On April 2, 2019 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first in class collagenase-based product marketed as XIAFLEX in the U.S. and Xiapex in Europe, reported its financial results for the fourth quarter and full year ended December 31, 2018 and provided a corporate update (Press release, BioSpecifics Technologies, APR 2, 2019, View Source [SID1234534878]).

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"2018 has been a year of clinical progress for XIAFLEX. With the encouraging Phase 3 data from Endo’s cellulite clinical trials reported in November, and more recently, the promising results from our BioSpecifics-sponsored Phase 1 clinical trial of CCH for the treatment of uterine fibroids reported this month, we are well poised for continued clinical and commercial advancements in 2019 and beyond," said Dr. Ron Law, Ph.D., J.D., Principal Executive Officer of BioSpecifics. "From a financial perspective, we were pleased to see strong XIAFLEX net sales for the whole year and a 30% increase in sales for the fourth quarter compared to the same quarter in 2017 and look forward to continued growth in both marketed indications."

Fourth Quarter and Full Year 2018 Financial Results
BioSpecifics reported net income of $6.2 million for the fourth quarter ended December 31, 2018, or $0.85 per basic share and $0.84 per share on a fully diluted basis, compared to net income of $2.6 million, or $0.37 per basic share and $0.36 per share on a fully diluted basis, for the same period in 2017. For the full year ended December 31, 2018, the Company reported a net income of $20.1 million, or $2.77 per basic share and $2.73 per share on a fully diluted basis, compared to a net income of $11.3 million, or $1.58 per basic share and $1.55 per share on a fully diluted basis for the same period in 2017.

Total revenue for the fourth quarter ended December 31, 2018 was $9.9 million, compared to $6.7 million for the same period in 2017. For the full year ended December 31, 2018, total revenue was $33.0 million, compared to $27.4 million for the same period in 2017. The increase in total revenues for the quarterly and year-end periods was primarily due to increased sales of XIAFLEX for the treatment of Peyronie’s Disease and Dupuytren’s Contracture reported to us by Endo.

Royalty and mark-up on cost of goods sold (COGS) revenues recognized under BioSpecifics’ agreement with Endo for the fourth quarter ended December 31, 2018 were $9.9 million compared to $6.7 million for the same period in 2017, an increase of $3.2 million or 48 percent. Total royalty and mark-up on COGS revenues for the year ended December 31, 2018 increased to $32.9 million as compared to $27.4 million in the same period in 2017. This increase in royalties and the mark-up on COGS in each quarterly and year end periods was primarily due to increased sales of XIAFLEX for the treatment of Peyronie’s Disease and Dupuytren’s Contracture reported to us by Endo.

Licensing revenue consists of licensing fees, sublicensing fees and milestones. No licensing revenue was recognized for the fourth quarter ended December 31, 2018 as compared to approximately $4,000 for the same period in 2017. Licensing fees recognized for the years ended December 31, 2018 and 2017 were $40,000 and $18,000, respectively. Development licensing fees recognized for CCH are related to the cash payments received under the License Agreement in prior years and amortized over the expected development period. For the year ended December 31, 2018, we recognized the remaining nonrefundable upfront product license in accordance with ASC 606.

Research and development (R&D) expenses for the fourth quarter ended December 31, 2018 were $0.2 million compared to $0.3 million for the same period in 2017. For the year ended December 31, 2018, R&D expenses were $0.8 million, compared to $1.2 million in the same period in 2017.

General and administrative expenses for the fourth quarter ended December 31, 2018 were $2.5 million, compared to $1.6 million for the same period in 2017. For the year ended December 31, 2018, general administrative expenses were $8.8 million, compared to $8.5 million in the same period in 2017.

Provision for income taxes for the fourth quarter ended December 31, 2018 were $1.5 million, compared to $2.4 million for the same period in 2017. For the year ended December 31, 2018, provision for income taxes were $4.7 million as compared to $7.0 million in the same period of 2017.

As of December 31, 2018, BioSpecifics had cash and cash equivalents and investments of $82.0 million, compared to $65.1 million as of December 31, 2017.

As of December 31, 2018, BioSpecifics had 7.3 million shares of common stock outstanding.

Commercial & Pipeline Highlights and Anticipated Upcoming Milestones

XIAFLEX Commercial Franchise Expected to Grow in the Mid-to-High Teens Percent Range in 2019: XIAFLEX future growth initiatives continue to support the increase in consumer awareness for both Peyronie’s Disease and Dupuytren’s Contracture. Endo reported expanded branded consumer activation and unbranded disease state awareness programs for both commercial indications in 2019.
Full Phase 1 Uterine Fibroids Data Presented at 66th Annual SRI Scientific Meeting in March 2019: Data from the Phase 1 clinical trial of CCH for the treatment of uterine fibroids were presented at the 66th Annual Meeting of the Society of Reproductive Investigation (SRI) on March 14, 2019 in Paris, France. This presentation follows positive top-line results announced in October 2018. The reported data showed safety and statistically significant reductions in collagen content compared to control fibroids with a median reduction of 39 percent (p<0.05), as well as a 21 percent average reduction in density of collagen bundles. BioSpecifics intends to use the Phase 1 data to inform the development of future clinical studies.
Positive Phase 3 RELEASE-1 and RELEASE-2 Cellulite Data Reported: Endo presented positive results from two Phase 3 studies, RELEASE-1 and RELEASE-2, of CCH for the treatment of cellulite. Statistically significant improvements with CCH versus placebo were observed for 8 of 8 (RELEASE-1) and 7 of 8 (RELEASE-2) secondary endpoints, in addition to patient-centric endpoints. These data were presented at 2019 American Academy of Dermatology Annual Meeting on March 2, 2019. In November 2018, Endo announced initial positive data from the two trials with highly statistically significant levels of improvement in the appearance in the target buttock at Day 71 reported. The study achieved the primary endpoint (RELEASE-1, p=0.006 & RELEASE-2, p=0.002) of composite responder analysis demonstrating at least a 2-level composite improvement independently reported by patient and clinician on the photonumeric scales of cellulite severity.
BLA filing for CCH for Cellulite Expected in 2H19: Endo expects to file its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for CCH for the treatment of cellulite in the second half of 2019 with an expected commercial launch in the second half of 2020 upon approval.
Personnel Updates:

Promotion of Dr. Ron Law to Principal Executive Officer: In November 2018, BioSpecifics announced the appointment of Ron Law, Ph.D., J.D., as Senior Vice President of Business Development and in March 2019, he was promoted to Principal Executive Officer. In his new role, Dr. Law is responsible for business development, day-to-day operations and investor relations for BioSpecifics.
Promotion of Pat Caldwell to Principal Accounting Officer: In March 2019, BioSpecifics promoted Pat Caldwell to Principal Accounting Officer. Mr. Caldwell has been a financial advisor and consultant for the Company for 12 years. Previously, he was the Vice President of Finance and Controller at PDL BioPharma (formerly Protein Design Labs) for 13 years and later became a business and financial consultant for the Company.

On April 2, 2019 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported that it will present at the 18th Annual Needham Healthcare Conference at 3:30 PM ET on Tuesday, April 9, 2019 (Press release, Pacira Pharmaceuticals, APR 2, 2019, View Source;p=irol-newsArticle&ID=2393147 [SID1234534894]). Live audio of the presentation can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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On April 2, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Peter Lawrence, President and Chief Operating Officer, and Dr. Marc Schegerin, Chief Financial Officer and Head of Strategy, will present at the 18th Annual Needham Healthcare Conference on April 9, 2019 at 10:00 a.m. ET at the Westin New York Grand Central in New York City (Press release, ArQule, APR 2, 2019, View Source [SID1234534911]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

On April 2, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has entered into a definitive agreement with certain institutional investors to receive gross proceeds of approximately $3.2 million (Press release, Can-Fite BioPharma, APR 2, 2019, View Source [SID1234534927]).

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In connection with the offering, the Company will issue 4,923,078 registered American Depository Shares (ADSs) of Can-Fite at a purchase price of $0.65 per ADS in a registered direct offering. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one ADS. The warrants will have an exercise price of $0.86 per ADS, will be immediately exercisable and will expire five years from the issuance date. The closing of the offering is expected to take place on or about April 4, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The ADSs described above (but not the warrants or the ADSs underlying the warrants) are being offered pursuant to a shelf registration statement (File No. 333-220644) which became effective on October 11, 2017. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company will file a prospectus supplement and the accompanying base prospectus with the SEC relating to the offering of such ADSs. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained at the SEC’s website at View Source, or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone: (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction

On April 2, 2019 LIDDS AB reported that Clinical data shows that intratumoral delivery of TLR agonists in combination with immune checkpoint inhibitors can effectively treat solid cancers (Press release, Lidds, APR 2, 2019, View Source [SID1234555907]). NanoZolid technology is very suitable to provide sustained intratumoral release and minimize the need for repeated injections. LIDDS has performed pre-clinical studies with promising results using a TLR9 agonist formulated with NanoZolid.

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Toll-like receptors (TLR) are a key target for the pharmaceutical industry in the fight against cancer. TLRs are expressed on various immune cells, including dendritic cells, and they initiate the body’s immune response. TLR activation can lead to an immunologically active or inflamed tumor environment which then recruits the cytotoxic T-cells necessary for an anti-tumor response in immunotherapy.

-The NanoZolid technology addresses key issues in developing TLR agonists as repeated intratumoral injections are needed using standard formulations, says Monica Wallter, CEO LIDDS.

-We will be focusing our project on TLR9, one of the most promising targets for increasing response and reversing resistance to immunotherapies. TLR9 agonists have been shown to be most effective when injected directly into a tumor, says Monica Wallter.

-A preclinical programme is ongoing to broaden the results obtained to date and we are now preparing for a Phase I clinical trial using NanoZolid combined with a TLR9 agonist. The first human study is planned to commence in 2020, says Monica Wallter.

Preclinical studies have shown that activation of TLR pathways can lead to potent immunological effects that generate anti-tumor immunity and shrink tumors. Most importantly, these effects can act in synergy with immune checkpoint inhibitors.

-There is significant commercial potential in this area of research and drug development and the market for TLR agonists is expected to be worth hundreds of millions of dollars over the coming years, says Monica Wallter.

The most relevant target cancers for the TLR9 project are head and neck cancer, prostate cancer and lymphomas. These cancers are diagnosed in around 2 million patients each year.

Toll-like receptors have been studied for many years and the emerging clinical data suggests that their time has come as important anti-cancer agents when used in combination with immune checkpoint inhibitors.