On May 10, 2018 Geron Corporation (Nasdaq:GERN) reported financial results for the first quarter ended March 31, 2018 (Press release, Geron, MAY 10, 2018, View Source [SID1234526544]).

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First Quarter 2018 Results

For the first quarter of 2018, the company reported operating revenues of $318,000 and operating expenses of $7.8 million compared to $537,000 and $8.0 million, respectively, for the comparable 2017 period. Net loss for the first quarter of 2018 was $7.2 million, or $0.04 per share, compared to $7.2 million, or $0.05 per share, for the comparable 2017 period.

Revenues for the first quarter of 2018 and 2017 included royalty and license fee revenues under various non-imetelstat license agreements. The company adopted the new revenue recognition accounting standard as of January 1, 2018 using the modified retrospective transition method. Financial results for the first quarter of 2018 are presented under the new accounting standard, but prior period amounts have not been adjusted and continue to be reported under accounting standards used historically. Therefore, there is a lack of comparability to the prior period presented. As a result, the decrease in revenues for the first quarter of 2018 compared to the same period in 2017 reflects not only a reduction in the number of active non-imetelstat license agreements and decreased product sales from licensees, but also a change in the method accounting. However, the company does not expect the adoption of the new revenue recognition accounting standard to have a material impact to its financial statements on an ongoing basis.

Research and development expenses for the three months ended March 31, 2018 and 2017 were $2.4 million and $3.4 million, respectively. The decrease in research and development expenses for the first quarter of 2018 compared to the same period in 2017 primarily reflects reduced personnel related expenses due to lower stock-based compensation expense and lower clinical development expenses under the imetelstat collaboration with Janssen Biotech, Inc. (Janssen).

General and administrative expenses for the three months ended March 31, 2018 and 2017 were $5.3 million and $4.7 million, respectively. The increase in general and administrative expenses for the first quarter of 2018 compared to the same period in 2017 primarily reflects higher consulting and legal costs associated with business development activities.

Interest and other income for the three months ended March 31, 2018 and 2017 was $394,000 and $332,000, respectively. The increase in interest and other income for the first quarter of 2018 compared to the same period in 2017 primarily reflects higher yields on the company’s marketable securities portfolio. For the three months ended March 31, 2018, the company also recognized a loss of $125,000 for the change in the fair value of an equity investment as required under a new accounting standard adopted by the company as of January 1, 2018.

The company ended the first quarter of 2018 with $103.2 million in cash and marketable securities. Subsequently, in April 2018, the company completed the sale of the remaining common stock subject to its At Market Issuance Sales Agreement (Sales Agreement). Under the Sales Agreement, the company sold a cumulative total of approximately 13.8 million shares of common stock and raised net cash proceeds of approximately $48.7 million after deducting sales commissions and offering expenses payable by Geron. No further shares of common stock can be issued under the Sales Agreement. The company expects the net cash proceeds to provide additional capital structure flexibility to potentially support (i) the future development of imetelstat in collaboration with Janssen, if Janssen elects to continue the collaboration, including potentially conducting one or more imetelstat independent development plans (IDPs) under the Collaboration Agreement; (ii) the further development of imetelstat by Geron in the event the collaboration with Janssen does not continue and Geron elects to continue development of imetelstat; or (iii) prospective in-licenses or acquisitions of other oncology products, programs or companies.

"As we have previously announced, we expect Janssen to make its decision about whether to continue their development of imetelstat by the end of third quarter of 2018," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "Regardless of Janssen’s future decision, we believe imetelstat warrants further development because of the activity observed in lower risk MDS patients from Part 1 of IMerge as presented at ASH (Free ASH Whitepaper) last December, and the evolving overall survival in relapsed or refractory MF patients observed in IMbark."

Annual Meeting of Stockholders

Geron’s Annual Meeting of Stockholders will be held at 4:00 p.m. PDT / 7:00 p.m. EDT on May 15, 2018. Further information about the Annual Meeting is available on Geron’s website at www.geron.com on the homepage and in the Investors section under Events.

Due to the proximity of the Annual Meeting, Geron management will not be hosting a separate first quarter conference call

On May 10, 2018 Medtronic plc (NYSE: MDT) reported that it will report financial results for its fourth quarter and fiscal year 2018 on Thursday, May 24, 2018. A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at View Source (Press release, Medtronic, MAY 10, 2018, View Source/phoenix.zhtml?c=251324&p=RssLanding&cat=news&id=2348600 [SID1234526512]). The news release will include summary financial information for the company’s fourth quarter and fiscal year 2018, which ended on Friday, April 27, 2018.

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Medtronic will host a webcast at 7:00 a.m. CDT to discuss financial results for its fourth quarter and full fiscal year 2018. The webcast can be accessed at View Source on May 24, 2018.

Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source.

Looking ahead, Medtronic plans to report its fiscal year 2019 first, second and third quarter financial results on Tuesday, August 21, 2018, Tuesday, November 20, 2018, and Tuesday, February 19, 2019, respectively. Medtronic also plans on hosting its biennial Institutional Investor & Analyst Day on Tuesday, June 5, 2018. Confirmation and additional details will be provided closer to the specific event.

On May 10, 2018 Juniper Pharmaceuticals (Nasdaq: JNP), a diversified healthcare company with core businesses of its CRINONE (progesterone gel) franchise and fee-for-service pharmaceutical development and manufacturing business, JPS, reported financial results for the three-month period ended March 31, 2018 (Press release, Juniper Pharmaceuticals, MAY 10, 2018, View Source [SID1234526504]). Cash and equivalents were $20.7 million at March 31, 2018 compared to $21.4 million at December 31, 2017.

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"We made tremendous progress thus far this year having achieved two important strategic priorities for 2018 aimed at building shareholder value, while also driving strong growth momentum in our core businesses," said Alicia Secor, Chief Executive Officer. "At the beginning of the year, we successfully secured an extension of our supply agreement for CRINONE, and we expect to realize continued long-term growth in this important core business."

Ms. Secor added, "More recently, we executed on our goal of finding a partner for the development and commercialization of our intravaginal ring (IVR) technology. Our agreement with Daré Bioscience provides for significant milestone payments for each IVR candidate and royalties on any future sales. Our engagement with Rothschild to pursue strategic alternatives is progressing, and in parallel we remain very focused on the growth of our core businesses, JPS and CRINONE, which are on track to deliver continued double-digit growth for 2018."

First Quarter and Recent Corporate Highlights

Announced a 4.5-year extension through 2024 of the CRINONE supply agreement with Merck KGaA, Darmstadt, Germany.
Successfully secured an exclusive, worldwide license agreement with Daré Bioscience for the development and commercialization of the Company’s IVR technology platform, including its three preclinical IVR candidates targeting unmet needs in women’s health. Under the agreement, Daré Bioscience will be responsible for conducting all research, development and commercial activities for this program.
Rothschild continues to act as an independent financial advisor to assist the Company in the exploration of additional strategic alternatives as part of the ongoing effort to enhance shareholder value.
Appointed Richard Messina to the Company’s Board of Directors. Mr. Messina brings to the Board the perspective of a long-term shareholder.
First Quarter Financial Results

"Growth in our core businesses has continued into 2018 with CRINONE product revenues up 30% and revenues from JPS up 55% for the quarter ended March 31, 2018 versus the same quarter in 2017," said Jeff Young, Chief Financial Officer at Juniper. "We remain in a solid financial position, expect to continue to deliver double-digit growth in our core businesses, and to be cash flow positive for full year 2018."

First quarter total revenues increased 38% to $15.5 million, compared with $11.2 million for the quarter ended March 31, 2017.

Product revenues were $10.1 million compared to $7.7 million in the first quarter of 2017, driven by continued in-market growth of CRINONE (progesterone gel) by Merck KGaA, Darmstadt, Germany.

Service revenues from Juniper Pharma Services were $5.5 million, an increase of $1.9 million, versus the first quarter of last year, driven by new and existing customer growth.

Gross profit increased 39% to $6.5 million as compared to $4.7 million in the prior year quarter.

Total operating expenses were $5.5 million in the first quarter of 2018, a $0.7 million decrease as compared to the prior year quarter.

Juniper recorded net income of $0.8 million in the first quarter of 2018, or $0.06 per diluted share, compared to a net loss of $1.4 million, or $0.13 net loss per diluted share, in the same period of 2017.

Liquidity

Cash and cash equivalents were $20.7 million as of March 31, 2018 versus $21.4 million at December 31, 2017.

Conference Call

As previously announced, Juniper’s management will hold a conference call to discuss financial results for the first quarter ended March 31, 2018, as follows:

Date:

May 10, 2018

Time:

8:30 a.m. ET

Dial-in numbers:

Toll free: (866) 374-4635 (U.S.), (855) 669-9657 (Canada), or International: (412) 902-4218

Webcast (live and archive): www.juniperpharma.com, under "Investors" or click here.

The teleconference replay will be available approximately one hour after completion through Thursday, May 17, 2018, at (877) 344-7529 (U.S.), (855) 669-9658 (Canada) or (412) 317-0088 (International). The replay access code is 10119657.

The archived webcast will be available for one year via the aforementioned URLs.

On May 10, 2018 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the "Company") reported its financial results for the first quarter ended March 31, 2018 (Press release, Aurinia Pharmaceuticals, MAY 10, 2018, View Source [SID1234526503]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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"Our first quarter has been characterized by diligently executing our clinical programs. We remain on track to complete recruitment for our Phase III trial in lupus nephritis later this year and are pleased with the trial’s progress. Start-up activities are underway for our FSGS and Dry Eye programs, and we expect to commence these in June. We continue to be well-capitalized into 2020 and look forward to a productive 2018," said Richard Glickman, Aurinia CEO and Chairman of the Board.

2018 Highlights

Our Phase III clinical trial ("AURORA") to evaluate voclosporin for the treatment of lupus nephritis ("LN"), which we initiated in May of 2017, is on track to complete enrollment in Q4 2018. We have 212 clinical trial sites activated and able to enroll patients around the globe.
A Phase II proof-of-concept study in focal segmental glomerulosclerosis ("FSGS") is expected to initiate in June 2018. This will be an open-label study of 20 treatment naïve patients. We submitted our Investigational New Drug application ("IND") to the FDA in Q1 2018. We received agreement from the FDA with regards to the guidance we provided on this study, and the IND is now active.
We also expect to initiate a Phase IIa head-to-head tolerability study of voclosporin ophthalmic solution ("VOS") versus Restasis (cyclosporine ophthalmic emulsion 0.05%) for the treatment of Dry Eye Syndrome ("DES") in June 2018, with data expected to be available by the end of 2018. This will be a four-week study of approximately 90 patients. Upon productive meetings with the FDA, we re-activated our existing IND and are aligned to proceed. We believe calcineurin inhibitors ("CNIs") are a mainstay of treatment for DES, and the goal of this program is to develop a best-in-class treatment option, and upon completion, we will look to evaluate strategic alternatives for this asset.
We strengthened the breadth and scope of our Board of Directors with the additions of Dr. Michael Hayden and Joseph Hagan in February of 2018.
Financial Liquidity at March 31, 2018

At March 31, 2018, we had cash, cash equivalents and short term investments of $159.1 million and working capital of $156.7 million compared to $173.5 million of cash, cash equivalents and short term investments and $167.1 million of working capital at December 31, 2017. Net cash used in operating activities was $14.4 million for the first quarter ended March 31, 2018 compared to $9.7 million for the first quarter ended March 31, 2017.

We believe, based on our current plans, that we have sufficient financial resources to fund our existing LN program, including the AURORA trial and the NDA submission to the FDA, conduct the planned Phase II trials for FSGS and DES, and fund operations into 2020.

Financial Results for the First Quarter ended March 31, 2018

We reported a consolidated net loss of $15.5 million or $0.18 per common share for the first quarter ended March 31, 2018, as compared to a consolidated net loss of $51.9 million or $0.92 per common share for the first quarter ended March 31, 2017.

The loss for the first quarter ended March 31, 2018 reflected a $2.6 million increase in the estimated fair value of derivative warrant liabilities compared to an increase of $40.8 million in the estimated fair value of derivative warrant liabilities for the first quarter ended March 31, 2017. An increase in estimated fair value of derivative warrant liabilities increases the loss recorded for the period.

The increases in the estimated fair value of derivative warrant liabilities were primarily the result of increases in our share prices at March 31, 2018 and March 31, 2017 compared to December 31, 2017 and December 31, 2016 respectively.

The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the Company.

The net loss before these non-cash changes in estimated fair value of derivative warrant liabilities was $12.8 million for the first quarter ended March 31, 2018 compared to $11.2 million for the same period in 2017.

Research and development ("R&D") expenses increased to $8.9 million in the first quarter of 2018, compared to $7.3 million in the first quarter of 2017. The increase in these expenses resulted from higher clinical patient enrollment and treatment costs for our AURORA trial and costs associated with the planning and start-up phase for the FSGS and DES Phase II trials, and the LN continuation study. R&D expenses for the first quarter ended March 31, 2017 included costs related to the AURORA planning phase and completion costs for the Phase II AURA trial.

Corporate, administration and business development expense also increased to $3.8 million for the first quarter ended March 31,2018, compared to $3.4 million for the first quarter ended March 31, 2017, primarily reflecting increased personnel costs due to the expansion of our activities.

This press release should be read in conjunction with our unaudited interim condensed consolidated financial statements and the Management’s Discussion and Analysis for the first quarter ended March 31, 2018 which are accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

On May 10, 2018 Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) reported financial results and a business update for the first quarter ended March 31, 2018 (Press release, Adamis Pharmaceuticals, MAY 10, 2018, View Source [SID1234526502]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, said, "We have made a substantial amount of progress on several fronts since the beginning of the year. The development of our product pipeline continues to move forward and we have several target milestones that we hope to reach later this year. We believe the completion of these milestones will increase shareholder value. As for our progress on Symjepi , we continue to be pleased with developments regarding our discussions with potential commercialization partners. We believe that we are closer to concluding the process of naming our licensing partner and we remain focused on bringing this product to market."

Company Highlights and Product Updates

Some of the company’s product updates and accomplishments since the beginning of 2018 include the following:

Symjepi (epinephrine) Injection 0.15mg – The FDA determined that the company’s NDA for Symjepi (epinephrine) Injection 0.15mg was sufficiently complete to permit a substantive review and indicated that no potential review issues were identified as of the date of the agency’s communication in February. Approval is expected in the second half of this year.
Symjepi human factors data – Adamis presented human factors data for Symjepi at the American Academy of Allergy Asthma and Immunology joint congress with the World Allergy Organization, and another human factors study was published in the Annals of Allergy, Asthma and Immunology.
APC-1000 (Beclomethasone HFA) – Our product candidate received approval from the FDA to proceed with Phase 3 clinical studies. We continue to make progress in this area.
APC-6000 (Naloxone PFS) – We are working toward filing a New Drug Application (NDA) later this year and have completed pharmacokinetic (PK) studies.
Sales of several products sold by our U.S. Compounding, Inc. subsidiary have been increasing including Adamis’ unique compound to manage ulcers in horses. One horse that was receiving U.S. Compounding’s product recently came in first in the 2018 Kentucky Derby.
Second Quarter Financial Results

Revenues were approximately $3.2 million and $3.0 million for the three months ended March 31, 2018 and 2017, respectively. The increase in revenues (4.6%) for the three months ended March 31, 2018 compared to the comparable period of 2017 reflected an increase in the volume of sales of USC’s compounded pharmaceutical formulations resulting in part from increased sales and marketing personnel and efforts. The company’s revenues for the first quarter of 2018 increased approximately 11.9% compared to the revenues for the fourth quarter of 2017.

At March 31, 2018, the Company had cash and cash equivalents of $10.1 million. Net cash used in operating activities for the three months ended March 31, 2018 and 2017, was approximately $7.9 million and $3.5 million, respectively. Net cash used in operating activities increased primarily due to the increase in operating losses; increase in accounts receivable, inventories and prepaid expenses; and a decrease in accounts payable and accrued expenses as compared to 2017.

Selling, general and administrative expenses ("SG&A") for the three months ended March 31, 2018 and 2017 were approximately $6.5 million and $5.6 million, respectively. The increase in SG&A expenses was primarily due to new hires, compensation and stock option expenses, increases in accounting, audit and other professional fees, patent expenses, selling expenses and market research expenses related to Symjepi (epinephrine) and our APC-6000 product candidate.

Research and development expenses were approximately $2.2 million and $1.5 million for the three months ended March 31, 2018 and 2017, respectively. The increase in research and development expenses for the three months ended March 31, 2018, compared to the comparable period of the prior year was due in part to an increase in development costs of our product candidates and compensation and stock option expenses, in part due to new hires.

Net loss for the first quarter of 2018 was approximately $7.6 million, compared to net loss of approximately $5.8 million for the same period in 2017.

Future Milestones

Some of the company’s goals for the 2018 year include the following:

Finalizing and announcing the commercialization strategy for Symjepi (epinephrine) Injection 0.3mg;
FDA approval for Symjepi TM (epinephrine) Injection 0.15mg;
Initiate pivotal Phase 3 studies of APC-1000 in asthmatics;
Complete a "proof of concept" study with dry powder inhaler platform using fluticasone;
Filing an NDA for Naloxone injection;
Increase sales of compounded medications from our U.S. Compounding, Inc. subsidiary by at least 30%.