On November 6, 2019 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the third quarter ended September 30, 2019 (Press release, Vanda Pharmaceuticals, NOV 6, 2019, View Source [SID1234550521]).

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"These results affirm Vanda’s corporate strategy, and continue to demonstrate our ability to grow our commercial assets and expand our pipeline of products," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. "I am proud of the progress we have made in our research and development programs, with several new filings expected to be submitted within the next two years. Furthermore, Vanda has put in place a proactive regulatory strategy to better support our patients and products."

Key Financial Highlights:

Total net product sales from HETLIOZ and Fanapt were $59.5 million in the third quarter of 2019, a 21% increase compared to $49.1 million in the third quarter of 2018.
HETLIOZ net product sales were $37.6 million in the third quarter of 2019, a 26% increase compared to $29.9 million in the third quarter of 2018.
Fanapt net product sales were $21.9 million in the third quarter of 2019, a 14% increase compared to $19.2 million in the third quarter of 2018.
Cash, cash equivalents and marketable securities (Cash) were $299.6 million as of September 30, 2019, representing an increase to Cash of $59.0 million compared to September 30, 2018.
Key Research and Development Highlights:

Tradipitant

Enrollment in EPIONE, the Phase III clinical study of tradipitant in atopic dermatitis, is complete. Results from EPIONE are expected in the first quarter of 2020.
In October 2019, EPIONE II, a second Phase III clinical study of tradipitant in atopic dermatitis, began enrolling patients.
Enrollment in the Phase III study of tradipitant in gastroparesis is ongoing as Vanda continues to engage with the U.S. Food and Drug Administration (FDA) on tradipitant’s regulatory path.
Vanda plans to initiate the Phase III program of tradipitant in motion sickness in the fourth quarter of 2019. Vanda expects to file a New Drug Application with the FDA for tradipitant for the treatment of motion sickness in 2020.
HETLIOZ (tasimelteon)

Vanda received a complete response letter (CRL) on August 16, 2019 from the FDA related to the supplemental New Drug Application (sNDA) of HETLIOZ for the treatment of Jet Lag Disorder (JLD). Vanda met with the FDA to discuss the CRL in a Post Action meeting and is determining its next steps.
Vanda plans to meet with the FDA in the fourth quarter of 2019 to discuss the HETLIOZ Smith-Magenis Syndrome clinical study results and expects to submit an sNDA by year-end 2019.
An observational study of delayed sleep phase disorder (DSPD) is ongoing. Vanda plans to initiate a Phase III clinical study of HETLIOZ in DSPD patients by year-end 2019.
Fanapt (iloperidone)

A pharmacokinetic study for the once-a-month long acting injectable (LAI) formulation of Fanapt is ongoing.
A study of Fanapt in bipolar disorder is planned to begin by year-end 2019.
VTR-297 (histone deactetylase (HDAC) inhibitor)

Enrollment in the Phase I clinical study (1101) of VTR-297 in hematologic malignancies is ongoing.
Corporate Highlights:

Vanda announced the appointment of Anne Sempowski Ward to its Board of Directors, effective October 28, 2019, increasing the total number of members on the Board to six.
Vanda announced the hiring of Scott L. Howell as its Chief People Officer, Aranthan "AJ" Jones II as its Chief Corporate Affairs and Communications Officer and Joakim "Kim" Wijkstrom as its Chief Marketing Officer, further bolstering the executive leadership team.
GAAP Financial Results

Net income was $100.4 million for the third quarter of 2019, or $1.88 per share, compared to net income of $7.2 million, or $0.14 per share, for the third quarter of 2018.

The income tax benefit of $88.1 million reflected in the financial results for the third quarter of 2019 includes the favorable impact of the release of Vanda’s deferred tax asset valuation allowance.

Income before income taxes was $12.3 million in the third quarter of 2019, a 69% increase compared to $7.3 million in the third quarter of 2018.

2019 Financial Guidance

Vanda reiterates its 2019 net product sales guidance and expects results in the upper half of the range. In addition, Vanda provides an update to Year-end 2019 Cash and expects to achieve the following financial objectives in 2019:

Conference Call

Vanda has scheduled a conference call for today, Wednesday, November 6, 2019, at 4:30 PM ET. During the call, Vanda’s management will discuss the third quarter 2019 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5377942. A replay of the call will be available on Wednesday, November 6, 2019, beginning at 7:30 PM ET and will be accessible until Wednesday, November 13, 2019, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5377942.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

On November 6, 2019 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, reported business highlights and financial results for the third quarter ended September 30, 2019 (Press release, Ardelyx, NOV 6, 2019, View Source [SID1234550520]).

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"The third quarter was particularly exciting with two transformational milestones occurring in rapid succession and serving as major catalysts for growth and momentum at Ardelyx," said Mike Raab, president and chief executive officer of Ardelyx. "First, we were pleased to report successful results from our Phase 3 AMPLIFY study for tenapanor in hyperphosphatemia, positioning us one step closer to submitting our New Drug Application to the FDA and potentially providing our drug broadly to patients in need. On the heels of that milestone, we announced the approval of IBSRELA. This approval marked a momentous achievement for Ardelyx as our first ever product approved and represented the culmination of more than a decade of diligent execution and commitment by our talented team. Importantly, these milestones propel us toward fulfilling our mission to bring innovative first-in-class medicines to improve treatments for patients in need."

Business and Pipeline Updates

In October 2019, Ardelyx hosted Analyst Day, the second of an anticipated annual event. The event featured Myles Wolf, M.D., chief of nephrology at Duke University, and the company’s new team of sales and marketing leaders. The event focused on the significant need to improve hyperphosphatemia management in patients on dialysis, challenges with today’s treatment options that are limited to phosphate binders, and the commercial strategy to bring tenapanor to market, if and when approved. A replay of the event is available on the Events and Presentations page under the investor relations section of Ardelyx’s website at www.ardelyx.com.
In September 2019, Ardelyx announced positive results from the pivotal Phase 3 AMPLIFY study evaluating tenapanor in dialysis patients who have uncontrolled hyperphosphatemia despite phosphate binder treatment. The AMPLIFY study met the primary and all key secondary endpoints, including demonstrating a statistically significant (p=0.0004) reduction in serum phosphorus levels for patients treated with tenapanor and phosphate binders compared to phosphate binders alone. Approximately two times more patients achieved the established serum phosphorus treatment goal of less than 5.5mg/dL in the tenapanor arm compared to binders alone (p -values≤0.0097) for each week of treatment.
In September 2019, Ardelyx received FDA approval for IBSRELA (tenapanor). The company continues discussions with potential strategic partners to market IBSRELA in the United States.
Upcoming Milestones

The company currently expects to announce results in the fourth quarter of 2019 from the PHREEDOM clinical trial, the company’s second Phase 3 clinical trial evaluating tenapanor as a monotherapy treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) who are on dialysis.

Third Quarter 2019 Financial Results

Cash Position: As of September 30, 2019, Ardelyx had total capital resources including cash, cash equivalents and short-term investments of $103.5 million compared to total capital resources including cash, cash equivalents and short-term investments of $168.1 million as of December 31, 2018.
R&D Expenses: Research and development expenses were $17.5 million for the three months ended September 30, 2019, a decrease of $0.4 million, or 2 percent, compared to $17.9 million for the three months ended September 30, 2018. The decrease in expense was primarily related to reduction in the company’s manufacturing expense of tenapanor, a reduction in costs associated with the continued clinical development of tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis and a decrease in professional services, partially offset by an increase in expenses in the company’s hyperkalemia program, RDX013, an increase in headcount and related personnel costs and an increase in stock-based compensation expenses.
G&A Expenses: General and administrative expenses were $6.9 million for the three months ended September 30, 2019, an increase of $0.9 million, or 16 percent, compared to $6.0 million for the three months ended September 30, 2018. The increase was primarily related to an increase in stock-based compensation costs and an increase in professional services, partially offset by a decrease in personnel costs related to a one-time severance payment during the three months ended September 30, 2018.
Net Loss: Net loss for the three months ended September 30, 2019 was $23.5 million, or $0.37 per share, compared to a net loss of $24.1 million, or $0.39 per share, for the three months ended September 30, 2018.
Financial Guidance

Ardelyx maintains its expectation that its cash, cash equivalents and short-term investments are sufficient to fund the company’s operations until at least early 2021 based on its current operating plans.

On November 6, 2019 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported it will report its third quarter 2019 financial results and business progress on Tuesday, November 12, 2019, after the close of the U.S. financial markets (Press release, Tocagen, NOV 6, 2019, View Source [SID1234550519]).

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On November 6, 2019 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported net revenue of $8.6 million for the third quarter ended September 30, 2019 (Press release, Biolase Technology, NOV 6, 2019, View Source [SID1234550518]).

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Third Quarter and Recent Operating and Financial Highlights

The Company’s Inaugural Advancing Dentistry Symposium attracted over 250 professionals in the dental field, providing an opportunity for collaboration and immersive education around technologies and techniques that are advancing dentistry
During the symposium, a first-of-its-kind landmark study by the McGuire Institute on the clinical efficacy of Waterlase-assisted treatment of periodontitis versus open-flap gum surgery was previewed
Waterlase dental lasers received clearance in the U.S. and Canada for crown and veneer removal
Increased financial flexibility and working capital with new credit facility and bolstered balance sheet with $8.5 million equity offering
"Despite being a transition year for BIOLASE as we migrate from an R&D centric company to a full-scale commercial operation, we are progressing as expected, and I am pleased with the team’s overall performance," commented Todd Norbe, President and Chief Executive Officer. "We recently achieved a significant regulatory milestone in the U.S. and Canada as our Waterlase dental lasers received clearance for crown and veneer removal, and we successfully hosted our inaugural two-day Advancing Dentistry symposium with over 250 dental professionals in attendance. At the event, Dr. Donald Clem previewed a first-of-its-kind landmark study by the McGuire Institute on the clinical efficacy of Waterlase-assisted treatment of periodontitis versus traditional open-flap gum surgery. We expect the six-month interim data will be published by the end of 2019 and anticipate the full study data will be published in a scientific journal during the first half of 2020. I continue to believe we have developed the best product to advance dentistry and believe this data will be a positive catalyst for our business. Our focus now is on expanding the reach of this great technology."

2019 Third Quarter Financial Results

Net revenue for the third quarter of 2019 was $8.6 million, in-line with the Company’s previously disclosed revenue estimate, compared to net revenue of $10.9 million for the third quarter of 2018. U.S. laser revenue was $2.3 million for the third quarter of 2019 compared to U.S. laser revenue of $3.8 million for the third quarter of 2018, due to the U.S. sales force realignment announced last quarter. U.S. consumables and other revenue for the third quarter of 2019, which consists of revenue from consumable products such as disposable tips, decreased 5.8% compared to the third quarter of 2018. Outside the U.S., laser revenue declined to $2.8 million for the third quarter of 2019 compared to $3.3 million for the third quarter of 2018, primarily due to generating an order backlog from international distributors as we continue to seek more favorable pricing and payment terms.

Gross margin for the third quarter of 2019 was 34% compared to 36% for the third quarter of 2018. The lower gross margin reflects the impact of fixed costs on lower net revenues, partially offset by operating cost efficiencies. Total operating expenses were $7.9 million for the third quarter of 2019 compared to $8.5 million for the third quarter of 2018, a decrease of $0.6 million despite an increase in provision for bad debt relating to our former distributor in China. Operating loss for the third quarter of 2019, was $4.9 million, compared to an operating loss of $4.5 million for the third quarter of 2018, a decrease of $0.4 million year over year. As previously announced, the net loss for the third quarter of 2019 was $5.5 million, or $0.25 per share compared to a net loss of $4.7 million, or $0.23 per share for the third quarter of 2018.

The Reconciliation of GAAP Net Loss to Adjusted EBITDA at the end of this news release provides the details of the Company’s non-GAAP disclosures and the reconciliation of GAAP net loss and net loss per share to the Company’s Adjusted EBITDA and Adjusted EBITDA per share.

The Adjusted EBITDA for the third quarter of 2019 was $2.7 million, or $0.12 per share compared with Adjusted EBITDA of $3.7 million, or $0.18 per share for the third quarter of 2018.

Cash, cash equivalents, and restricted cash totaled $2.4 million as of September 30, 2019.

Subsequent to the end of the third quarter, on October 29, 2019, the Company completed an $8.5 million public offering of common stock and a private placement of convertible preferred stock, strengthening its balance sheet. On October 31, 2019, the Company secured a $3.0 million revolving line of credit from Pacific Mercantile Bank, the wholly-owned subsidiary of Pacific Mercantile Bancorp, increasing the Company’s financial flexibility and for working capital purposes.

"The new line of credit and recently completed equity offering are significant developments for BIOLASE as they significantly improve our working capital, strengthen our balance sheet and allow us to enter 2020 in a far stronger position," added John Beaver, Executive Vice President and Chief Financial Officer. "We now have the financial flexibility and resources to execute our business plan to return to sustainable, profitable revenue growth and we remain committed to achieving adjusted EBITDA break-even in the current fourth quarter."

Conference Call Information

BIOLASE, Inc. will host a conference call today at 4:30 p.m. Eastern Time to discuss its operating results for the third quarter ended September 30, 2019, and to answer questions. For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 800-458-4148. For international participants outside the U.S./Canada, the dial-in number is 323-794-2093. For all callers, refer to the Conference ID 9068935. To access the live webcast, visit the Investor Relations section of the BIOLASE website at www.biolase.com and see "Investor Events".

An audio archive of the webcast will be available for 30 days on the Investor Relations section of the BIOLASE website.

On November 6, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, reported its third quarter 2019 financial results (Press release, AcelRx Pharmaceuticals, NOV 6, 2019, View Source [SID1234550517]).

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"Achieving 125 REMS-certified facilities two months ahead of our year-end goal demonstrates healthcare providers’ increasing interest in DSUVIA," said Vince Angotti, Chief Executive Officer of AcelRx. "We also expect to achieve our year-end objective of 125 formulary approvals and anticipate expanded use across a variety of healthcare settings as the feedback on DSUVIA from healthcare professionals continues to be very positive," continued Angotti.

Third Quarter and Recent Highlights

130 healthcare facilities are now REMS-certified and able to purchase DSUVIA and 105 formulary approvals have been achieved through October 31, 2019; approximately 60% of REMS certifications and formulary approvals have occurred since the date of the Company’s last earnings call
AcelRx was selected to present at one of the two plenary sessions of the 2019 Military Health System Research Symposium; the presentation was entitled "Pooled Safety Analysis of Patients Who Were Exposed to < 300 mcg vs. ≥300 mcg of Sublingual Sufentanil in a 24 Hour Period for Treatment of Acute Pain"
Pooled dosing and efficacy data from use of the sufentanil sublingual tablet (SST) 30 mcg among multiple demographic subgroups (age, sex, race, and body mass index) was accepted for publication in the Journal of PeriAnesthesia Nursing to aid nurses in understanding the effectiveness and duration of action of SST 30 mcg in the management of moderate-to-severe acute pain across a variety of patient demographics
Financial Information

Cash, cash equivalents and short-term investments balance of $80.4 million as of September 30, 2019;
Combined R&D and SG&A expenses for the third quarter of 2019 totaled $12.0 million compared to $8.8 million for the third quarter of 2018. Excluding stock-based compensation expense, these amounts were $10.7 million for the third quarter of 2019 compared to $7.1 million for the third quarter of 2018. R&D and SG&A expenses for the first nine months of 2019 totaled $35.8 million compared to $23.6 million in the first nine months of 2018. Excluding stock-based compensation expense, these figures were $32.3 million for the first nine months of 2019 compared to $19.9 million for the first nine months of 2018. The increase in R&D and SG&A expenses is primarily due to increased personnel-related expenses for the commercial launch of DSUVIA. See the "Reconciliation of Non-GAAP Financial Measures" table below for a reconciliation of the non-GAAP operating expenses described above to their related GAAP measures;
Net cash outflow for the third quarter of 2019 was $11.1 million, which included $0.6 million in debt service;
For the third quarter of 2019, net loss was $12.7 million, or $0.16 per basic and diluted share, compared to $12.5 million, or $0.21 per basic and diluted share, for the third quarter of 2018. Net loss for the first nine months of 2019 was $38.8 million, or $0.49 per basic and diluted share, compared to $34.6 million, or $0.64 per basic and diluted share, for the prior year period.
Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast Wednesday, November 6, 2019 at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of the Company’s website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the Company’s website at www.acelrx.com.

About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners.