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SCYNEXIS Reports First Quarter 2019 Financial Results and Provides Company Update

On May 8, 2019 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended March 31, 2019, and provided an update on recent clinical developments (Press release, Scynexis, MAY 8, 2019, View Source [SID1234535964]).

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"We are encouraged by the positive interim results and patient cases from our ongoing studies evaluating oral ibrexafungerp in severe and difficult-to-treat fungal infections," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We also continue to advance oral ibrexafungerp in our ongoing Phase 3 VANISH study in patients with VVC, with the goal of sharing top-line data in the first half of 2020. In parallel, with the positive results seen in our complete reproductive and developmental toxicology package, we are moving closer to a potential New Drug Application (NDA) submission for VVC in the second half of 2020."

Ibrexafungerp (formerly SCY-078), the first representative of a novel family of compounds referred to as triterpenoids, is being developed for oral and intravenous administration and is in clinical development for the treatment of several serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp would be the only oral alternative to azoles for the treatment of VVC and prevention of recurrent VVC.

Ibrexafungerp Update

Data presented at the 2019 American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting (ACOG) support a future NDA submission of oral ibrexafungerp for the treatment of VVC and highlight potential differentiation versus VVC standard-of-care.
Pre-clinical studies, conducted as part of a full reproductive and developmental toxicity package, showed that ibrexafungerp did not cause reproductive harm to adult animals or developmental harm to offspring. These findings are extremely meaningful for women with VVC, often of child-bearing age, and can differentiate oral ibrexafungerp against fluconazole, which has a warning for potential risks of spontaneous abortion and congenital abnormalities in its prescribing information.
Additional data presented further support the utility of ibrexafungerp as a treatment for VVC, including clinical results from a prior Phase 2b dose-finding study of oral ibrexafungerp in patients with VVC and preclinical data demonstrating in vitro activity against fluconazole-resistant Candida spp.
All ACOG 2019 posters and presentations can be found on the SCYNEXIS website.

SCYNEXIS is currently enrolling patients in the VANISH Phase 3 registration program evaluating the safety and efficacy of oral ibrexafungerp in patients with acute VVC and is on track to initiate a planned Phase 3 trial for the prevention of recurrent VVC (the CANDLE study) in the second quarter of 2019.

New data from six presentations at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) shows favorable clinical activity in difficult-to-treat fungal infections, including Candida auris.
An oral presentation showcased results from the first interim analysis of 20 patients with various Candida infections from the FURI study, an open-label trial of oral ibrexafungerp in patients with refractory fungal infections. Oral ibrexafungerp demonstrated a clinical benefit in 17 of the 20 patients, with 11 patients achieving a complete or partial response and six patients achieving a stable disease response. Enrollment in the study continues to progress in the U.S. and Europe.
A poster presentation highlighted clinical findings for two patients with Candida auris candidemia enrolled in the CARES study, who were successfully treated with oral ibrexafungerp. Candida auris is a pathogen defined by the Centers for Disease Control and Prevention (CDC) as "an emerging fungus that presents a serious global health threat."
Preliminary results from the FURI and CARES studies build toward a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
All ECCMID 2019 posters and presentations can be found on the SCYNEXIS website.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $39.1 million as of March 31, 2019, with net working capital of $35.4 million.

Research and development expenses increased to $9.7 million for the quarter ended March 31, 2019, compared to $5.3 million in the first quarter of 2018. The increase of $4.4 million, or 82%, was primarily driven by a milestone payment made during the quarter upon initiation of the Phase 3 VVC registration study, an increase of $1.1 million in clinical development, and a net increase of $0.5 million in other research and development expenses, offset in part by a decrease of $0.5 million in chemistry, manufacturing, and controls (CMC) and a decrease of $0.7 million in preclinical development expense.

Selling, general and administrative expenses in the first quarter of 2019 increased to $2.2 million, compared with $2.0 million in the first quarter of 2018.

Total other expense was $11.0 million in the first quarter of 2019, compared to total other income of $3.2 million in the first quarter of 2018. The increase in other expense is attributable to the non-cash losses recognized during the first quarter of 2019 of $6.5 million and $3.4 million associated with the fair value adjustments for warrant liabilities and derivative liability, respectively. Additionally, during the first quarter of 2019, we recognized a loss on extinguishment of debt of $0.8 million.

Net loss for the first quarter of 2019 was $22.9 million, or $0.46 per share. This compares with a net loss for the first quarter of 2018 of $4.0 million, or $0.12 per share.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel family of compounds referred to as "fungerps" (antifungal triterpenoids). This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous formulations. Ibrexafungerp has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species, and is being evaluated in multiple clinical programs: the VANISH registration program for the treatment of VVC is enrolling, the Phase 3 trial for the prevention of recurrent VVC is being initiated in the second quarter of 2019, the SCYNERGIA Phase 2 trial for invasive aspergillosis (IA) and the FURI and CARES Phase 3 trials for the treatment of patients with refractory infections are ongoing. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), IA and VVC, and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

Perrigo Company plc Reports First Quarter 2019 Financial Results, Begins Consumer Self-Care Transformation

On May 8, 2019 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the first quarter ended March 30, 2019 (Press release, Perrigo Company, MAY 8, 2019, View Source [SID1234535963]).

Perrigo CEO & President Murray S. Kessler commented, "Perrigo began its transformation from healthcare to consumer self-care during the first quarter of 2019, as the company made meaningful progress on portfolio reconfiguration, accelerating the innovation pipeline, pursuing close-in adjacencies, identifying significant cost savings and strengthening the organization’s talent, processes and performance plans. The leadership team and I are excited to share our Board-approved strategy and the significant progress made during the quarter against that strategy at tomorrow’s Investor Conference. Beyond the company-wide effort to initiate over 40 transformation activities, Perrigo delivered consolidated first quarter results that exceeded our internal target and included approximately $5 million in initial consumer transformation investments. It is also worth noting that our RX division was a significant contributor to this solid start to the year as a result of strong new product activity and continued moderation of pricing pressure in the generics sector."

Kessler continued, "While it will take several years and there is much work to do to fully execute the full consumer self-care transformation, I remain excited and confident in our ability to recapture ‘The Perrigo Advantage’ and bring the Company back to profitable and sustainable growth, as well as reduce the uncertainty that has arisen from the Irish and U.S. tax challenges. The Company will provide 2019 guidance tomorrow morning, before the U.S. market opens, as well as its plans to deliver long-term financial results in-line with our consumer peers."

Reporting Segments Update

The Company updated its reporting segments to align with its self-care strategy. Our Israeli diagnostic business was moved from the Consumer Self-Care International ("CSCI") segment to the RX segment and certain adjustments were made to the Company’s allocations between segments. These updates have no impact on the Company’s historical consolidated financial position, results of operations, or cash flows. A Current Report on Form 8-K containing recast quarterly and annual information for calendar years 2018, 2017, and 2016 for this update will be issued tonight.

Refer to Tables I – IV at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Reported net sales for the first quarter of calendar year 2019 were approximately $1.2 billion, including new product sales of $55 million, which were partially offset by less favorable price/volume mix and discontinued products of $23 million. Net sales were down 1% excluding a $36 million negative impact from currency.

Reported net income was $64 million, or $0.47 per diluted share, versus $81 million, or $0.57 per diluted share, in the prior year. Excluding certain charges as outlined in Table I, first quarter 2019 adjusted net income was $146 million, or $1.07 per diluted share including a discrete tax benefit of $0.06 per share, versus $178 million, or $1.26 per diluted share, for the same period last year.

Consumer Self-Care Americas reported net sales were $582 million, or 3.3% lower than the prior year, driven by lower net sales in: 1) the cough and cold and analgesics categories, due to a less severe cough and cold season versus last year, 2) the infant nutrition category, due primarily to lower net sales from the exited infant foods product line (see the "Infant Foods Product line Exit" section below for details) and 3) the animal health business, due primarily to the previously announced loss of a partnered product. Discontinued products in the quarter were $11 million, of which $5 million were related to the animal health business.

Increased net sales in the gastrointestinal category, driven by strong omeprazole volumes compared to the prior year, and new product sales of $7 million partially offset the net sales decline in CSCA. Excluding net sales from the animal health and exited infant foods product line, along with unfavorable currency movements compared to the prior year, CSCA net sales were down 1.5%.

Total sales volume within the CSCA business decreased 1% in the first quarter versus the prior year as higher volumes in the gastrointestinal and allergy categories were more than offset by lower volumes in the cough and cold and analgesics categories.

Based on the most recent 52-weeks MULO data, total OTC retail market dollars grew 0.5% versus the same 52-weeks a year ago, highlighting a more limited new product launch cycle in the U.S. OTC market. Private label grew 1.4% versus national brand growth of 0.1%, according to the most recent 52-weeks MULO data. Growth in private label was driven primarily by the gastrointestinal, allergy and dermatological categories.

First quarter reported gross profit margin was 31.6%. Adjusted gross profit margin was 32.5% or 350 bps lower than the prior year due primarily to less favorable mix, greater operating inefficiencies and higher input costs versus last year.

Reported operating expenses were relatively flat year over year. Reported distribution, selling, general and administrative ("DSG&A") expenses were relatively flat compared to the prior year as greater advertising and promotional expenses versus last year were partially offset by lower distribution costs. R&D dollar investments were similar to the prior year as the Company continued to invest for future growth.

Reported operating margin was 16.2%. Adjusted operating margin was 18.3%, 400 bps lower than the prior year due primarily to adjusted gross margin flow through.

CSCI reported net sales were $351 million, 1.7% higher than the prior year, excluding unfavorable currency movement of $34 million. This segment continued to realize the benefits of the previously discussed portfolio pruning, leaving the core business primed for growth.

Strong new product sales of $26 million were driven primarily by the launch of XLS Forte 5, a next generation weight loss product within the lifestyle category, along with the launch of a natural cough syrup under the Phytosun brand. Additionally, net sales increased in the dermatological category, driven by the recent launch of the Pure Glow range of products under the ACO brand.

These positive drivers were partially offset by lower net sales in the lifestyle and personal care categories, due primarily to new product cannibalization, and the absence of net sales from discontinued products of $2 million.

According to IRI/InQvia (IMS) data, the markets in which the Company competes have produced low to mid-single-digit growth over the last 12 months, with CSCI maintaining its overall market share.

Reported and adjusted gross margin decreased 120 bps and 130 bps respectively, compared to the prior year due primarily to less favorable product mix and the unfavorable impact of foreign currency on input costs versus last year.

Reported operating expenses were lower compared to the prior year due primarily to the positive impact of foreign currency. CSCI growth investments increased on a constant currency basis versus last year as the Company continued to invest for future growth.

Reported operating margin was 2.3%. Adjusted operating margin decreased 190 bps to 15.4% due to gross margin flow through as well as increased advertising and promotion investments as a percentage of net sales partially offset by lower selling expenses versus last year.

RX reported net sales were $242 million in the quarter, or 1.8% higher than the prior year, due primarily to new product sales of $22 million and improved customer service levels. These positives were partially offset by decelerating pricing pressure in core products and discontinued products of $10 million.

Reported gross margin was 39.9%. Adjusted gross margin was 48.6%, or 260 bps lower than the prior year, due primarily to less favorable product mix versus last year.

Reported operating margin was 25.1%. Adjusted operating margin was 33.9%, or 190 bps lower than the prior year due primarily to adjusted gross margin flow through and increased R&D investments, which were partially offset by lower DSG&A expenses versus last year.

Infant Foods Product Line Exit

In 2018, the Company made the decision to exit its infant foods product line, which contributed $34 million to CSCA’s net sales in 2018. The infant foods product line contributed $5 million in net sales during the first quarter of 2019, and the Company does not expect any further contributions from this product line going forward.

Investor Day Event

The Company will hold its Investor Day tomorrow, May 9, 2019, in New York City to discuss its strategy as well as 2019 guidance and key growth opportunities. The event will feature presentations from Murray S. Kessler, CEO and President, and other members of the Company’s leadership team.

The event is scheduled to begin at 8:00 AM EST and will be webcast live. All interested parties are invited to access the event at View Source

Prometic reports its 2019 first quarter financial results

On May 8, 2019 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic" or the "Corporation") reported its unaudited financial results for the first quarter ended March 31, 2019 (Press release, ProMetic Life Sciences, MAY 8, 2019, View Source [SID1234535962]).

"We are pleased to have completed the recapitalization transactions and equity offering in April that have provided both an improved capital structure and necessary cash liquidity from the $ 75 million gross proceeds received from Structured Alpha LP and Consonance Capital Management", stated Mr. Kenneth Galbraith, Chief Executive Officer. "In addition, the Corporation expects to commence the previously-announced rights offering in the coming weeks, which could provide up to a maximum of $75 million in additional gross proceeds to the Corporation".

"We made excellent progress during the quarter towards completing the necessary development work to permit re-filing of our Ryplazim (plasminogen) ("RyplazimTM ") BLA before the end of 2019. In addition, our bioseparations business had an excellent quarter with revenue growth of 55% compared to the same quarter in 2018."

"We look forward to reporting further progress on our business and R&D activities in the coming months and appreciate the continued support of our shareholders in helping to build a successful and focused global life sciences corporation, with the potential to address unmet medical needs of patients with serious diseases in multiple therapeutic areas of interest", added Mr. Galbraith.

2019 First Quarter Results

Revenues

Total revenues for the quarter ended March 31, 2019 were $8.2 million compared to $4.3 million during the comparative period of 2018 which represents an increase of $3.9 million.

Revenues from the sale of goods were $7.8 million during the quarter ended March 31, 2019 compared to $3.8 million during the corresponding period of 2018, representing an increase of $4.0 million which was due to an increase in the sales of our specialty plasma collected at our plasma collection center in Winnipeg by $1.9 million and the increase of the volume of sales of goods from our Bioseparations segment by $2.1 million compared to the comparative period in 2018.

Cost of sales and other production expenses
Cost of sales and other production expenses were $4.4 million during the quarter ended March 31, 2019 compared to $4.8 million for the corresponding period in 2018, representing a decrease of $0.4 million.

Research and Development ("R&D")
R&D expenses were $19.2 million during the quarter ended March 31, 2019 compared to $22.4 million for the corresponding period in 2018, representing a decrease of $3.2 million.

R&D expenses include the cost to manufacture plasma-derived therapeutics and small molecule therapeutics to be used in clinical trials and for the development of our production processes. The manufacturing and purchase cost of these therapeutics was $9.2 million during the quarter ended March 31, 2019 compared to $7.0 million during the quarter ended March 31, 2018, an increase of $2.2 million.

Other R&D expenses were $10.0 million during the quarter ended March 31, 2019 compared to $15.4 million for the corresponding period in 2018, a decrease of $5.5 million. The decrease is mainly due to the reduction in pre-clinical and clinical trial activity in both the plasma-derived therapeutics and small molecule segments.

Administration, Sales & Marketing
Administration, selling and marketing expenses remained stable at $7.6 million during the quarter ended March 31, 2019 compared to $7.7 million for the corresponding period in 2018 with consulting fees slightly declined offset by employee compensation expense increased.

Finance Costs
Finance costs were $7.4 million for the quarter ended March 31, 2019 compared to $4.2 million during the corresponding period of 2018, representing an increase of $3.1 million. This increase reflects the increased level of debt at higher effective interest rates applied during the quarter ended March 31, 2019 compared to the same period of 2018.

Furthermore, the increase in finance costs are also due to the adoption of the new lease standard, IFRS 16, Leases ("IFRS 16"), under which lease liabilities are recognized for the discounted value of the future lease payments at initial adoption and with interest expense recognized over the term of each lease. The new standard was adopted using the modified retrospective approach and as such, the 2018 figures are not restated. Previously, the embedded interest component in each lease payment was recognized as part of the lease expense included in the various functions presented in the statement of operations such as cost of sales and other production expenses, R&D and administration, selling and marketing. The interest expense over the lease liabilities was $1.8 million in the quarter ended March 31, 2019.

Net Loss
The Corporation incurred a net loss of $28.8 million during the quarter ended March 31, 2019 compared to a net loss of $34.6 million for the corresponding period of 2018, representing a decrease in the net loss of $5.8 million. This is mainly driven by the increase in revenue from sales of goods of $4.0 million, the decrease in R&D of $3.2 million and the increase in the gain of foreign exchange of $2.9 million which is due to a lower USD/CAD exchange rate over the comparative period. This was partially offset by the increase in finance costs expense of $3.1 million in the quarter ended March 31, 2019 compared to the corresponding period in 2018.

Commenting on the 2019 first quarter financial results, Bruce Pritchard, Prometic’s Chief Operating Officer – International and Chief Financial Officer, stated, "Our focus on cost control continues with an improvement in all areas, with the exception of finance costs, over the same quarter of 2018. Clearly, finance costs increased as a result of the increased borrowing required to finance the Corporation in the absence of substantial new equity or business development deals since the first quarter of 2018."

Small Molecule Therapeutics Segment

Q1 2019 Updates:

Following the completion of the review and prioritization of all programs and assets, and completion of refinancing transactions, the main priorities for the small molecule therapeutics segment are:

PBI-4050 – Prometic is planning to file an Investigational New Drug application to enable the commencement of the phase 3 clinical study of PBI-4050 in Alström Syndrome during H2-2019.
PBI-4050 – Prometic is planning a randomized, placebo-controlled phase 2 clinical study of PBI-4050 in patients with Nonalcoholic steatohepatitis ("NASH") to be initiated later in the year, subject to receipt of further financing.
PBI-4050 – Prometic is planning a randomized, placebo-controlled, phase 2 clinical study of PBI-4050 in patients with idiopathic pulmonary fibrosis ("IPF") to be initiated later in the year, subject to receipt of further financing
PBI-4547 – Prometic is planning a phase 1 clinical study to be initiated before the end of 2019.
Plasma-Derived Therapeutics Segment

Q1 2019 Updates:

Following the completion of the review and prioritization of all programs and assets, and completion of refinancing transactions, the main priorities for the plasma-derived therapeutics segment are

RyplazimTM – Refile the BLA for Ryplazim during H2-2019.
RyplazimTM – Conclude ongoing commercialization discussions and secure a strategic transaction with a third party partner for the commercialization of RyplazimTM for global markets.
Corporate and Operational Update

Q1 2019 Updates:

Management and the Board of Directors engaged in a comprehensive strategy to improve the financial and business conditions of the Corporation and, in January 2019, commenced a process to explore and evaluate potential strategic alternatives focused on maximizing shareholder value, including potential acquisitions, joint ventures, strategic alliances, or other merger and acquisition or capital markets transactions as well as any other transaction or alternative available to the Corporation.
In February 2019, the Corporation engaged Lazard, a global financial advisory and asset management firm, to review and execute key strategic transactions focused on maximizing shareholder value. The Corporation has not set a timetable for this process, and there can be no assurance that a transaction will be entered into or consummated, or, if a transaction is undertaken, as to its terms, structure or timing.
In conjunction with the strategic review and liquidity issues faced by the Corporation, in February 2019, the Board of Directors formed a special committee of independent board directors to oversee the strategic review process.
In February and March 2019, the Corporation secured two additional tranches for a total of US$15.0 million from SALP under its existing credit facility with SALP.
During the first quarter of 2019, the Corporation issued 12,870,600 common shares under the ATM for total net cash proceeds of $4.1 million.
Subsequent Events to Q1 2019:

The Corporation announced its intention to enter into a series of related arrangements to restructure Prometic’s outstanding indebtedness, reduce its interest and certain other payment obligations, and raise sufficient cash to build a robust balance sheet for the next phase of Prometic’s development.
The Corporation closed the recapitalization transactions and equity offering previously announced on April 15, 2019. Prometic received $75 million (approximately US$56 million) in gross proceeds from the equity offering led by Consonance Capital Partners and SALP and converted into equity substantially all of its indebtedness to SALP.
The Corporation announced Mr. Kenneth Galbraith as its CEO as well as the appointment of new Board leadership and structure in selecting Mr. Stefan Clulow as Chair of the Board and Prof. Simon Best as Lead Independent Director.
The Corporation implemented a new management structure to provide leadership to the Corporation and announced the appointment of Dr. Gary Bridger, Mr. Tim Wach and Mr. Neil Klompas to the Board of Directors.
Conference Call Information

Prometic will host a conference call at 8:30 am (ET) on Thursday May 9, 2019. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available as of Thursday May 9, 2019 at 11:00 am. The numbers to access the replay are 1-416-849-0833 and 1-855-859-2056 (passcode: 8892627). A live audio webcast of the conference call, with slides, will be available through the following : View Source

Additional Information in Respect to the First Quarter Ended March 31, 2019

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended March 31, 2019 will be filed on SEDAR (View Source) and will be available on the Corporation’s website at www.prometic.com.

Titan Pharmaceuticals To Release First Quarter 2019 Financial Results On May 15 – Conference Call To Follow

On May 8, 2019 Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) reported that it will announce its first quarter 2019 financial results after market close on Wednesday, May 15, 2019 (Press release, Titan Pharmaceuticals, MAY 8, 2019, View Source;conference-call-to-follow-300846864.html [SID1234535961]). Following the release, Titan management will host a conference call at 4:30 p.m. EDT / 1:30 p.m. PDT to review the financial results and discuss business developments in the period.

The conference call will be hosted by Sunil Bhonsle, President and CEO; Kate Beebe DeVarney, Ph.D., Executive Vice President and Chief Scientific Officer; Dane Hallberg, Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman.

The live conference call may be accessed by dialing 1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and providing passcode 1059834. The call will also be broadcast live and archived on Titan’s website at www.titanpharm.com/news/events.

Audentes Therapeutics to Participate in the Bank of America Merrill Lynch 2019 Health Care Conference

On May 8, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, reported that it will participate in the Bank of America Merrill Lynch Health Care Conference, taking place May 15-17 in Las Vegas, NV (Press release, Audentes Therapeutics, MAY 8, 2019, View Source [SID1234535959]).

Matthew R. Patterson, Chairman and Chief Executive Officer, will participate in the following events during the conference:

Fireside Chat
Wednesday, May 15, 2019, at 3:40 pm PDT

Panel Discussion: Gene Therapy Landscape
Wednesday, May 15, 2019, at 4:20 pm PDT

To access a live webcast of the fireside chat, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. A replay of the live webcast will be available on the Audentes website for approximately 30 days following the conference.