On August 8, 2018 Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, reported its financial results for the second quarter ended June 30, 2018 (Press release, Keryx Biopharmaceuticals, AUG 8, 2018, View Source [SID1234528540]). The company also reviewed its commercial progress with Auryxia and provided a general business update.

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"We are very pleased with the continued strong performance of Auryxia, which is a testament to the appreciation physicians have for the product profile and to the commitment and drive of our commercial and field-based teams," said Jodie Morrison, interim chief executive officer of Keryx Biopharmaceuticals. "On June 28th, we announced that Keryx had entered a definitive merger agreement with Akebia Therapeutics that will create a fully integrated company focused on the development and commercialization of therapeutics for patients with chronic kidney disease. We believe that the combined company will be well positioned to create significant shareholder value and accelerate growth beyond what either company would achieve separately."

Business Highlights

Net U.S. Auryxia product sales were $24.1 million in the second quarter of 2018, as compared to $14.1 million in the same quarter in 2017, representing growth of 71 percent.
Approximately 42,500 Auryxia prescriptions were reported in the second quarter of 2018, representing 8.4 million Auryxia tablets. This compares to approximately 21,100 prescriptions and 4.5 million Auryxia tablets in the second quarter of 2017.
The breadth and depth of physicians prescribing Auryxia continued to expand in the second quarter of 2018 compared to the same period in 2017, with approximately 50 percent more physicians writing Auryxia prescriptions and prescribers on average writing Auryxia for more of their patients.
On June 28, 2018, Keryx announced that it had entered a definitive merger agreement with Akebia Therapeutics, Inc. that is expected to close by the end of 2018, subject to shareholder approvals and customary closing conditions. If approved, Keryx shareholders would gain access to an innovative Phase 3 product candidate with the potential to compete in a complementary multi-billion-dollar market upon successful completion of its development program. Additionally, Keryx shareholders gain a seasoned executive with decades of experience in the renal field to lead the combined organization.
Second Quarter Ended June 30, 2018 Financial Results

"Revenue growth in the second quarter of 2018, as compared to the second quarter of 2017, was driven by significant increases in Auryxia prescription and tablet demand," said Scott Holmes, senior vice president and chief financial officer of Keryx Biopharmaceuticals. "Post the close of the second quarter we established an asset-based revolving credit facility with Silicon Valley Bank for up to $40 million. We believe this non-dilutive financing instrument will provide financial flexibility to our company as we continue to increase demand for Auryxia in both indications."

Total revenues for the quarter ended June 30, 2018 were $25.7 million, compared with $15.1 million during the same period in 2017. Total revenues for the second quarter of 2018 include $24.1 million in net U.S. Auryxia product sales, as compared to $14.1 million in the second quarter of 2017. Total revenues for the second quarter of 2018 also include $1.6 million in license revenue, as compared to $1.0 million during the same period in 2017.

Cost of goods sold for the quarter ended June 30, 2018 were $7.4 million, compared with $4.4 million during the same period in 2017.

Selling, general and administrative expenses for the quarter ended June 30, 2018 were $28.7 million, as compared to $25.0 million during the same period in 2017. Selling, general and administrative expenses for the quarter ended June 30, 2018 included $4.4 million in non-cash stock compensation expense, as compared to $3.2 million during the second quarter of 2017.

Research and development expenses for the quarter ended June 30, 2018 were $8.8 million, as compared to $9.0 million during the same period in 2017. Research and development expenses for the quarter ended June 30, 2018 included $0.6 million in non-cash stock compensation expense, as compared to $0.5 million during the same period in 2017.

Net loss for the quarter ended June 30, 2018 was $21.5 million, or $0.18 per share, as compared to a net loss of $86.5 million, or $0.77 per share, for the same period in 2017. Net loss for the quarter ended June 30, 2018 included $1.3 million in non-cash interest expense related to the amortization of a discount recognized in connection with the modification of the convertible senior notes. Net loss for the quarter ended June 30, 2017 included $63.0 million in non-cash charges related to the restructuring of our convertible debt.

Cash and cash equivalents as of June 30, 2018 totaled $49.5 million.

Conference Call Information
Keryx Biopharmaceuticals will host an investor conference call today, August 8, 2018, at 8:00 a.m. ET to discuss financial results for the second quarter of 2018. To participate in the conference call, please dial (888) 584-2172, (774) 264-7578 (international) and refer to conference ID: 9756999. The call will be webcast live with slides and accessible through the Investors section of the company’s website at www.keryx.com for a period of 15 days after the call.

About Auryxia (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration (FDA) on September 5, 2014 for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis and approved by the FDA on November 6, 2017 for the treatment of iron deficiency anemia in patients with chronic kidney disease not on dialysis. Auryxia tablets were designed to contain 210 mg of ferric iron, equivalent to 1 gram of ferric citrate, and offers convenient mealtime dosing. The starting dose of Auryxia for the treatment of hyperphosphatemia for patients on dialysis is six tablets per day (two per meal) and for the treatment of iron deficiency anemia in patients not on dialysis is three tablets per day (one per meal). For more information about Auryxia and the U.S. full prescribing information, please visit www.Auryxia.com.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate)

CONTRAINDICATION

AURYXIA (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.

WARNINGS AND PRECAUTIONS

Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.
ADVERSE REACTIONS

Most common adverse reactions with AURYXIA were:

Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)
Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%)
SPECIFIC POPULATIONS

Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.
To report suspected adverse reactions, contact Keryx Biopharmaceuticals at 1-844-445-3799.

Please click here to view the Full Prescribing Information for Auryxia.

On August 8, 2018 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported a business update and financial results for the second quarter ended June 30, 2018 (Press release, Leap Therapeutics, AUG 8, 2018, View Source [SID1234528560]).

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"Over the past few months, we have seen patients in the studies of both of our antibody programs experience clinical responses in combination with checkpoint inhibitors, including in patients who would not be expected to respond to checkpoint inhibitors alone. We look forward to continuing to read out data throughout the second half of 2018 from these ongoing clinical trials, including from our study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in October," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "In addition, we recently announced a TRX518 collaboration with Pfizer and EMD Serono to add to our existing DKN-01 collaborations with Merck and Roche."

Recent Highlights

Since the end of the first quarter, we have made substantial progress with the development of our product candidates:

· Presented clinical results from our study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer.

· Combination has been well tolerated with no dose limiting toxicity.

· In the high-dose DKN-01 cohort of dose escalation, two of four evaluable patients naïve to anti-PD-1/PD-L1 therapy have had a partial response, with two other evaluable patients having a best response of stable disease.

· Both of the responding patients have a tumor phenotype which is typically less responsive to anti-PD-1 therapy.

· Currently enrolling expansion cohorts in patients who are naïve to anti-PD-1/PD-L1 therapy and patients who are refractory to anti-PD-1/PD-L1 therapy.

· The treatment-naïve cohort has passed the Simon Stage 2 threshold.

· Enrollment of the full study is expected during the first quarter of 2019.

· Additional data from this study will be presented at the ESMO (Free ESMO Whitepaper) 2018 Annual Meeting in October.

· Announced a collaboration agreement with Pfizer and Merck KGaA, Darmstadt, Germany to evaluate TRX518 in combination with BAVENCIO (avelumab) and cyclophosphamide chemotherapy.

· Under the terms of the collaboration, we will be conducting a Phase I/II clinical trial in advanced solid tumors including expansion populations in patients with relapsed/refractory ovarian, breast, and prostate cancers.

· The study is expected to begin enrolling patients in the first quarter of 2019.

· Presented initial data from our clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab).

· The first two patients treated with the higher dose of TRX518 in combination with KEYTRUDA have experienced clinical benefit after the end of two cycles of therapy.

· Esophageal squamous cell carcinoma patient demonstrated a partial response with a 36% reduction in tumor volume.

· Ocular melanoma patient experienced stable disease with a 23% reduction in tumor volume.

· Seven patients have been treated with the lower dose of TRX518 in combination with OPDIVO.

· Urothelial carcinoma patient who had progressed while on KEYTRUDA has had a partial response with a 39% reduction in tumor volume after the end of two cycles.

· Four other patients experienced progressive disease, one patient was non-evaluable, and one patient has not yet had any on treatment disease evaluation.

·Enrollment continues in the dose escalation phase for both the KEYTRUDA and OPDIVO combinations and in the dose expansion phase for the gemcitabine combination.

Selected Second Quarter 2018 Financial Results

Net loss was $7.4 million for the second quarter of 2018, compared to $6.9 million for the same period in 2017.

Research and development expenses were $4.2 million for the second quarter 2018, compared to $4.9 million for same period in 2017. The decrease of $0.7 million was primarily due to a decrease of $0.4 million in manufacturing costs related to clinical trial material, a decrease of $0.2 million in clinical trial costs and a decrease of $0.2 million in consulting fees associated with research and development activities. These decreases were partially offset by an increase of $0.1 million in stock based compensation expense.

General and administrative expenses were $2.6 million for the second quarter 2018, compared to $2.1 million for the same period in 2017. The increase of $0.5 million in general and administrative expenses was primarily due to a $0.4 million increase in legal, audit and consulting fees associated with corporate and business development activities and an increase of $0.1 million of stock based compensation expense.

Cash, cash equivalents and marketable securities totaled $30.5 million at June 30, 2018. Research and development incentive receivables totaled $1.8 million. The Company believes that its current cash and cash equivalents and the anticipated receipt of the research and development incentive receivable will be sufficient to fund the Company’s operating expenses into the fourth quarter of 2019.

On August 7, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported financial results for the second quarter ended June 30, 2018, and provided an update on recent developments (Press release, Bellicum Pharmaceuticals, AUG 7, 2018, View Source [SID1234528497]).

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"We made substantial progress during the second quarter, with key data readouts expected later in 2018," said Bellicum’s President & CEO Rick Fair. "Registration studies with our polyclonal allogeneic cell therapy, BPX-501, are on track and we expect to file MAAs in the European Union in 2019. In anticipation of these filings, we have begun to staff a European organization and initiate pre-launch activities. In addition, based on the encouraging results to date in pediatric leukemias, we are advancing plans to expand the BPX-501 opportunity with a late-stage trial in adult AML patients."

Continued Mr. Fair: "The Phase 1 study of our lead GoCAR-T program, BPX-601, continues to enroll and we plan to report initial results before the end of 2018. We are also hard at work preparing IND/IMPD regulatory submissions for two new dual-switch GoCAR-T programs we expect to enter the clinic in 2019."

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

Registration Studies on Track in Europe with BPX-501
Prospective enrollment was completed in the BP-004 and C-004 pediatric trials in patients with leukemias, lymphomas, and inherited blood disorders. These trials will serve as the basis for the planned 2019 European MAA regulatory filings. During the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June, Bellicum reported compelling interim data from BP-004:

Additional interim results from both the BP-004 and the C-004 clinical trials will be presented at a medical conference later this year, with final results expected in early 2019. Bellicum also continues to advance its plans to initiate a late-stage trial of BPX-501 in adult AML patients by the end of the year.

Commercial Planning Activities Underway in Europe for BPX-501
Bellicum named Thierry Darcis, M.D., M.B.A., as General Manager of Europe to lead commercialization plans for BPX-501. Dr. Darcis has extensive experience launching orphan products in Europe and has led commercial teams that supported successful product introductions for ViroPharma and NPS Pharmaceuticals. He also held leadership roles with Zogenix, Novartis Vaccines and GlaxoSmithKline.

BPX-601 and BPX-701 Trials Advancing
BPX-601 is Bellicum’s first GoCAR-T product candidate and is the first controllable CAR-T cell to enter clinical trials. The Company expects to report preliminary findings from the Phase 1 dose-escalation safety study of BPX-601 in adults with nonresectable pancreatic cancer who test positive for prostate stem cell antigen (PSCA) later this year, and is currently implementing an amendment to expand the study to gastric and prostate cancer patients. A Phase 1 study of BPX-701 continues to screen patients, and additional clinical sites are being added to the trial to accelerate enrollment.

Second Quarter 2018 Financial Results

Bellicum reported a net loss of $24.2 million for the second quarter of 2018 and $47.0 million for the six months ended June 30, 2018, respectively, compared to a net loss of $24.5 million and $46.4 million for the comparable periods of 2017. The results included non-cash, share-based compensation charges of $3.6 million and $7.2 million for the second quarter and six months ended June 30, 2018, and $3.2 million and $6.6 million for the comparable periods in 2017.

As of June 30, 2018, cash, restricted cash and investments totaled $135.3 million. Based on current operating plans, Bellicum continues to expect that current cash resources will be sufficient to meet operating requirements through 2019.

Research and development expenses were $18.4 million and $34.9 million, for the three and six months ended June 30, 2018, respectively, compared to $18.0 million and $33.3 million during the comparable periods in 2017.

General and administrative expenses were $5.4 million and $11.1 million for the three and six months ended June 30, 2018, respectively, compared to $5.5 million and $11.4 million during the comparable periods in 2017.

At June 30, 2018, Bellicum had 43,346,220 shares of common stock outstanding.

Conference Call and Webcast
Bellicum management will host a webcast and conference call at 5:00 p.m. Eastern today to discuss the financial results and provide a corporate update. To access the call, participants should dial 877-407-3103 (domestic) and 201-493-6791 (international) at least 10 minutes prior to the start of the call. The event will be webcast live and can also be accessed in the Investors & Media section of bellicum.com. An archived version of the webcast will also be available for replay in the Investors & Media section of the Bellicum website for at least two weeks following the call.

About BPX-501
BPX-501 is an adjunct T cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.

About BPX-601
BPX-601 is a GoCAR-T product candidate containing Bellicum’s proprietary inducible MyD88/CD40, or iMC, activation switch, designed to treat solid tumors expressing prostate stem cell antigen, or PSCA. Preclinical data show enhanced T cell proliferation, persistence and in vivo anti-tumor activity compared to traditional CAR-T therapies. In addition to pancreatic cancer, PSCA is expressed in several other solid tumor indications, including gastric and prostate cancers.

About BPX-701
BPX-701 is a high affinity T cell receptor product candidate designed with the CaspaCIDe safety switch. In preclinical studies, PRAME-specific clones showed high reactivity against a panel of PRAME positive tumor cell lines, metastatic melanoma, sarcomas and neuroblastoma tissues. In vitro study data showed that BPX-701 demonstrated strong affinity to panels of cancer cells presenting PRAME peptides and low affinity to non-tumor cells, as well as elimination of BPX-701 cells in response to rimiducid.

On August 7, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three and six months ended June 30, 2018 (Press release, Eagle Pharmaceuticals, AUG 7, 2018, View Source [SID1234528517]). Highlights of and subsequent to the second quarter of 2018 include:

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Business and Recent Highlights:

EHS clinical trial for RYANODEX will be conducted August 20 – 24, 2018 during the Hajj pilgrimage;
Eagle received a favorable decision by the U.S. District Court for the District of Columbia granting seven years of orphan drug exclusivity (ODE) in the U.S., for BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI) until December 2022 and denying the Food and Drug Administration’s (FDA’s) attempt to preemptively exclude TREANDA generics from the scope of exclusivity;
Data from the fulvestrant clinical trial expected in the fourth quarter of 2018;
Advancing discussions with U.S. military to formalize clinical and regulatory plans for RYANODEX in the treatment of nerve agent exposure;
United States Patent and Trademark Office issued patent number 10,010,533 for BENDEKA. The USPTO has now issued or allowed a total of 15 U.S. patents in the BENDEKA family of patents expiring from 2021 to 2033;
Eagle was first to file a vasopressin 1ml injection ANDA, which was accepted for filing by the FDA in April; and
A second source manufacturing facility for Eagle’s bendamustine products has been approved by the FDA.
Financial Highlights:

Second quarter 2018

Total revenue for the second quarter of 2018 was $59.3 million, compared to $50.1 million in the second quarter of 2017;
Eagle launched bendamustine hydrochloride 500ml solution ("Big Bag") on May 15, 2018 and Big Bag product sales were $8.1 million in the second quarter of 2018;
Q2 2018 Ryanodex product sales were $7.2 million, up 38% compared to Q2 2017;
Q2 2018 net income was $2.7 million, or $0.18 per basic and $0.17 per diluted share, compared to net income of $4.5 million, or $0.30 per basic and $0.28 per diluted share in Q2 2017;
Q2 2018 Adjusted Non-GAAP net income was $14.7 million, or $0.99 per basic and $0.95 per diluted share, compared to Adjusted Non-GAAP net income of $7.9 million, or $0.52 per basic and $0.49 per diluted share in Q2 2017;
During Q2 2018, Eagle purchased an additional $3.5 million of Eagle common stock as part of its share buyback program; since August 2016, Eagle has repurchased $91.3 million of Eagle common stock; and
Cash and cash equivalents were $100.2 million, accounts receivable was $69.4 million, and debt was $47.5 million as of June 30, 2018.
Reiterating 2018 Expense Guidance:
R&D expense is expected to be in the range of $46 – $50 million ($40 – $44 million on a non-GAAP basis)
SG&A expense is expected to be in the range of $61 – $64 million ($44 – $47 million on a non-GAAP basis)
"We believe 2018 will be another solid year of growth for Eagle, with continued near-term value creation, and strong upside potential with our advanced pipeline that could meaningfully contribute to the long-term value of the business. This includes protecting the value and longevity of our existing bendamustine franchise where we recently prevailed in litigation and received orphan drug exclusivity until December 2022 for BENDEKA, as well as having recently launched "Big Bag", our 500 mL liquid form bendamustine solution that does not require reconstitution, filling an important need in the market for a lower-cost alternative. Our RYANODEX portfolio is advancing as we take advantage of product and label expansion opportunities for Exertional Heat Stroke and evaluate the neurological impact of nerve agent exposure in collaboration with the U.S. military," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"As a result of the favorable court ruling requiring the FDA to grant BENDEKA orphan drug exclusivity, the FDA will not be able to approve any drug applications referencing BENDEKA until the ODE expires in December 2022. The court also denied the FDA’s attempt to preemptively exclude TREANDA generics from the scope of BENDEKA’s ODE. We continue to believe that an appropriate application of ODE would first allow generic TREANDA entrants in December 2022, rather than November 2019 and intend to vigorously pursue our position with the FDA and through additional litigation, if necessary," added Tarriff.

"We look forward to completing our clinical study for RYANODEX for EHS scheduled during the Hajj Pilgrimage, to support the data we have previously collected. We anticipate reporting results for our fulvestrant study later this year, along with progress on other products under development. We look forward to sharing our continued progress to create value for patients and shareholders," concluded Tarriff.

Second Quarter 2018 Financial Results

Total revenue for the three months ended June 30, 2018 was $59.3 million, as compared to $50.1 million for the three months ended June 30, 2017. Royalty revenue was $36.3 million, compared to $37.4 million in the second quarter of 2017. BENDEKA royalties were $34.7 million, compared to $35.1 million in the second quarter of 2017. A summary of total revenue is outlined below:

Gross margin was 69% in the second quarter of 2018, as compared to 72% in the second quarter of 2017. The gross margin on Big Bag was 68%, reflecting royalty obligations to our partners as well as cost of goods sold.

Research and development expenses increased to $15.3 million for the second quarter of 2018, compared to $6.7 million in the second quarter of 2017, largely due to external clinical costs associated with the fulvestrant clinical study. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter of 2018 was $13.4 million.

SG&A expenses decreased to $16.0 million in the second quarter of 2018 compared to $23.3 million in the second quarter of 2017. The decrease was due to the expiration of the Spectrum co-promotion agreement at the end of June 2017, as well as a reduction in marketing expenses. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2018 SG&A expense was $11.7 million.

Net income for the second quarter of 2018 was $2.7 million, or $0.18 per basic and $0.17 per diluted share, compared to net income of $4.5 million, or $0.30 per basic and $0.28 per diluted share in the three months ended June 30, 2017, due to the factors discussed above.

Adjusted Non-GAAP net income for the second quarter of 2018 was $14.7 million, or $0.99 per basic and $0.95 per diluted share, compared to Adjusted Non-GAAP net income of $7.9 million or $0.52 per basic and $0.49 per diluted share in the second quarter of 2017. For a full reconciliation of Adjusted Non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

Liquidity

As of June 30, 2018, the Company had $100.2 million in cash and cash equivalents and $69.4 million in net accounts receivable, $45.9 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $47.5 million in outstanding debt.

In the second quarter of 2018, we purchased $3.5 million of Eagle’s common stock as part of our expanded $100 million share buyback program. Since August 2016, we have repurchased $91.3 million of our common stock.

2018 Expense Guidance

2018 R&D expense is expected to be in the range of $46 – $50 million. This reflects expenses for (i) the enrollment of fulvestrant and RYANODEX EHS clinical trials; (ii) API outlays for the fulvestrant and vasopressin programs; and (iii) additional development work on the RYANODEX nerve agent program. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense is expected to be in the range of $40 – $44 million.

2018 SG&A expense is expected to be in the range of $61 – $64 million. Excluding stock-based compensation and other non-cash and non-recurring items, SG&A expense is expected to be in the range of $44 – $47 million.

Conference Call

As previously announced, Eagle management will host its second quarter 2018 conference call as follows:

Date Tuesday, August 7, 2018
Time 8:30 A.M. EDT
Toll free (U.S.) 877-876-9177
International 785-424-1669
Webcast (live and replay)
www.eagleus.com, under the "Investor + News" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-727-5306 (US) or 402-220-2670 (International) and entering conference call ID EGRXQ218. The webcast will be archived for 30 days at the aforementioned URL.

On August 7, 2018 Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, reported financial results and provided an update on commercial activities for the quarter ended June 30, 2018 (Press release, Cempra, AUG 7, 2018, View Source [SID1234528650]). Melinta continued to make progress this quarter in its mission to save lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions.

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Q2 2018 and Recent Business Highlights

Completed the hiring of 71 additional field sales personnel bringing total sales representatives to 170

Completed realignment and cross-training of experienced anti-infective sales force across all four products, including Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin) and Minocin (minocycline) for Injection

Made strong progress on hospital approval process of new launches, Vabomere and Baxdela

Vabomere granted New Technology Add-On Payment (NTAP) by Centers for Medicare & Medicaid Services (CMS), effective Oct. 1, 2018

Continued growth in retail market for Baxdela, driven by specialty retail focus of our sales force

Completed enrollment ahead of schedule for Baxdela Phase III trial for treatment of adults with community acquired bacterial pneumonia ("CABP")

Entered into partnership with CARB-X, receiving up to approximately $6 million to help advance pre-clinical and clinical development of a novel antibiotic class

Launched new antibiotic stewardship program designed to address the growing threat of antimicrobial resistance

Completed follow-on public offering of shares of common stock, raising approximately $115 million in net proceeds

Demonstrated breadth of commercial and clinical programs with 20 presentations at the American Society of Microbiology’s ASM Microbe 2018 meeting

"Melinta took important steps forward during the second quarter, with solid sales performance from our new launches of Baxdela and Vabomere and the completion of a public follow-on offering of common shares that significantly strengthened our long-term financial position," said Dan Wechsler, President and CEO of Melinta. "Product sales remained steady during the quarter and we continued to make excellent progress on our recent launches. We expect our sales trajectory to increase in the second half of the year, powered by our significantly increased presence in the marketplace and our expanded and now fully cross-trained sales force of 170 highly experienced sales representatives, with average hospital expertise of 15 years."

"We also continued to make advancements within our pipeline during the quarter. Our Phase III trial of Baxdela for the treatment of adults with CABP completed enrollment ahead of schedule and is on track for top-line data by the end of 2018. Our discovery organization also continued to advance their important work following the announcement of our agreement with CARB-X that will provide us funding to advance the development of a novel antimicrobial from our ESKAPE pathogen program."

"With the completion of our public offering, we are now in a strong financial position to support our continued growth."

2018 Upcoming Potential Catalysts

Pivotal Phase 3 data for Baxdela in CABP

Vabomere EMA regulatory approval decision

Vabomere Medicare NTAP status effective Oct. 1, 2018

Additional ex-U.S. submissions for Baxdela in Central and South America

Ex-U.S. partnership opportunities for Vabomere, Orbactiv and Minocin for Injection

Additional data and publications at ID Week

IND-enabling studies for the lead ESKAPE compound

Q2 2018 Financial Results

Melinta reported revenue of $12.0 million for the quarter ended June 30, 2018. In addition, the company earned $2.1 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), which it recorded as other income.

During the quarter, as part of the final stages of the integration of the Infectious Disease business acquired from The Medicines Company, Melinta implemented a new, direct-to-wholesaler distribution process that will shorten the Company’s overall supply chain cycle, reduce inventory levels at wholesalers and save fees paid to wholesalers. The change resulted in a one-time negative impact on second quarter revenues of $2.7 million, primarily impacting Orbactiv.

Second quarter of 2018 total net revenue of $12.0 million compares to total net revenue of $4.0 million for the same period in 2017, prior to the acquisition of The Medicines Company ID business and the launch of Baxdela. In the second quarters of 2018 and 2017, we recognized contract research revenue totaling $2.8 million and $4.0 million, respectively. In the second quarter of 2018, net product sales were $9.2 million. The net product sales reflect solid performance of new launches and include the impact described above of the implementation of the new, direct-to-wholesaler distribution process, which occurred during the quarter and resulted in a one-time negative impact of $2.7 million, primarily impacting Orbactiv.

Excludes BARDA grant funding included in Other Income of $2.1 million

Cost of goods sold ("COGS") was $11.0 million for the quarter ended June 30, 2018, of which $6.7 million was comprised of non-cash amortization of intangible assets and the step-up basis in inventory acquired from The Medicines Company in January 2018. Cost of goods sold also included charges of $2.4 million for Baxdela and Vabomere inventory that is approaching shelf life. Adjusted COGS was $2.0 million, excluding these non-cash charges, resulting in an Adjusted Gross Margin of 84% for the second quarter. There were no product sales and therefore no costs of goods sold in the prior year period.

Research and development ("R&D") expenses were $15.8 million for the quarter ended June 30, 2018, compared to $14.1 million for the same period in 2017. The increase was driven by additional headcount and development activities resulting from the acquisition of the infectious disease business from The Medicines Company and the recent merger with Cempra. Adjusted R&D expenses were $15.6 million, which reflects the adjustment for non-cash expenses of $0.2 million.

Selling, general and administrative ("SG&A") expenses were $34.9 million for the quarter ended June 30, 2018, compared to $7.7 million for the same period in 2017. The increase was driven by additional expenses associated with being a larger, public, commercial organization, including the operational impact of both the acquisition of the infectious disease business from The Medicines Company and the Cempra merger, consisting of additional headcount, facilities and commercial infrastructure. Approximately $1.7 million of SG&A expenses were a result of acquisition-related costs and lease exit costs, resulting in Adjusted SG&A expenses of $32.7 million.

Net loss was $55.8 million, or $1.38 per share, for the quarter ended June 30, 2018 compared to a net loss of $20.4 million for the same period in 2017. Net loss per share is impacted by changes in our share count as a result of the Cempra merger and financing related to the acquisition of the infectious disease business from The Medicines Company.

On May 29, 2018, Melinta completed a follow-on public offering of 21.9 million shares of its common stock. The underwriters of the public offering also exercised in full their option to purchase an additional 2.6 million shares of Melinta’s common stock. Net proceeds from the offering were approximately $115.1 million after deducting underwriting discounts and commissions and expenses paid. As of June 30, 2018, Melinta had cash and cash equivalents of $150.1 million.

Q2 2018 and Recent Pipeline and Publication Highlights

20 presentations at ASM Microbe 2018, including pharmacoeconomic analyses of Vabomere and Orbactiv (oritavancin), and analyses showing the rising incidence of Gram-negative pathogens in skin and skin structure infections (SSSIs) and the changes to empiric therapy that may be considered to improve outcomes

12 presentations at the MAD-ID 2018 Annual Meeting, including detailed safety and efficacy findings from the Phase 3 PROCEED studies of Baxdela in patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Findings from the Orbactiv real-world registry demonstrating efficacy and safety consistent with the Phase 3 SOLO program published in Open Forum Infectious Diseases

12 Presentations at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2018 including six from Vabomere TANGO-2 trial, as well as new in vitro and in vivo findings for Baxdela and a pyrrolocytosine lead molecule

Pyrrolocytosine compound RX-P2382 against ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species and Escherichia coli) at ECCMID 2018

TANGO-2 Trial at ECCMID 2018, highlighting outcomes in vulnerable patient populations

Discovery Platform Oral Presentations at ECCMID 2018 and ASM Microbe 2018 Highlighting Progress Towards Leads for Drug-resistant Neisseria gonorrhoeae and Multidrug- and Extremely Drug-resistant ESKAPE Pathogens

Conference Call and Webcast

Melinta’s earnings conference call for the quarter ended June 30, 2018 will be broadcast at 8:30 a.m. ET on August 7, 2018. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Melinta’s website at www.melinta.com.

Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151. The conference ID is 9594878. Investors can also access the call at View Source

A live webcast of the call will be available online from the Investor Relations section of the company website at www.melinta.com and will be archived there for 30 days. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 9594878.