset" on the consolidated statement of financial position. Consequently, an amortization of $4,884,000 has been recorded in relation to this transaction in Fiscal 2019 compared to $2,442,000 during Fiscal 2018 and is included in cost of sales.

R&D Expenses amounted to $10,841,000 for Fiscal 2019 compared to $7,994,000 in Fiscal 2018.

The increase in R&D expenses is largely due to regulatory and medical activities in Europe, to the development of tesamorelin and to investments in the oncology platform.

R&D expenses also included medical affairs initiatives aimed at raising awareness among physicians and nurses who interact with patients living with MDR HIV-1 and lipodystrophy, in addition to regulatory affairs activities, such as handling of the European filing of Trogarzo and quality assurance activities.

These expenses were partially offset by the decision of the FDA to release Theratechnologies from its last post-approval commitments relating to EGRIFTA.

Selling expenses for the year ended November 30, 2019 amounted to $26,482,000 compared to $21,693,000 for the same period last year.

The increase in selling expenses is largely associated with preparation work related to the approval and launch of Trogarzo in Europe as well as the launch of EGRIFTA SVTM and the direct-to-consumer campaign in the United States.

The amortization of the intangible asset value established for the EGRIFTA and Trogarzo commercialization rights in North America is also included in selling expenses. We recorded an expense of $2,412,000 in Fiscal 2019 compared to $1,767,000 in Fiscal 2018.

General and administrative expenses for the year ended November 30, 2019 amounted to $8,330,000 compared to $5,828,000 for the same period in Fiscal 2018.

The increase in general and administrative expenses is mainly associated with business growth, increased activity in Europe, the listing on NASDAQ and additional investor relations initiatives.

Finance income, consisting of interest income, for the year ended November 30, 2019 amounted to $1,097,000 compared to $608,000 in Fiscal 2018. Higher finance income is mostly related to a higher average liquidity position.

Finance costs for the year ended November 30, 2019 were $5,080,000 compared to $3,016,000 in Fiscal 2018. Finance costs in Fiscal 2019 mostly represent interest of $3,317,000 on the convertible senior unsecured notes issued on June 18, 2018, compared to $1,486,000 last year.

Finance costs also included accretion expense, which amounted to $1,673,000 during Fiscal 2019 compared to $1,041,000 during Fiscal 2018.

Adjusted EBITDA for Fiscal 2019 was $323,000 compared to $1,664,000 in Fiscal 2018, reflecting increased investments towards building our infrastructure in Europe, the development of our oncology platform and the listing of our common shares on the NASDAQ. These higher expenses were partially offset by higher revenues related to growing Trogarzo sales. See "Non-IFRS Financial Measures" below.

Taking into account the revenue and expense variations described above, we recorded a net loss of $12,496,000 or $0.16 per share in Fiscal 2019 compared to a net loss of $4,700,000 or $0.06 in Fiscal 2018.

As at November 30, 2019, cash, bonds and money market funds amounted to $41,244,000.

Fourth Quarter 2019 Financial Results

Consolidated revenue for the three months ended November 30, 2019 amounted to $16,400,000 compared to $13,983,000 for the same period last year, representing an increase of 17.3%.

For the fourth quarter of Fiscal 2019, sales of EGRIFTA reached $8,731,000 compared to $9,732,000 in the fourth quarter of the prior year. While unit sales to our US distributor were up 5.3% compared to Q4 of 2018, net sales decreased for two main reasons: (i) net sales for Q4 2019 were impacted by an unexpected charge related to government rebates not previously recorded by one of our distributing pharmacies. A portion of units sold to this pharmacy were previously incorrectly identified by the pharmacy as commercial patients, when they were actually government reimbursed patients, who are eligible to rebates, and (ii) net sales for Q4 2018 were positively impacted by the reversal of a provision related to chargebacks and rebates.

In the fourth quarter of 2019, Trogarzo sales amounted to $7,669,000 compared to $4,251,000 for the same quarter of 2018, representing an increase of 80.4%.

For the three-month period ended November 30, 2019, cost of sales was $6,989,000 compared to $4,751,000 in the comparable period of Fiscal 2018. Cost of goods sold was $5,754,000 compared to $3,516,000 for the same period last year. The increase in cost of goods sold is mainly due to higher sales of Trogarzo. Cost of sales include an amortization of $1,221,000 in the fourth quarter of 2019 and of 2018 in connection with the settlement of the future royalty obligation which has been accounted as "Other asset" on the consolidated statement of the financial position.

R&D expenses in the three-month period ended November 30, 2019 amounted to $3,877,000 compared to $2,063,000 in the comparable period of Fiscal 2018. As previously explained, this increase is largely due to investments made towards the approval of Trogarzo in Europe, the development of our oncology platform and of tesamorelin for the treatment of NASH in people living with HIV as well as medical activities related to Trogarzo.

Selling expenses in the three-month period ended November 30, 2019 amounted to $7,673,000 compared to $5,233,000 in the comparable period of Fiscal 2018.

The increase in selling expenses is largely associated with preparation work related to the approval and launch of Trogarzo in Europe as well as to the launch of EGRIFTA SVTM and to the direct-to-consumer campaign in the United States.

The amortization of the intangible asset value established for the EGRIFTA and Trogarzo commercialization rights in North America is also included in selling expenses. We recorded an expense of $642,000 for the fourth quarter of Fiscal 2019 compared to $487,000 for the same quarter the previous year.

General and administrative expenses in the fourth quarter of Fiscal 2019 amounted to $3,258,000 compared to $1,865,000 reported in the same period of Fiscal 2018. The increase is mainly associated with business growth, the expansion in Europe and the listing of our common shares on NASDAQ.

Finance income, consisting of interest income, for the three-month period ended November 30, 2019 was $217,000 compared to $276,000 in the comparable quarter of Fiscal 2018. Lower finance income is a reflection of our slightly lower liquidity position during the fourth quarter of Fiscal 2019 compared to the same period of 2018.

Finance costs for the fourth quarter of Fiscal 2019 were $1,275,000 compared to $1,330,000 for the same quarter of Fiscal 2018. As previously stated, finance costs are mostly comprised of interest on the Notes.

Finance costs also include accretion expense, which was $440,000 for the fourth quarter of 2019 compared to $357,000 for the same period last year. Accretion expense was is mainly associated with the Notes issued in June 2018.

Adjusted EBITDA for the fourth quarter of 2019 was $(3,217,000) compared to $1,996,000 in same period of Fiscal 2018. See "Non-IFRS Financial Measures" below.

The variation from Q4 2018 to Q4 2019 is mainly due to the increased activity in Europe, our investment in new research and development activities and the previously described charges related to government rebates. Our Q4 2018 Adjusted EBITDA was also positively impacted by the reversal of chargebacks and provisions, as previously mentioned.

Taking into account the revenue and expense variations described above, we recorded a net loss of $6,445,000 or $0.08 per share in the fourth quarter of Fiscal 2019 in comparison to a net loss of $983,000 or $0.01 per share in the fourth quarter of 2018.

We ended the fourth quarter of 2019 with $41,244,000 in cash, bonds and money market funds.

For the three-month period ended November 30, 2019, operating activities used $2,760,000 compared to generating $2,622,000 in the comparable period of Fiscal 2018.

In the fourth quarter of Fiscal 2019, changes in operating assets and liabilities had a positive impact on cash flow of $488,000. These changes include an increase of $9,096,000 in accounts payable and accrued liabilities and a decrease in accounts receivable of $1,258,000, which were mainly offset by a $8,082,000 increase in inventories. These changes are related to an increase in our commercial activities.

Non-IFRS Financial Measures

Reconciliation of net profit or loss to adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA)

Adjusted EBITDA is a non-IFRS financial measure. A reconciliation of the Adjusted EBITDA to net profit (loss) is presented in the table below. We use adjusted financial measures to assess our operating performance. Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than IFRS do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. We use Adjusted EBITDA to measure operating performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our business, and because we believe it provides meaningful information on our financial condition and operating results.

We obtain our Adjusted EBITDA measurement by adding to net profit or loss, finance income and costs, depreciation and amortization, and income taxes. We also exclude the effects of certain non-monetary transactions recorded, such as share-based compensation for the stock option plan, lease inducements and write-downs (or related reversals) of inventories, for our Adjusted EBITDA calculation. We believe it is useful to exclude these items as they are either non-cash expenses, items that cannot be influenced by management in the short term, or items that do not impact core operating

performance. Excluding these items does not imply they are necessarily nonrecurring. Share-based compensation costs are a component of employee remuneration and can vary significantly with changes in the market price of the Company’s shares. In addition, other items that do not impact core operating performance of the Company may vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of our operating results over a period of time. Our method for calculating Adjusted EBITDA may differ from that used by other companies.

Conference Call Details

A conference call will be held today at 8:30 a.m. (ET) to discuss the results. The conference call will be open to questions from financial analysts. Media and other interested individuals are invited to participate in the call on a "listen-only" basis.

The conference call can be accessed by dialling 1-877-223-4471 (North America) or 1-647-788-4922 (International). The conference call will also be accessible via webcast at View Source Audio replay of the conference call will be available on the same day starting at 11:30 a.m. (ET) until March 10, 2020, by dialling 1-800-585-8367 (North America) or 1-416-621-4642 (International) and by entering the playback code 5896409.

On February 25, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL and peripheral-blood lymphocyte, PBL), reported fourth quarter and year-end 2019 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, FEB 25, 2020, View Source [SID1234554728]).

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"During 2019 we made tremendous progress in advancing Iovance TIL and PBL products," said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "We conducted two planned pivotal programs for lifileucel in melanoma and LN-145 in cervical, initiated patient dosing in earlier lines of therapy and received clearance from FDA on a new IND to proceed to dose patients with our PBL product, IOV-2001. In anticipation for commercialization of Iovance TIL, we are building our internal manufacturing capability and expanding our commercial team and infrastructure. With the first potential cell therapy in solid tumors, as well as a broad TIL platform, Iovance is poised to become the leader in development, manufacturing, and commercialization of TIL cell therapy for solid tumors."

2019 Highlights and 2020 Updates

Clinical

·Initiation and completion of patient dosing in the pivotal melanoma program, cohort 4 in the C-144-01 trial: Patient dosing in the pivotal cohort 4 of the C-144-01 study was initiated in March 2019 and completed in January 2020, three months ahead of schedule. Iovance intends to submit a biologics license application (BLA) to FDA subsequent to consultation with the agency in 2020.
·Presentation of data for lifileucel in metastatic melanoma and LN-145 for metastatic cervical cancer at major medical meetings: Several clinical data presentations continued to demonstrate efficacy and safety of lifileucel in metastatic melanoma (from C-144-01 study) and LN-145 in recurrent, metastatic, or persistent cervical cancer (from C-145-04 study).
oMelanoma update
·The data for the C-144-01 study in melanoma demonstrated a 36.4% ORR by investigator as presented at ASCO (Free ASCO Whitepaper).1
·In a recent data cut for the C-144-01 study, a median duration of response (DOR) was not reached at 15.5 months of median study follow up (Jan. 2020).2
·Expansion of TIL treatment to earlier lines of therapy for melanoma, head and neck, and non-small cell lung cancer (NSCLC) patients. Patient dosing in the IOV-COM-202 clinical study was initiated in May 2019 to evaluate TIL plus pembrolizumab in patients with immune checkpoint inhibitor naïve melanoma, squamous cell carcinoma of the head and neck (HNSCC), and NSCLC. In the fourth cohort, LN-145 alone is offered to relapsed/refractory NSCLC patients.

Regulatory

·Receipt of Breakthrough Therapy designation (BTD), Fast Track designation and holding End of Phase 2 Meeting for LN-145 in cervical cancer: LN-145 was granted Fast Track and BTD from FDA in recurrent, metastatic or persistent cervical cancer with disease progression on or after chemotherapy. Following an end of Phase 2 meeting, the ongoing C-145-04 clinical study was expanded to dose 75 patients to support registration of LN-145. Additional cohorts in earlier and later line cervical cancer patients were added to study C-145-04 in anticipation of a changing landscape in this indication, specifically, a cohort allowing patients post anti-PD-1 was added.
·Clearance of the investigational new drug (IND) application by FDA and initiation of patient dosing for PBL (IOV-2001) therapy in the first hematologic indication, CLL: An IND application for IOV-2001 was accepted by FDA in the blood cancer indication, relapsed or refractory CLL or small lymphocytic lymphoma (SLL). The first patient was dosed in a Phase 1/2 study (IOV-CLL-01 study).

Manufacturing

·Continuation of high manufacturing success rate: The Gen 2 TIL therapy manufacturing process continues to be robust with a demonstrated success rate, as measured from the receipt of the starting material to the shipment of TIL product, of well over 90 percent in approximately 300 patients.
·Clinical introduction of Gen 3 TIL therapy: A proprietary 16-day, third generation TIL therapy manufacturing process (Gen 3) entered the clinic for initial evaluation in the expanded C-145-03 clinical study in head and neck cancer patients with significant unmet need, for which shorter time to TIL infusion may offer a potential benefit.
·Clinical introduction of PD-1 selected TIL therapy (LN-145-S1): A proprietary, selected TIL product LN-145-S1, aimed at taking further advantage of TIL’s ability to recognize the tumor, is also entering the clinic for initial evaluation in the expanded C-145-03 study in head and neck cancer, and subsequently in a new cohort in the IOV-COM-202 study.

Corporate

·Iovance manufacturing facility on track for commercial production in 2022: Iovance began construction of a state-of-the-art, 136,000 square foot commercial-scale production facility in Philadelphia for its TIL therapies in June 2019. The new facility is expected to be completed by year-end 2021 to support commercial supply in 2022, with capacity to meet demand for thousands of patients in multiple cancers. Iovance expects to invest approximately $85 million over three years for equipment and construction of the facility.
·The National Cancer Institute (NCI), with support from Iovance, received an award for TIL therapy technology transfer: NCI won the Federal Laboratory Consortium’s 2020 Excellence In Technology Transfer Award for "New, First-in-class Immunotherapy, for Treatment of Recurrent, Metastatic Cervical Cancer" for its collaboration with Iovance. Iovance supported NCI’s application for the award and remains a CRADA partner for ongoing research in TIL therapy.3
·New Iovance patents issued: Iovance has been granted or allowed a total of 10 U.S. patents for compositions and methods of treatment in a broad range of cancers related to its 22-day Gen 2 manufacturing process.

Research and Development

·Licensing of novel IL-2 analog (IOV-3001): Iovance obtained a license from Novartis to develop and commercialize an expectedly better IL-2 analog, an antibody cytokine engrafted protein, referred to as IOV-3001, as a targeted and selective IL-2 analog.
·Licensing of TALEN technology to develop gene edited TIL: Under a research collaboration and exclusive worldwide license agreement with Cellectis, Iovance licensed certain Cellectis TALEN technology to develop genetically edited TIL to potentially create more potent therapeutics in several cancer indications. The worldwide exclusive license enables Iovance’s use of TALEN technology addressing multiple gene targets to modify TIL for therapeutic use.

Anticipated 2020 Milestones

·Last patient dosed in the pivotal program of LN-145 for cervical cancer
·Pre-BLA Meeting with U.S. FDA
·Melanoma top-line pivotal data
·BLA submission

Fourth Quarter and Full-Year 2019 Financial Results

Net loss for the fourth quarter ended December 31, 2019, was $63.6 million, or $0.50 per share, compared to a net loss of $32.6 million, or $0.27 per share, for the fourth quarter ended December 31, 2018. Net loss for the full-year ended December 31, 2019, was $197.6 million, or $1.59 per share, compared to a net loss of $123.6 million, or $1.27 per share, for the full-year ended December 31, 2018.

Research and development expenses were $54.2 million for the fourth quarter ended December 31, 2019, an increase of $26.8 million compared to $27.4 million for the fourth quarter ended December 31, 2018. Research and development expenses were $166.0 million for the 12 months ended December 31, 2019, an increase of $66.2 million compared to $99.8 million for the prior year period. The increases in fourth quarter and full year 2019 over the prior year periods were primarily attributable to an increase in costs associated with manufacturing activities and capacity, clinical trials due to higher enrollment, and growth of the internal research and development team.

General and administrative expenses were $10.9 million for the fourth quarter 2019, an increase of $3.4 million compared to $7.5 million for the fourth quarter 2018. General and administrative expenses were $40.8 million for the 12 months ended December 31, 2019, an increase of $12.4 million compared to $28.4 million for the full year ended December 31, 2018. The increases in fourth quarter and full year 2019 over the prior year periods were primarily attributable to growth of the internal general and administrative team, as well as higher intellectual property legal costs and market research activities in preparation for commercialization.

Cash, cash equivalents, short term investments and restricted cash

At December 31, 2019, the company held $312.5 million in cash, cash equivalents, short-term investments and restricted cash compared to $468.5 million at December 31, 2018.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and full-year 2019 results and provide a corporate update. The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 4693108. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.

On February 25, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it will release its financial results for the fourth quarter and year-ended December 31, 2019, after the close of market on Tuesday, March 10, 2020 (Press release, Castle Biosciences, FEB 25, 2020, View Source [SID1234554744]).

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Company management will host a conference call and webcast to discuss its financial results and provide a corporate update at 4:30 p.m. Eastern time on the same day.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed at View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until March 31, 2020.

To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479, internationally, at least 10 minutes prior to the start of the call, using the conference ID 5836318.

There will be a brief Question & Answer session following the corporate update.

On February 25, 2020 Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Penumbra, FEB 25, 2020, View Source [SID1234554761]).

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Financial Highlights:

Revenue of $145.3 million for the fourth quarter of 2019, an increase of 20.3%, or 20.8% in constant currency1, over the fourth quarter of 2018.
Revenue of $547.4 million for the full year 2019, an increase of 23.0%, or 24.2% in constant currency1, over the prior year.
Fourth Quarter 2019 Financial Results
Total revenue grew to $145.3 million for the fourth quarter of 2019 compared to $120.8 million for the fourth quarter of 2018, an increase of 20.3%, or 20.8% on a constant currency basis. The United States represented 66% of total revenue and international represented 34% of total revenue for the fourth quarter of 2019. Revenue from sales of neuro products grew to $85.4 million for the fourth quarter of 2019, an increase of 15.4%, or 16.1% on a constant currency basis. Revenue from sales of vascular products grew to $59.8 million for the fourth quarter of 2019, an increase of 27.9%, or 28.1% on a constant currency basis.

Gross profit was $98.1 million, or 67.6% of total revenue, for the fourth quarter of 2019, compared to $78.7 million, or 65.2% of total revenue, for the fourth quarter of 2018.

Total operating expenses were $87.5 million, or 60.3% of total revenue, for the fourth quarter of 2019, compared to $72.0 million, or 59.6% of total revenue, for the fourth quarter of 2018. R&D expenses were $12.9 million for the fourth quarter of 2019, compared to $10.9 million for the fourth quarter of 2018. SG&A expenses were $74.7 million for the fourth quarter of 2019, compared to $61.2 million for the fourth quarter of 2018.

Operating income was $10.6 million for the fourth quarter of 2019, compared to an operating income of $6.7 million for the fourth quarter of 2018.

As of December 31, 2019, cash and cash equivalents and marketable investments totaled $189.4 million.

Full Year 2019 Financial Results
Total revenue grew to $547.4 million for the year ended December 31, 2019, compared to $444.9 million for 2018, an increase of 23.0%, or 24.2% on a constant currency basis. The United States represented 65% of total revenue and international represented 35% of total revenue for the year ended December 31, 2019. Revenue from sales of neuro products grew to $331.7 million for the year ended December 31, 2019, an increase of 12.7%, or 14.1% on a constant currency basis. Revenue from sales of vascular products grew to $215.7 million for the year ended December 31, 2019, an increase of 43.2%, or 44.0% on a constant currency basis.

Gross profit was $372.0 million, or 68.0% of total revenue, for the year ended December 31, 2019, compared to $292.5 million, or 65.7% of total revenue, for the year ended December 31, 2018.

Total operating expenses for the year ended December 31, 2019 were $324.5 million, or 59.3% of total revenue. This compares to total operating expenses of $293.4 million, or 65.9% of total revenue, for the year ended December 31, 2018, which included a $30.8 million acquired in-process research and development ("IPR&D") charge in connection with the acquisition of a controlling interest in MVI Health Inc. in the third quarter of 2018. Excluding the IPR&D charge, total non-GAAP operating expenses2 were $262.6 million, or 59.0% of total revenue, for the year ended December 31, 2018. R&D expenses were $51.7 million for the year ended December 31, 2019, compared to $36.2 million for the year ended December 31, 2018. SG&A expenses were $272.7 million for the year ended December 31, 2019, compared to $226.4 million for the year ended December 31, 2018.

Operating income was $47.5 million for the year ended December 31, 2019. This compares to an operating loss of $0.9 million for the year ended December 31, 2018, including the IPR&D charge. Excluding the IPR&D charge, non-GAAP operating income2 was $30.0 million for the year ended December 31, 2018.

Full Year 2020 Financial Outlook
Penumbra projects total revenue for 2020 to be in the range of $635 million to $645 million, which represents growth of 16% to 18% over last year. This outlook includes the impact of recent reimbursement changes in Japan. Excluding Japan, Penumbra projects revenue growth for 2020 to be above 20%.

Webcast and Conference Call Information
Penumbra, Inc. will host a conference call to discuss financial results for the fourth quarter and year ended December 31, 2019 after market close on Tuesday, February 25, 2020 at 5:00 PM Eastern Time. The conference call can be accessed live over the phone by dialing (833) 227-5837 for domestic callers or (647) 689-4064 for international callers (conference id: 3899277), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for two weeks following the completion of the call.

On February 25, 2020 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, reported that management will present at the Cowen 40th Annual Health Care Conference in Boston, Massachusetts on Wednesday, March 4, 2020 at 10:00am Eastern Time (Press release, Athenex, FEB 25, 2020, View Source [SID1234573882]). The presentation will be followed by a 30-minute breakout session.

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The presentation will be available via webcast and can be accessed at the Investor Relations section of the Company’s website, located at www.athenex.com.