On August 9, 2018 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company historically focused on seeking to advance innovative medicines in urology and rheumatology, reported financial results for the second quarter and first half of 2018 and provided a corporate update on its near-term priorities (Press release, Apricus Biosciences, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363184 [SID1234528648]).

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On July 30, 2018, the Company announced the signing of a definitive agreement to merge with Seelos Therapeutics, Inc., a privately-held biotechnology company, in an all-stock transaction. The merged company will focus on the development and commercialization of central nervous system (CNS) therapeutics with known mechanisms of action in areas with a highly unmet medical need. Upon completion of the proposed merger, the name of the merged company will be Seelos Therapeutics, Inc., and the company is expected to begin trading on the Nasdaq Capital Market under the ticker symbol "SEEL." Upon closing of the transaction, Apricus shareholders of record are expected to own approximately 14% of the combined company based on an estimated $90 million valuation at closing, subject to certain adjustments set forth in the merger agreement. In addition, Apricus shareholders of record at closing will receive a Contingent Value Right (CVR) which will provide such holders 90% of any proceeds above $500,000 obtained by Seelos for the U.S. Vitaros rights.

"Throughout the second quarter of this year, we have been focused on a comprehensive review of strategic alternatives conducted through a structured process. On July 30, 2018 we announced that the Apricus Board of Directors has concluded that the proposed merger with Seelos was in the best interest of our shareholders, as it will provide an opportunity to create value from a diversified pipeline of late-stage clinical assets in areas of high unmet need," said Richard Pascoe, Chief Executive Officer. "We will continue to work with Seelos management in the coming months to complete the merger in the fourth quarter of 2018."

Second Quarter and 1H 2018 Financial Results

Net loss during the quarter ended June 30, 2018 was $2.3 million, or loss per share of $0.10, compared to a net loss of $1.5 million, or loss per share of $0.13, during the second quarter of 2017. Net loss during the first half of 2018 was $4.5 million, or loss per share of $0.23, compared to net income of $6.6 million, or earnings per share of $0.69, during the first half of 2017. Net income during the first half of 2017 was primarily due to the $11.8 million gain recorded upon the sale of our ex-U.S. Vitaros rights and assets to Ferring.

For all periods presented, financial statement activity related to our ex-U.S. Vitaros business has been presented as discontinued operations. As of June 30, 2018, the Company’s cash totaled $6.8 million, compared to $6.3 million as of December 31, 2017.

On August 9, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the second quarter ended June 30, 2018 (Press release, Perrigo Company, AUG 9, 2018, View Source [SID1234528664]).

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Additional first half of the year reported results: Reported CHC Americas net sales increased 0.9%. Reported operating margin in the CHC International segment was 2.6%. Reported operating margin in the RX segment was 28.1%.

Perrigo President and CEO, Uwe Roehrhoff commented, "For the first half of calendar year 2018, adjusted EPS performance met our operating goals, driven by the strength of our durable consumer businesses. During the same period, the RX business performed below our expectations and experienced weakness due primarily to a shortfall in new product launches coupled with challenging market dynamics, which is expected to carry forward into the second half of the year. This has resulted in changes to our 2018 operating plan, which are reflected in our updated guidance. I am extremely disappointed in this development and want to reinforce that my primary focus is to create value for shareholders."

Mr. Roehrhoff continued, "Our consumer businesses delivered durable results for the first half of the year. CHC Americas net sales grew approximately 1% on a constant currency basis, while our market-leading OTC and infant nutrition businesses grew approximately 2.5% combined, versus prior year. Adjusted operating margin in the CHC International segment improved to 16.1% for the first half of year, or a 190 basis point improvement compared to the prior year. First half net sales in the RX segment were lower than the prior year by 8% due to challenging market dynamics. Despite the delay in key new product launches in the RX segment, its adjusted operating margin for the first half of 2018 was approximately 40%. Finally, we utilized our strong balance sheet to repurchase approximately $265 million dollars of shares in the first half of 2018."

Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures 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.

Second Quarter Results

Reported net sales for the second quarter of calendar year 2018 were approximately $1.2 billion, which included new product sales of $42 million and the absence of sales from discontinued products of $17 million. Net sales decreased 4.0% compared to the prior year excluding the year-over-year effect of: 1) $7 million in net sales from the exited Russian and unprofitable distribution businesses in 2017 in the CHC International segment, 2) net sales from the divested Israel API business of $16 million and 3) favorable foreign currency movements of $19 million.

Reported net income was $36 million, or $0.26 per diluted share, versus net loss of $70 million, or $0.49 per diluted share, in the prior year. Excluding charges as outlined in Table I, second quarter 2018 adjusted net income was $169 million, or $1.22 per diluted share, versus adjusted net income of $175 million, or $1.22 per diluted share, for the same period last year.

Segment Results

Second quarter reported net sales decreased 1.2% on a constant currency basis due primarily to lower net sales in the animal health business compared to the prior year. Strong net sales in the cough/cold/allergy/sinus category and infant formula business, coupled with new product sales of $15 million, were partially offset by lower net sales in the smoking cessation category and discontinued products of $4 million.

CHC Americas second quarter reported gross profit margin was 32.7%. Adjusted gross profit margin was 34.5%, 120 basis points lower than the prior year due primarily to lower net sales the animal health business and higher input costs.

Reported second quarter operating margin was 9.6%. Second quarter adjusted operating margin was 20.4%, 60 basis points lower than the prior year as gross margin flow through was offset by proactive cost management efforts.

Reported net sales increased 1.2% compared to the second quarter of 2017. Excluding $7 million in net sales from the exited Russian and unprofitable distribution businesses in 2017, and favorable foreign currency movements of $20 million, net sales decreased 2.2% due primarily to lower sales in the anti-parasite, lifestyle and analgesics categories in addition to discontinued products of $8 million. Partially offsetting these effects were new product sales of $19 million and higher net sales in the diagnostics business.

Second quarter reported gross margin was 47.5%. Adjusted gross margin increased 160 basis points over the previous year to 53.3%, driven by improved product mix, new product launches and the continued benefit of insourcing initiatives.

Reported operating margin was 1.5%. Adjusted operating margin expanded 60 basis points to 15.2% due to higher gross margin contribution, partially offset by higher growth investments in the quarter compared to the prior year.

Reported net sales in the second quarter were $209 million compared to $240 million last year. New product sales of $8 million were more than offset by lower net sales of existing products of $35 million, due primarily to price erosion. Discontinued products were $5 million.

Reported gross margin was 45.3%. Adjusted gross margin was 55.1%, 370 basis points lower than the same quarter last year, due to strong product mix in 2017.

Reported operating margin was 27.3%. Adjusted operating margin was 39.4% compared to 46.5% in the prior year, due primarily to gross margin flow through and higher R&D investments as a percentage of net sales.

Guidance

The Company now expects calendar year 2018 reported operating income to be in the range of $548 million to $578 million, reported effective tax rate to be approximately 25.0%, and reported diluted EPS to be in the range of $2.11 to $2.31.

Primarily due to revised expectations for the RX segment and unfavorable foreign currency translation of $65 million, the Company now expects calendar year 2018 net sales to be in the range of $4.8 billion to $4.9 billion. The Company further expects adjusted operating income in the range of $960 million to $990 million, an adjusted effective tax rate of approximately 20.0% and an adjusted diluted EPS range of $4.75 to $4.95.

Conference Call

The Company will host a conference call at 8:30 a.m. EDT (5:30 a.m. PDT), August 9, 2018. The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 877-870-4263, International 412-317-0790, and reference ID #2297446. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EDT) Thursday, August 9, until midnight August 24, 2018. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10122783.

On August 9, 2018 Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, reported its operating and financial results for the second quarter ended June 30, 2018 (Press release, Dova Pharmaceuticals, AUG 9, 2018, View Source [SID1234528822]).

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"In the second quarter, we achieved our most significant milestone in Dova’s corporate history with the approval and launch of DOPTELET in the United States" said Alex C. Sapir, President and Chief Executive Officer of Dova. "We are pleased with the feedback we are hearing from physicians both in terms of how the drug is performing clinically, as well as the reimbursement support their patients are receiving through DOVA1SOURCE. This has translated to a high level of payer approval, as over 80% of referrals have been approved. In addition, we remain well-positioned financially, with approximately $135M in cash and equivalents to fund the operational success of the company for the foreseeable future."

DOPTLET Launch Highlights

·On May 21st, DOPTELET was approved by the U.S. Food and Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. DOPTELET was launched in the United States on June 4th.

·A total of 148 health care professionals have prescribed DOPTELET to their patients since launch with an increasing number using DOPTELET for multiple patients within their practice.

· For prescriptions that have completed the adjudication process with payers, the Company has seen greater than 80% of those prescriptions approved by the payer with an average approval time of 6.9 days.

·The Company has made significant progress in its outreach efforts to target prescribers having reached 62% of top hepatologists an average of 3.1 times since launch.

· Pivotal Phase 3 data for DOPTELET were published in Gastroenterology (View Source). The data were also highlighted at several key global scientific conferences including Digestive Disease Week (DDW) 2018, the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), and the 64th International Society on Thrombosis and Haemostasis (ISTH).

Other Important Highlights for the Quarter

·On April 27th, the Company submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for DOPTELET for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure. The EMA has granted a Standard Review Assessment with a targeted decision date of July 2019.

· A supplemental New Drug Application (sNDA) for the treatment of patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to a previous treatment remains on track for submission to the FDA in the third quarter of 2018.

· The Company has initiated a Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT).

· The Company repaid, in full, the secured promissory note that was issued to Eisai on March 31, 2016 of $31.1 million. The Company refinanced a portion of the note by entering into a Loan and Security Agreement with Silicon Valley Bank (SVB) for $20.0 million on April 17, 2018. The loan matures on April 17, 2021 unless a specified revenue milestone is achieved in which case the maturity date will be extended to April 17, 2022.

·Nancy J. Wysenski, an industry veteran with over 30 years of commercial and sales leadership, joined the Company’s Board of Directors. As the former Chief Commercial Officer at Vertex, she was responsible for launching Incivek, a treatment for hepatitis C, which is considered by many to be the most successful drug launch in U.S. history.

Dova will provide an update and additional details on DOPTELET’s launch activities during today’s call as well as at its upcoming Investor and Analyst Day scheduled for September 20, 2018 in New York City, New York. To RSVP for this event, please email John Woolford at [email protected].

Second Quarter and Financial Results

Dova reported a net loss of $20.0 million for the second quarter of 2018, compared to a net loss of $5.5 million for the same period in 2017.

For the second quarter of 2018, Dova reported net product sales from DOPTELET of $2.0 million. The Company recognizes revenue using the sell-in methodology when products are delivered to its specialty pharmacy partners. The majority of net sales recognized in the quarter were related to the initial stocking of DOPTELET at the specialty pharmacies. In addition, in March 2018, Dova entered into an exclusive distribution agreement with Shanghai Fosun Pharmaceutical Industrial

Development Co., Ltd., (Fosun Pharma Industrial). Dova received a $5.0 million upfront payment from Fosun Pharma Industrial of which $2.6 million was recognized as revenue during the second quarter of 2018. There were no product sales or other revenue in the second quarter of 2017.

Cost of product sales for the second quarter were $0.5 million, of which approximately $0.3 million consisted of a one-time stock-based compensation charge.

Research and development expenses were $4.5 million in the second quarter of 2018, compared to $3.3 million for the same period in 2017. The increase was primarily due to the initiation of Phase 3 clinical trials to evaluate DOPTELET for patients with thrombocytopenia undergoing surgery regardless of disease etiology and chemotherapy-induced thrombocytopenia.

Selling, general and administrative expenses were $18.6 million in the second quarter of 2018, compared to $1.9 million for the same period in 2017. The increase was primarily due to building Dova’s commercial infrastructure to support the launch of DOPTELET, increased corporate infrastructure, and additional costs associated with operating as a public company.

As of June 30, 2018, Dova had $134.7 million in cash and equivalents compared to $94.8 million as of December 31, 2017.

Company to Host Conference Call

Dova will host a conference call today, August 9, 2018 at 4:30 p.m. ET to discuss second quarter 2018 financial results and recent operational highlights. A question-and-answer session will follow Dova’s remarks.

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 9093837 five to 10 minutes before the start of the call.

A live audio webcast of the call will also be available via the "Investor Relations" page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS

Most common adverse reactions (> 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com

On August 9, 2018 JHL Biotech has reported it received a positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for its proposed bevacizumab biosimilar, JHL1149 to treat patients with non-small cell lung cancer (NSCLC) (Press release, JHL Biotech, AUG 9, 2018, View Source [SID1234528582]).

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The EMA, like other regulatory authorities such as the U.S. Food and Drug Administration and State Drug Administration of China (SDA), adopts the principle of a step-wise approach and the totality of the evidence from all studies in regulating the development and approval of biosimilars. In its correspondence to JHL, the EMA confirmed it agrees with JHL’s development approach, clinical development proposal, and study design of the global Phase III clinical study for JHL1149 in patients with non-small cell lung cancer (NSCLC). Based on the EMA’s review of these factors, the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully

On August 9, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported its financial results for the second quarter ended June 30, 2018 (Press release, Puma Biotechnology, AUG 9, 2018, View Source [SID1234528600]). Unless otherwise stated, all comparisons are for the second quarter 2018 compared to the second quarter 2017.

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On July 17, 2017, Puma Biotechnology received approval from the U.S. Food and Drug Administration (FDA) for NERLYNX (neratinib) for the treatment of early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and the Company began shipment to wholesalers at the end of July 2017. Prior to the launch of NERLYNX the Company had no product revenue. Net product revenue from sales of NERLYNX in the second quarter of 2018 amounted to $50.8 million, compared to net product revenue of $36.0 million and $20.1 million in the first quarter of 2018 and fourth quarter of 2017, respectively.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $44.3 million, or $1.17 per share, for the second quarter of 2018, compared to a net loss applicable to common stock of $77.8 million, or $2.10 per share, for the second quarter of 2017. Net loss applicable to common stock for the first six months of 2018 was $68.7 million, or $1.82 per share, compared to $150.7 million, or $4.08 per share, for the first six months of 2017.

Non-GAAP adjusted net loss was $22.2 million, or $0.59 per share, for the second quarter of 2018, compared to non-GAAP adjusted net loss of $50.9 million, or $1.38 per share, for the second quarter of 2017. Non-GAAP adjusted net loss for the first six months of 2018 was $21.2 million, or $0.56 per share, compared to non-GAAP adjusted net loss of $94.0 million, or $2.54 per share, for the first six months of 2017. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the second quarter of 2018 was $17.6 million. Net cash used in operating activities for the first six months of 2018 was $23.9 million. At June 30, 2018, Puma had cash and cash equivalents of $95.9 million and marketable securities of $38.6 million, compared to cash and cash equivalents of $81.7 million at December 31, 2017.

"In the second quarter of 2018, we saw strong commercial progress for Puma," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We continued to grow NERLYNX sales in the United States, with net sales of NERLYNX rising approximately 41% from the 2018 first quarter. We were also pleased that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for NERLYNX for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU)."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) in the third quarter of 2018, a decision by the European Commission (EC) regarding the Marketing Authorisation Application for neratinib; (ii) in the second half of 2018 or first half of 2019, reporting data from the Phase III NALA trial in third-line metastatic breast cancer patients; (iii) in the second half of 2018 and first half of 2019, submitting for regulatory approval of NERLYNX for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries; (iv) in the fourth quarter of 2018, reporting additional data from the Phase II CONTROL trial; and (v) in the fourth quarter of 2018 and first half of 2019, reporting additional data from the Phase II SUMMIT trial."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first and only commercial product to date, and license revenue. The FDA approved NERLYNX for commercial sale in the United States in July 2017 and Puma commenced shipment to wholesalers in late July. For the second quarter of 2018, total revenue was $50.8 million, all of which was net product revenue. For the first six months of 2018, total revenue was $117.3 million, of which $86.8 million was net product revenue and $30.5 million was license revenue received from Puma’s sub-licensees.

Operating Costs and Expenses

Operating costs and expenses were $92.2 million for the second quarter of 2018, compared to $78.2 million for the second quarter of 2017. Operating costs and expenses for the first six months of 2018 were $182.1 million, compared to $151.4 million for the first six months of 2017.

Cost of Sales:

Cost of sales was $8.8 million for the second quarter of 2018 and $15.2 million for the first six months of 2018. The Company had no product sales prior to the third quarter of 2017.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were $40.1 million for the second quarter of 2018, compared to $24.9 million for the second quarter of 2017. SG&A expenses for the first six months of 2018 were $76.7 million, compared to $43.3 million for the first six months of 2017. This approximately $33.4 million increase was attributable to an increase of approximately $8.5 million in external expenses, such as marketing, commercialization support and commercial strategy. Additionally, internal expenses increased approximately $22.0 million, primarily due to the hiring of a salesforce for the commercialization of NERLYNX in the United States. Finally, employee stock-based compensation increased approximately $2.9 million due to the hiring of the salesforce in conjunction with the NERLYNX commercial launch. Puma expects SG&A expenses in 2018 and into 2019 to remain higher than in 2017 as it launches NERLYNX commercially in the United States and other territories.

Research and Development Expenses:

Research and development (R&D) expenses were $43.3 million for the second quarter of 2018, compared to $53.3 million for the second quarter of 2017. R&D expenses for the first six months of 2018 were $90.2 million, compared to $108.1 million for the first six months of 2017. The $17.9 million year-to-date decrease resulted primarily from a decrease of approximately $12.1 million for stock-based compensation and a decrease of approximately $9.0 million for clinical trial expenses. This was partially offset by an increase of approximately $3.2 million in other expenses, such as additional personnel needed to support medical affairs and quality assurance. We expect R&D expenses in 2018 to continue to decline slightly when compared with R&D expenses in 2017 based on a decline in clinical trial activities as existing trials continue to wind down.