On August 26, 2020 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), the global leader in robotic energy based therapies, reported financial results for the second quarter of 2020 and provided an update on strategic and operational developments (Press release, EDAP TMS, AUG 26, 2020, View Source [SID1234564097]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "Notwithstanding the significant physician and hospital outreach challenges posed by the COVID-19 pandemic during the second quarter, we continued to advance late-stage discussions, resulting in the completion of several notable deals toward the end of the period. Of particular note, our recent sales momentum, which carried into the current quarter, was characterized by a healthy mix of stand-alone Focal One sales, stand-alone Exact-Vu sales, and bundled sales of both complementary technologies that represent the industry’s first true ‘end-to-end’ solution for the urology suite. These are exactly the types of sales synergies that we envisioned when we announced our worldwide distribution agreement with Exact Imaging in May, and the traction we are seeing continues to exceed our internal forecasts. In parallel with these recent sales announcements, we continue to build our pipeline, assisted by highly regarded reference hospitals that were early adopters of Ablatherm and continue to champion our Focal One HIFU technology.

"Regarding our financial results, as with the first quarter, we did see an impact on revenue, driven mostly by lower procedure volumes as hospitals focused on treating COVID patients. This was in line with our expectations. However, because of the essential nature of timely prostate cancer screenings and treatments, it is anticipated these procedures must ultimately resume and continue, and we do see signs that our key markets in the U.S. and elsewhere are returning to a more normalized environment. We are optimistic that a gradual return to pre-pandemic procedure volumes, coupled with continued sales successes, will set the stage for improved financial results in the back half of the year and a strong 2021," Mr. Oczachowski concluded.

As a result of the company’s recent strategic shift toward current and emerging opportunities in HIFU, as well as its recently announced exclusive worldwide distribution agreement with Exact Imaging, beginning with the second quarter of 2020, EDAP is reporting its financial results in three segments: (1) HIFU, which includes sales of Focal One, Ablatherm and related consumables and services, (2) Lithotripsy, which includes revenue generated from the existing Sonolith range, and (3) Distribution, which includes the sale of complementary products such as lasers and micro-ultrasound systems and products from third parties.
EDAP’s new reporting segments align with organizational changes implemented within the company to better support the expansion of its HIFU development and sales activities as well as to maximize the potential of its distribution activities. This improved reporting format will allow for an unbiased comparative analysis of our past, current and future operational results.

Second Quarter 2020 Results

Total revenue for the second quarter 2020 was EUR 9.3 million (USD 10.3 million), a decrease of 26% compared to total revenue of EUR 12.5 million (USD 14.0 million) for the same period in 2019. Second quarter 2020 revenue reflects the impact of the ongoing COVID-19 pandemic on both procedure volumes and equipment sales.

Total revenue in the HIFU business for the second quarter 2020 was EUR 2.6 million (USD 2.8 million), a 44.2% decrease compared to EUR 4.6 million (USD 5.1 million) for the second quarter of 2019.

Total revenue in the LITHO business for the second quarter 2020 was EUR 2.9 million (USD 3.3 million), a 22.8% decrease compared to EUR 3.8 million (USD 4.3 million) for the second quarter of 2019

Total revenue in the Distribution business for the second quarter 2020 was EUR 3.8 million (USD 4.2 million), a 8.3% decrease compared to EUR 4.1 million (USD 4.6 million) for the second quarter of 2019.

Gross profit for the second quarter 2020 was EUR 4.3 million (USD 4.8 million), compared to EUR 6.3 million (USD 7.1 million) for the year-ago period. Gross profit margin on net sales was 46.8% in the second quarter of 2020, compared to 50.7% in the year-ago period. The decline in gross profit year-over-year was due to in part to lower sales in HIFU business as compared to the year-ago period driven primary by COVID-19.

Operating expenses were EUR 4.0 million (USD 4.5 million) for the second quarter of 2020, compared to EUR 4.7 million (USD 5.3 million) for the same period in 2019.

Operating profit for the second quarter of 2020 was EUR 0.3 million (USD 0.3 million), compared to an operating profit of EUR 1.7 million (USD 1.9 million) in the second quarter of 2019.

Net loss for the second quarter of 2020 was EUR 0.2 million (USD 0.2 million), or EUR (0.01) per diluted share, as compared to net income of EUR 1.4 million (USD 1.6 million), or EUR 0.05 per diluted share in the year-ago period.

For the first six months 2020 Results

Total revenue for the first half of 2020 was EUR 16.9 million (USD 18.7 million), a decrease of 25% compared to total revenue of EUR 22.6 million (USD 25.6 million) for the same period in 2019. As mentioned, first half 2020 revenue reflects the impact of the ongoing COVID-19 pandemic on the company’s activities.

Total revenue in the HIFU business for the first six months of 2020 was EUR 4.5 million (USD 5.0 million), a 47.0% decrease compared to EUR 8.4 million (USD 9.5 million) for the first six months of 2019.

Total revenue in the LITHO business for the first six months of 2020 was EUR 5.9 million (USD 6.5 million), a 13.0% decrease compared to EUR 6.7 million (USD 7.6 million) for the first six months of 2019.

Total revenue in the Distribution business for the first six month of 2020 was EUR 6.5 million (USD 7.2 million), a 12.3% decrease compared to EUR 7.4 million (USD 8.4 million) for the first six month of 2019.

Gross profit for the first six months of 2020 was EUR 7.4 million (USD 8.2 million), compared to EUR 11.2 million (USD 12.6 million) for the year-ago period. Gross profit margin on net sales was 43.9% for the first six months of 2020, compared to 49.5% in the year-ago period. The decline in gross profit year-over-year was due in part to lower sales in the HIFU business driven by COVID-19.

Operating expenses were EUR 8.5 million (USD 9.5 million) for the first six months of 2020, compared to EUR 9.3 million (USD 10.5 million) for the same period in 2019.

Operating loss for the first six months of 2020 was EUR 1.2 million (USD 1.3 million), compared to an operating profit of EUR 1.9 million (USD 2.1 million) for the same period of 2019.

Net loss for the first six months of 2020 was EUR 1.5 million (USD 1.6 million), or EUR (0.05) per diluted share, as compared to a net income of EUR 1.7 million (USD 1.9 million), or EUR 0.06 per diluted share in the year-ago period.

As of June 30, 2020, the Company recorded a strong cash position of EUR 15.7 million (USD 17.6 million).

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT on Thursday, August 27, 2020. Please refer to the information below for conference call dial-in information and webcast registration.

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On August 26, 2020 Teva Pharmaceutical reported that it is the latest company to be charged with conspiring to maintain artificially high prices for generic drugs (Press release, Teva, AUG 26, 2020, View Source [SID1234564087]). On Tuesday, the U.S. Department of Justice charged the Israel-based company with three counts of fixing prices to reap more than $350 million from customers through the scheme.

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The charges against Teva mark the seventh company to be charged for its participation in conspiracies to fix prices, rig bids and allocate customers for generic drugs, the federal government said in its announcement. Teva is one of the largest generic drugmakers in the world. Approximately one of every 10 generic prescriptions in the U.S. is for a Teva-made product.

Teva said it is disappointed the government has levied the charges against the company. Citing its own internal investigation conducted over a four-year period, Teva said the company has not participated in a price-fixing conspiracy. Teva said it firmly rejects the allegations and will vigorously defend itself against the charges.

"Teva has fully cooperated throughout the course of the Department of Justice (DOJ) investigation and has attempted to reach a resolution in the best interest of the Company, its stakeholders and the patients the company serves. The DOJ has shown an unwillingness to consider alternatives that would not deeply impact Teva and the stakeholders who depend on the company, including the patients who benefit from our medicines," the company said in a statement this morning.

The government levied three charges against the company for its involvement in conspiring with other generic drugmakers including Glenmark Pharmaceuticals Inc., USA, Apotex Corp., Taro Pharmaceuticals U.S.A., Inc., Sandoz, and others over a period of months between 2013 and 2015. In the first charge against Teva, the government said Teva, Glenmark, Apotex, and unnamed co-conspirators agreed to increase prices for cholesterol drug pravastatin and other generic drugs. In the second charge against Teva, the government said the company and its co-conspirators "agreed to increase prices, rig bids, and allocate customers for generic drugs including, but not limited to, drugs used to treat and manage arthritis, seizures, pain, skin conditions, and blood clots." And the last charge against Teva said the company colluded with Sandoz and others to increase prices, rig bids, and allocate customers for generic drugs including, but not limited to, drugs used to treat brain cancer, cystic fibrosis, arthritis, and hypertension.

"Today’s charges, the latest in a series of law enforcement actions taken against large drug companies, confirm that this kind of criminal behavior in the generic pharmaceutical industry will not be tolerated," James A. Dawson, Acting Assistant Director in Charge of the FBI’s Washington Field Office said in a statement. "Price fixing and bid rigging is a crime, and the American people—who rely on these drugs to treat serious ailments—are the ones who pay the price when companies like Teva conspire to raise their costs."

Each of the charges against Teva carries a maximum penalty of $100 million.

Earlier this year, Hector Armando Kellum, a former senior executive with the Novartis subsidiary Sandoz, pled guilty for his role in a price-fixing scheme for generic drugs developed by his company, including clobetasol and nystatin triamcinolone cream. In March, Sandoz, the generics arm of Swiss pharma giant Novartis, agreed to pay $195 million to settle its role in the price-fixing scheme.

In July, Taro USA admitted to its role in the conspiracy and agreed to pay a $205.7 million penalty. Also in July, a grand jury returned an indictment against Glenmark for the conspiracy.

On August 26, 2020 Sinovent, a Suzhou clinical stage biologics company, reported that it raised $145 million in a Series C round led by Loyal Valley Innovation Capital (Press release, Sinovent, AUG 26, 2020, View Source [SID1234564084]). The company has 12 biologic products in development, four in clinical trials and another four molecules preparing to file INDs in China. Sinovent’s lead program is a Wnt pathway porcupine inhibitor aimed at cancers of the digestive system, including colon cancer, esophageal cancer and gastric cancer. Founded in 2016, Sinovent’s 12 research pipelines address needs in therapeutic areas that include oncology, central nervous system, autoimmune and infectious diseases.

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On August 26, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, AUG 26, 2020, View Source [SID1234564079]):

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Citi’s 15th Annual BioPharma Virtual Conference at 8:55 a.m. ET on Wednesday, September 9, 2020
Morgan Stanley 18th Annual Global Healthcare Conference at 9:00 a.m. ET on Monday, September 14, 2020
Cantor Fitzgerald Virtual Global Healthcare Conference at 10:00 a.m. ET on Tuesday, September 15, 2020
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

On August 26, 2020 Oncopeptides AB reported that Interim Report Q2 2020 (Press release, Oncopeptides, AUG 26, 2020, View Source [SID1234564078])

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Financial overview April 1 – June 30, 2020

Net sales amounted to SEK 0.0 M (0.0)
Loss for the period was SEK 401.0 M (loss: 171.9)
Loss per share, before and after dilution, was SEK 6.79 (loss: 3.52)
On June 30 cash and cash equivalents amounted to SEK 937.8 M (626.8)
Significant events during the period April 1 – June 30, 2020

Marty J Duvall was appointed CEO from July 1, and Jakob Lindberg assumed the role as
Chief Scientific Officer
NDA for accelerated approval of melflufen in the U.S was submitted
A laboratory for preclinical development was taken over to strengthen the technology platform and build the company’s pipeline
A directed share issue of SEK 1,414 M (USD 144 M) (before issue costs) to well-known life science investors, out of which SEK 716.4 M (before issue costs) was paid in after the end of the reporting period was completed
Enrollment in the OCEAN phase 3 study continues after the initial recruitment goal of 450 patients was reached in May
Final data from the pivotal HORIZON study were presented at EHA (Free EHA Whitepaper)
Patient enrollment to the company’s exploratory clinical studies was resumed in May after a temporary pause due to the COVID-19 pandemic
Significant events after the reporting period

The first patient was enrolled in the phase 1/2 AL-Amyloidosis study. This is the first study with melflufen in an indication outside multiple myeloma
Oncopeptides started a phase 2 study called PORT to evaluate an alternative administration of melflufen
Financial overview of the group

Conference call for investors, analysts and the media
The Interim Report Q2 2020 and an operational update will be presented by CEO Marty J Duvall and members of Oncopeptides management team, Wednesday August 26, 2020 at 14:00 (CET). The conference call will also be streamed via a link on the website: www. oncopeptides.com.

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CET on August 26, 2020.