Market Newsdesk

—FY20 Full-Year


Net Revenue


s


and


Gross Profit


Achieve Historical Highs 


o


f


$4


3


M


illion


and


$


31


M


illion


, Respectively—

—Robust


Growing


Prescription Sales of FC2 Key Growth Driver; 


Product


Sales


Expected to Continue


Strong


Upward Trajectory—

—Company


’s Late


Clinical


Stage Oncology


Drug


Pipeline


Advancing


—

—Company


Sells PREBOOST Business for $20 Million—

—Company to Host Investor Conference Call Today at 8 AM ET


—

MIAMI, Dec. 09, 2020 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of cancer, today announced record net revenues and gross profit for its fiscal 2020 fourth quarter and full year ended September 30, 2020.

Fourth
-Quarter Financial Highlights:
Fiscal 20
20
vs Fiscal 201
9

• Net revenues increased 35% to $11.7 million from $8.7 million
• FC2 prescription net revenues climbed 87% to $8.7 million from $4.7 million
• Gross profit rose 64% to $9.6 million from $5.8 million
• Gross margin increased to 81% of net revenues from 67% of net revenues
• Operating loss was $11.3 million, which includes a $14.1 million non-cash impairment charge related to intangible assets. Adjusted operating income, which excludes the non-cash impairment charge, was $2.8 million versus an operating loss of $1.5 million
• Net loss, which includes the non-cash impairment charge, was $11.8 million, or $0.17 per share, compared with $3.1 million, or $0.05 per share

Full-
Year Financial Highlights:
Fiscal 20
20
vs Fiscal 20
19

• Net revenues rose 34% to $42.6 million from $31.8 million
• FC2 prescription sales climbed 93% to $27.1 million from $14.1 million
• Gross profit rose 42% to $30.8 million from $21.7 million
• Gross margin increased to 72% of net revenues from 68% of net revenues
• Operating loss was $14.7 million, which included a $14.1 million non-cash impairment charge related to intangible assets. Adjusted operating loss, which excludes the non-cash impairment charge, narrowed to $0.6 million from $6.4 million
• Net loss, which includes the non-cash impairment charge, was $19.0 million, or $0.28 per share, compared with $12.0 million, or $0.19 per share

“We reported stellar financial results for both the fiscal 2020 fourth quarter and full year largely driven by strong sales of our FC2 product,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer. “In particular, prescription sales of FC2 sharply increased, helping to raise our gross margin in the recently completed fourth quarter to more than 81% of total net revenues. We anticipate further growth of prescription FC2 sales in the coming year.”

Company Sells PREBOOST B
usiness

The Company has completed the sale of its PREBOOST^® for the treatment of premature ejaculation business to Roman Health Ventures Inc. for $20 million in cash, consisting of $15 million paid at closing, $2.5 million payable 12 months after closing and $2.5 million payable 18 months after closing.

“Proceeds from the transaction, along with current cash and anticipated cash flow from operations, are expected to be sufficient to self-fund our existing drug product development program, without the need for a new equity financing, until at least the end of fiscal year 2022,” said Dr. Steiner. “We plan to continue to generate robust growing revenues from our sexual health business which as a standalone business would be very valuable. Coming off a record year of $42.6 million in net revenues with a gross margin of 72%, and expecting another record year in fiscal year 2021, we could have options to monetize the business as we did with the PREBOOST business.”

“Veru has evolved into a late clinical stage oncology drug development and commercialization company, having made excellent progress on our development program. Our multiple drug candidates continue to advance, and we are confident that we will achieve significant milestones in 2021. The Company expects it will have sufficient resources generated from our sexual health business and existing sources of cash to fund clinical development of all our registration clinical trials without the need for new equity financing through the end of fiscal year 2022.”

Some
Pharmaceutical Pipeline Recent Highlights
:

The Company expects to issue a news release later today with a more detailed update on its pipeline of late clinical stage drug candidates including the in-licensing of a novel late clinical stage breast cancer drug product entering a Phase 3 clinical trial.

TADFYN

™

(


T


adalafil 5mg and


F


inasteride 5mg


C


ombination


C


apsule)


for the


T


reatment of


L


ower


U


rinary


T


ract


S


ymptoms


C


aused by


B


enign


P


rostatic


H


yperplasia (BPH


)

The Company had a successful pre-NDA meeting with the FDA last year and the 12-month stability testing on three manufacturing / commercial batches required by the FDA is being completed. We expect to submit the NDA for TADFYN™ in the first quarter of calendar year 2021 and plan to launch, if approved, via telemedicine channels in late calendar year 2021.

VERU-111 for Metastatic Castration and Androgen Targeting AgentResistant Prostate Cancer

In September, the Company announced that it had fully enrolled a Phase 2 clinical trial of VERU-111, its novel, oral, targeting alpha and beta tubulin of microtubules to disrupt the cytoskeleton (cytoskeleton disruptor for metastatic castration and androgen receptor targeting agent resistant prostate cancer. In both the Phase 1b study (n=39) and in the Phase 2 study (n=41), VERU-111 63mg oral daily continuous dosing for 21 day cycles has been well tolerated with no reports of neutropenia and neutrotoxicity and has demonstrated promising efficacy with evidence of PSA declines and objective and durable tumor responses. The Company has received input from the FDA and anticipates initiating a Phase 3 VERU-111 VERACITY registration clinical trial during the first quarter of calendar 2021.

VERU-1


00


Androgen Deprivation Therapy


for Advanced Prostate Cancer

VERU100 is a long-acting GnRH antagonist peptide formulation administered as a small volume, three-month depot subcutaneous injection without a loading dose. There are no GnRH antagonist depot injectable formulations commercially approved beyond a one-month duration. The Company anticipates initiating a Phase 2 trial to evaluate VERU-100 dosing in the first quarter of calendar year 2021 and a Phase 3 registration clinical trial during the second half of calendar year 2021.

VERU-111 COVID-19: Phase 2 Clinical Trial

The Company is also developing VERU-111 for COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). The drug’s dual antiviral and anti-inflammatory action has the potential to broadly treat the cytokine storm associated with high COVID-19 mortality rates. The Company is close to completing enrollment of a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19 in patients at high risk for ARDS.

Impairment Charge

During the fourth quarter the Company took a one-time, non-cash impairment charge of $14.1 million related to in process research and development associated with the financial accounting for the Aspen Park Pharmaceuticals, Inc. acquisition, all as further described in the Company’s Form 10-K for the fiscal year ended September 30, 2020. The non-cash charge is primarily related to the Company’s decision to prioritize clinical development for late clinical stage oncology drug development candidates with greater market differentiation, larger markets, and higher profit potential.

Non-GAAP Financial Information

Certain financial results for fiscal years 2020 and 2019 are presented on both a reported and a non-GAAP, adjusted basis. Reported results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The non-GAAP results are adjusted to exclude the one-time, non-cash impairment charge in the fourth quarter of fiscal year 2020. Management believes non-GAAP financial measures provide useful information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the Company’s business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The Company has reconciled these non-GAAP financial measures to the nearest reported GAAP measures in the reconciliation table below.

Event Details

Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10149625, for one week.

The Company does not expect to update the guidance provided above regarding its expectation that it will not need a new equity financing. The Company notes that the statements of future performance made in this release are based upon current expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the “Safe Harbor” Statement below.

About Veru Inc.

Veru Inc. is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of cancer. The Veru prostate cancer pipeline includes VERU-111, VERU-100, and Zuclomiphene citrate. VERU-111 is an oral, first-in-class, new chemical entity that targets, crosslinks, and disrupts alpha and beta tubulin subunits of microtubules to disrupt the cytoskeleton (cytoskeleton disruptor). VERU-111 is being evaluated in open label Phase 1b and Phase 2 clinical trials in men with metastatic castration and androgen receptor targeting agent resistant prostate cancer. The Phase 1b clinical study completed enrollment of 39 men and is ongoing. The Phase 2 clinical trial has completed the enrollment of 41 men who have metastatic castration resistant prostate cancer and who have also become resistant to at least one novel androgen receptor targeting agent, such as abiraterone, enzalutamide, or apalutamide but prior to IV chemotherapy, and is ongoing. VERU-100 is a novel, proprietary peptide formulation designed to address the current limitations of commercially available androgen deprivation therapies (ADT) for advanced prostate cancer. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist administered as a small volume, 3-month depot subcutaneous injection without a loading dose. VERU-100 immediately suppresses testosterone with no testosterone surge upon initial or repeated administration — a problem which occurs with currently approved luteinizing hormone-releasing hormone (LHRH) agonists used for ADT. There are no GnRH antagonists commercially approved beyond a one-month injection. A Phase 2 trial to evaluate VERU100 dosing is anticipated to begin in the first quarter of calendar year 2021. Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist being developed to treat hot flashes, a common side effect caused by ADT in men with advanced prostate cancer. The Company is planning for an End of Phase 2 meeting with the FDA. VERU-111 is also being evaluated in a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19 in subjects at high risk for ARDS.

Veru is also advancing the Tadalafil and Finasteride combination capsule (TADFYN™) for the administration of tadalafil 5mg and finasteride 5mg oral daily dosing for benign prostatic hyperplasia (BPH). Tadalafil (CIALIS^®) is currently approved for treatment of BPH and erectile dysfunction and finasteride is currently approved for treatment of BPH (finasteride 5mg PROSCAR^®) and male pattern hair loss (finasteride 1mg PROPECIA^®). The Company had a successful pre-NDA meeting with the FDA last year and the 12-month stability testing on three manufacturing/commercial batches required by FDA is being completed. The Company expects to submit the NDA for TADFYN™ in the first quarter of calendar year 2021 and plans to launch, if approved, via telemedicine channels in late calendar year 2021.

The Company’s commercial product is the FC2 Female Condom / FC2 Internal Condom^® (“FC2”), an FDA-approved product for the dual protection against unintended pregnancy and the transmission of sexually transmitted infections. The Company’s Female Health Company Division markets and sells FC2 commercially and in the public health sector both in the U.S. and globally. In the U.S., FC2 is available by prescription through multiple third party telemedicine and internet pharmacy providers, retail pharmacies, as well as OTC via the Company’s website at www.fc2.us.com. In the global public health sector, the Company markets FC2 to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world. To learn more about Veru products please visit www.verupharma.com.

“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:

The statements in this release that are not historical facts are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding
the Company’s anticipation that it will not need new equity financing until at least
the end of
fiscal year 202
2,
options to monetize the FC2 business,
the regulatory pathway to secure FDA approval of the Company’s drug candidates, the anticipated timeframe for clinical studies and FDA submissions, clinical study results including potential benefits and the absence of adverse events
, and the expectation of further growth of prescription FC2 sales
. Any forward-looking
statements in this release are based upon the Company’s current plans and strategies and reflect the Company’s current assessment of the risks and uncertainties related to its business and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions. If any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: risks related to the development of the Company’s product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; potential delays in the timing of and results from clinical trials and studies
, including potential delays in the recruitment of patients and their ability to effectively participate in such trials and studies due to COVID
19,
and the risk that such results will not support marketing approval and commercialization; potential delays in the timing of any submission to the FDA and regulatory approval of products under development and the risk that
disruptions at the FDA caused by the COVID-19 pandemic may delay the review of submissions or approvals for new drugs
; the risk of a
delay or failure in reaching agreement with the FDA on the design of a clinical trial or in obtaining authorization to commence a clinical trial;
clinical results or early data from clinical trials may not be replicated or continue to occur in additional trials or may not otherwise support further development in the specified product candidate or at all; o
ur pursuit of a COVID-19 treatment candidate is at an early stage and we may be unable to develop a drug that successfully treats the virus in a timely manner, if at all; risks related to our
commitment of financial resources and personnel to the development of a COVID-19 treatment which may cause delays in or otherwise negatively impact our other development programs, despite uncertainties about the longevity and extent of COVID-19 as a global health concern
;
government entities may take actions that directly or indirectly have the effect of limiting opportunities
for VERU-111 as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments;
the risk that the Company’s products may not be commercially successful; risks related to the impact of the COVID-19 pandemic on our business, the nature and extent of which is highly uncertain and unpredictable;
risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations
, including our ability to secure timely grant or other funding to develop VERU-111 as a potential COVID-19 treatment
; product demand and market acceptance; competition in the Company’s markets and therapeutic areas and the risk of new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions;
the risk that the Company will be affected by regulatory developments, including a reclassification of products; price erosion, both from competing products and increased government pricing pressures; manufacturing and quality control problems; compliance and regulatory matters, including costs and delays resulting from extensive governmental regulation, and effects of healthcare insurance and regulation, including reductions in reimbursement and coverage or reclassification of products; some of the Company’s products are in development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including the uncertainty of obtaining patents, the effectiveness of the patents or other intellectual property protections and ability to enforce them against third parties, the uncertainty regarding patent coverages, the possibility of infringing a third party’s patents or other intellectual property rights, and licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay, restructuring or substantial delayed payments; the risk that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; a governmental tender award indicates acceptance of the bidder’s price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount or award; penalties and/or debarment for failure to satisfy tender awards; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; risks related to concentration of accounts receivable with our largest customers and the collection of those receivables; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, COVID-19 (including the impact of COVID-19 on suppliers of key raw materials), product testing, transportation delays or regulatory actions; risks related to the costs and other effects of litigation, including product liability claims; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions, dispositions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the fiscal year ended September 30, 2019 and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.

FINANCIAL SCHEDULES FOLLOW

Veru Inc.

Condensed
Consolidated Balance Sheets

(unaudited)

	September 30,				September 30,
	2020				2019
Cash and cash equivalents	$	13,588,778			$	6,295,152
Accounts receivable, net		5,227,237				5,021,057
Inventory, net		6,704,134				3,647,406
Prepaid expenses and other current assets		1,494,541				1,843,297
Total current assets		27,014,690				16,806,912
Property and equipment, net		312,691				351,895
Operating lease right-of-use assets		1,352,315				—
Deferred income taxes		9,466,800				8,433,669
Intangible assets, net		5,752,127				20,168,495
Goodwill		6,878,932				6,878,932
Other assets		766,120				988,867
Total assets	$	51,543,675			$	53,628,770
Accounts payable	$	2,812,673			$	3,124,751
Accrued expenses and other current liabilities		4,385,632				5,509,575
Credit agreement, short-term portion		5,841,874				5,385,649
Residual royalty agreement, short-term portion		1,100,193				—
Operating lease liability, short-term portion		586,769				—
Total current liabilities		14,727,141				14,019,975
Credit agreement, long-term portion		—				2,886,382
Residual royalty agreement		5,617,494				3,845,518
Operating lease liability, long-term portion		990,020				—
Other liabilities		97,704				543,759
Total liabilities		21,432,359				21,295,634
Total stockholders’ equity		30,111,316				32,333,136
Total liabilities and stockholders’ equity	$	51,543,675			$	53,628,770

Veru Inc.

Condensed
Consolidated Statements of Operations

(unaudited)

	Three Months Ended September 30,								Year Ended September 30,
	2020				2019				2020				2019
Net revenues	$	11,749,186			$	8,728,403			$	42,592,060			$	31,803,387
Cost of sales		2,187,039				2,895,670				11,805,202				10,146,565
Gross profit		9,562,147				5,832,733				30,786,858				21,656,822
Operating expenses		20,831,918				7,290,308				45,533,552				28,092,716
Operating loss		(11,269,771	)			(1,457,575	)			(14,746,694	)			(6,435,894	)
Non-operating expenses		(1,671,834	)			(2,024,022	)			(5,305,282	)			(5,885,405	)
Loss before income taxes		(12,941,605	)			(3,481,597	)			(20,051,976	)			(12,321,299	)
Income tax benefit		(1,109,060	)			(421,140	)			(1,078,441	)			(303,933	)
Net loss	$	(11,832,545	)		$	(3,060,457	)		$	(18,973,535	)		$	(12,017,366	)
Net loss per basic and diluted common share outstanding	$	(0.17	)		$	(0.05	)		$	(0.28	)		$	(0.19	)
Basic and diluted weighted average common shares outstanding		69,863,681				65,037,604				66,753,450				63,323,127

Veru Inc.

Condensed
Consolidated Statements of
Cash Flow
s

(unaudited)

	Year Ended September 30,
	2020				2019
Net loss	$	(18,973,535	)		$	(12,017,366	)
Adjustments to reconcile net loss to net cash used in operating activities		21,389,716				8,096,208
Changes in operating assets and liabilities		(4,346,276	)			(1,564,049	)
Net cash used in operating activities		(1,930,095	)			(5,485,207	)
Net cash used in investing activities		(105,760	)			(108,517	)
Net cash provided by financing activities		9,329,481				8,129,367
Net increase in cash		7,293,626				2,535,643
Cash at beginning of period		6,295,152				3,759,509
Cash at end of period	$	13,588,778			$	6,295,152

Veru Inc.

Operating Income (Loss) by Segment

(unaudited)

	Three Months Ended September 30, 2020
	Sexual Health Business				Research & Development				Corporate				Total
Net revenues
FC2	$	10,963,903			$	—			$	—			$	10,963,903
PREBOOST		785,283				—				—				785,283
Total net revenues		11,749,186				—				—				11,749,186
Cost of sales		2,187,039				—				—				2,187,039
Gross profit		9,562,147				—				—				9,562,147
Operating expenses		1,119,483				3,264,429				16,448,006				20,831,918
Operating income (loss)	$	8,442,664			$	(3,264,429	)		$	(16,448,006	)		$	(11,269,771	)
	Three Months Ended September 30, 2019
	Sexual Health Business				Research & Development				Corporate				Total
Net revenues
FC2	$	8,467,311			$	—			$	—			$	8,467,311
PREBOOST		261,092				—				—				261,092
Total net revenues		8,728,403				—				—				8,728,403
Cost of sales		2,895,670				—				—				2,895,670
Gross profit		5,832,733				—				—				5,832,733
Operating expenses		1,144,811				3,658,478				2,487,019				7,290,308
Operating income (loss)	$	4,687,922			$	(3,658,478	)		$	(2,487,019	)		$	(1,457,575	)

(Continued)

Veru Inc.

Operating Income (Loss) by Segment

(unaudited)

	Year Ended September 30, 2020
	Sexual Health Business				Research & Development				Corporate				Total
Net revenues
FC2	$	40,556,818			$	—			$	—			$	40,556,818
PREBOOST		2,035,242				—				—				2,035,242
Total net revenues		42,592,060				—				—				42,592,060
Cost of sales		11,805,202				—				—				11,805,202
Gross profit		30,786,858				—				—				30,786,858
Operating expenses		4,291,732				16,871,057				24,370,763				45,533,552
Operating income (loss)	$	26,495,126			$	(16,871,057	)		$	(24,370,763	)		$	(14,746,694	)
	Year Ended September 30, 2019
	Sexual Health Business				Research & Development				Corporate				Total
Net revenues
FC2	$	30,919,366			$	—			$	—			$	30,919,366
PREBOOST		884,021				—				—				884,021
Total net revenues		31,803,387				—				—				31,803,387
Cost of sales		10,146,565				—				—				10,146,565
Gross profit		21,656,822				—				—				21,656,822
Operating expenses		4,956,947				13,973,938				9,161,831				28,092,716
Operating income (loss)	$	16,699,875			$	(13,973,938	)		$	(9,161,831	)		$	(6,435,894	)

(Concluded)

Veru Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(unaudited)

	Three Months Ended September 30,								Year Ended September 30,
	2020				2019				2020				2019
Operating income (loss) reconciliation:
GAAP operating loss	$	(11,269,771	)		$	(1,457,575	)		$	(14,746,694	)		$	(6,435,894	)
Impairment of intangible assets		14,100,000				—				14,100,000				—
Non-GAAP adjusted operating income (loss)	$	2,830,229			$	(1,457,575	)		$	(646,694	)		$	(6,435,894	)

Contact:

Sam Fisch, Director of Investor Relations
800-972-0538

Silver Spring, MD, Dec. 09, 2020 (GLOBE NEWSWIRE) —

Capital Digestive Care is pleased to announce the opening of a new HyGieaCare® Center in Rockville, MD. The Center, the first of its kind serving the Maryland and Washington, D.C. areas, offers an easier alternative to conventional oral preparation for colonoscopy.

The HyGieaCare® Prep System, cleared by the U.S. Food and Drug Administration, effectively cleanses the bowel using a gentle infusion of warm, gravity-flow filtered water. The use of this innovative method means patients may skip many of the elements that make traditional bowel prep inconvenient and uncomfortable. With the HyGieaCare Prep System, patients can experience safe and easy bowel prep on the same day as their scheduled colonoscopy. More than 15,000 patients across the country have chosen HyGieaCare for their colonoscopy prep with excellent clinical results and a 96% patient satisfaction rate.

“For many patients, the traditional oral prep can be the most difficult part of a colonoscopy and can even result in patients deciding to forgo this potentially life-saving screening,” said Dr. Michael Weinstein, President & CEO of Capital Digestive Care. “The comfort and convenience of the HyGieaCare system may eliminate that barrier for some patients and can help save lives.

The HyGieaCare prep is performed in a clean and comfortable environment immediately prior to the patient’s scheduled procedure. A trained technician provides instruction and is available for support throughout the appointment. A gentle gravity-flow stream of warm water flows into the bowel through a sterile, disposable nozzle inserted into the rectum, comfortably and discreetly evacuating the colon as stool is loosened. Water continually flows until the colon is fully cleansed. A HyGieaCare technician monitors the procedure which typically takes one hour.

The HyGieaCare system can also provide relief to patients who suffer from chronic constipation. Traditional treatment for constipation includes a combination of diet, exercise, supplements and/or prescription medication, all of which can be hard for patients to comply with consistently or worse, may not be effective. Using the same warm water infusion method, patients can be safely and effectively relieved of chronic constipation at the HyGieaCare Center without the use of medication.

The Capital Digestive Care HyGieaCare Center is currently scheduling patients. For more information, please visit the Capital Digestive Care website.

About Capital Digestive Care

Founded in 2009, Capital Digestive Care is the largest private gastroenterology practice in the Mid-Atlantic. More than 80 physicians and advanced care practitioners treat a wide range of conditions—from the common complaint of heartburn to the complex management of Crohn’s Disease—and offer critical services for the prevention of colon cancer for more than 75,000 patients annually. With business operations located in Silver Spring, MD, Capital Digestive Care’s integrated care model connects its doctors to more than 20 office locations and outpatient surgery centers as well as specialized laboratory services and the largest clinical research program of its kind in the region.  For more information on Capital Digestive Care, please visit www.capitaldigestivecare.com.

 

About HyGieaCare, Inc.

In 2015, Gavriel Meron, who was the founder and CEO of Given Imaging Ltd. (PillCam), founded Hygieacare Inc., a US Delaware corporation, to create a new standard of care to ensure patients are ready for colonoscopy utilizing the FDA cleared Hygieacare System. To date over 15,000 patients have benefitted from Hygieacare procedures. Hygieacare Centers are located in the US – Austin, TX; Norfolk, VA; Cincinnati, OH; Jackson, MS; and Rockville, MD. The goal of Hygieacare is to provide unique services and solutions to gastroenterologists to deliver better GI outcomes for their patients and their practice through Hygieacare Centers to be established in the US and throughout the world. For more information visit https://hygieacare.com.

 

Contact:
Jennifer Mosley, Director of Marketing

[email protected]

Michal Gorodish – VP Marketing
HyGIeaCare Inc.
[email protected]

 

Jennifer Mosley
Capital Digestive Care
2404855259
[email protected]

CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, Dec. 09, 2020 (GLOBE NEWSWIRE) — Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, today announced that it will issue a press release reporting its financial results for the three months ended September 30, 2020, on Wednesday, December 16, 2020, and will host a conference call to discuss these results at 8 a.m. EST that day.

Participants may register in advance for the conference call to be held on December 16, 2020, at http://emea.directeventreg.com/registration/6768815. Upon registering, each participant will be provided with Participant Dial In Numbers, a Direct Event Passcode, and a unique Registrant ID. Registrants can then join up to 10 minutes prior to the start of the call. The webcast of the conference call and the related earnings presentation will also be available on the Investor Relations page of the company’s website at http://investors.centogene.com.

About CENTOGENE

CENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies. Our goal is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our extensive rare disease knowledge, including epidemiological and clinical data, as well as innovative biomarkers. CENTOGENE has developed a global proprietary rare disease platform based on our real-world data repository with over 3.6 billion weighted data points from approximately 570,000 patients representing over 120 different countries as of August 31, 2020.

The Company’s platform includes epidemiologic, phenotypic, and genetic data that reflects a global population, and also a biobank of these patients’ blood samples. CENTOGENE believes this represents the only platform that comprehensively analyzes multi-level data to improve the understanding of rare hereditary diseases, which can aid in the identification of patients and improve our pharmaceutical partners’ ability to bring orphan drugs to the market. As of August 31, 2020, the Company collaborated with over 40 pharmaceutical partners covering over 45 different rare diseases

Important Notice and Disclaimer

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of our strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project” or “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the Company. However, these forward-looking statements are not a guarantee of our performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, such as negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, possible changes in current and proposed legislation, regulations and govern-mental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our ability to manage growth and enter into new client relationships, our dependency on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations of our operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The Company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please refer to the Risk Factors section in our Annual Report for the year ended December 31, 2019 on Form 20-F filed with the SEC on April 23, 2020, Form 6-K containing our financial results for the three months ended March 31, 2020, filed with the SEC on June 15, 2020 and other current reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

Media Contact:

CENTOGENE 
Sun Kim
Chief Strategy and Investor Relations Officer
[email protected]     

FTI Consulting 
Bridie Lawlor O’Boyle
+1.917.929.5684 
[email protected]

BEIJING, Dec. 09, 2020 (GLOBE NEWSWIRE) — ZW Data Action Technologies, Inc. (Nasdaq: CNET) (“ZW Data” or the “Company”), an integrated online advertising, precision marketing, data analytics, and other value-added services company, today announced the official opening of its first live streaming platform (the “Platform”) in Guangzhou, China.

The Company selected Guangzhou, the hub of the economically vibrant Guangdong-Hong Kong-Macao Greater Bay Area, for the location of the Platform. The Platform boasts a 5,000-square-meter office that provides a powerful livestreaming channel. It features livestreaming ecommerce, ecommerce support service, influencer stream shopping, private traffic boosting, supply chain service, and supply chain finance. On its opening day, the Platform proudly welcomed its first tenant, Live Streaming Professionals Committee of China Association of National Advertisers.

Live streaming ecommerce has exploded in China in the past few years. iMedia Research’s data indicated that the industry is projected to reach roughly $1.5 trillion in 2020, and $2.2 trillion by 2021. Following the accelerating trend, the Company expects its live streaming business to bring in $50 million revenue in 2021 and keep a double digit growth. The Company also plans to develop live streaming business as its core business and as one of the major profit generators.

This boom also brought challenges such as data loss, data fabrication, difficulties to detect counterfeit and shoddy products, and fraud complaint barriers. The Company strives to address these challenges and provide a reliable and secure environment for its clients. The Platform is powered by the Company’s Blockchain Integrated Framework for Retail Business (“BIF”) as its first application scenario. BIF enables the Platform to record complete live streaming data, and ensure accurate and credible data for shopping transactions.

“The Platform is our first step toward creating a digitized smart ecosystem for small and medium sized retailers. We believe the Platform will facilitate and streamline information, material, and financial flows for live streaming ecommerce. We also expect that the Platform will also develop into a business incubator to nurture retailers, brands, and Internet influencers. Our goal is to build an ecosystem that grows with our clients,” commented Handong Cheng, Chairman and Chief Executive Officer of ZW Data.

About ZW Data Action Technologies Inc.

Established in 2003 and headquartered in Beijing, China, ZW Data Action Technologies Inc. (the “Company”) offers online advertising, precision marketing, data analytics and other value-added services for enterprise clients. Leveraging its fully integrated services platform, proprietary database, and cutting-edge algorithms, ZW Data Action Technologies delivers customized, result-driven business solutions for small and medium-sized enterprise clients in China. The Company also develops blockchain and artificial intelligence enabled web/mobile applications and software solutions for general public, enterprise clients, and government agencies. More information about the Company can be found at: http://www.zdat.com/.

Safe Harbor Statement

This release contains certain “forward-looking statements” relating to the business of ZW Data Action Technologies Inc., which can be identified by the use of forward-looking terminology such as “believes,” “expects,” “anticipates,” “estimates” or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including business uncertainties relating to government regulation of our industry, market demand, reliance on key personnel, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission. These forward-looking statements are based on ZW Data Action Technologies current expectations and beliefs concerning future developments and their potential effects on the Company. There can be no assurance that future developments affecting ZW Data Action Technologies will be those anticipated by ZW Data Action Technologies. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of the Company) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. ZW Data Action Technologies undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

For more information, please contact:

Sherry Zheng
Weitian Group LLC
Email: [email protected]
Phone: +1 718-213-7386