On August 8, 2019 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of best-in-class bioproduction tools for cell and gene therapies, reported financial results and operational highlights for the three and six months ended June 30, 2019 (Press release, BioLife Science, AUG 8, 2019, View Source [SID1234538468]).

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Revenue from biopreservation media and automated thaw product sales for the second quarter of 2019 reached a record of $6.7 million, an increase of 29% compared with the second quarter of 2018. For the first half of 2019 revenue totaled $12.5 million, representing an increase of 39% compared with the prior-year period. Product revenue growth for both periods was driven by sales of CryoStor and HypoThermosol biopreservation media and the recently acquired ThawSTAR automated thaw products to the high-growth cell and gene therapy market.

Mike Rice, BioLife President & CEO, commented, "Throughout the second quarter, we demonstrated our ability to efficiently manage our business during a sustained period of rapid growth. Demand for our proprietary biopreservation media products continues to be strong from new and existing customers. During the quarter we received 14 new cross-reference requests for our FDA master files from cell and gene therapy companies who intend to use CryoStor and/or HypoThermosol in upcoming clinical trials. Based on these new requests, direct customer forecasts and anticipated demand from our worldwide network of distributors, we are optimistic about how the business will perform for the balance of 2019.

"We also realized strong initial demand for automated thaw products in our first full quarter following the acquisition of Astero Bio, with 39 new customer orders. Of note, most of these customers came from the cell and gene therapy segment. We look forward to a Q4 launch of a new ThawSTAR CB automated thaw product for large volume cell and gene therapies to be frozen in cryobags. With respect to SAVSU, we remain bullish on our ability to capture a significant share of the cell and gene therapy cold chain management market. Since January 2019, the evo system has been used in initial shipments by more than 50 cell and gene therapy companies. We look forward to integrating our sales and marketing activities and exhibiting our expanded product portfolio at 10 cell and gene therapy scientific conferences throughout the rest of the year."

Second Quarter 2019 Revenue Highlights

Cell & Gene Therapy Market Segment

Total product revenue: $4.0 million; representing 59% of total revenue with 33% growth over the same period last year.
Shipped initial orders to 51 new biopreservation media customers and 39 new automated thaw products customers, most of which were cell and gene therapy companies in the regenerative medicine market segment.
Received 14 new cross-reference requests for our FDA master files for CryoStor and HypoThermosol.
Worldwide Distributor Network

Product revenue: $2.2 million; representing 33% of total revenue with 31% growth over the same period last year.
Key worldwide distributors include: STEMCELL Technologies, MilliporeSigma, Thermo Fisher and VWR.
Second Quarter and Six Month 2019 Financial Results

BioLife Solutions is presenting various financial metrics under U.S. Generally Accepted Accounting Principles (GAAP) and as adjusted (non-GAAP) to reflect acquisition-related activity. A reconciliation of GAAP to non-GAAP metrics appears at the end of this news release.

Revenue

Total revenue for the second quarter of 2019 increased 29% to $6.7 million compared with $5.2 million for the second quarter of 2018.
Sales of ThawSTAR automated thaw products totaled $374,000 in the second quarter.
Total revenue for the six months ended June 30, 2019 increased 39% to $12.5 million compared with $9.0 million for the first six months of 2018.
Gross Margin

Gross margin (GAAP) for the second quarter of 2019 increased to 70.8% from 70.3% in the second quarter of 2018. Adjusted gross margin (non-GAAP) for the second quarter of 2019 increased to 72.3% from 70.3% in 2018.
Gross margin (GAAP) for the six months ended June 30, 2019 increased to 71.1% from 67.7% for the same period in 2018. Adjusted gross margin (non-GAAP) for the six months ended June 30, 2019 increased to 71.9% from 67.7% in 2018.
Operating Expenses

Operating expenses (GAAP) for the second quarter of 2019 were $3.8 million compared with $2.4 million for the second quarter of 2018. Adjusted operating expenses (non-GAAP) for the second quarter of 2019 were $3.7 million compared with $2.4 million in 2018.
Operating expenses (GAAP) for the six months ended June 30, 2019 were $7.5 million compared with $4.7 million for the same period in 2018. Adjusted operating expenses (non-GAAP) for the six months ended June 30, 2019 were $7.1 million compared with $4.7 million in 2018.
Operating Income

Operating income (GAAP) for the second quarter of 2019 was $919,000 compared with $1.3 million for the second quarter of 2018. Adjusted operating income (non-GAAP) for the second quarter of 2019 was $1.2 million compared with $1.3 million in 2018.
Operating income (GAAP) for the six months ended June 30, 2019 was $1.4 million compared with $1.4 million for the same period in 2018. Adjusted operating income (non-GAAP) for the six months ended June 30, 2019 was $1.9 million compared with $1.4 million in 2018.
Net Income Attributable to Common Stockholders

Net income attributable to common stockholders (GAAP) for the second quarter of 2019 was $838,000 compared with $1.0 million for the second quarter of 2018. Adjusted net income attributable to common stockholders (non-GAAP) for the second quarter of 2019 was $1.1 million compared with $1.0 million in 2018.
Net income attributable to common stockholders (GAAP) for the six months ended June 30, 2019 was $1.3 million compared with $943,000 for the same period in 2018. Adjusted net income attributable to common stockholders (non-GAAP) for the six months ended June 30, 2019 was $1.7 million compared with $943,000 in 2018.
Earnings per Share

Earnings per diluted share (GAAP) for the second quarter of 2019 were $0.03 compared with $0.05 for the second quarter of 2018. Adjusted earnings per diluted share (non-GAAP) for the second quarter of 2019 were $0.04 compared with $0.05 in 2018.
Earnings per diluted share (GAAP) for the six months ended June 30, 2019 were $0.05 compared with $0.05 for the same period in 2018. Adjusted earnings per diluted share (non-GAAP) for the six months ended June 30, 2019 were $0.07 compared with $0.05 in 2018.
EBITDA

EBITDA, a non-GAAP measurement, for the second quarter of 2019 was $917,000 compared with $1.2 million for the second quarter of 2018. Adjusted EBITDA for the second quarter of 2019 was $1.9 million compared with $1.7 million in 2018.
EBITDA, a non-GAAP measurement, for the six months ended June 30, 2019 was $1.3 million compared with $1.3 million for the same period in 2018. Adjusted EBITDA for the six months ended June 30, 2019 was $3.3 million compared with $2.3 million in 2018.
Cash

Cash and cash equivalents as of June 30, 2019 were $19.6 million compared with $30.7 million as of December 31, 2018. The decrease reflects $12.5 million in cash consideration paid in conjunction with the acquisition of Astero Bio Corporation, which closed in early April.
Roderick de Greef, BioLife Chief Financial Officer, remarked, "In addition to successfully integrating Astero’s operations during the second quarter, our financial results at all levels remained strong."

2019 Financial Guidance

Management updated 2019 financial guidance to include contributions from Astero (beginning April 1) and SAVSU (beginning August 8), as follows:

Total revenue of $27.5 million to $30.5 million, representing growth of 39% to 55% over 2018.
Gross margin is expected to be in a range of 69% to 70% on a GAAP and non-GAAP basis, compared with 69% in 2018.
Operating expenses on a GAAP basis ranging from $18.5 to $19.5 million, up from previous guidance of $15.5 to $16.5 million as a result of acquisition costs, amortization of intangible assets and the addition of SAVSU related operating expenses. Adjusted operating expenses (non-GAAP) ranging from $17 to $18 million.
Full-year positive adjusted operating income, adjusted net income and adjusted EBITDA.
Conference Call & Webcast

The Company will host a conference call and live webcast at 4:30 p.m. ET this afternoon. To access the live webcast, please go to www.biolifesolutions.com/earnings/. Alternatively, you may access the live conference call by dialing (844) 825-0512 (U.S. & Canada) or (315) 625-6880 (International) with the following Conference ID: 1368786. A webcast replay will be available approximately two hours after the call and will be archived on www.biolifesolutions.com for 90 days.

On August 8, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, reported financial results for the second quarter ended June 30, 2019 (Press release, IntelGenx, AUG 8, 2019, View Source [SID1234538500]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2019 Second Quarter Financial Summary:

Revenue was $197,000, compared to $234,000 in the second quarter of 2018
Adjusted EBITDA was ($2.1 million), compared to ($1.9 million) in Q2-2018
Cash and short-term investments totaled $6.1 million as at June 30, 2019 compared to $3.7 million in Q2-2018
Recent Developments:

Received its first shipment of cannabis extract from Tilray, Inc. (NASDAQ:TLRY) ("Tilray"), providing sufficient quantities for ongoing R&D batch production of cannabis-infused VersaFilm.
In connection with its ongoing Montelukast clinical program, announced that a poster, entitled "The BUENA Study: A Phase 2a Clinical Trial to Test Safety and Efficacy of Montelukast VersaFilm in Alzheimer’s Patients," will be presented in collaboration with Prof. Dr. Ludwig Aigner’s group from the Paracelsus Medical University in Salzburg at the 12th edition of Clinical Trials on Alzheimer’s Disease (CTAD2019), to be held in San Diego, California, from December 4-7, 2019.
Entered into a definitive worldwide agreement with Aquestive Therapeutics, Inc. (NASDAQ:AQST) for the co-development and commercialization of Tadalafil oral films for the treatment of erectile dysfunction.
Filed a non-provisional U.S. patent application for newly-developed platform that enables the incorporation of oil-based (lipophilic) active ingredients into oral film formulations.
Received a second U.S. Patent for its topical oral film technology platform.
Company remains on track to resubmit the RIZAPORT new drug application in Q3, which will address the questions contained in the U.S. Food and Drug Administration’s Complete Response letter IntelGenx received in Q2.
Promoted its oral films CDMO services at CPhI North America and received significant interest from potential partners for the development and manufacture of novel oral film products based on its proprietary VersaFilm technology platform.
"We made progress on two key VersaFilm programs recently, with the addition of BUENA clinical trial sites in Ottawa and Peterborough, and the commencement of cannabis-infused VersaFilm R&D production as part of our worldwide partnership with Tilray," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "We believe our oral cannabis-infused films offer a discrete, precise and convenient option for adult-use and medical cannabis consumers, putting IntelGenx in a strong position among the many other companies preparing to launch edible cannabis products soon after their legalization in Canada later this year. Now approaching a period of anticipated growth, we look forward to updating our stakeholders as we continue to make progress towards bringing these and other VersaFilm products to market."

Financial Results:

Total revenues for the three-month period ended June 30, 2019 amounted to $197,000, a decrease of $37,000 compared to $234,000 for the three-month period ended June 30, 2018. The decrease is mainly attributable to the $37,000 decrease in R&D revenues.

Operating costs and expenses were $2.5 million for the second quarter of 2019, versus $2.4 million for the corresponding three-month period of 2018. The increase for the three-month period ended June 30, 2019 is mainly attributable to a $325,000 increase in R&D expenses primarily related to the Montelukast clinical program.

For the second quarter of 2019, the Company had an operating loss of $2.3 million, compared to an operating loss of $2.1 million for the comparable period of 2018.

Net comprehensive loss for the three-month period ended June 30, 2019 was $2.5 million, or $0.03 on a basic and diluted per share basis, compared to $2.4 million, or $0.04 on a basic and diluted per share basis, for the comparable period of 2018.

As of June 30, 2019, the Company’s cash and short-term investments totalled $6.1 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2019 second quarter financial results today on August 8, 2019, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 5684153. A live and archived webcast of the call will be available on IntelGenx’s website at www.intelgenx.com under "Presentations" in the Investors section.

On August 8, 2019 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, reported its results from operations for the quarter ended June 30, 2019 (Press release, Medicure, AUG 8, 2019, View Source [SID1234538566]).

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Quarter Ended June 30, 2019 Highlights:

Recorded net revenue from the sale of AGGRASTAT (tirofiban hydrochloride) of $6.2 million during the quarter ended June 30, 2019 compared to $7.2 million for the quarter ended June 30, 2018 and $4.8 million for the quarter ended March 31, 2019;
$45.7 million in cash as at June 30, 2019;
Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended June 30, 2019 was $103,000 compared to adjusted EBITDA of $882,000 for the quarter ended June 30, 2018; and
Net loss for the quarter ended June 30, 2019 was $957,000 (of which, $813,000 was due to a loss from foreign exchange) compared to net income of $1.6 million for the quarter ended June 30, 2018.
Financial Results

Net revenues for the three months ended June 30, 2019 were $6.3 million compared to $7.8 million for the three months ended June 30, 2018. Net revenues from AGGRASTAT for the three months ended June 30, 2019 were $6.2 million compared to $7.2 million for the three months ended June 30, 2018. Additionally, ReDSTM point of care system ("ReDSTM"), contributed $51,000 of net revenue for the three months ended June 30, 2019 and the three months ended June 30, 2018 contained $606,000 of revenue from ZYPITAMAGTM following the launch of the product in the period.

Net revenues for the six months ended June 30, 2019 were $11.2 million compared to $13.9 million for the six months ended June 30, 2018. Net revenues from AGGRASTAT for the six months ended June 30, 2019 were $11.0 million compared to $13.3 million for the six months ended June 30, 2018. Additionally, ReDSTM, contributed $154,000 of net revenue for the six months ended June 30, 2019 and the six months ended June 30, 2018 contained $606,000 of revenue from ZYPITAMAGTM following the launch of the product in the period.

The Company continued to experience strong patient market share and strong hospital demand for AGGRASTAT during the three and six months ended June 30, 2019, however increases in volume compared to the three and six months ended June 30, 2018 were offset by increased price competition that resulted in lower discounted prices for AGGRASTAT throughout the quarter.

Diversification of revenues remains an important aspect of the Company’s focus with Medicure concentrating on the sales and marketing of AGGRASTAT, growing the sales of ZYPITAMAGTM (pitavastatin) and marketing the ReDSTM system.

Adjusted EBITDA for the three months ended June 30, 2019 was $103,000 compared to $882,000 for the three months ended June 30, 2018. The decrease in adjusted EBITDA for the three months ended June 30, 2019 is the result of the lower revenues experienced during the quarter ended June 30, 2019.

Adjusted EBITDA for the six months ended June 30, 2019 was negative $1.6 million compared to $1.8 million for the six months ended June 30, 2018. The decrease in adjusted EBITDA for the six months ended June 30, 2019 is the result of lower revenues and higher selling costs, as a result of the increase in the Company’s product portfolio, experienced during the quarter ended June 30, 2019.

Net loss for the three months ended June 30, 2019 was $957,000 or $0.06 per share. This compares to net income of $1.6 million or $0.10 per share for the three months ended June 30, 2018. Net loss for the three months ended June 30, 2019 is the result of lower revenues experienced during the quarter and a foreign exchange loss relating to a decrease in the value of the U.S. dollar experienced during the quarter ended June 30, 2019.

Net loss for the six months ended June 30, 2019 was $3.7 million or $0.24 per share. This compares to net income of $3.0 million or $0.19 per share for the six months ended June 30, 2018. Net loss for the six months ended June 30, 2019 is the result of lower revenues, higher selling costs and cost of goods sold experienced during the period and a foreign exchange loss relating to a decrease in the value of the U.S. dollar experienced during the six months ended June 30, 2019.

At June 30, 2019, the Company had unrestricted cash totaling $45.7 million compared to $71.9 million of cash and short-term investments as of December 31, 2018. The decrease in cash is primarily due to the investment of U.S. $10 million made in Sensible Medical Innovations Ltd., the purchase of $3.6 million of the Company’s common shares under its normal course issuer bid, a significant reduction in the Company’s accounts payable and accrued liabilities and a decrease in the value of the U.S. dollar as at June 30, 2019 compared to December 31, 2018. Cash flows used in operating activities for the three months ended June 30, 2019 totaled $7.1 million.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non-cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three and six months ended June 30, 2019 and 2018 results prepared using International Financial Reporting Standards ("IFRS"), do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Topic: Medicure’s Q2 2019 Results

Call date: Friday, August 9, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 7554403#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On August 8, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported that its Chief Business Officer, Stephen Worsley, will present at the 2019 Wedbush PacGrow Healthcare Conference on Tuesday, Aug. 13 at 1:20 p.m. EDT in New York City (Press release, Sutro Biopharma, AUG 8, 2019, View Source [SID1234538383]).

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A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section on the company’s website at www.sutrobio.com. A replay of the webcast will be available following the event for approximately 30 days.

On August 8, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported its financial results for the three- and six-months ended June 30, 2019 (Press release, Eagle Pharmaceuticals, AUG 8, 2019, View Source [SID1234538419]). Highlights of, and subsequent to, the second quarter of 2019 include:

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Business and Financial Highlights:

On August 5, 2019, Eagle announced a clinical development plan, following guidance from the U.S. Food and Drug Administration (FDA), for its fulvestrant formulation, intended to deliver maximum estrogen receptor inhibition in patients with estrogen receptor (ER)-positive breast cancer:
Eagle plans to initiate a pilot study shortly
Once the pilot study results are reviewed, a clinical pivotal trial based upon the parameters determined with FDA will be conducted in a target patient population
The pivotal trial is expected to be completed within approximately 12 months of commencing enrollment
The Company’s mid- and late-stage pipeline programs are on track;
Total revenue for the second quarter of 2019 was $56.7 million, compared to $59.3 million in the second quarter of 2018;
Q2 2019 BELRAPZO product sales were $15.4 million, compared to $8.1 million in Q2 2018;
Q2 2019 RYANODEX product sales were $2.9 million, compared to $7.2 million in Q2 2018;
Q2 2019 net income was $6.7 million, or $0.49 per basic and $0.48 per diluted share, compared to net income of $2.7 million, or $0.18 per basic and $0.17 per diluted share in Q2 2018;
Q2 2019 adjusted non-GAAP net income was $11.8 million, or $0.86 per basic and $0.84 per diluted share, compared to adjusted non-GAAP net income of $14.7 million, or $0.99 per basic and $0.95 per diluted share in Q2 2018;
During Q2 2019, Eagle purchased an additional $15.0 million of Eagle common stock as part of its share buyback program; since August 2016, Eagle has repurchased $168.9 million of Eagle common stock; and
Cash and cash equivalents were $108.1 million, net accounts receivable was $60.3 million, and debt was $41.3 million as of June 30, 2019.
"We had another strong quarter; earnings from our bendamustine portfolio have established a solid platform from which to advance our R&D programs and explore additional opportunities to add to our portfolio. Our fulvestrant program looks very promising and we believe our novel formulation has a unique profile that may lead to improved efficacy outcomes for breast cancer patients. With guidance from FDA, we plan to conduct a pilot study shortly followed by a pivotal trial to test our hypothesis," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"Moreover, we continue to advance the other assets in our portfolio. We are in discussions with the U.S. military regarding treatment of radiation syndrome, and we also plan to request a meeting with FDA shortly to discuss the regulatory path for our nerve agent indication. We continue to advance EA-111, our intramuscular version of dantrolene," added Tarriff.

"With these initiatives underway, and our pemfexy and vasopressin litigations proceeding as anticipated, we believe we are closer than ever before to unlocking the significant value of the multiple assets in our pipeline. We intend to continue to invest in our research and development programs and align our resources to support the successful launch of our assets, once approved," concluded Tarriff.

Second Quarter 2019 Financial Results

Total revenue for the three months ended June 30, 2019 was $56.7 million, as compared to $59.3 million for the three months ended June 30, 2018.

Royalty revenue was $27.3 million in the second quarter of 2019, compared to $36.3 million in the second quarter of 2018. BENDEKA royalties were $26.5 million in the second quarter of 2019, compared to $34.7 million in the second quarter of 2018. A summary of total revenue is outlined below:

Gross Margin was 62% during the second quarter of 2019, as compared to 69% in the second quarter of 2018. The compression in gross margin in the second quarter of 2019 was primarily driven by an increase in BENDEKA product sales to our marketing partner, on which Eagle earns no profit.

R&D expense was $9.0 million for the quarter, compared to $15.3 million in the same quarter in the prior year. The second quarter year over year decrease reflects a substantial reduction in fulvestrant expense, partially offset by the cost to bring vasopressin to market. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter was $7.8 million.

SG&A expense in the second quarter of 2019 increased to $17.2 million compared to $16.0 million in the second quarter of 2018. External legal spend associated with litigation on PEMFEXY, vasopressin and bendamustine and higher stock compensation expense account for the year over year increase. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2019 SG&A expense was $12.4 million.

Net income for the second quarter of 2019 was $6.7 million, or $0.49 per basic and $0.48 per diluted share, compared to net income of $2.7 million, or $0.18 per basic and $0.17 per diluted share in the second quarter of 2018, due to the factors discussed above.

Adjusted non-GAAP net income for the second quarter of 2019 was $11.8 million, or $0.86 per basic and $0.84 per diluted share, compared to Adjusted non-GAAP net income of $14.7 million or $0.99 per basic and $0.95 per diluted share in the second quarter of 2018. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

2019 Expense Guidance

R&D spend in 2019, on a non-GAAP basis, is expected to be $32.0-$36.0 million, as compared to $38.0 million in 2018.
SG&A spend in 2019, on a non-GAAP basis, is expected to be $51.0-$54.0 million, as compared to $43.0 million in 2018.
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of June 30, 2019, the Company had $108.1 million in cash and cash equivalents and $60.3 million in net accounts receivable, $37.6 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $41.3 million in outstanding debt. Therefore, at June 30, 2019, the Company had net cash and receivables of $127.2 million.

In the second quarter of 2019, we purchased $15.0 million of Eagle’s common stock as part of our share buyback program. Since August 2016, we have repurchased $168.9 million of our common stock.

Conference Call

As previously announced, Eagle management will host its second quarter 2019 conference call as follows:

Date

Thursday, August 8, 2019

Time

8:30 A.M. EDT

Toll free (U.S.)

877-876-9173

International 785-424-1667
Webcast (live and replay) www.eagleus.com, under the "Investor + News" section
A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-5685 (US) or 402-220-2567 (International) and entering conference call ID EGRXQ219. The webcast will be archived for 30 days at the aforementioned URL.